You are on page 1of 32

Tuesday,

May 17, 2005

Part III

Department of
Health and Human
Services
42 CFR Parts 50 and 93
Public Health Service Policies on
Research Misconduct; Final Rule

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17MYR3.SGM 17MYR3
28370 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

DEPARTMENT OF HEALTH AND I. Public Comments—General a case rather than procedural


HUMAN SERVICES The Notice of Proposed Rulemaking complications; the proposal recognizes
(NPRM) proposing to remove 42 CFR the importance of primary reliance on
42 CFR Parts 50 and 93 part 50, subpart A and replace it with the institutions to respond to allegations
a new part 93 was published in the of research misconduct; and the
RIN 0940–AA04 Federal Register on April 16, 2004 (69 clarification and harmonization of
FR 20778). Comments were requested definitions, standards, and procedures
Public Health Service Policies on on or before June 15, 2004. In addition are appreciated.
Research Misconduct to this invitation for public comment on Most of the commentators endorsed
any aspect of the proposed rulemaking, the changes in the definition of research
AGENCY: U.S. Department of Health and misconduct and the incorporation of the
Human Services (HHS). the NPRM requested comment on
three elements necessary for a finding of
specific aspects of the proposed rule
ACTION: Final rule. research misconduct in conformity with
including: (A) Whether there should be
the Federal Policy on Research
any limitation on the ability of
SUMMARY: This final rule removes 42 Misconduct issued by the Office of
institutions to conduct a research
CFR part 50, subpart A, Science and Technology Policy (OSTP).
misconduct proceeding through a
‘‘Responsibilities of Awardee and Some expressed support for the PHS
consortium or other entity qualified by
Applicant Institutions for Dealing With practice of excluding coverage of
practice and experience to conduct
and Reporting Possible Misconduct in authorship disputes in the absence of a
research misconduct proceedings
Science,’’ and replaces it with a new, clear allegation of plagiarism. There
(§ 93.306); (B) the use of Administrative were expressions of support for the
more comprehensive part 93, ‘‘Public
Law Judges (ALJs) to conduct HHS coverage of PHS intramural programs
Health Service Policies on Research
research misconduct hearings rather and PHS contractors, the coverage of the
Misconduct.’’ The proposed part 93 was
than a panel of three decisionmakers plagiarism of a PHS supported research
published for public comment on April
(§ 93.502); (C) treating the decision of record, even if the respondent does not
16, 2004. The final rule reflects both
the ALJ as a recommended decision to receive such support, the clarification of
substantive and non-substantive
the Assistant Secretary for Health (ASH) the role of the complainant, the
amendments in response to public
as opposed to the current practice in adoption of a six-year limitation on the
comments and to correct errors and
which the decision of the panel on the pursuit of misconduct allegations,
improve clarity, but the general
merits of the HHS findings of separation of adjudication and appeal
approach of the NPRM is retained. The
misconduct and administrative actions, from the inquiry and investigation
purpose of the final rule is to implement
other than debarment, constitutes final stages, setting a time limit on the
legislative and policy changes
agency action (§§ 93.500(d) and investigation by the institution, and the
applicable to research misconduct that
93.523(c)); (D) authorizing the ALJ to inclusion of ALJs in the hearing process.
occurred over the last several years,
appoint a scientific expert (that These and other supportive comments
including the common Federal policies
appointment is required if requested by may be discussed in the consideration
and procedures on research misconduct
either party) to advise the ALJ on of specific changes to the proposed rule
issued by the Office of Science and
scientific issues, but not provide that follows.
Technology Policy on December 6,
testimony for the record (§ 93.502(b)); There were also general, negative
2000.
(E) consistent with current practice, comments on the proposed rule, some of
DATES: This final rule will become permitting HHS to amend its findings of which were in direct opposition to
effective June 16, 2005. research misconduct up to 30 days positive comments. Some commentators
ADDRESSES: Address any comments or before the scheduled hearing (§ 93.514); feel that the proposal is overly detailed
questions regarding this final rule to: (F) extending the period for retaining and thus contrary to the OSTP goal of
Chris B. Pascal, J.D., Director, Office of records of the research misconduct a more uniform Federal-wide approach.
Research Integrity, 1101 Wootton proceeding, including inquiries, from 3 Another criticizes the continuation in
Parkway, Suite 750, Rockville, MD to 7 years (§ 93.317); (G) imposing a 120- the proposed rule of a trend toward
20852. Some commonly asked questions day deadline for the completion of any legalization of scientific disputes by
and answers to them will be posted on institutional appeal from a finding of immediately casting parties into
the Office of Research Integrity Web site research misconduct (§ 93.314); and (H) adversarial roles. Other commentators
prior to the effective date of the whether the HHS estimates on the object to the change from a hearing
regulation. The URL for the ORI Web potential burden of information conducted by a three-member panel to
site is: http://ori.hhs.gov. collection requirements are accurate and one conducted by an ALJ, stating that
You may submit comments and whether those requirements are there has not been any showing of a
questions on this final rule by sending necessary for the proper performance of need to change the current practice. One
electronic mail (e-mail) to HHS functions. commentator felt that HHS should be
research@osophs.dhhs.gov. Submit Twenty-eight documents commenting responsible for investigating allegations
electronic comments as either a on the NPRM were submitted to HHS by of misconduct at institutions that have
WordPerfect file, version 9.1 or higher, mail or e-mail. Most of the documents repeatedly failed to properly investigate
or a Microsoft Word 97 or 2000 file addressed multiple sections of the research misconduct. These and other
format. You may also submit comments proposed rule. A number of the critical comments may be discussed in
or questions as an ASCII file avoiding commentators made general positive the consideration of specific changes
the use of special characters and any comments such as that: the proposed that follow.
form of encryption. rule is well drafted, provides valuable Some letters of comment repeated
guidance for researchers and comments that had been made in
FOR FURTHER INFORMATION CONTACT: institutions and is much improved over response to the OSTP proposal for a
Brenda Harrington, (301) 443–3400. the current regulation; the detail and government-wide Federal policy on
(This is not a toll-free number). transparency of the procedures will research misconduct. Because OSTP
SUPPLEMENTARY INFORMATION: result in a better focus on the merits of considered those comments prior to

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28371

issuing its final policy and this final This rulemaking establishes the dissemination of research information;
rule is consistent with the aspects of the necessary HHS jurisdiction to and (v) plagiarism of research records
OSTP policy addressed in the implement the new term ‘‘reviewing produced in the course of PHS
comments, those comments will not be research’’ in the OSTP definition of supported research, research training, or
further discussed here. research misconduct. In ORI’s PHS supported activities related to that
Comments on specific sections of the experience, plagiarism can occur during research or research training. The
regulation are addressed below under the review process when a manuscript examples of activities that are related to
headings based on the general issue is submitted for publication. In the great research or research training are
raised by the comments. If that issue majority of cases where an allegation intended to be illustrative, not
encompasses more than one section of arises that a PHS supported research exhaustive. They are intended to convey
the regulation, all those sections will be record was plagiarized, we expect that the concept that under its research and
discussed under that heading. the reviewers will be current recipients research training authorities, PHS funds
of PHS research funds because the many activities that are closely related
II. Changes Made in Response to reviewers are selected based on their to research and research training, but
Comments subject matter expertise and the might not be considered to be within the
A. Applicability, Secs. 93.100(b) and research in question is PHS funded common understanding of what
93.102(b) biomedical and behavioral research. In constitutes research or research training.
A number of commentators concluded cases where the respondent is PHS Consistent with the intent of, and
that the applicability section, 93.102, supported or affiliated with a PHS practice under the current regulation,
supported institution, we would expect allegations of research misconduct
and the descriptions of applicability in
the misconduct allegation to be pursued involving those funded activities, or
other sections unreasonably extend HHS
by the PHS supported institution. In applications for the funding of those
jurisdiction beyond PHS supported
those cases where the reviewer who is activities, are covered.
biomedical or behavioral research and In each section that refers to the
alleged to have committed plagiarism is
research training. One commentator applicability of the regulation we have
solely funded by another Federal
recommended that descriptions of referenced the applicability section or
agency, ORI would refer the allegation
applicability be uniform throughout the repeated the applicability of the
to that agency. In addition, jurisdiction
regulation. There were specific regulation to PHS supported research,
does not attach to allegations of
objections to: (1) The statement in Sec. research training, and activities related
plagiarism where there is no PHS
93.100(b) that covered institutions must support for the research record in to that research or research training.
comply with the regulation with respect question. Thus, we have removed the
to allegations of misconduct ‘‘occurring B. Subsequent Use Exception to Six
phrase ‘‘regardless of whether the user Year Limitation on Misconduct
at or involving research or research or reviewer currently receives PHS
training projects or staff of the Allegations, Sec. 93.105(b)(1)
support’’ from Sec. 93.102.
institution’’; (2) the coverage, in Sec. To eliminate redundancy and clarify In response to a comment requesting
93.102(a) and other sections describing the general policy and applicability clarification, we have amended
applicability, of ‘‘activities related to provisions, Secs. 93.100 and 93.102, we paragraph (b)(1) of Sec. 93.105. The
that research or research training;’’ and have: (1) Moved the statement of amendment clarifies that even though
(3) the extension of coverage in Sec. applicability to institutions from Sec. HHS or an institution does not receive
93.102(a) to allegations of misconduct 93.100(b) to Sec. 93.102(b) and rewritten an allegation of research misconduct
involving any research record generated it to be more concise; and (2) moved within six years of when the
from covered research, research paragraph (c) of Sec. 93.100 to misconduct is alleged to have occurred,
training, or activities related to that paragraph (a) of that section and the regulation would apply if, within six
research or training, regardless of combined the proposed paragraphs (a) years of when the allegation is received,
whether the user or reviewer receives and (d) into a new paragraph (b). the respondent has cited, republished,
PHS support or whether an application The provision setting forth the types or otherwise used for his or her
resulted in any PHS support. of allegations to which the regulation potential benefit the research record that
Several clarifying changes have been applies has been moved from Sec. is the subject of the allegation of
made in response to these comments, 93.102(a) to paragraph (b) of that section misconduct.
but these changes do not change the and has been amended to clarify that the
intended substance of the provisions in C. Rebuttable Presumption of
regulation applies to allegations of
the NPRM. The current regulation, 42 Misconduct in the Absence of Records,
research misconduct involving: (i)
CFR 50.101, covers each entity that Secs. 93.106(a)(1) and 93.516(b)
Applications or proposals for PHS
applies for a ‘‘research, research-training support for biomedical or behavioral Commentators raised several concerns
or research-related grant or cooperative extramural or intramural research, about proposed Sec. 93.106(a)(1) and
agreement’’ under the PHS Act. Such an research training, or activities related to Sec. 93.516(b) under which the absence
entity must establish policies and that research or research training, such of, or respondent’s failure to provide
procedures for investigating and as the operation of tissue or data banks research records adequately
reporting instances of alleged or the dissemination of research documenting the questioned research
misconduct involving ‘‘research or information; (ii) PHS supported establishes a presumption of research
research training or related research biomedical or behavioral extramural or misconduct that can be rebutted by
activities that are supported with funds intramural research; (iii) PHS supported credible evidence corroborating the
available under the PHS Act.’’ Thus, biomedical or behavioral extramural or research or providing a reasonable
applicability to research-related intramural research training programs; explanation for the absence of, or
activities is not new. The NPRM was not (iv) PHS supported extramural or respondent’s failure to provide the
intended to change the applicability to intramural activities that are related to research records. The concerns
those activities as it is expressed in the biomedical or behavioral research or included: (1) Retroactive application of
current regulation and has been applied research training, such as the operation the provision where there was no
in practice under that regulation. of tissue and data banks or the previous requirement for the retention

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28372 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

of the records; (2) holding the exclusion of honest error or difference F. Definition of Research Record, Sec.
respondent responsible for the retention of opinion from the definition of 93.224
of records over which he/she may have research misconduct does not create a One commentator recommended that
no control; and (3) there is no guidance separate element of proof; institutions the research record include the
on what would be a ‘‘reasonable and agencies are not required to comments of the complainant and
explanation’’ for the absence of records. disprove possible honest error or respondent on the inquiry and
In response to these comments, we difference of opinion. Given that investigation reports. We agree that
have eliminated the rebuttable guidance, this final rule retains honest documents and materials provided by
presumption of research misconduct. error or difference of opinion as an the respondent as part of his/her
Sections 93.106 and 93.516 have been affirmative defense that the respondent comments on the inquiry and
changed to state that the destruction, has the burden of proving by a investigation reports, or at any other
absence of, or respondent’s failure to preponderance of the evidence. stage of the research misconduct
provide records adequately
documenting the questioned research is However, we recognize that there is proceeding do not differ significantly
evidence of research misconduct where an overlap between the responsibility of from those provided in response to
the institution or HHS establishes by a respondents to prove this affirmative questions regarding the research. Only
preponderance of the evidence that the defense and the burden of institutions the latter were included in the proposed
respondent intentionally, knowingly, or and HHS to prove that research definition of research record.
recklessly had research records and misconduct was committed Accordingly, we have amended Sec.
destroyed them, had the opportunity to intentionally, knowingly, or recklessly. 93.224 (formerly Sec. 93.226) so that the
maintain the records but failed to do so, Accordingly, consistent with the definition of research record includes
or maintained the records, but failed to opinion of the United States Supreme documents and materials that embody
produce them in a timely manner, and Court in Martin v. Ohio, 480 U.S. 228, the facts resulting from the research that
that respondent’s conduct constitutes a 107 S. Ct. 1098 (1987), we have are provided by the respondent at any
significant departure from accepted amended Sec. 93.106 to require point in the course of the research
practices of the relevant research consideration of admissible, credible misconduct proceeding. The purpose of
community. This is in keeping with the evidence respondent submits to prove including documents provided by
definition of falsification to include honest error or difference of opinion in respondent in the research record is to
omitting data or results such that the determining whether the institution and hold the respondent responsible for the
research is not accurately represented in HHS have carried their burden of integrity of those research documents
the research record (Sec. 93.103(b)) and proving by a preponderance of the regardless of when they were prepared
with the requirements for a finding of evidence that the alleged research or furnished to the institution or HHS.
research misconduct in Sec. 93.104. misconduct was committed Because the complainant is not being
This answers the concerns about intentionally, knowingly, or recklessly. held responsible for the record of data
retroactive application and that the This consideration would be required, or results that embodies the facts
respondent may not have had control regardless of whether respondent carries resulting from the research at issue, we
over the records by holding the his/her burden of proving honest error are not including comments provided
respondent to the accepted practices of or difference of opinion by a by the complainant during the research
his/her research community. The weight preponderance of the evidence. misconduct proceeding in the definition
to be accorded the evidence of research of the term ‘‘research record.’’ Those
In light of this change, we have comments may be considered by the
misconduct under these circumstances removed the reference to the institution
must be determined by the trier of fact institution and/or HHS and they may be
or HHS making a prima facie showing admitted as evidence in any hearing, but
in each case. of research misconduct as unnecessary they are not part of the research record.
D. Respondent’s Burden To Prove and confusing. Because this is the only If the complainant possesses documents
Honest Error or Difference of Opinion, use of prima facie in the regulation, we that embody the facts resulting from the
Secs. 93.106(a)(2) and 93.516(b) have removed the definition of that research that is the subject of the
As proposed, Sec. 93.106(a)(2) term. research misconduct proceeding, those
provided that once the institution or E. Coordination With Other Agencies, documents are research records and the
HHS makes a prima facie showing of Sec. 93.109 institution is responsible for
research misconduct the respondent has maintaining and securing those
the burden of proving any affirmative Some commentators pointed out that documents in the same manner as other
defenses raised, including honest error Sec. 93.109(a), as proposed, is not research records. Those documents are
or difference of opinion. There were a consistent with the statement in the distinct from analyses of research
number of objections to that section on OSTP Policy that a lead agency should records or results that a complainant
the grounds that shifting the burden of be designated when more than one may prepare prior to or in the course of
proving honest error or difference of agency has jurisdiction. We have a research misconduct proceeding to
opinion to the respondent effectively amended paragraph (a) to state that if support his or her allegation of
shifts the burden of the institution and more than one agency of the Federal misconduct. Any such documents may
HHS to prove each element of research government has jurisdiction, HHS will be considered evidence pertinent to the
misconduct or, at the least, creates cooperate with the other agencies in allegation, but they are not part of the
confusion. Some of the commentators designating a lead agency. We have research record.
opined that the institution and the HHS added a sentence clarifying that where
HHS is not the lead agency, it may, in G. Reporting Inquiries to ORI, Sec.
have the burden of proving the absence
consultation with the lead agency, take 93.300(a)
of honest error or difference of opinion.
As stated in the preamble of the action to protect the health and safety of Several commentators interpreted the
Federal Register notice promulgating the public, promote the integrity of the general language in proposed Sec.
the final OSTP Research Misconduct PHS supported research and research 93.300(a), requiring institutions to have
Policy (65 FR 76260, Dec. 6, 2000), the process, or to conserve public funds. policies and procedures for ‘‘reporting

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28373

inquiries and investigations of alleged that any securing of scientific ‘‘entity.’’ Any outside person
research misconduct in compliance instruments not interfere with ongoing conducting a research misconduct
with this part,’’ to require the reporting research. Scientific instruments are proceeding would be subject to the
of all inquiries to ORI, contrary to the included in the definition of ‘‘research requirements for precautions against
requirement in Sec. 93.309 for reporting record’’ in Sec. 93.224 to the extent they conflicts of interest in Secs. 93.300(b)
only those inquiries resulting in a are, or contain physical or electronic and 93.304(b).
finding that an investigation is records of data or results that embody
warranted. We have amended Sec. the facts resulting from scientific L. Standards for Investigation, Sec.
93.300(a) to clarify that the institution’s inquiry. In response to these comments 93.310(g) and (h)
policies and procedures must comply we have added language to paragraphs A number of commentators felt that
with the requirements of the regulation (a) and (c) of Sec. 93.305, paragraph (b) the provisions of proposed Sec.
for addressing allegations of research of Sec. 93.307, and paragraph (d) of Sec. 93.310(g) and (h) establish a
misconduct. This includes the 93.310 permitting institutions to secure performance standard that cannot be
requirements of Sec. 93.309. copies of data or other research records met through the use of the terms ‘‘any’’
It was also recommended that this on shared scientific instruments, so long and ‘‘all.’’ We have amended paragraphs
section be amended to require that the as those copies are substantially (g) and (h) to require, respectively,
institution’s written policies and equivalent in evidentiary value to the interviews of each person who has been
procedures be provided to the instruments themselves. It is expected reasonably identified as having
complainant and other interested parties that institutions will exercise discretion information regarding relevant aspects
on request. We have added a in determining whether copies of the of the investigation, and the pursuit of
requirement that the policies and data are substantially equivalent in all significant issues and leads
procedures be provided to members of evidentiary value to the instruments discovered that are determined relevant
the public upon request to Sec. themselves, consulting with ORI as the to the investigation. The institutions are
93.302(a)(1) because it addresses the institution determines necessary. The responsible for making the relevancy
availability of the institution’s policies evidentiary value of scientific determinations that are included in
and procedures to HHS and ORI upon instruments will vary from case to case. these paragraphs.
request. In some cases their value may be
dependent upon the manner in which M. Opportunity To Comment on the
H. Precautions To Protect Against they record data, rather than the data Investigation Report and Review the
Conflicts of Interest, Secs. 93.300(b) and they contain. In those cases, it may be Supporting Evidence, Sec. 93.312(a) and
93.304(b) reasonable for the institution to permit (b)
In response to a general comment that continued use of the instrument, so long One commentator proposed language
the regulation should ensure that those as it remains available for inspection by clarifying the period for the respondent
conducting inquiries and investigations those conducting the inquiry and to comment on the investigation report.
do not have conflicts of interest, we investigation. Another commentator felt that the
have amended Secs. 93.300(b) and
K. Using a Consortium or Other Entity institution should be required to give
93.304(b) to require institutions to
To Conduct Research Misconduct the respondent an opportunity to review
include precautions against conflicts of
Proceedings, Sec. 93.306 all research records and evidence upon
interest on the part of those involved in
One commentator recommended that which the investigation report is based.
the inquiry or investigation. This
there should be greater detail regarding We believe that clarification of the 30-
expands upon the requirement in Sec.
the kinds of practice and experience day period for comment by the
93.310(f) that institutions take
that would qualify an outside entity to respondent and for comment by the
reasonable steps to ensure an impartial
conduct research misconduct complainant, at the discretion of the
investigation, ‘‘including participation
proceedings, how possible conflicts of institution, is needed. We have
of persons with appropriate scientific
interest would be handled, and whose amended paragraphs (a) and (b) of Sec.
expertise who do not have unresolved
responsibility it would be to determine 93.312 accordingly. In addition, we
personal, professional, or financial
whether the outside entity is qualified. have amended paragraph (b) to make it
conflicts of interest with those involved
The proposed Sec. 93.306 contains a clear that institutions have the
with the inquiry or investigation.’’
catchall phrase providing that an discretion to provide the complete
I. Reporting of Aggregated Information institution may use a consortium or investigation report to the complainant
by Institutions, Sec. 93.302(c) other entity to conduct research for comment or relevant portions of it.
Several commentators recommended misconduct proceedings, if the The OSTP Guidelines for Fair and
deletion of proposed Sec. 93.302(c) institution prefers not to conduct its Timely Procedures, Section IV of the
because its broad language would own proceeding. In light of the Uniform Federal Policy, provide that
encompass research misconduct incorporation of this broad discretion in one of the safeguards for subjects of
proceedings that are outside the the proposed section, we have allegations is reasonable access to the
jurisdiction of HHS. We agree with the simplified Sec. 93.306 to provide that an data and other evidence supporting the
intent of these comments and have institution may use the services of a allegations and the opportunity to
amended this provision to refer to consortium or person that the respond to the allegations, the
aggregated information on the institution reasonably determines to be supporting evidence and the proposed
institution’s research misconduct qualified by practice and experience to findings of research misconduct, if any.
proceedings covered by this part. conduct research misconduct Consistent with that guidance, we have
proceedings. Thus, the institution may amended Sec. 93.312(a) to require
J. Responsibility for Securing Research decide to use an outside consortium or institutions to give the respondent,
Records and Evidence, Secs. 93.305, person for any reason and it determines concurrently with the draft investigation
93.307(b) and 93.310(d) whether that outside consortium or report, a copy of, or supervised access
Several commentators recommended person is qualified. We have substituted to, the evidence on which the report is
that Sec. 93.305 be amended to ensure the defined term ‘‘person’’ for the term based.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28374 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

N. Institutional Appeals, Sec. 93.314(a) that records are irrelevant. We have complainant and others. We are open to
One commentator requested language added two exceptions to the further dialogue with the research
clarifying that the 120-day period for requirement for retention of the records community on this issue.
completing institutional appeals applies for a period of 7 years that is now in
R. Standard for the Assistant Secretary
only to appeals from the finding of paragraph (b) of Sec. 93.317. The
for Health’s Review of the ALJ’s
institution is not responsible for
misconduct, not appeals from personnel Decision, Secs. 93.500(d) and 93.523
maintaining the records if they have
actions. We have implemented this One commentator recommended that
been transferred to HHS in accordance
comment through the addition of there be criteria for the Assistant
with paragraph (c), formerly (b), or ORI
appropriate language to Sec. 93.314(a). Secretary for Health (ASH) to review the
has advised the institution in writing
O. Completing the Research Misconduct that it no longer needs to retain the ALJ’s decision, similar to the ‘‘arbitrary
Process, Sec. 93.316 records. and capricious, or clearly erroneous’’
As stated in the preamble of the standard for the HHS debarring official
Several commentators objected to this to review the ALJ’s decision (paragraph
NPRM (69 FR at 20784) the 7-year
provision because they interpreted it as (e) of Sec. 93.500).
retention period is based on concerns
requiring that ORI be notified when an In response to this comment, we have
that the 3-year period for retaining
inquiry ends in a finding of no added to Sec. 93.523(b) a standard of
inquiry records in the current
misconduct. These commentators review for the ASH’s review of the
regulation, 42 CFR 50.103(d)(6) is too
recommended that the regulation short to permit HHS or the Department decision of the ALJ. The standard of
address the question of whether of Justice to investigate potential civil or review for the ASH is the same
settlements based on an admission of criminal fraud cases. While the 7-year ‘‘arbitrary and capricious or clearly
misconduct are reportable. In response retention period is potentially erroneous’’ standard that applies to the
to these comments we have amended burdensome, that burden will fall on a debarring official’s review where
Sec. 93.316(a) to require that limited number of institutions, 53 debarment or suspension is a
institutions notify ORI if they plan to according to the Paperwork Reduction recommended HHS administrative
close a case at the inquiry, investigation, Act burden estimate in the preamble to action. In addition, we have amended
or appeal stage on the basis that the the NPR, and the burden is mitigated by Secs. 93.500 and 93.523 to establish a
respondent has admitted research exceptions for transfer of custody to procedure for the ASH review, clarify
misconduct, a settlement with the HHS and for a written notification from the relationship between the ASH
respondent has been reached, or for any ORI that the records do not have to be review and the debarring official’s
other reason, except a determination at retained by the institution. Upon the decision on recommended debarment or
the inquiry stage that an investigation is effective date of this final rule, the 7- suspension actions, and identify what
not warranted, or a finding of no year retention period for records of constitutes the final HHS action. The
misconduct at the investigation stage, research misconduct proceedings will Assistant Secretary for Health notifies
which must be reported to ORI under supercede the more general the parties of an intention to review the
Sec. 93.315. We have also changed Sec. requirements for the retention of records ALJ’s recommended decision within 30
93.316(b) to provide for ORI relating to grants. We note that the 7- days after service of the recommended
consultation with the institution on its year retention period is consistent with decision. Upon review, the ASH may
basis for closing a case, rather than the provision in the HHS general grants modify or reject the decision in whole
simply reviewing the institution’s administration regulation, 45 CFR or in part after determining it, or the
decision, and expanded the actions ORI 74.53(b)(1) providing that if any review, part modified or rejected, to be arbitrary
may take to include approving or claim, financial management review, or and capricious or clearly erroneous. If
conditionally approving closure of the audit is started during the 3-year the ASH does not notify the parties of
case and taking compliance action. retention period, the pertinent records an intent to review the recommended
must be retained until all such matters decision within the 30-day period, that
P. Retention and Custody of Records of
have been resolved and final action decision becomes final and constitutes
the Research Misconduct Proceeding,
taken. the final HHS action, unless debarment
Sec. 93.317
or suspension is an administrative
There were several objections that the Q. ORI Allegation Assessments, Sec. action recommended in the decision. If
seven-year retention period: (1) Creates 93.402 debarment or suspension is a
storage problems; (2) should not apply Several commentators recommended recommended HHS action either in a
to scientific instruments; and (3) is requiring that ORI notify the institution decision of the ALJ that the ASH does
contrary to the 3-year retention period of any allegation received by ORI, not review, or in the decision of the
for records relating to grants in OMB regardless of how ORI disposes of the ASH after review, the decision
Circular A–110. One commentator allegation. Consistent with this constitutes proposed findings of fact to
recommended that the term ‘‘records of recommendation, we have amended the HHS debarring official.
research misconduct proceedings’’ be paragraph (d) of Sec. 93.402 to provide As noted in the discussion of changes
defined to include a relevancy standard. that if ORI decides that an inquiry is not not based on comments, we have
In order to clarify what must be warranted, it will close the case and amended several sections to ensure that
retained, we have added a new may forward the allegation in the Assistant Secretary for Health
paragraph (a) to Sec. 93.317 defining accordance with paragraph (e) which cannot be responsible both for making
records of research misconduct provides that allegations not covered by findings of research misconduct and for
proceedings by referring to the sections the regulation may be forwarded to the reviewing the ALJ’s recommended
of the regulation that describe what appropriate HHS component, Federal or decision on those findings, if
records institutions must prepare in the State agency, institution or other respondent contests the findings by
course of research misconduct appropriate entity. In deciding whether requesting a hearing. ORI will be
proceedings. The definition includes a to forward a specific allegation to the responsible for making those findings,
relevancy standard and requires that an institution, ORI will consider potential consistent with its responsibilities as
institution document any determination confidentiality issues for the the reviewer of institutional findings of

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28375

research misconduct and as a party to The proposed Sec. 93.502 provides II. Changes Not Based on Comments
any hearing on those findings. This some guidance on the selection of
A. Grandfather Exception to Six Year
maintains the separation between scientific and technical experts by Limitation on Receipt of Misconduct
investigation and adjudication, because requiring that they have appropriate Allegations, Sec. 93.105(b)(3)
any inquiry or investigation would be expertise to assist the ALJ in evaluating
conducted by the institution, or if scientific or technical issues related to We have changed the condition for
conducted by HHS, it would not be the HHS findings of research the grandfather exception from ‘‘had the
conducted by ORI (Sec. 93.400(a)(4)). misconduct. Furthermore, experts may allegation of research misconduct under
not have real or apparent conflicts of review or investigation on the effective
S. Extension for Good Cause To date of this regulation’’ to ‘‘had received
Supplement the Hearing Request, Sec. interest, or as added in this final rule,
the allegation of research misconduct
93.501(d) bias or prejudice that might reasonably
before the effective date of this part.’’
impair their objectivity in the
One commentator recommended that This makes the condition for the
proceeding.
the 30-day limit for supplementing the grandfather exception consistent with
hearing request be measured from In paragraph (b)(1) of Sec. 93.502 of the event that tolls the running of the
notification of the appointment of the this final rule we are providing further six-year limitation: the receipt of the
ALJ, rather than from receipt of the guidance on the selection of an expert misconduct allegation by the institution
charge letter. The commentator notes to advise the ALJ. Upon a motion by the or HHS.
that the ALJ may not be appointed ALJ or one of the parties to appoint an
B. Confidentiality, 93.108
within 30 days after receipt of the expert to advise the ALJ, the ALJ must
charge letter and recommends an permit the parties to submit Consistent with longstanding practice
amendment providing that the ALJ may nominations. If such a motion is made and with Sec. 93.403, we have added a
grant an additional period of no more by a party, the ALJ must appoint an provision to clarify that ORI is within
than 60 days from the respondent’s expert, either: (1) The expert, if any, the category of those who need to know
receipt of notification of the who is agreeable to both parties and the identity of the respondent and
appointment of the ALJ. This comment found to be qualified by the ALJ; or, (2) complainant and that an institution may
makes a good point, but 60 days from if the parties cannot agree upon an not invoke confidentiality to withhold
notice of the appointment of the ALJ is expert, the expert chosen by the ALJ. that information from ORI as it conducts
too long a period, given that there may its review under Sec. 93.403.
be an additional 30 days for These provisions will ensure the
selection of well-qualified experts, C. Definition of Deciding Official, Sec.
appointment of the ALJ after the request 93.207, and Authority of ORI, Sec.
for a hearing is filed. Thus, we have minimize disputes, speed the
appointment process by providing 93.400.
amended paragraph (d) to provide that
after receiving notification of the precise procedural rules, and enhance To ensure that the Assistant Secretary
appointment of the ALJ, the respondent fairness by providing for greater for Health is not responsible for both
has 10 days to file with the ALJ a involvement of the parties in the making findings of research misconduct
proposal for supplementation of the process. and for reviewing the recommended
hearing request that includes a showing Consistent with the greater decision of the ALJ on those findings if
of good cause for supplementation. Note involvement of the parties in the respondent contests the findings by
that this 10-day period is consistent selection of the expert and with the requesting a hearing, Sec. 93.400 has
with the period for responding to a comment recommending a more been amended to give ORI the authority
motion in Sec. 93.510(c) and that in formalized process for the expert to to make findings of research
accordance with Sec. 93.509(d), the ALJ provide advice, we are adding Sec. misconduct. That section and Sec.
may modify the 10-day period for good 93.502((b)(2) to clarify the role of the 93.404 have also been amended to
cause shown. clarify that ORI proposes administrative
expert appointed by the ALJ. The ALJ
actions to HHS (defined as the Secretary
T. Role of Scientific Expert Appointed may seek advice from the appointed
or his delegate) and upon HHS
by ALJ, Sec. 93.502 expert at any time during the discovery
approval, proceeds to implement those
It was recommended that advice of or hearing phase of the proceeding.
proposed actions in accordance with the
the scientific expert appointed to advise Advice must be provided in the form of
procedures in the regulation.
the ALJ be part of the record and a written report, containing the expert’s Accordingly, the definition of, and
available to both parties. It was further background and qualifications, which is references to the term ‘‘deciding
recommended that the scientific expert served upon the parties. The report and official’’ have been deleted. Giving ORI
be available for questioning by the the expert’s qualifications and advice the responsibility for making findings of
parties. Another commentator may be challenged by the parties in the research misconduct is consistent with
recommended specific guidance in the form of a motion or through testimony its responsibilities for reviewing
regulation to assist ALJs in retaining of the parties’ own experts, unless the institutional findings of research
appropriate scientific expertise. Another ALJ determines such testimony to be misconduct and for defending those
commentator felt that the appointment inadmissible in accordance with Sec. findings if the respondent challenges
of an expert to assist the ALJ should be 93.519, or that such testimony would them. This change will maintain the
mandatory in every case, while others unduly delay the proceeding. In this separation between investigation and
felt such an appointment should be manner, the report and any comment on adjudication, because ORI will not
mandatory in those cases involving it would be part of the record. These conduct any inquiry or investigation on
complex scientific, medical or technical procedures will greatly enhance the behalf of HHS.
issues. For the reasons explained below detail and quality of the expert advice These changes have necessitated
under the heading, ‘‘Significant available for consideration by the ALJ changing references to HHS and ORI
Comments Not Resulting in Changes,’’ and provide greater transparency and and other clarifying changes in Secs.
we are not requiring the appointment of confidence to the scientific community 93.403–406, 93.411, 93.500–501, 93.503,
an expert to assist the ALJ in every case. on the expertise provided to the ALJ. and 93.516–517. As provided in Sec.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28376 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

93.406, the ORI finding of research or evidence encompass scientific Secretary for Health (Secs. 93.500(c) and
misconduct is the final HHS action only instruments shared by a number of 93.523(b) and (c)).
if the respondent does not contest the users, custody may be limited to copies
I. HHS Administrative Action—
charge letter within the prescribed of the data or evidence on such
Recovery of Funds, Sec. 93.407(b)
period. The administrative actions, instruments, so long as those copies are
proposed by ORI and approved by HHS, substantially equivalent to the We have clarified what funds HHS
become final in the same manner, evidentiary value of the instruments. may seek to recover in connection with
except that the debarring official’s This is consistent with the identical a finding of research misconduct by
decision is the final HHS action on any requirements that become applicable amending Sec. 93.407(b) to refer to the
debarment or suspension action. when the institution notifies the potential recovery of PHS funds spent in
respondent of the allegation and when support of activities that involved
C. Definition of Good Faith, Sec. 93.210
the respondent is notified of an research misconduct.
Under Secs. 93.227 and 93.300(d), investigation. (Secs. 93.305(a) and
committee members are protected J. Appointment of the ALJ—Description
93.310(d)). These requirements are
against retaliation for good faith of Functions, Sec. 93.502(a)
necessary because of the potential for
cooperation with a research misconduct the destruction or alteration of the We have amended Sec. 93.502(a) to
proceeding. As proposed, Sec. 93.211 research records. To minimize that describe the functions of the ALJ more
(now Sec. 93.210) defined ‘‘good faith’’ potential, an institution should take completely.
for complainants and witnesses, but not custody of the records whenever it has
for committee members. We have added reason to believe that the records may K. Limits on the Authority of the ALJ,
such a definition, stating that a be subject to alteration or destruction Sec. 93.506(a) and (c)
committee member acts in good faith if because of an allegation or potential We have added references in Secs.
he/she cooperates with the research allegation of research misconduct. This 93.506(a) and (c) stating that the ALJ
misconduct proceeding by carrying out may protect the respondent, as well as does not have the authority to find
the duties assigned impartially for the the institution. invalid or refuse to follow Federal
purpose of helping an institution meet statutes or regulations, Secretarial
its responsibilities under this regulation. G. Interaction With Other Offices, Sec.
93.401 delegations of authority, or HHS
A committee member does not act in policies. This is consistent with a
good faith if his/her acts or omissions To accurately reflect ORI’s authority similar provision in the regulation upon
on the committee are dishonest or and practices, we have expanded this which the research misconduct hearing
influenced by personal, professional, or section to authorize ORI to provide process is based, 42 CFR part 1005,
financial conflicts of interest with those expertise and assistance to the which governs the hearing process for
involved in the research misconduct Department of Justice, the HHS OIG exclusion of health care providers.
proceeding. Inspector General, PHS and other
L. Actions for Violating an Order or
D. Definition of Institutional Member, Federal offices, and State or local offices
Disruptive Conduct, Sec. 93.515(b)(6)
Sec. 93.214 involved in investigating or otherwise
pursuing research misconduct We have changed ‘‘taking a negative
We have added more examples of
allegations or related matters. inference from the absence of research
institutional members.
H. Procedures for Debarment or records, documents, or other
E. Institutional Policies and information’’ to ‘‘drawing the inference
Suspension Actions Based on
Procedures—Reporting the Opening of that spoliated evidence was unfavorable
Misconduct Findings, Secs. 93.405,
an Investigation, Sec. 93.304(d) to the party responsible for its
93.500–501, 93.503 and 93.523.
We have simplified the date for spoliation.’’ This change is intended to
institutions to report the opening of We have amended these sections to clarify the nature of the negative
investigations to ORI. This report must clarify the relationship between the inference that may be reached by the
be made on or before the date on which regulations governing debarment and ALJ and distinguish the spoliation of
the investigation begins. Institutions are suspension and the procedures in evidence during or in anticipation of the
encouraged to report the opening of an subpart E for contesting ORI findings of hearing, from the absence or destruction
investigation to ORI as promptly as research misconduct and proposed HHS of records that may be evidence of
possible after the decision to open an administrative actions. Section research misconduct. In this context,
investigation is made. 93.500(d) (comparable to Sec. 93.500(c) spoliation has essentially the same
of the NPRM) explains that the meaning as is accepted by Federal
F. Taking Custody of and Securing procedures under subpart E provide the courts, i.e., the destruction or significant
Records at the Beginning of an Inquiry, notification, opportunity to contest and alteration of evidence during or in
Sec. 93.307(b) fact finding required under the HHS anticipation of the hearing.
We have added a requirement that on regulation governing debarment and
M. Corrections and Minor Changes
or before the date on which the suspension. Consistent with that
respondent is notified of the inquiry, or regulation, the debarring official In addition to the significant changes
the inquiry begins, whichever is earlier, provides notification of the proposed not based on comments described
the institution must, to the extent it has debarment or suspension as part of the above, we have made changes to: (1)
not already done so, promptly take all charge letter (Sec. 93.405(a)) and makes Correct errors, such as references to PHS
reasonable and practical steps to obtain the final decision on debarment and rather than HHS, or to a hearing officer,
custody of all the research records and suspension actions whether that rather than the ALJ; (2) use uniform
evidence needed to conduct the decision is based upon respondent’s language in describing the same
research misconduct proceeding, failure to contest the charge letter (Secs. condition or event in different sections
inventory the records and evidence and 93.406, 93.501(a) and 93.503(c)), the of the regulation; (3) adding citations to
sequester them in a secure manner, decision of the ALJ, or the decision of other sections, where appropriate, to
except that where the research records the ALJ as modified by the Assistant make cross-references more concise and

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28377

technically correct; and (4) use plain, We have not changed Sec. 93.108 or have protected the integrity of PHS
and more precise language. the other provisions requiring supported research. We also note that
institutions to provide confidentiality to the Offices of the Inspector General at
III. Significant Comments Not Resulting
respondents, complainants, and various Federal agencies routinely
in Changes
research subjects who are identifiable accept oral and anonymous allegations
A. Definition of Research Misconduct, from research records or evidence. We in their pursuit of fraud, waste, and
Sec. 93.103 believe these provisions provide the abuse.
Although most commentators same protections as the OSTP policy.
D. Definition of Research Record, Sec.
supported the new definition of Institutions have considerable
93.226
discretion in implementing the
research misconduct, there were a We did not make any changes in this
confidentiality protections and are free
number of comments recommending section in response to comments that
to extend them to witnesses and
changes, including that: (1) The the inclusion of oral presentations will
committee members. However,
definition should be based on inhibit open scientific discourse and
consistent with the limitation of the
deception; (2) the definition of objections to the interpretation of ‘‘data
OSTP confidentiality provision to
falsification is inadequate because it and results’’ to include computers and
complainants and respondents, we are
does not cover the nonexperimental scientific equipment. The definition of
not requiring that they do so.
manipulation of human or animal ‘‘research record’’ is consistent with the
subjects with the goal of influencing C. Definition of Allegation—Inclusion of definition of that term in the OSTP
research results, or bias in the coding of Oral Allegations, Sec. 93.201 Policy. Oral presentations are a widely
qualitative data; (3) the definition of Several commentators objected to the accepted method of conveying scientific
plagiarism should expressly exclude inclusion of oral allegations in the information and research results. There
authorship and credit disputes; and (4) definition of the term ‘‘allegation.’’ is no logical reason why scientists
the definition of misconduct should be Although, the current PHS regulation at should be permitted to falsify, fabricate,
expanded to include negligent and 42 CFR part 50, subpart A, does not and plagiarize PHS supported
intentional mistreatment of animals. define the term allegation, it has been biomedical and behavioral research,
As explained in the preamble of the longstanding ORI practice to accept oral research training and activities related
NPRM, the proposed definition of allegations, including oral, anonymous to that research and research training in
research misconduct, which is included allegations. Experience has shown that oral presentations. The interpretation of
in this final rule without change, oral allegations may contain relatively the OSTP definition to include
includes OSTP’s description of complete information, but if they do computers and scientific instruments is
‘‘fabrication, falsification, and not, they are often followed by more reasonable and consistent with the
plagiarism.’’ That description is clear complete allegations, or lead to more wording of the definition. Laboratory
and sufficiently concrete to provide the complete information. records, ‘‘both physical and electronic,’’
basis for reasonable determinations of The definition of allegation must be are covered in the OSTP definition.
whether research misconduct has considered in the context of the criteria Computers and scientific instruments
occurred and whether the misconduct warranting an inquiry. Under Sec. contain electronic records. As explained
was intentional, knowing, or reckless. 93.307(a), an inquiry is warranted if the above, we have made changes to clarify
Given the careful consideration that has allegation: (1) Falls within the definition that if those electronic records can be
been given to this definition and the of research misconduct; (2) involves extracted from the computer or
value of a uniform government-wide PHS supported biomedical or behavioral instrument without change and
definition, we are adopting the research, research training, or activities recorded for later use, the computer or
definition as it was proposed. We note related to that research or research instrument need not be retained as the
that the nonexperimental manipulation training; and (3) is sufficiently credible repository of the record.
of human or animal subjects to and specific so that potential evidence
influence the research results would of research misconduct may be E. Definition of Retaliation, Sec. 93.226;
appear to be a manipulation of research identified. Information sufficient to Protection From Retaliation Secs.
materials or processes within the make these determinations can be 93.300(d) and 93.304(l)
intendment of the definition of transmitted orally. If such information is One commentator recommended that
falsification. not transmitted orally or by other the definition be amended to include
means, the institution cannot initiate an retaliation against the respondent for
B. Confidentiality, Secs. 93.108, inquiry based upon the oral allegation. his/her efforts to defend against the
93.300(e) and 93.304(a) Under Sec. 93.300(b), an institution is charges of research misconduct. The
Several commentators recommended obligated to respond to each allegation proposed definition would not include
including witnesses and committee of research misconduct involving PHS action resulting from research
members and strengthening the supported biomedical or behavioral misconduct proceedings or personnel
confidentiality protections to provide research, research training or activities actions. It was also recommended that
the same protections as the OSTP related to that research or research Secs. 93.300(d) and 93.304(l) be
Policy. Other commentators training. The response must consist of amended to require institutions to
recommended that: (1) The rule give assessing the allegation to determine if protect respondents from retaliation by
examples of what disclosures are the criteria for initiating an inquiry are referring to ‘‘all participants.’’
limited and state when an institution is met and should consist of reasonable The purpose of the retaliation
free to announce the results of an efforts to obtain further information provision is to encourage researchers to
investigation to scientific journals; (2) about the allegation. We do not believe come forward with good faith
the identity of the complainant and his/ these are unreasonable burdens in allegations of research misconduct and
her statement be disclosed to the response to oral allegations, particularly to encourage good faith cooperation
respondent; and (3) that the sanctions since oral allegations can, and have with a research misconduct proceeding.
for a violation of confidentiality be conveyed information leading to In ORI’s experience, there has been no
specified. findings of research misconduct that showing of a need to protect

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28378 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

respondents from retaliation in order to environment that promotes the opinion is to be considered in
ensure they will take steps to defend responsible conduct of research means determining whether the institutions
against an allegation of misconduct. In an environment that promotes and HHS have met their burden of
contrast, experience has shown a need competent, ethical research that is free proving that element, a prerequisite to a
to restore the reputations of respondents of misconduct. This is directly related to finding of research misconduct.
where there is a finding of no the purposes of the regulation to Under Sec. 93.307(c), the purpose of
misconduct and Sec. 93.304(k) requires establish the responsibilities of an inquiry is to conduct an initial
institutions to do that. If a need to institutions in responding to research review of the evidence to determine if
protect respondents from retaliation is misconduct issues and to promote the an investigation is warranted. An
shown, institutions have broad integrity of PHS supported research and investigation is warranted under Sec.
discretion under the rule to address that the research process (Sec. 93.101). 93.307(d) if: (1) There is a reasonable
situation on a case-by-case basis or basis for concluding that the allegation
G. Responsibility for Maintenance of involves PHS supported research,
adopt a policy to remedy the problem.
Research Records and Evidence, Sec. research training, or activities related to
F. Responsibility of Institutions To 93.305 that research or research training and
Foster Responsible Conduct of Research, One commentator recommended that falls within the definition of research
Sec. 93.300(c) this section be amended to require the misconduct, and (2) preliminary
Several commentators objected to the prompt return to the respondent of information-gathering and fact-finding
requirement that institutions foster a records that, upon inventory, are found from the inquiry indicates that the
research environment that promotes the not to be relevant to the misconduct allegation may have substance. It is
responsible conduct of research, arguing proceeding. Paragraph (a) of Sec. 93.305 important to note that possible honest
that it is beyond the scope of a requires the institution to obtain error or difference of opinion goes to the
regulation on research misconduct. One custody of all records and evidence issue of whether the alleged research
letter, signed by four separate needed to conduct the research misconduct was committed
organizations, stated: ‘‘Though misconduct proceeding. That intentionally, knowingly, or recklessly,
responsible conduct of research is requirement would not extend to not whether the allegation involves
clearly an imperative that our records that are reasonably determined fabrication, falsification, or plagiarism.
institutions embrace, the nature of the by the institution not to be needed to A finding that the research misconduct
general research environment and the conduct the proceeding. We believe the is conducted intentionally, knowingly,
promotion of the responsible conduct of imposition of an affirmative duty to or reckless is necessary for a finding of
research are not tied only to research return records that are determined to be research misconduct; a finding that is
misconduct as ORI staff have asserted in irrelevant could adversely affect not made until the investigation is
many venues, and, as a consequence, inquiries and investigations, because completed, absent an admission at an
should not be linked in this particular experience has shown that research earlier stage.
policy.’’ misconduct proceedings are better Given this fact, and the preliminary
These commentators are reading too served by broadly securing all records nature of the fact finding at the inquiry
much into this provision. This is not a thought to be relevant. The respondent stage, it would be appropriate for the
requirement for institutions to establish is protected by paragraph (b) of Sec. inquiry report to note if there is possible
a new program for the responsible 93.305 under which he/she may obtain evidence of honest error or difference of
conduct of research. Rather, this copies of the records or reasonable, opinion for consideration in the
provision appropriately updates the supervised access. investigation, but it would be
language of the current regulation inappropriate for the inquiry report to
requiring institutions to foster a research H. Institutional Inquiry—Consideration
conclude, on the basis of an initial
environment that discourages of Honest Error or Difference of
review of the evidence of honest error
misconduct in all research and deals Opinion, Sec. 93.307
or difference of opinion, that the
forthrightly with possible misconduct Several commentators recommended allegation should be dismissed. The
associated with research for which PHS amending this section to impose an determination of whether the alleged
funds have been provided or requested affirmative burden on institutions to misconduct is intentional, knowing, or
(42 CFR 50.105). The new provision assess whether honest error or reckless, including consideration of
recognizes the continuing importance of difference of opinion exempts the evidence of honest error or difference of
the responsible conduct of research to allegation from consideration as opinion, should be made at the
competent research that is free of any research misconduct. investigation stage, following a
research misconduct. As stated by the As noted earlier in this complete review of the evidence. As
Institute of Medicine (IOM) in its 2002 supplementary information, we have noted in the preamble of the OSTP final
report, Integrity in Scientific Research: concluded that honest error or policy, institutions and HHS do not
Creating an Environment That Promotes difference of opinion is an affirmative have the burden of disproving possible
Responsible Conduct, ‘‘instruction in defense based on the statement in the honest error or differences of opinion.
the responsible conduct of research preamble of the OSTP final rule that
need not be driven by federal mandates, institutions and agencies are not I. Institutional Investigation, Sec. 93.310
for it derives from a premise required to disprove possible honest and Investigation Time Limits, Sec.
fundamental to doing science: the error or difference of opinion in order to 93.311
responsible conduct of research is not make a finding of research misconduct. Some commentators recommended
distinct from research; on the contrary, However, because of the overlap that complainants be given a right to
competency in research encompasses between this affirmative defense and the participate in the process. As explained
the responsible conduct of that research responsibility of institutions and HHS to in the preamble of the NPRM,
and the capacity for ethical prove that the alleged research complainants are witnesses in that they
decisionmaking.’’ (Report at p. 9). In the misconduct was committed do not control or direct the process, do
context of this regulation, the directive intentionally, knowingly, or recklessly, not have special access to evidence,
in Sec. 93.300(c) to foster a research evidence of honest error or difference of except as determined by the institution

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28379

or ORI, and do not act as decision participate in those cases involving IV. General Issues and Requests for
makers. This ensures that the institution complex scientific, medical or technical Clarification
will carry out its responsibility under issues. As stated in the preamble of the Several general comments and
Sec. 93.310(f) to conduct investigations NPRM, we believe that the change to a requests for clarification are addressed
that are fair. single decisionmaker will substantially in the following question and answer
Other commentators felt that the improve and simplify the process for all format.
respondent should have an explicit right parties. The change provides a process Q. Is the detail in the final rule
to review and comment on evidence and similar to Medicare and State health contrary to the goal of the OSTP Federal
cross-examine witnesses at the
care program exclusion cases brought by Policy on Research Misconduct to
investigation stage, and the right to
the Office of the Inspector General provide a more uniform Federal-wide
request an extension of time for
(OIG), which have similar impacts on approach?
conducting the investigation. The
the reputations of the respondents. This A. No, the final rule is consistent with
proposed regulation requires that: (1)
process is also consistent with the OSTP Federal Policy. As stated
Where appropriate, the respondent be
Recommendation 92–7 of the elsewhere in this Supplementary
given copies of, or reasonable,
Administrative Conference of the Information we have made some
supervised access to the research
United States that ALJs should hear and changes in order to adhere more closely
records secured by the institution on or
decide cases involving the imposition of to the Federal Policy and refused to
before the date it notifies the respondent
sanctions having a substantial economic make other changes that would have
of the allegation, inquiry or
effect. Use of an ALJ with ready access been inconsistent with the Federal
investigation (Sec. 93.305(b)); (2) the
respondent be notified in writing of the Policy. The Supplementary Information
to scientific and technical expertise,
allegations before the investigation section of the Notice of Proposed
rather than multiple decision makers,
begins (Sec. 93.310(c)); (3) the Rulemaking (69 FR 20778, 20780 (April
will streamline the process without 16, 2004)) explained that the proposed
institution interview the respondent and compromising the quality of decisions
any witnesses he/she identifies who rule contained more detail than the
that are dependent upon resolution of existing rule because institutions had
may have substantive information scientific, medical, or technical issues.
regarding any relevant aspects of the over the years asked for more detailed
investigation (Sec. 93.310(g)); and (4) In addition to the comments guidance and that detailed guidance
the respondent be given 30 days to recommending mandatory appointment would ensure thorough and fair
review and comment on the of an expert in complex cases, another inquiries and investigations and greater
investigation report (Sec. 93.312). These commentator recommended that the ALJ accountability on the part of all
provisions have been retained and, as be required to appoint a scientific or participants in research misconduct
noted above, we have added to this final technical expert to assist the ALJ in proceedings. Similarly, it was explained
rule a requirement that respondent be every case, rather than the ALJ being that the more detailed hearing process
given copies of, or supervised access to authorized to appoint such an expert was being proposed in response to
the evidence supporting the and being required to appoint such an concerns that the current informal
investigation report, concurrent with the expert upon the request of one of the procedures lack the consistency and
period for comment. We believe these parties, as proposed in the NPRM. We clarity provided by binding rules of
requirements ensure that the respondent are not changing the provision to procedure for other types of cases. Thus,
will have a fair opportunity to present the detail in the final rule is necessary
require the appointment of an expert in
relevant evidence during the research to ensure more uniformity among the
every case or in all cases involving
misconduct proceeding, particularly various institutions that will be
complex issues. We believe that such a conducting research misconduct
when viewed in the context of the rigid requirement is not needed to
respondent’s right to contest any HHS proceedings and to ensure fair, uniform
ensure fairness. In complex cases, it will procedures for the benefit of
findings of research misconduct and
always be in the interest of at least one respondents. The detail in the proposed
proposed administrative sanctions
of the parties to ensure that the ALJ rule, which is retained in this final rule,
before an ALJ. It is important to note
that the final rule does not prohibit fully understands the issues by is entirely consistent with the goals of
institutions from giving respondents requesting the appointment of an expert. the OSTP Federal Policy to provide for
greater rights during the investigation, Upon such a request, the appointment fair and timely procedures and to strive
so long as they do not contravene HHS of an expert is mandatory. Furthermore, for uniformity in implementation.
requirements; the rule establishes a floor the ALJ, who is in the best position to Q. How should institutions deal with
for their participation. assess the complexity of the case in light bad faith allegations?
of his/her own knowledge and training, A. The final rule, Sec. 93.300(d),
J. Appointment of the ALJ and Scientific may appoint an expert in the absence of requires institutions to take all
Expert, Sec. 93.502 reasonable and practical steps to protect
any motion by a party. The self-interest
Two scientific societies objected to of the parties and the duty of the ALJ the positions and reputations of good
the ALJ provision, recommending that to exercise his/her discretion to provide faith complainants and protect them
the current three member adjudication a fair hearing should ensure that an from retaliation by respondents and
panel be retained. Another scientific expert is appointed where necessary to other institutional members. By negative
society raised concerns about the extent ensure fairness. We will closely monitor implication, such steps are not required
to which scientists would be involved the appointment of experts in future for bad faith complainants. Bad faith
in the process, if they were not part of hearings and, if problems are apparent, complainants are those who, under the
the adjudication panel (these concerns definition of ‘‘good faith’’ in Sec.
consider amending the regulations to
have been addressed through the 93.210, do not have a belief in the truth
compel the appointment of an expert in
changes in this section discussed above) of their allegation that a reasonable
and four associations supported the ALJ order to ensure that the ALJ will have person in the complainant’s position
provision, provided that scientific or the benefit of expert advice in cases could have based on the information
technical experts are required to involving complex issues. known to the complainant at the time.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28380 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

We have determined there is no need for institution has a research misconduct assistance or otherwise continued to fail
the final rule to further address bad faith proceeding pending at the time the new to properly carry out its responsibilities
allegations, given that institutions may regulation becomes effective with under the final rule.
have internal standards of conduct that respect to that institution, ORI would Q. Are sanctions required or available
address matters not addressed in the expect the new procedural requirements for imposition against those who violate
final rule (Sec. 93.319). However, the to be applicable to the institution’s the confidentiality requirements in the
definition of ‘‘good faith’’ provides subsequent steps in that proceeding, final rule?
important guidance for institutions unless the institution or respondent A. The final rule does not provide for
because it makes clear that an allegation would be unduly burdened or treated specific sanctions against those who
can lack sufficient credibility and unfairly. However, the definition of violate the confidentiality protections in
specificity so that potential evidence of research misconduct that was in effect Sec. 93.108, but an institution would be
research misconduct cannot be at the time the misconduct occurred subject to the general sanctions for
identified (Sec. 93.307(a)(3)), but still would apply. failure to comply with the final rule and
may not be a bad faith allegation. Thus, Q. Should HHS take action to provide its assurance if it fails to comply with
if institutions exercise their discretion immunity from personal liability for Sec. 93.108. Section 93.300(e) requires
to adopt procedures addressing bad institutions, committee members, and institutions to provide confidentiality to
faith allegations, we urge them to witnesses who participate in research the extent required by Sec. 93.108, and
include fair procedures for determining misconduct proceedings? Sec. 93.304 requires that an institution
whether there has been a bad faith A. As the commentator who raised seeking an approved assurance have
allegation. ORI is prepared to work this issue implied, a Federal statute, written policies and procedures that,
collaboratively with the research rather than an HHS regulation, would be consistent with Sec. 93.108, provide for
community to develop guidance in this needed to provide this immunity. protecting the confidentiality of
area if research institutions and Earlier attempts by HHS to develop respondents, complainants and research
associations desire to do so. legislation providing immunity were subjects. The final rule does not impose,
Q. Will the final rule apply unsuccessful. ORI does not currently or require institutions to impose
retroactively? have sufficient data to make the case for sanctions against institutional members
A. No, the final rule will become Federal legislation. Interested parties are who violate the confidentiality
effective 30 days after the date it is encouraged to submit evidence that provisions of Sec. 93.108, but
published in the Federal Register and would help us in determining whether institutions have the discretion to
will apply prospectively. The effect of there is a need for Federal legislation to impose such sanctions by making
that prospective application will provide immunity for committee compliance with those provisions a
depend upon how the provisions of the members and witnesses or to propose condition of employment. Institutions
rule interact with the activities of the ways to provide such protection in the may also wish to develop specific
institution and ORI. Upon the absence of such legislation. policies addressing actions the
expiration of 30 days, the final rule will Q. Should HHS have primary institution may take when institutional
immediately apply to institutions that responsibility for responding to members violate the confidentiality
are receiving PHS support for research, allegations of research misconduct at requirements.
research training or activities related to institutions that have repeatedly failed Q. Does a respondent have a right to
that research or research training. For to handle such allegations properly? continue his/her research after
institutions not receiving such PHS A. Under the final rule, HHS has the allegations of research misconduct have
support, the regulation will not apply discretion to take responsibility for been made?
until they submit an application for that responding to allegations of research A. The final rule does not directly
support. misconduct at institutions that are address the issue of whether the
If an institution to which the final failing to handle such allegations respondent has a right to continue his/
rule applies immediately has completed properly. Under Sec. 93.400, ORI may her research after an allegation of
an inquiry or investigation and reports respond directly to any allegation of research misconduct has been made.
to ORI after the effective date of the final research misconduct at any time before, Section 93.305 requires the institution
rule, ORI will take further action, make during, or after an institution’s response to: (1) promptly obtain custody of and
findings, and provide an opportunity for to the matter. The ORI response may sequester all research records and
a hearing in accordance with the final include, but is not limited to, reviewing evidence needed to conduct the
rule. If a request for a hearing is an institution’s findings and process research misconduct proceeding; and (2)
received by the DAB Chair after the and recommending that HHS perform where appropriate, give the respondent
effective date of the final rule, the an inquiry or investigation. In addition, copies of, or reasonable, supervised
hearing will be conducted in accordance ORI may make findings and impose access to the research records. There are
with the final rule. This will ensure that HHS administrative actions related to an at least two reasons for providing such
respondents have the benefit of the institution’s compliance with the final access: to enable the respondent to
detailed, fair hearing procedures in the rule. Where an institution has failed in prepare a defense against the allegation,
final rule. Because it is not possible to the past to respond promptly or and/or to continue the research.
address every possible scenario relating properly to allegations of research As proposed and adopted in this final
to the prospective application of the misconduct, ORI will monitor closely its rule, Sec. 93.305(b) requires the
final rule, institutions that have subsequent responses to allegations of institution to provide the respondent
received allegations of misconduct, or research misconduct. However, ORI copies of, or supervised access to the
have ongoing inquiries or investigations would intervene only as it determines research records secured by the
upon the effective date of this final rule necessary and would first provide institution, unless that would be
should contact ORI to determine how advice and assistance to the institution. inappropriate. The determination of
the rule will apply to those ongoing ORI would exercise its discretion to when it would be inappropriate to
activities. ORI will make every effort to respond directly to an allegation of provide such copies or access is left to
minimize burdens and ensure that all research misconduct only if the the discretion of the institution. In
parties are treated fairly. Generally, if an institution disregarded that advice or exercising this discretion, institutions

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28381

should consider separately the issues of effect on the supply, distribution, or use private sector, of $100 million or more
whether the respondent should of energy sources under Executive Order in any one year. This final rule will not
continue the research and whether and 13211. result in expenditures of this
under what circumstances the magnitude, and thus the Secretary
A. Executive Order 12866
respondent should be given copies of or certifies that such statements are not
access to the research records. In These final regulations have been necessary.
considering the former issue, drafted and reviewed in accordance
with Executive Order 12866 (58 FR C. Regulatory Flexibility Act
institutions should weigh, among other
factors, the special circumstances listed 51735), section 1(b), Principles of The Regulatory Flexibility Act (5
in Sec. 93.318, the importance of Regulation. The Department has U.S.C. 601, et seq.) requires agencies to
continuing the research, and whether determined that this final rule is a prepare a regulatory flexibility analysis
the expertise of the respondent is ‘‘significant regulatory action’’ under describing the impact of the final rule
unique. Institutions must also be Executive Order 12866, section 3(f), on small entities, but also permits
cognizant of the interests of the PHS Regulatory Planning and Review agency heads to certify that the final
funding agency and the need to confer because it will materially alter the rule will not, if promulgated, have a
with that agency about suspension or obligations of recipients of PHS significant economic impact on a
discontinuation of the research or to biomedical and behavioral research and substantial number of small entities.
obtain approval if the Principal research training grants. However, the The primary effect of this rule is to
Investigator is being replaced. If the final regulation is not economically require covered institutions to
respondent does not continue the significant as defined in section 3(f)(1), implement policies and procedures for
research, it would be appropriate, because it will not have an annual effect responding to research misconduct
absent special circumstances, to give on the economy of $100 million or more cases. The Department certifies that this
him/her a copy of the records, or or adversely affect in a material way the rule will not have a significant impact
reasonable, supervised access to them economy, a sector of the economy, on a substantial number of small
for the purpose of preparing a defense productivity, competition, jobs, the entities, as defined by the Regulatory
to the allegations. In order to ensure that environment, public health or safety, or Flexibility Act, based on the following
the respondent has this opportunity at State, local, or tribal governments or facts.
the investigation stage, Sec. 93.312(a) communities. Therefore, the Approximately 47 percent (1862) of
requires the institution to give the information enumerated in section the 4000 institutions that currently have
respondent a copy of, or supervised 6(a)(3)(C) of the Executive Order is not research misconduct assurances are
access to the evidence upon which the required. The final rule has been small entities. The primary impact of
draft investigation report is based reviewed by the Office of Management the final rule on covered institutions
concurrently with the provision of the and Budget (OMB) under the terms of results from the reporting and record
draft report for comment by the the Executive Order. keeping provisions which are analyzed
respondent. Recipients of PHS biomedical and in detail under the heading, ‘‘The
Q. Does the 120-day time limit for behavioral research grants will have to Paperwork Reduction Act.’’ Significant
completing an investigation include the comply with the reporting and record annual burdens apply only if an
30-day period for respondent to review keeping requirements in the proposed institution learns of possible research
and comment on the draft report? regulation. As shown below in the misconduct and begins an inquiry,
A. Yes. Section 93.311 provides in Paperwork Reduction Act analysis, investigation, or both. In 2001, 86
pertinent part that an institution must those burdens encompass essentially all inquiries and 46 investigations were
complete all aspects of an investigation of the activities of the institutions that conducted among all the institutions.
within 120 days of beginning it, are required under the proposed No investigations were conducted by a
including providing the draft report for regulation. The estimated total annual small entity and only one conducted an
comment in accordance with Sec. burden is 19,727.5 hours. The U.S. inquiry. Small entities would be able to
93.312, and sending the final report to Department of Labor, Bureau of Labor avoid entirely the potential burden of
ORI under Sec. 93.315. Under Sec. Statistics, sets the mean hourly wage for conducting an inquiry or investigation
93.313(g), the final report must include Educational Administrators, by filing a Small Organization Statement
and consider any comments made by Postsecondary at $ 36.12. The mean under section 93.303. The burden of
the respondent or complainant on the hourly wage for lawyers is $ 51.56. The filing this Statement is .5 hour. Thus,
draft investigation report. If additional average hourly cost of benefits for all the significant burden of conducting
time is needed, the institution can civilian workers would add $ 7.40 to inquiries and investigations will not fall
request reasonable extensions for these amounts. In order to ensure that on a substantial number of small
completion of the investigation. all possible costs are included and to entities.
account for potentially higher rates at A small organization that files the
Analysis of Impacts some institutions, we estimated the cost Small Organization Statement must
As discussed in greater detail below, per burden hour at $ 100. This results report allegations of research
we have examined the potential impact in a total annual cost for all institutions misconduct to ORI and comply with all
of this final rule as directed by of $ 1,972,750. provisions of the proposed regulation
Executive Orders 12866 and 13132, the other than those requiring the conduct
Unfunded Mandates Act of 1995, the B. The Unfunded Mandates Reform Act of inquiries and investigations. The total
Regulatory Flexibility Act, and the of 1995 annual average burden per response for
Paperwork Reduction Act of 1995. Sections 202 and 205 of the Unfunded creating written policies and procedures
We have also determined that this Mandates Reform Act of 1995 (2 U.S.C. for addressing research misconduct is
final rule will not: (1) Have an impact 1532 and 1535) require that agencies approximately 16 hours. However,
on family well-being under section 654 prepare several analytic statements approximately 99 percent of currently
of the Treasury and General before promulgating a rule that may funded institutions already have these
Government Appropriations Act of result in annual expenditures of State, policies and procedures in place and
1999; nor (2) have a significant adverse local, and tribal governments, or by the spend approximately .5 hour updating

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28382 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

them. The most significant of the requirements in Secs. 93.305, 93.307, government wide Federal Policy on
burdens that might fall on an entity and 93.310 for securing records Research Misconduct. Second, the
filing a Small Organization Statement is contained in scientific instruments we proposed rule incorporates the
taking custody of research records and do not believe that those changes recommendations of the HHS Review
evidence when there is an allegation of significantly affect the burden of the Group on Research Misconduct and
research misconduct. The average collection requirements. Research Integrity that were approved
burden per response is 35 hours, but As explained above, the addition of a by the Secretary of HHS on August 25,
based on reports of research misconduct relevancy standard to Sec. 93.317 and 1999. Third, the proposed rule
over the last three years, less than 5 provisions for transferring the custody integrates a decade’s worth of
small entities would have to incur that of records to HHS will lessen the overall experience and understanding since the
burden in any year. burden of retaining records of research agency’s first regulations were
Based on the forgoing analysis that misconduct proceedings, although we promulgated.
was not commented upon when it have added a requirement that the Description of Respondents: The
appeared in the Notice of Proposed institutions document any ‘‘respondents’’ for the collection of
Rulemaking, the Department concludes determination that records are information described in this regulation
that this final rule will not impose a irrelevant. In addition, we are adding an are institutions that apply for or receive
significant burden on a substantial explanatory note to the burden estimate PHS support through grants, contracts,
number of small entities. for Sec. 93.317. This note explains that or cooperative agreements for any
not all of the 53 respondents that are project or program that involves the
D. Executive Order 13132: Federalism
expected to conduct research conduct of biomedical or behavioral
This final rule will not have misconduct proceedings each year, on research, biomedical or behavioral
substantial direct effects on the States, average, will have to to retain the research training, or activities related to
on the relationship between the national records of those proceedings for a full that research or training (see definition
government and the States, or on the seven years. If ORI determines that a of ‘‘Institution’’ at Sec. 93.213).
distribution of power and thorough, complete investigation has
responsibilities among the various been conducted and finds that there was Subpart C—Responsibilities of
levels of government. Therefore, in no research misconduct or settles a case, Institutions
accordance with section 6 of Executive it will notify the institution that it does Compliance and Assurances
Order 13132, we have determined that not have to retain the records of the
this rule does not have sufficient research misconduct proceeding, unless Section 93.300(a)
federalism implications to warrant the ORI is aware of an action by federal or See Sec. 93.304 for burden statement.
preparation of a federalism summary state government to which the records
impact statement. may pertain. Historically, about 60 Section 93.300(c)
E. The Paperwork Reduction Act percent of cases closed by ORI do not See Sec. 93.302(a)(2)(i) for burden
result in PHS misconduct findings or statement.
Sections 300–305, 307–311, 313–318, PHS administrative actions. Thus, it is
and 413 of the rule contain information expected that in the majority of cases Section 93.300(i)
collection requirements that are subject ORI will notify the institutions that they See Sec. 93.301(a) for burden
to review by the OMB under the do not have to retain the records for the statement.
Paperwork Reduction Act of 1995 (44 full seven-year period.
U.S.C. 3501, et seq.). The title, We have added a burden statement for Section 93.301(a)
description, and respondent description the requirement in Sec. 93.302(a)(1) that Covered institutions must provide
of the information collection institutions provide their policies and ORI with an assurance either by
requirements are shown below with an procedures on research misconduct, submitting the initial certification (500
estimate of the annual reporting upon request, to ORI, HHS, and institutions) or by submitting an annual
burdens. Included in the estimates is the members of the public (this third item report (3500 institutions).
time for reviewing instructions, was added in response to comments). Number of Respondents—4000.
gathering and maintaining the data Based on recent data, we have increased Number of Responses per
needed, and completing and reviewing the number of respondents in the items Respondent—1.
the collection of information. Public relating to the conduct of investigations Annual Average Burden per
comments on these estimates and other by institutions. In addition, we have Response—.5 hour.
aspects of compliance with the made minor changes to account for the Total Annual Burden—2000 hours.
Paperwork Reduction Act were invited renumbering of sections and paragraphs
in the NPRM. and to correct errors. With these Section 93.302(a)(1)
As indicated in the foregoing changes, the estimates published in the Covered institutions must, upon
discussion of the comments, a number NPRM are adopted as the burden request, provide their policies and
of them addressed reporting and estimates of the final rule. The procedures on research misconduct to
recordkeeping burdens. In response to information collection requirements in ORI, authorized HHS personnel, and
comments that the proposed reporting the final rule have been submitted to members of the public.
requirements in Secs. 93.300(a), OMB for review. Number of Respondents—2000.
93.302(c) and 93.316 were subject to an Title: Public Health Service Policies Number of Responses per
overly broad interpretation, we have on Research Misconduct. Respondent—1.
made clarifying changes to limit their Description: This final rule revises the Annual Average Burden per
scope. This did not result in any change current regulation, 42 CFR 50.101, et Response—.5 hour.
in the burden estimates, because those seq., in three significant ways and will Total Annual Burden—1000 hours.
estimates were based upon a restrictive supersede the current regulation. First,
interpretation of the requirements. the proposed rule integrates the White Section 93.302(a)(2)(i)
While changes were made to make it House Office of Science and Technology Each applicant institution must
easier for institutions to meet the Policy’s (OSTP) December 6, 2000, inform its research members

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28383

participating in or otherwise involved promptly take custody of all research Section 93.309(a)
with PHS supported biomedical or records and evidence and then When a covered institution issues an
behavioral research, research training or inventory and sequester them. Covered inquiry report in which it finds that an
activities related to that research or institutions must also take custody of investigation is warranted, the
research training, including those additional research records or evidence institution must provide ORI with a
applying for PHS support, of the discovered during the course of a specified list of information within 30
institution’s policies and procedures research misconduct proceeding. Once days of the inquiry report’s issuance.
and emphasize the importance of the records are in custody, the Number of Respondents—20.
compliance with these policies and institutions must maintain them until Number of Responses per
procedures. ORI requests them, HHS takes final Respondent—1.
Number of Respondents—4000. action, or as required under Sec. 93.317. Annual Average Burden per
Number of Responses per Number of Respondents—53. Response—16 hours.
Respondent—1. Number of Responses per
Annual Average Burden per Total Annual Burden—320 hours.
Respondent—1.
Response—.5 hour. Annual Average Burden per Section 93.309(c)
Total Annual Burden—2000 hours. Response—35 hours. Covered institutions must keep
Section 93.302(b) Total Annual Burden—1855 hours. sufficiently detailed documentation of
See Sec. 93.301(a) for burden inquiries to permit a later assessment by
Section 93.305(b)
statement. ORI of reasons why decision was made
Where appropriate, covered to forego an investigation.
Section 93.302(c) institutions must give the respondent Number of Respondents—37.
In addition to the annual report, copies of or reasonable, supervised Number of Responses per
covered institutions must submit access to the research record. Respondent—1.
aggregated information to ORI on Number of Respondents—53. Annual Average Burden per
request regarding research misconduct Number of Responses per Response—1 hour.
proceedings. Respondent—1. Total Annual Burden—37 hours.
Number of Respondents—100. Annual Average Burden per The Institutional Investigation
Number of Responses per Response—5 hours.
Respondent—1. Total Annual Burden—265 hours. Section 93.310(b)
Annual Average Burden per See Sec. 93.309(a) for burden
Response—1 hour. The Institutional Inquiry
statement.
Total Annual Burden—100. Section 93.307(b)
Section 93.310(c)
Section 93.303 At the time of or before beginning an
inquiry, covered institutions must notify Covered institutions must notify the
Covered institutions that, due to their
the presumed respondent in writing. respondent of allegations of research
small size, lack the resources to develop
Number of Respondents—53. misconduct before beginning the
their own research misconduct policies
Number of Responses per investigation.
and procedures may elect to file a
Respondent—1. Number of Respondents—20.
‘‘Small Organization Statement’’ with
Annual Average Burden per Number of Responses per
ORI.
Number of Respondents—75. Response—1 hour. Respondent—1.
Number of Responses per Annual Average Burden per
Total Annual Burden—53 hours.
Respondent—1. Response—1.
Annual Average Burden per Section 93.307(e) Total Annual Burden—20 hours.
Response—.5 hour. See Sec. 93.309 for burden statement. Section 93.310(d)
Total Annual Burden—37.5 hours.
Section 93.307(f) See Sec. 93.305(a), (c), and (d) for
Section 93.304 burden statement.
Covered institutions must provide the
Covered institutions with active respondent an opportunity to review Section 93.310(g)
assurances must have written policies and comment on the inquiry report and
and procedures for addressing research Covered institutions must record or
attach any comments to the report. transcribe all witness interviews,
misconduct. Approximately 3500 Number of Respondents—53.
institutions already have these policies provide the recording or transcript to
Number of Responses per the witness for correction, and include
and procedures in place in any given Respondent—1.
year and spend minimal time (.5 hour) the recording or transcript in the record
Annual Average Burden per of the investigation.
updating them. Approximately 500
Response—1 hour. Number of Respondents—20.
institutions each year spend an average
Total Annual Burden—53 hours. Number of Responses per
of two days creating these policies and
procedures for the first time. Section 93.308(a) Respondent—1.
Number of Respondents—4000. Annual Average Burden per
Number of Responses per Covered institutions must notify the Response—15 hours.
Respondent—1. respondent whether the inquiry found Total Annual Burden—300 hours.
Annual Average Burden per that an investigation is warranted.
Number of Respondents—53. Section 93.311(b)
Response—2.5 hours.
Total Annual Burden—10,000 hours. Number of Responses per If unable to complete the investigation
Respondent—1. in 120 days, covered institutions must
Section 93.305(a), (c), and (d) Annual Average Burden per submit a written request for an
When a covered institution learns of Response—.5 hour. extension from ORI.
possible research misconduct, it must Total Annual Burden—26.5 hours. Number of Respondents—16.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28384 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

Number of Responses per government to which the records Dated: January 14, 2005.
Respondent—1. pertain. Cristina V. Beato,
Annual Average Burden per Acting Assistant Secretary for Health.
Response—1 hour. Section 93.318
Dated: May 3, 2005.
Total Annual Burden—16 hours. Covered institutions must notify ORI Michael O. Leavitt,
Section 93.313 immediately in the event of any of an Secretary of Health and Human Services.
See Sec. 93.315 for burden statement. enumerated list of exigent ■ Accordingly, under the authority of 42
circumstances. U.S.C. 289b, HHS is amending 42 CFR
Section 93.314(b)
Number of Respondents—2. parts 50 and 93 as follows:
If unable to complete any institutional
Number of Responses per
appeals process relating to the PART 50—POLICIES OF GENERAL
Respondent—1. APPLICABILITY
institutional finding of misconduct
within 120 days from the appeal’s filing, Annual Average Burden per
Response—1 hour. ■ 1. The authority citation for 42 CFR
covered institutions must request an
part 50 continues to as follows:
extension in writing and provide an Total Annual Burden—2 hours.
explanation. Authority: Sec. 215, Public Health Service
Number of Respondents—5. Subpart D—Responsibilities of the U.S. Act, 58 Stat. 690 (42 U.S.C. 216); Sec. 1006,
Number of Responses per Department of Health and Human Public Health Service Act, 84 Stat. 1507 (42
U.S.C. 300a–4), unless otherwise noted.
Respondent—1. Services Institutional Compliance
Annual Average Burden per Issues Subpart A [Removed]
Response—.5 hour.
Total Annual Burden—2.5 hours. Section 93.413(c)(6) ■ 2. Part 50, Subpart A (§§ 50.101–
Section 93.315 ORI may require noncompliant 50.105) is removed and reserved.
■ 3. A new Part 93, with subparts A, B,
At the conclusion of the institutional institutions to adopt institutional
integrity agreements. C, D and E is added to read as follows:
investigation process, covered
institutions must submit four items to Number of Respondents—1. PART 93—PUBLIC HEALTH SERVICE
ORI: the investigation report (with Number of Responses per POLICIES ON RESEARCH
attachments and appeals), final Respondent—1. MISCONDUCT
institutional actions, the institutional
finding, and any institutional Annual Average Burden per Sec.
Response—20 hours. 93.25 Organization of this part.
administrative actions. 93.50 Special terms.
Number of Respondents—20. Total Annual Burden—20 hours.
Number of Responses per Subpart A—General
The Department has submitted a copy
Respondent—1. of this final rule to OMB for its review 93.100 General policy.
Annual Average Burden per 93.101 Purpose.
of these information collection 93.102 Applicability.
Response—80 hours.
Total Annual Burden—1600 hours. requirements under the Paperwork 93.103 Research misconduct.
Reduction Act of 1995 (44 U.S.C. 3501– 93.104 Requirements for findings of
Section 93.316(a) 3520). Prior to the effective date of this research misconduct.
final rule, HHS will publish a notice in 93.105 Time limitations.
Covered institutions that plan to end 93.106 Evidentiary standards.
an inquiry or investigation before the Federal Register announcing OMB’s
93.107 Rule of interpretation.
completion for any reason must contact decision to approve, modify, or 93.108 Confidentiality.
ORI before closing the case and disapprove the information collection 93.109 Coordination with other agencies.
submitting its final report. provisions in this final rule. An agency
Subpart B—Definitions
Number of Respondents—10. may not conduct or sponsor, and a
Number of Responses per person is not required to respond to, a 93.200 Administrative action.
Respondent—1. 93.201 Allegation.
collection of information unless it 93.202 Charge letter.
Annual Average Burden per displays a currently valid OMB control 93.203 Complainant.
Response—2 hours. number. 93.204 Contract.
Total Annual Burden—20 hours. 93.205 Debarment or suspension.
List of Subjects 93.206 Debarring official.
Other Institutional Responsibilities
93.207 Departmental Appeals Board or
42 CFR Part 50
Section 93.317(a) and (b) DAB.
Administrative practice and 93.208 Evidence.
See Sec. 93.305(a), (c), and (d), for 93.209 Funding component.
burden statement. It is expected that not procedure, Science and technology, 93.210 Good faith.
all of the 53 respondents that learn of Reporting and recordkeeping 93.211 Hearing.
misconduct will have to retain the requirements, Research, Government 93.212 Inquiry.
records of their research misconduct contracts, Grant programs. 93.213 Institution.
proceedings for seven years. If ORI 93.214 Institutional member
determines that a thorough, complete 42 CFR Part 93 93.215 Investigation.
investigation has been conducted and 93.216 Notice.
Administrative practice and 93.217 Office of Research Integrity or ORI.
finds that there was no research procedure, Science and technology, 93.218 Person.
misconduct, or settles the case, it will Reporting and recordkeeping 93.219 Preponderance of the evidence.
notify the institution that it does not requirements, Research, Government 93.220 Public Health Service or PHS.
have to retain the records of the research 93.221 PHS support.
contracts, Grant programs.
misconduct proceeding, unless ORI is 93.222 Research.
aware of an action by federal or state 93.223 Research misconduct proceeding.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28385

93.224 Research record. 93.413 HHS compliance actions. § 93.50 Special terms.
93.225 Respondent. This part uses terms throughout the
93.226 Retaliation. Disclosure of Information
text that have special meaning. Those
93.227 Secretary or HHS. 93.414 Notice.
terms are defined in Subpart B of this
Subpart C—Responsibilities of Institutions Subpart E—Opportunity to Contest ORI part.
Compliance and Assurances Findings of Research Misconduct and HHS
Administrative Actions Subpart A—General
93.300 General responsibilities for
compliance. General Information § 93.100 General policy.
93.301 Institutional assurances. 93.500 General policy. (a) Research misconduct involving
93.302 Institutional compliance with 93.501 Opportunity to contest findings of
assurances.
PHS support is contrary to the interests
research misconduct and administrative of the PHS and the Federal government
93.303 Assurances for small institutions.
actions. and to the health and safety of the
93.304 Institutional policies and
procedures. Hearing Process public, to the integrity of research, and
93.305 Responsibility for maintenance and
93.502 Appointment of the Administrative
to the conservation of public funds.
custody of research records and (b) The U.S. Department of Health and
evidence. Law Judge and scientific expert.
93.503 Grounds for granting a hearing Human Services (HHS) and institutions
93.306 Using a consortium or person for that apply for or receive Public Health
research misconduct proceedings. request.
93.504 Grounds for dismissal of a hearing Service (PHS) support for biomedical or
The Institutional Inquiry request. behavioral research, biomedical or
93.307 Institutional inquiry. 93.505 Rights of the parties. behavioral research training, or
93.308 Notice of the results of the inquiry. 93.506 Authority of the Administrative Law activities related to that research or
93.309 Reporting to ORI on the decision to Judge. research training share responsibility for
initiate an investigation. 93.507 Ex parte communications. the integrity of the research process.
The Institutional Investigation 93.508 Filing, forms, and service. HHS has ultimate oversight authority for
93.509 Computation of time. PHS supported research, and for taking
93.310 Institutional investigation.
93.510 Filing motions. other actions as appropriate or
93.311 Investigation time limits.
93.312 Opportunity to comment on the 93.511 Prehearing conferences. necessary, including the right to assess
investigation report. 93.512 Discovery. allegations and perform inquiries or
93.313 Institutional investigation report. 93.513 Submission of witness lists, witness investigations at any time. Institutions
93.314 Institutional appeals. statements, and exhibits. and institutional members have an
93.315 Notice to ORI of institutional 93.514 Amendment to the charge letter.
affirmative duty to protect PHS funds
findings and actions. 93.515 Actions for violating an order or for
from misuse by ensuring the integrity of
93.316 Completing the research misconduct disruptive conduct.
process. 93.516 Standard and burden of proof.
all PHS supported work, and primary
93.517 The hearing. responsibility for responding to and
Other Institutional Responsibilities reporting allegations of research
93.518 Witnesses.
93.317 Retention and custody of the 93.519 Admissibility of evidence. misconduct, as provided in this part.
research misconduct proceeding record. 93.520 The record.
93.318 Notifying ORI of special § 93.101 Purpose.
93.521 Correction of the transcript.
circumstances. The purpose of this part is to—
93.319 Institutional standards. 93.522 Filing post-hearing briefs.
93.523 The Administrative Law Judge’s (a) Establish the responsibilities of
Subpart D—Responsibilities of the U.S. ruling. HHS, PHS, the Office of Research
Department of Health and Human Services Integrity (ORI), and institutions in
Authority: 42 U.S.C. 216, 241, and 289b. responding to research misconduct
General Information
§ 93.25 Organization of this part. issues;
93.400 General statement of ORI authority. (b) Define what constitutes
93.401 Interaction with other offices and This part is subdivided into five
interim actions.
misconduct in PHS supported research;
subparts. Each subpart contains (c) Define the general types of
Research Misconduct Issues information related to a broad topic or administrative actions HHS and the PHS
93.402 ORI allegation assessments. specific audience with special may take in response to research
93.403 ORI review of research misconduct responsibilities as shown in the misconduct; and
proceedings. following table. (d) Require institutions to develop
93.404 Findings of research misconduct and implement policies and procedures
and proposed administrative actions. In subpart You will find provisions related for—
93.405 Notifying the respondent of findings . . . to . . .
of research misconduct and HHS (1) Reporting and responding to
administrative actions. A .............. General information about this allegations of research misconduct
93.406 Final HHS actions. rule. covered by this part;
93.407 HHS administrative actions. B .............. Definitions of terms used in this (2) Providing HHS with the
93.408 Mitigating and aggravating factors in part. assurances necessary to permit the
HHS administrative actions. C .............. Responsibilities of institutions institutions to participate in PHS
93.409 Settlement of research misconduct with PHS support. supported research.
proceedings. D .............. Responsibilities of the U.S. De- (e) Protect the health and safety of the
93.410 Final HHS action with no settlement partment of Health and public, promote the integrity of PHS
or finding of research misconduct. Human Services and the Of- supported research and the research
93.411 Final HHS action with a settlement fice of Research Integrity.
or finding of misconduct. process, and conserve public funds.
E .............. Information on how to contest
Institutional Compliance Issues ORI research misconduct find- § 93.102 Applicability.
ings and HHS administrative
93.412 Making decisions on institutional actions. (a) Each institution that applies for or
noncompliance. receives PHS support for biomedical or

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28386 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

behavioral research, research training or or results such that the research is not documenting the questioned research is
activities related to that research or accurately represented in the research evidence of research misconduct where
research training must comply with this record. the institution or HHS establishes by a
part. (c) Plagiarism is the appropriation of preponderance of the evidence that the
(b)(1) This part applies to allegations another person’s ideas, processes, respondent intentionally, knowingly, or
of research misconduct and research results, or words without giving recklessly had research records and
misconduct involving: appropriate credit. destroyed them, had the opportunity to
(i) Applications or proposals for PHS (d) Research misconduct does not maintain the records but did not do so,
support for biomedical or behavioral include honest error or differences of or maintained the records and failed to
extramural or intramural research, opinion. produce them in a timely manner and
research training or activities related to that the respondent’s conduct
that research or research training, such § 93.104 Requirements for findings of
constitutes a significant departure from
research misconduct.
as the operation of tissue and data banks accepted practices of the relevant
and the dissemination of research A finding of research misconduct research community.
information; made under this part requires that—
(a) There be a significant departure (2) The respondent has the burden of
(ii) PHS supported biomedical or going forward with and the burden of
behavioral extramural or intramural from accepted practices of the relevant
research community; and proving, by a preponderance of the
research; evidence, any and all affirmative
(iii) PHS supported biomedical or (b) The misconduct be committed
intentionally, knowingly, or recklessly; defenses raised. In determining whether
behavioral extramural or intramural HHS or the institution has carried the
research training programs; and
(c) The allegation be proven by a burden of proof imposed by this part,
(iv) PHS supported extramural or
preponderance of the evidence. the finder of fact shall give due
intramural activities that are related to
consideration to admissible, credible
biomedical or behavioral research or
§ 93.105 Time limitations. evidence of honest error or difference of
research training, such as the operation
(a) Six-year limitation. This part opinion presented by the respondent.
of tissue and data banks or the
dissemination of research information; applies only to research misconduct (3) The respondent has the burden of
and occurring within six years of the date going forward with and proving by a
(v) Plagiarism of research records HHS or an institution receives an preponderance of the evidence any
produced in the course of PHS allegation of research misconduct. mitigating factors that are relevant to a
supported research, research training or (b) Exceptions to the six-year decision to impose administrative
activities related to that research or limitation. Paragraph (a) of this section actions following a research misconduct
research training. does not apply in the following proceeding.
(2) This includes any research instances:
(1) Subsequent use exception. The § 93.107 Rule of interpretation.
proposed, performed, reviewed, or
reported, or any research record respondent continues or renews any Any interpretation of this part must
generated from that research, regardless incident of alleged research misconduct further the policy and purpose of the
of whether an application or proposal that occurred before the six-year HHS and the Federal government to
for PHS funds resulted in a grant, limitation through the citation, protect the health and safety of the
contract, cooperative agreement, or republication or other use for the public, to promote the integrity of
other form of PHS support. potential benefit of the respondent of research, and to conserve public funds.
(c) This part does not supersede or the research record that is alleged to
have been fabricated, falsified, or § 93.108 Confidentiality.
establish an alternative to any existing
regulations or procedures for handling plagiarized. (a) Disclosure of the identity of
fiscal improprieties, the ethical (2) Health or safety of the public respondents and complainants in
treatment of human or animal subjects, exception. If ORI or the institution, research misconduct proceedings is
criminal matters, personnel actions following consultation with ORI, limited, to the extent possible, to those
against Federal employees, or actions determines that the alleged misconduct, who need to know, consistent with a
taken under the HHS debarment and if it occurred, would possibly have a thorough, competent, objective and fair
suspension regulations at 45 CFR part substantial adverse effect on the health research misconduct proceeding, and as
76 and 48 CFR subparts 9.4 and 309.4. or safety of the public. allowed by law. Provided, however,
(d) This part does not prohibit or (3) ‘‘Grandfather’’ exception. If HHS that:
otherwise limit how institutions handle or an institution received the allegation (1) The institution must disclose the
allegations of misconduct that do not of research misconduct before the identity of respondents and
fall within this part’s definition of effective date of this part. complainants to ORI pursuant to an ORI
research misconduct or that do not review of research misconduct
§ 93.106 Evidentiary standards.
involve PHS support. proceedings under § 93.403.
The following evidentiary standards
§ 93.103 Research misconduct. apply to findings made under this part. (2) Under § 93.517(g), HHS
Research misconduct means (a) Standard of proof. An institutional administrative hearings must be open to
fabrication, falsification, or plagiarism or HHS finding of research misconduct the public.
in proposing, performing, or reviewing must be proved by a preponderance of (b) Except as may otherwise be
research, or in reporting research the evidence. prescribed by applicable law,
results. (b) Burden of proof. (1) The institution confidentiality must be maintained for
(a) Fabrication is making up data or or HHS has the burden of proof for any records or evidence from which
results and recording or reporting them. making a finding of research research subjects might be identified.
(b) Falsification is manipulating misconduct. The destruction, absence Disclosure is limited to those who have
research materials, equipment, or of, or respondent’s failure to provide a need to know to carry out a research
processes, or changing or omitting data research records adequately misconduct proceeding.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28387

§ 93.109 Coordination with other agencies. Federal Acquisition Regulation (FAR), applied to a committee member means
(a) When more than one agency of the 48 CFR Chapter 1, excluding any small cooperating with the research
Federal government has jurisdiction of purchases awarded pursuant to FAR misconduct proceeding by carrying out
the subject misconduct allegation, HHS Part 13. the duties assigned impartially for the
will cooperate in designating a lead purpose of helping an institution meet
§ 93.205 Debarment or suspension. its responsibilities under this part. A
agency to coordinate the response of the
agencies to the allegation. Where HHS is Debarment or suspension means the committee member does not act in good
not the lead agency, it may, in Government wide exclusion, whether faith if his/her acts or omissions on the
consultation with the lead agency, take temporary or for a set term, of a person committee are dishonest or influenced
appropriate action to protect the health from eligibility for Federal grants, by personal, professional, or financial
and safety of the public, promote the contracts, and cooperative agreements conflicts of interest with those involved
integrity of the PHS supported research under the HHS regulations at 45 CFR in the research misconduct proceeding.
and research process and conserve part 76 (nonprocurement) and 48 CFR
subparts 9.4 and 309.4 (procurement). § 93.211 Hearing.
public funds.
(b) In cases involving more than one Hearing means that part of the
§ 93.206 Debarring official. research misconduct proceeding from
agency, HHS may refer to evidence or
reports developed by that agency if HHS Debarring official means an official the time a respondent files a request for
determines that the evidence or reports authorized to impose debarment or an administrative hearing to contest ORI
will assist in resolving HHS issues. In suspension. The HHS debarring official findings of research misconduct and
appropriate cases, HHS will seek to is either— HHS administrative actions until the
(a) The Secretary; or time the ALJ issues a recommended
resolve allegations jointly with the other
(b) An official designated by the decision.
agency or agencies.
Secretary.
§ 93.212 Inquiry.
Subpart B—Definitions § 93.207 Departmental Appeals Board or Inquiry means preliminary
DAB. information-gathering and preliminary
§ 93.200 Administrative action.
Administrative action means— Departmental Appeals Board or DAB fact-finding that meets the criteria and
(a) An HHS action in response to a means, depending on the context— follows the procedures of §§ 93.307–
research misconduct proceeding taken (a) The organization, within the Office 93.309.
to protect the health and safety of the of the Secretary, established to conduct
hearings and provide impartial review § 93.213 Institution.
public, to promote the integrity of PHS
of disputed decisions made by HHS Institution means any individual or
supported biomedical or behavioral
operating components; or person that applies for or receives PHS
research, research training, or activities
(b) An Administrative Law Judge support for any activity or program that
related to that research or research
(ALJ) at the DAB. involves the conduct of biomedical or
training and to conserve public funds;
behavioral research, biomedical or
or § 93.208 Evidence. behavioral research training, or
(b) An HHS action in response either Evidence means any document, activities related to that research or
to a breach of a material provision of a tangible item, or testimony offered or training. This includes, but is not
settlement agreement in a research obtained during a research misconduct limited to colleges and universities, PHS
misconduct proceeding or to a breach of proceeding that tends to prove or intramural biomedical or behavioral
any HHS debarment or suspension. disprove the existence of an alleged fact. research laboratories, research and
§ 93.201 Allegation. development centers, national user
§ 93.209 Funding component.
Allegation means a disclosure of facilities, industrial laboratories or other
Funding component means any research institutes, small research
possible research misconduct through organizational unit of the PHS
any means of communication. The institutions, and independent
authorized to award grants, contracts, or researchers.
disclosure may be by written or oral cooperative agreements for any activity
statement or other communication to an that involves the conduct of biomedical § 93.214 Institutional member.
institutional or HHS official. or behavioral research, research training Institutional member or members
§ 93.202 Charge letter. or activities related to that research or means a person who is employed by, is
Charge letter means the written research training, e.g., agencies, an agent of, or is affiliated by contract
notice, as well as any amendments to bureaus, centers, institutes, divisions, or or agreement with an institution.
the notice, that are sent to the offices and other awarding units within Institutional members may include, but
respondent stating the findings of the PHS. are not limited to, officials, tenured and
research misconduct and any HHS untenured faculty, teaching and support
§ 93.210 Good faith.
administrative actions. If the charge staff, researchers, research coordinators,
Good faith as applied to a clinical technicians, postdoctoral and
letter includes a debarment or
complainant or witness, means having a other fellows, students, volunteers,
suspension action, it may be issued
belief in the truth of one’s allegation or agents, and contractors, subcontractors,
jointly by the ORI and the debarring
testimony that a reasonable person in and subawardees, and their employees.
official.
the complainant’s or witness’s position
§ 93.203 Complainant. could have based on the information § 93.215 Investigation.
Complainant means a person who in known to the complainant or witness at Investigation means the formal
good faith makes an allegation of the time. An allegation or cooperation development of a factual record and the
research misconduct. with a research misconduct proceeding examination of that record leading to a
is not in good faith if made with decision not to make a finding of
§ 93.204 Contract. knowing or reckless disregard for research misconduct or to a
Contract means an acquisition information that would negate the recommendation for a finding of
instrument awarded under the HHS allegation or testimony. Good faith as research misconduct which may include

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28388 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

a recommendation for other appropriate § 93.222 Research. Subpart C—Responsibilities of


actions, including administrative Research means a systematic Institutions
actions.
experiment, study, evaluation, Compliance and Assurances
§ 93.216 Notice. demonstration or survey designed to
develop or contribute to general § 93.300 General responsibilities for
Notice means a written compliance.
knowledge (basic research) or specific
communication served in person, sent Institutions under this part must—
by mail or its equivalent to the last knowledge (applied research) relating
broadly to public health by establishing, (a) Have written policies and
known street address, facsimile number procedures for addressing allegations of
or e-mail address of the addressee. discovering, developing, elucidating or
confirming information about, or the research misconduct that meet the
Several sections of Subpart E of this part requirements of this part;
have special notice requirements. underlying mechanism relating to,
biological causes, functions or effects, (b) Respond to each allegation of
§ 93.217 Office of Research Integrity or research misconduct for which the
diseases, treatments, or related matters
ORI. institution is responsible under this part
to be studied.
in a thorough, competent, objective and
Office of Research Integrity or ORI fair manner, including precautions to
§ 93.223 Research misconduct
means the office to which the HHS ensure that individuals responsible for
proceeding.
Secretary has delegated responsibility carrying out any part of the research
for addressing research integrity and Research misconduct proceeding misconduct proceeding do not have
misconduct issues related to PHS means any actions related to alleged unresolved personal, professional or
supported activities. research misconduct taken under this financial conflicts of interest with the
§ 93.218 Person.
part, including but not limited to, complainant, respondent or witnesses;
allegation assessments, inquiries, (c) Foster a research environment that
Person means any individual, investigations, ORI oversight reviews, promotes the responsible conduct of
corporation, partnership, institution, hearings, and administrative appeals. research, research training, and
association, unit of government, or legal activities related to that research or
entity, however organized. § 93.224 Research record.
research training, discourages research
§ 93.219 Preponderance of the evidence. Research record means the record of misconduct, and deals promptly with
data or results that embody the facts allegations or evidence of possible
Preponderance of the evidence means research misconduct;
resulting from scientific inquiry,
proof by information that, compared (d) Take all reasonable and practical
including but not limited to, research
with that opposing it, leads to the steps to protect the positions and
proposals, laboratory records, both
conclusion that the fact at issue is more reputations of good faith complainants,
probably true than not. physical and electronic, progress
reports, abstracts, theses, oral witnesses and committee members and
§ 93.220 Public Health Service or PHS. presentations, internal reports, journal protect them from retaliation by
articles, and any documents and respondents and other institutional
Public Health Service or PHS means members;
the unit within the Department of materials provided to HHS or an
(e) Provide confidentiality to the
Health and Human Services that institutional official by a respondent in
extent required by § 93.108 to all
includes the Office of Public Health and the course of the research misconduct
respondents, complainants, and
Science and the following Operating proceeding. research subjects identifiable from
Divisions: Agency for Healthcare research records or evidence;
§ 93.225 Respondent.
Research and Quality, Agency for Toxic (f) Take all reasonable and practical
Substances and Disease Registry, Respondent means the person against steps to ensure the cooperation of
Centers for Disease Control and whom an allegation of research respondents and other institutional
Prevention, Food and Drug misconduct is directed or who is the members with research misconduct
Administration, Health Resources and subject of a research misconduct proceedings, including, but not limited
Services Administration, Indian Health proceeding. to, their providing information, research
Service, National Institutes of Health, records, and evidence;
and the Substance Abuse and Mental § 93.226 Retaliation. (g) Cooperate with HHS during any
Health Services Administration, and the Retaliation for the purpose of this part research misconduct proceeding or
offices of the Regional Health means an adverse action taken against a compliance review;
Administrators. (h) Assist in administering and
complainant, witness, or committee
§ 93.221 PHS support. member by an institution or one of its enforcing any HHS administrative
members in response to— actions imposed on its institutional
PHS support means PHS funding, or members; and
applications or proposals therefor, for (a) A good faith allegation of research (i) Have an active assurance of
biomedical or behavioral research, misconduct; or compliance.
biomedical or behavioral research (b) Good faith cooperation with a
training, or activities related to that § 93.301 Institutional assurances.
research misconduct proceeding.
research or training, that may be (a) General policy. An institution with
provided through: Funding for PHS § 93.227 Secretary or HHS. PHS supported biomedical or behavioral
intramural research; PHS grants, Secretary or HHS means the Secretary research, research training or activities
cooperative agreements, or contracts or of HHS or any other officer or employee related to that research or research
subgrants or subcontracts under those training must provide PHS with an
of the HHS to whom the Secretary
PHS funding instruments; or salary or assurance of compliance with this part,
delegates authority.
other payments under PHS grants, satisfactory to the Secretary. PHS
cooperative agreements or contracts. funding components may authorize

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28389

funds for biomedical and behavioral (b) By submitting a Small to protect or restore the reputation of
research, research training, or activities Organization Statement, the institution persons alleged to have engaged in
related to that research or research agrees to report all allegations of research misconduct but against whom
training only to institutions that have research misconduct to ORI. ORI or no finding of research misconduct is
approved assurances and required another appropriate HHS office will made;
renewals on file with ORI. work with the institution to develop and (l) All reasonable and practical efforts
(b) Institutional Assurance. The implement a process for handling to protect or restore the position and
responsible institutional official must allegations of research misconduct reputation of any complainant, witness,
assure on behalf of the institution that consistent with this part. or committee member and to counter
the institution— (c) The Small Organization Statement potential or actual retaliation against
(1) Has written policies and does not relieve the institution from these complainants, witnesses, and
procedures in compliance with this part complying with any other provision of committee members; and
for inquiring into and investigating this part. (m) Full and continuing cooperation
allegations of research misconduct; and
with ORI during its oversight review
(2) Complies with its own policies § 93.304 Institutional policies and
and procedures and the requirements of procedures. under Subpart D of this part or any
this part. Institutions seeking an approved subsequent administrative hearings or
assurance must have written policies appeals under Subpart E of this part.
§ 93.302 Institutional compliance with
and procedures for addressing research This includes providing all research
assurances. records and evidence under the
misconduct that include the following—
(a) Compliance with assurance. ORI (a) Consistent with § 93.108, institution’s control, custody, or
considers an institution in compliance protection of the confidentiality of possession and access to all persons
with its assurance if the institution— respondents, complainants, and within its authority necessary to
(1) Establishes policies and develop a complete record of relevant
research subjects identifiable from
procedures according to this part, keeps evidence.
research records or evidence;
them in compliance with this part, and (b) A thorough, competent, objective,
upon request, provides them to ORI, § 93.305 Responsibility for maintenance
and fair response to allegations of and custody of research records and
other HHS personnel, and members of
research misconduct consistent with evidence.
the public;
and within the time limits of this part, An institution, as the responsible
(2) Takes all reasonable and practical
specific steps to foster research integrity including precautions to ensure that legal entity for the PHS supported
consistent with § 93.300, including— individuals responsible for carrying out research, has a continuing obligation
(i) Informs the institution’s research any part of the research misconduct under this part to ensure that it
members participating in or otherwise proceeding do not have unresolved maintains adequate records for a
involved with PHS supported personal, professional, or financial research misconduct proceeding. The
biomedical or behavioral research, conflicts of interest with the institution must—
research training or activities related to complainant, respondent, or witnesses;
(a) Either before or when the
that research or research training, (c) Notice to the respondent,
institution notifies the respondent of the
including those applying for support consistent with and within the time
allegation, inquiry or investigation,
from any PHS funding component, limits of this part;
promptly take all reasonable and
about its policies and procedures for (d) Written notice to ORI of any
practical steps to obtain custody of all
responding to allegations of research decision to open an investigation on or
the research records and evidence
misconduct, and the institution’s before the date on which the
needed to conduct the research
commitment to compliance with the investigation begins;
(e) Opportunity for the respondent to misconduct proceeding, inventory the
policies and procedures; and records and evidence, and sequester
(ii) Complies with its policies and provide written comments on the
institution’s inquiry report; them in a secure manner, except that
procedures and each specific provision where the research records or evidence
of this part. (f) Opportunity for the respondent to
provide written comments on the draft encompass scientific instruments shared
(b) Annual report. An institution must by a number of users, custody may be
file an annual report with ORI which report of the investigation, and
provisions for the institutional limited to copies of the data or evidence
contains information specified by ORI on such instruments, so long as those
on the institution’s compliance with investigation committee to consider and
address the comments before issuing the copies are substantially equivalent to
this part. the evidentiary value of the instruments;
(c) Additional information. Along final report;
with its assurance or annual report, an (g) Protocols for handling the research (b) Where appropriate, give the
institution must send ORI such other record and evidence, including the respondent copies of, or reasonable,
aggregated information as ORI may requirements of § 93.305; supervised access to the research
request on the institution’s research (h) Appropriate interim institutional records;
misconduct proceedings covered by this actions to protect public health, Federal (c) Undertake all reasonable and
part and the institution’s compliance funds and equipment, and the integrity practical efforts to take custody of
with the requirements of this part. of the PHS supported research process; additional research records or evidence
(i) Notice to ORI under § 93.318 and that is discovered during the course of
§ 93.303 Assurances for small institutions. notice of any facts that may be relevant a research misconduct proceeding,
(a) If an institution is too small to to protect public health, Federal funds except that where the research records
handle research misconduct and equipment, and the integrity of the or evidence encompass scientific
proceedings, it may file a ‘‘Small PHS supported research process; instruments shared by a number of
Organization Statement’’ with ORI in (j) Institutional actions in response to users, custody may be limited to copies
place of the formal institutional policies final findings of research misconduct; of the data or evidence on such
and procedures required by §§ 93.301 (k) All reasonable and practical instruments, so long as those copies are
and 93.304. efforts, if requested and as appropriate, substantially equivalent to the

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28390 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

evidentiary value of the instruments; (d) Criteria warranting an applications, contracts, and publications
and investigation. An inquiry’s purpose is to listing PHS support;
(d) Maintain the research records and decide if an allegation warrants an (4) The basis for recommending that
evidence as required by § 93.317. investigation. An investigation is the alleged actions warrant an
warranted if there is— investigation; and
§ 93.306 Using a consortium or other (1) A reasonable basis for concluding (5) Any comments on the report by
person for research misconduct that the allegation falls within the the respondent or the complainant.
proceedings.
definition of research misconduct under (b) The institution must provide the
(a) An institution may use the services this part and involves PHS supported following information to ORI on
of a consortium or person that the biomedical or behavioral research, request—
institution reasonably determines to be research training or activities related to (1) The institutional policies and
qualified by practice and experience to that research or research training, as procedures under which the inquiry
conduct research misconduct provided in § 93.102; and was conducted;
proceedings. (2) Preliminary information-gathering (2) The research records and evidence
(b) A consortium may be a group of and preliminary fact-finding from the reviewed, transcripts or recordings of
institutions, professional organizations, inquiry indicates that the allegation may any interviews, and copies of all
or mixed groups which will conduct have substance. relevant documents; and
research misconduct proceedings for (e) Inquiry report. The institution (3) The charges for the investigation to
other institutions. must prepare a written report that meets consider.
(c) A consortium or person acting on the requirements of this section and (c) Documentation of decision not to
behalf of an institution must follow the § 93.309. investigate. Institutions must keep
requirements of this part in conducting (f) Opportunity to comment. The sufficiently detailed documentation of
research misconduct proceedings. institution must provide the respondent inquiries to permit a later assessment by
an opportunity to review and comment ORI of the reasons why the institution
The Institutional Inquiry on the inquiry report and attach any
decided not to conduct an investigation.
§ 93.307 Institutional inquiry. comments received to the report.
Consistent with § 93.317, institutions
(g) Time for completion. The
(a) Criteria warranting an inquiry. An institution must complete the inquiry must keep these records in a secure
inquiry is warranted if the allegation— within 60 calendar days of its initiation manner for at least 7 years after the
(1) Falls within the definition of unless circumstances clearly warrant a termination of the inquiry, and upon
research misconduct under this part; longer period. If the inquiry takes longer request, provide them to ORI or other
(2) Is within § 93.102; and than 60 days to complete, the inquiry authorized HHS personnel.
(3) Is sufficiently credible and specific record must include documentation of (d) Notification of special
so that potential evidence of research the reasons for exceeding the 60-day circumstances. In accordance with
misconduct may be identified. period. § 93.318, institutions must notify ORI
(b) Notice to respondent and custody and other PHS agencies, as relevant, of
of research records. At the time of or § 93.308 Notice of the results of the any special circumstances that may
before beginning an inquiry, an inquiry. exist.
institution must make a good faith effort (a) Notice to respondent. The
The Institutional Investigation
to notify in writing the presumed institution must notify the respondent
respondent, if any. If the inquiry whether the inquiry found that an § 93.310 Institutional investigation.
subsequently identifies additional investigation is warranted. The notice Institutions conducting research
respondents, the institution must notify must include a copy of the inquiry misconduct investigations must:
them. To the extent it has not already report and include a copy of or refer to (a) Time. Begin the investigation
done so at the allegation stage, the this part and the institution’s policies within 30 days after determining that an
institution must, on or before the date and procedures adopted under its investigation is warranted.
on which the respondent is notified or assurance. (b) Notice to ORI. Notify the ORI
the inquiry begins, whichever is earlier, (b) Notice to complainants. The Director of the decision to begin an
promptly take all reasonable and institution may notify the complainant investigation on or before the date the
practical steps to obtain custody of all who made the allegation whether the investigation begins and provide an
the research records and evidence inquiry found that an investigation is inquiry report that meets the
needed to conduct the research warranted. The institution may provide requirements of § 93.307 and § 93.309.
misconduct proceeding, inventory the relevant portions of the report to the (c) Notice to the respondent. Notify
records and evidence, and sequester complainant for comment. the respondent in writing of the
them in a secure manner, except that § 93.309 Reporting to ORI on the decision allegations within a reasonable amount
where the research records or evidence to initiate an investigation. of time after determining that an
encompass scientific instruments shared (a) Within 30 days of finding that an investigation is warranted, but before
by a number of users, custody may be investigation is warranted, the the investigation begins. The institution
limited to copies of the data or evidence institution must provide ORI with the must give the respondent written notice
on such instruments, so long as those written finding by the responsible of any new allegations of research
copies are substantially equivalent to institutional official and a copy of the misconduct within a reasonable amount
the evidentiary value of the instruments. inquiry report which includes the of time of deciding to pursue allegations
(c) Review of evidence. The purpose following information— not addressed during the inquiry or in
of an inquiry is to conduct an initial (1) The name and position of the the initial notice of investigation.
review of the evidence to determine respondent; (d) Custody of the records. To the
whether to conduct an investigation. (2) A description of the allegations of extent they have not already done so at
Therefore, an inquiry does not require a research misconduct; the allegation or inquiry stages, take all
full review of all the evidence related to (3) The PHS support, including, for reasonable and practical steps to obtain
the allegation. example, grant numbers, grant custody of all the research records and

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28391

evidence needed to conduct the days, the institution must ask ORI for an (4) Identify whether any publications
research misconduct proceeding, extension in writing. need correction or retraction;
inventory the records and evidence, and (c) Progress reports. If ORI grants an (5) Identify the person(s) responsible
sequester them in a secure manner, extension, it may direct the institution for the misconduct; and
except that where the research records to file periodic progress reports. (6) List any current support or known
or evidence encompass scientific applications or proposals for support
§ 93.312 Opportunity to comment on the
instruments shared by a number of that the respondent has pending with
investigation report.
users, custody may be limited to copies non-PHS Federal agencies.
of the data or evidence on such (a) The institution must give the (g) Comments. Include and consider
instruments, so long as those copies are respondent a copy of the draft any comments made by the respondent
substantially equivalent to the investigation report and, concurrently, a and complainant on the draft
evidentiary value of the instruments. copy of, or supervised access to, the investigation report.
Whenever possible, the institution must evidence on which the report is based. (h) Maintain and provide records.
take custody of the records— The comments of the respondent on the Maintain and provide to ORI upon
(1) Before or at the time the institution draft report, if any, must be submitted request all relevant research records and
notifies the respondent; and within 30 days of the date on which the records of the institution’s research
(2) Whenever additional items respondent received the draft misconduct proceeding, including
become known or relevant to the investigation report. results of all interviews and the
investigation. (b) The institution may provide the transcripts or recordings of such
(e) Documentation. Use diligent complainant a copy of the draft interviews.
efforts to ensure that the investigation is investigation report or relevant portions
thorough and sufficiently documented of that report. The comments of the § 93.314 Institutional appeals.
and includes examination of all research complainant, if any, must be submitted (a) While not required by this part, if
records and evidence relevant to within 30 days of the date on which the the institution’s procedures provide for
reaching a decision on the merits of the complainant received the draft an appeal by the respondent that could
allegations. investigation report or relevant portions result in a reversal or modification of
(f) Ensuring a fair investigation. Take of it. the findings of research misconduct in
reasonable steps to ensure an impartial the investigation report, the institution
§ 93.313 Institutional investigation report.
and unbiased investigation to the must complete any such appeal within
maximum extent practicable, including The final institutional investigation 120 days of its filing. Appeals from
participation of persons with report must be in writing and include: personnel or similar actions that would
appropriate scientific expertise who do (a) Allegations. Describe the nature of not result in a reversal or modification
not have unresolved personal, the allegations of research misconduct. of the findings of research misconduct
professional, or financial conflicts of (b) PHS support. Describe and
are excluded from the 120-day limit.
interest with those involved with the document the PHS support, including,
(b) If unable to complete any appeals
inquiry or investigation. for example, any grant numbers, grant
within 120 days, the institution must
(g) Interviews. Interview each applications, contracts, and publications
ask ORI for an extension in writing and
respondent, complainant, and any other listing PHS support.
provide an explanation for the request.
available person who has been (c) Institutional charge. Describe the
(c) ORI may grant requests for
reasonably identified as having specific allegations of research
extension for good cause. If ORI grants
information regarding any relevant misconduct for consideration in the
an extension, it may direct the
aspects of the investigation, including investigation.
institution to file periodic progress
witnesses identified by the respondent, (d) Policies and procedures. If not
reports.
and record or transcribe each interview, already provided to ORI with the
provide the recording or transcript to inquiry report, include the institutional § 93.315 Notice to ORI of institutional
the interviewee for correction, and policies and procedures under which findings and actions.
include the recording or transcript in the investigation was conducted. The institution must give ORI the
the record of the investigation. (e) Research records and evidence. following:
(h) Pursue leads. Pursue diligently all Identify and summarize the research (a) Investigation Report. Include a
significant issues and leads discovered records and evidence reviewed, and copy of the report, all attachments, and
that are determined relevant to the identify any evidence taken into any appeals.
investigation, including any evidence of custody but not reviewed. (b) Final institutional action. State
additional instances of possible research (f) Statement of findings. For each whether the institution found research
misconduct, and continue the separate allegation of research misconduct, and if so, who committed
investigation to completion. misconduct identified during the the misconduct.
investigation, provide a finding as to (c) Findings. State whether the
§ 93.311 Investigation time limits. whether research misconduct did or did institution accepts the investigation’s
(a) Time limit for completing an not occur, and if so— findings.
investigation. An institution must (1) Identify whether the research (d) Institutional administrative
complete all aspects of an investigation misconduct was falsification, actions. Describe any pending or
within 120 days of beginning it, fabrication, or plagiarism, and if it was completed administrative actions
including conducting the investigation, intentional, knowing, or in reckless against the respondent.
preparing the report of findings, disregard;
providing the draft report for comment (2) Summarize the facts and the § 93.316 Completing the research
in accordance with § 93.312, and analysis which support the conclusion misconduct process.
sending the final report to ORI under and consider the merits of any (a) ORI expects institutions to carry
§ 93.315. reasonable explanation by the inquiries and investigations through to
(b) Extension of time limit. If unable respondent; completion and to pursue diligently all
to complete the investigation in 120 (3) Identify the specific PHS support; significant issues. An institution must

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28392 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

notify ORI in advance if the institution PHS proceeding involving the research Subpart D—Responsibilities of the U.S.
plans to close a case at the inquiry, misconduct allegation under subparts D Department of Health and Human
investigation, or appeal stage on the and E of this part, whichever is later. Services
basis that the respondent has admitted (c) Provision for HHS custody. On
guilt, a settlement with the respondent General Information
request, institutions must transfer
has been reached, or for any other § 93.400 General statement of ORI
custody of or provide copies to HHS, of
reason, except the closing of a case at authority.
any institutional record relevant to a
the inquiry stage on the basis that an (a) ORI review. ORI may respond
investigation is not warranted or a research misconduct allegation covered
by this part, including the research directly to any allegation of research
finding of no misconduct at the misconduct at any time before, during,
investigation stage, which must be records and evidence, to perform
forensic or other analyses or as or after an institution’s response to the
reported to ORI under § 93.315. matter. The ORI response may include,
(b) After consulting with the otherwise needed to conduct an HHS
inquiry or investigation or for ORI to but is not limited to—
institution on its basis for closing a case (1) Conducting allegation
under paragraph (a) of this section, ORI conduct its review or to present
assessments;
may conduct an oversight review of the evidence in any proceeding under
(2) Determining independently if
institution’s handling of the case and subparts D and E of this part.
jurisdiction exists under this part in any
take appropriate action including: matter;
§ 93.318 Notifying ORI of special
(1) Approving or conditionally (3) Forwarding allegations of research
circumstances.
approving closure of the case; misconduct to the appropriate
(2) Directing the institution to At any time during a research institution or HHS component for
complete its process; misconduct proceeding, as defined in inquiry or investigation;
(3) Referring the matter for further § 93.223, an institution must notify ORI (4) Recommending that HHS should
investigation by HHS; or, immediately if it has reason to believe perform an inquiry or investigation or
(4) Taking a compliance action. that any of the following conditions issue findings and taking all appropriate
Other Institutional Responsibilities exist: actions in response to the inquiry,
(a) Health or safety of the public is at investigation, or findings;
§ 93.317 Retention and custody of the (5) Notifying or requesting assistance
research misconduct proceeding record.
risk, including an immediate need to
protect human or animal subjects. and information from PHS funding
(a) Definition of records of research components or other affected Federal
misconduct proceedings. As used in this (b) HHS resources or interests are and state offices and agencies or
section, the term ‘‘records of research threatened. institutions;
misconduct proceedings’’ includes: (c) Research activities should be (6) Reviewing an institution’s findings
(1) The records that the institution suspended. and process;
secures for the proceeding pursuant to (7) Making a finding of research
(d) There is reasonable indication of
§§ 93.305, 93.307(b) and 93.310(d), misconduct; and
possible violations of civil or criminal
except to the extent the institution (8) Proposing administrative actions
law.
subsequently determines and to HHS.
documents that those records are not (e) Federal action is required to (b) Requests for information. ORI may
relevant to the proceeding or that the protect the interests of those involved in request clarification or additional
records duplicate other records that are the research misconduct proceeding. information, documentation, research
being retained; (f) The research institution believes records, or evidence from an institution
(2) The documentation of the the research misconduct proceeding or its members or other persons or
determination of irrelevant or duplicate may be made public prematurely so that sources to carry out ORI’s review.
records; (3) The inquiry report and final HHS may take appropriate steps to (c) HHS administrative actions. (1) In
documents (not drafts) produced in the safeguard evidence and protect the response to a research misconduct
course of preparing that report, proceeding, ORI may propose
rights of those involved.
including the documentation of any administrative actions against any
decision not to investigate as required (g) The research community or public person to the HHS and, upon HHS
by § 93.309(d); should be informed. approval and final action in accordance
(4) The investigation report and all with this part, implement the actions.
§ 93.319 Institutional standards.
records (other than drafts of the report) (2) ORI may propose to the HHS
in support of that report, including the (a) Institutions may have internal debarring official that a person be
recordings or transcriptions of each standards of conduct different from the suspended or debarred from receiving
interview conducted pursuant to HHS standards for research misconduct Federal funds and may propose to other
§ 93.310(g); and under this part. Therefore, an institution appropriate PHS components the
(5) The complete record of any may find conduct to be actionable under implementation of HHS administrative
institutional appeal covered by § 93.314. its standards even if the action does not actions within the components’
(b) Maintenance of record. Unless meet this part’s definition of research authorities.
custody has been transferred to HHS misconduct. (d) ORI assistance to institutions. At
under paragraph (c) of this section, or any time, ORI may provide information,
ORI has advised the institution in (b) An HHS finding or settlement does technical assistance, and procedural
writing that it no longer needs to retain not affect institutional findings or advice to institutional officials as
the records, an institution must administrative actions based on an needed regarding an institution’s
maintain records of research institution’s internal standards of participation in research misconduct
misconduct proceedings in a secure conduct. proceedings.
manner for 7 years after completion of (e) Review of institutional assurances.
the proceeding or the completion of any ORI may review institutional assurances

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28393

and policies and procedures for (c) If ORI decides that an inquiry is official issues a notice of proposed
compliance with this part. warranted, it forwards the matter to the debarment or suspension to the
(f) Institutional compliance. ORI may appropriate institution or HHS respondent as part of the charge letter.
make findings and impose HHS component. The charge letter includes the ORI
administrative actions related to an (d) If ORI decides that an inquiry is findings of research misconduct and the
institution’s compliance with this part not warranted it will close the case and basis for them and any HHS
and with its policies and procedures, forward the allegation in accordance administrative actions. The letter also
including an institution’s participation with paragraph(e) of this section. advises the respondent of the
in research misconduct proceedings. (e) ORI may forward allegations that opportunity to contest the findings and
do not fall within the jurisdiction of this administrative actions under Subpart E
§ 93.401 Interaction with other offices and part to the appropriate HHS component, of this part.
interim actions. Federal or State agency, institution, or (b) The ORI sends the charge letter by
(a) ORI may notify and consult with other appropriate entity. certified mail or a private delivery
other offices at any time if it has reason service to the last known address of the
to believe that a research misconduct § 93.403 ORI review of research
misconduct proceedings.
respondent or the last known principal
proceeding may involve that office. If place of business of the respondent’s
ORI believes that a criminal or civil ORI may conduct reviews of research attorney.
fraud violation may have occurred, it misconduct proceedings. In conducting
shall promptly refer the matter to the its review, ORI may— § 93.406 Final HHS actions.
Department of Justice (DOJ), the HHS (a) Determine whether there is HHS Unless the respondent contests the
Inspector General (OIG), or other jurisdiction under this part; charge letter within the 30-day period
appropriate investigative body. ORI may (b) Consider any reports, institutional prescribed in § 93.501, the ORI finding
provide expertise and assistance to the findings, research records, and of research misconduct is the final HHS
DOJ, OIG, PHS offices, other Federal evidence; action on the research misconduct
offices, and state or local offices (c) Determine if the institution issues and the HHS administrative
involved in investigating or otherwise conducted the proceedings in a timely actions become final and will be
pursuing research misconduct and fair manner in accordance with this implemented, except that the debarring
allegations or related matters. part with sufficient thoroughness, official’s decision is the final HHS
objectivity, and competence to support action on any debarment or suspension
(b) ORI may notify affected PHS
the conclusions; actions.
offices and funding components at any
(d) Obtain additional information or
time to permit them to make appropriate
materials from the institution, the § 93.407 HHS administrative actions.
interim responses to protect the health
respondent, complainants, or other (a) In response to a research
and safety of the public, to promote the
persons or sources; misconduct proceeding, HHS may
integrity of the PHS supported research (e) Conduct additional analyses and
and research process, and to conserve impose HHS administrative actions that
develop evidence; include but are not limited to:
public funds. (f) Decide whether research
(c) The information provided will not (1) Clarification, correction, or
misconduct occurred, and if so who retraction of the research record.
be disclosed as part of the peer review committed it;
and advisory committee review (2) Letters of reprimand.
(g) Make appropriate research (3) Imposition of special certification
processes, but may be used by the misconduct findings and propose HHS
Secretary in making decisions about the or assurance requirements to ensure
administrative actions; and compliance with applicable regulations
award or continuation of funding. (h) Take any other actions necessary or terms of PHS grants, contracts, or
Research Misconduct Issues to complete HHS’ review. cooperative agreements.
§ 93.404 Findings of research misconduct (4) Suspension or termination of a
§ 93.402 ORI allegation assessments.
and proposed administrative actions. PHS grant, contract, or cooperative
(a) When ORI receives an allegation of agreement.
research misconduct directly or After completing its review, ORI
either closes the case without a finding (5) Restriction on specific activities or
becomes aware of an allegation or expenditures under an active PHS grant,
apparent instance of research of research misconduct or—
(a) Makes findings of research contract, or cooperative agreement.
misconduct, it may conduct an initial (6) Special review of all requests for
misconduct and proposes and obtains
assessment or refer the matter to the PHS funding.
HHS approval of administrative actions
relevant institution for an assessment, (7) Imposition of supervision
based on the record of the research
inquiry, or other appropriate actions. requirements on a PHS grant, contract,
misconduct proceedings and any other
(b) If ORI conducts an assessment, it or cooperative agreement.
information obtained by ORI during its
considers whether the allegation of (8) Certification of attribution or
review; or
research misconduct appears to fall authenticity in all requests for support
(b) Recommends that HHS seek to
within the definition of research and reports to the PHS.
settle the case.
misconduct, appears to involve PHS (9) No participation in any advisory
supported biomedical or behavior § 93.405 Notifying the respondent of capacity to the PHS.
research, research training or activities findings of research misconduct and HHS (10) Adverse personnel action if the
related to that research or research administrative actions. respondent is a Federal employee, in
training, as provided in § 93.102, and (a) When the ORI makes a finding of compliance with relevant Federal
whether it is sufficiently specific so that research misconduct or seeks to impose personnel policies and laws.
potential evidence may be identified or enforce HHS administrative actions, (11) Suspension or debarment under
and sufficiently substantive to warrant other than debarment or suspension, it 45 CFR Part 76, 48 CFR Subparts 9.4
an inquiry. ORI may review all readily notifies the respondent in a charge and 309.4, or both.
accessible, relevant information related letter. In cases involving a debarment or (b) In connection with findings of
to the allegation. suspension action, the HHS debarring research misconduct, HHS also may

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28394 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

seek to recover PHS funds spent in § 93.409 Settlement of research (3) Failure to report to ORI all
support of the activities that involved misconduct proceedings. investigations and findings of research
research misconduct. (a) HHS may settle a research misconduct under this part;
(c) Any authorized HHS component misconduct proceeding at any time it (4) Failure to cooperate with ORI’s
may impose, administer, or enforce HHS concludes that settlement is in the best review of research misconduct
administrative actions separately or in interests of the Federal government and proceedings; or
coordination with other HHS the public health or welfare.
(b) Settlement agreements are publicly (5) Other actions or omissions that
components, including, but not limited
available, regardless of whether the ORI have a material, adverse effect on
to ORI, the Office of Inspector General,
made a finding of research misconduct. reporting and responding to allegations
the PHS funding component, and the
of research misconduct.
debarring official.
§ 93.410 Final HHS action with no
settlement or finding of research § 93.413 HHS compliance actions.
§ 93.408 Mitigating and aggravating
factors in HHS administrative actions. misconduct. (a) An institution’s failure to comply
The purpose of HHS administrative When the final HHS action does not with its assurance and the requirements
actions is remedial. The appropriate result in a settlement or finding of of this part may result in enforcement
administrative action is commensurate research misconduct, ORI may: action against the institution.
with the seriousness of the misconduct, (a) Provide written notice to the (b) ORI may address institutional
and the need to protect the health and respondent, the relevant institution, the deficiencies through technical
safety of the public, promote the complainant, and HHS officials. assistance if the deficiencies do not
integrity of the PHS supported research (b) Take any other actions authorized substantially affect compliance with this
and research process, and conserve by law. part.
public funds. HHS considers § 93.411 Final HHS action with settlement (c) If an institution fails to comply
aggravating and mitigating factors in or finding of research misconduct. with its assurance and the requirements
determining appropriate HHS When a final HHS action results in a of this part, HHS may take some or all
administrative actions and their terms. settlement or research misconduct of the following compliance actions:
HHS may consider other factors as
finding, ORI may: (1) Issue a letter of reprimand.
appropriate in each case. The existence (a) Provide final notification of any
or nonexistence of any factor is not (2) Direct that research misconduct
research misconduct findings and HHS proceedings be handled by HHS.
determinative: administrative actions to the
(a) Knowing, intentional, or reckless. (3) Place the institution on special
respondent, the relevant institution, the
Were the respondent’s actions knowing review status.
complainant, and HHS officials. The
or intentional or was the conduct (4) Place information on the
debarring official may provide a
reckless? institutional noncompliance on the ORI
(b) Pattern. Was the research separate notice of final HHS action on
any debarment or suspension actions. Web site.
misconduct an isolated event or part of
(b) Identify publications which (5) Require the institution to take
a continuing or prior pattern of
require correction or retraction and corrective actions.
dishonest conduct?
(c) Impact. Did the misconduct have prepare and send a notice to the (6) Require the institution to adopt
significant impact on the proposed or relevant journal. and implement an institutional integrity
reported research record, research (c) Publish notice of the research agreement.
subjects, other researchers, institutions, misconduct findings.
(d) Notify the respondent’s current (7) Recommend that HHS debar or
or the public health or welfare? suspend the entity.
(d) Acceptance of responsibility. Has employer.
(e) Take any other actions authorized (8) Any other action appropriate to
the respondent accepted responsibility the circumstances.
by law.
for the misconduct by—
(1) Admitting the conduct; (d) If the institution’s actions
Institutional Compliance Issues
(2) Cooperating with the research constitute a substantial or recurrent
misconduct proceedings; § 93.412 Making decisions on institutional failure to comply with this part, ORI
(3) Demonstrating remorse and noncompliance. may also revoke the institution’s
awareness of the significance and (a) Institutions must foster a research assurance under §§ 93.301 or 93.303.
seriousness of the research misconduct; environment that discourages (e) ORI may make public any findings
and misconduct in all research and that of institutional noncompliance and HHS
(4) Taking steps to correct or prevent deals forthrightly with possible compliance actions.
the recurrence of the research misconduct associated with PHS
supported research. Disclosure of Information
misconduct.
(e) Failure to accept responsibility. (b) ORI may decide that an institution § 93.414 Notice.
Does the respondent blame others rather is not compliant with this part if the
than accepting responsibility for the institution shows a disregard for, or (a) ORI may disclose information to
actions? inability or unwillingness to implement other persons for the purpose of
(f) Retaliation. Did the respondent and follow the requirements of this part providing or obtaining information
retaliate against complainants, and its assurance. In making this about research misconduct as permitted
witnesses, committee members, or other decision, ORI may consider, but is not under the Privacy Act, 5 U.S.C. 552a.
persons? limited to the following factors— (b) ORI may publish a notice of final
(g) Present responsibility. Is the (1) Failure to establish and comply agency findings of research misconduct,
respondent presently responsible to with policies and procedures under this settlements, and HHS administrative
conduct PHS supported research? part; actions and release and withhold
(h) Other factors. Other factors (2) Failure to respond appropriately information as permitted by the Privacy
appropriate to the circumstances of a when allegations of research Act and the Freedom of Information
particular case. misconduct arise; Act, 5 U.S.C. 552.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28395

Subpart E—Opportunity To Contest (1) In writing; by a party, the ALJ must appoint an
ORI Findings of Research Misconduct (2) Signed by the respondent or by the expert, either:
and HHS Administrative Actions respondent’s attorney; and (i) The expert, if any, who is agreed
(3) Sent by certified mail, or other upon by both parties and found to be
General Information equivalent (i.e., with a verified method qualified by the ALJ; or,
§ 93.500 General policy. of delivery), to the DAB Chair and ORI. (ii) If the parties cannot agree upon an
(a) This subpart provides a (c) Contents of a request for hearing. expert, the expert chosen by the ALJ.
respondent an opportunity to contest The request for a hearing must— (2) The ALJ may seek advice from the
ORI findings of research misconduct (1) Admit or deny each finding of expert(s) at any time during the
and HHS administrative actions, research misconduct and each factual discovery and hearing phases of the
including debarment or suspension, assertion made in support of the proceeding. The expert(s) shall provide
arising under 42 U.S.C. 289b in finding; advice to the ALJ in the form of a
connection with PHS supported (2) Accept or challenge each proposed written report or reports that will be
biomedical and behavioral research, HHS administrative action; served upon the parties within 10 days
research training, or activities related to (3) Provide detailed, substantive of submission to the ALJ. That report
that research or research training. reasons for each denial or challenge; must contain a statement of the expert’s
(b) A respondent has an opportunity (4) Identify any legal issues or background and qualifications. Any
to contest ORI research misconduct defenses that the respondent intends to comment on or response to a report by
findings and HHS administrative raise during the proceeding; and a party, which may include comments
actions under this part, including (5) Identify any mitigating factors that on the expert’s qualifications, must be
debarment or suspension, by requesting the respondent intends to prove. submitted to the ALJ in accordance with
an administrative hearing before an (d) Extension for good cause to § 93.510(c). The written reports and any
Administrative Law Judge (ALJ) supplement the hearing request. (1) comment on, or response to them are
affiliated with the HHS DAB, when— After receiving notification of the part of the record. Expert witnesses of
(1) ORI has made a finding of research appointment of the ALJ, the respondent the parties may testify on the reports
misconduct against a respondent; and has 10 days to submit a written request and any comments or responses at the
(2) The respondent has been notified to the ALJ for supplementation of the hearing, unless the ALJ determines such
of those findings and any proposed HHS hearing request to comply fully with the testimony to be inadmissible in
administrative actions, including requirements of paragraph (c) of this accordance with § 93.519, or that such
debarment or suspension, in accordance section. The written request must show testimony would unduly delay the
with this part. good cause in accordance with proceeding.
(c) The ALJ’s ruling on the merits of paragraph (d)(2) of this section and set (c) No ALJ, or person hired or
the ORI research misconduct findings forth the proposed supplementation of appointed to assist the ALJ, may serve
and the HHS administrative actions is the hearing request. The ALJ may permit in any proceeding under this subpart if
subject to review by the Assistant the proposed supplementation of the he or she has any real or apparent
Secretary for Health in accordance with hearing request in whole or in part upon conflict of interest, bias, or prejudice
§ 93.523. The decision made under that a finding of good cause. that might reasonably impair his or her
section is the final HHS action, unless (2) Good cause means circumstances objectivity in the proceeding.
that decision results in a beyond the control of the respondent or (d) Any party to the proceeding may
recommendation for debarment or respondent’s representative and not request the ALJ or scientific expert to
suspension. In that case, the decision attributable to neglect or administrative withdraw from the proceeding because
under § 93.523 shall constitute findings inadequacy. of a real or apparent conflict of interest,
of fact to the debarring official in
Hearing Process bias, or prejudice under paragraph (c) of
accordance with 45 CFR 76.845(c).
(d) Where a proposed debarment or this section. The motion to disqualify
§ 93.502 Appointment of the must be timely and state with
suspension action is based upon an ORI Administrative Law Judge and scientific
finding of research misconduct, the particularity the grounds for
expert. disqualification. The ALJ may rule upon
procedures in this part provide the (a) Within 30 days of receiving a
notification, opportunity to contest, and the motion or certify it to the Chief ALJ
request for a hearing, the DAB Chair, in for decision. If the ALJ rules upon the
fact-finding required under the HHS consultation with the Chief
debarment and suspension regulations motion, either party may appeal the
Administrative Law Judge, must decision to the Chief ALJ.
at 45 CFR part 76, subparts H and G, designate an Administrative Law Judge
respectively, and 48 CFR Subparts 9.4 (e) An ALJ must withdraw from any
(ALJ) to determine whether the hearing proceeding for any reason found by the
and 309.4. request should be granted and, if the ALJ or Chief ALJ to be disqualifying.
§ 93.501 Opportunity to contest findings of hearing request is granted, to make
research misconduct and administrative recommended findings in the case after § 93.503 Grounds for granting a hearing
actions. a hearing or review of the administrative request.
(a) Opportunity to contest. A record in accordance with this part. (a) The ALJ must grant a respondent’s
respondent may contest ORI findings of (b) The ALJ may retain one or more hearing request if the ALJ determines
research misconduct and HHS persons with appropriate scientific or there is a genuine dispute over facts
administrative actions, including any technical expertise to assist the ALJ in material to the findings of research
debarment or suspension action, by evaluating scientific or technical issues misconduct or proposed administrative
requesting a hearing within 30 days of related to the findings of research actions, including any debarment or
receipt of the charge letter or other misconduct. suspension action. The respondent’s
written notice provided under § 93.405. (1) On the ALJ’s or a party’s motion general denial or assertion of error for
(b) Form of a request for hearing. The to appoint an expert, the ALJ must give each finding of research misconduct,
respondent’s request for a hearing must the parties an opportunity to submit and any basis for the finding, or for the
be— nominations. If such a motion is made proposed HHS administrative actions in

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28396 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

the charge letter, is not sufficient to (b) Except as otherwise limited by this (8) Require each party before the
establish a genuine dispute. subpart, the parties may— hearing to provide the other party and
(b) The hearing request must (1) Be accompanied, represented, and the ALJ with copies of any exhibits that
specifically deny each finding of advised by an attorney; the party intends to introduce into
research misconduct in the charge letter, (2) Participate in any case-related evidence;
each basis for the finding and each HHS conference held by the ALJ; (9) Issue a ruling, after an in camera
administrative action in the charge (3) Conduct discovery of documents inspection if necessary, to address the
letter, or it is considered an admission and other tangible items; disclosure of any evidence or portion of
by the respondent. If the hearing request (4) Agree to stipulations of fact or law evidence for which confidentiality is
does not specifically dispute the HHS that must be made part of the record; requested under this part or other
administrative actions, including any (5) File motions in writing before the Federal law or regulation, or which a
debarment or suspension actions, they ALJ; party submitted under seal;
are considered accepted by the (6) Present evidence relevant to the (10) Regulate the course of the hearing
respondent. issues at the hearing; and the conduct of representatives,
(c) If the respondent does not request (7) Present and cross-examine parties, and witnesses;
a hearing within the 30-day time period witnesses; (11) Examine witnesses and receive
prescribed in § 93.501(a), the finding(s) (8) Present oral arguments; evidence presented at the hearing;
and any administrative action(s), other (9) Submit written post-hearing briefs, (12) Admit, exclude, or limit evidence
than debarment or suspension actions, proposed findings of fact and offered by a party;
become final agency actions at the conclusions of law, and reply briefs (13) Hear oral arguments on facts or
expiration of the 30-day period. Where within reasonable time frames agreed law during or after the hearing;
there is a proposal for debarment or upon by the parties or established by the (14) Upon motion of a party, take
suspension, after the expiration of the ALJ as provided in § 93.522; and judicial notice of facts;
30-day time period the official record is (10) Submit materials to the ALJ and (15) Upon motion of a party, decide
closed and forwarded to the debarring other parties under seal, or in redacted cases, in whole or in part, by summary
official for a final decision. form, when necessary, to protect the judgment where there is no disputed
(d) If the ALJ grants the hearing confidentiality of any information issue of material fact;
request, the respondent may waive the contained in them consistent with this (16) Conduct any conference or oral
opportunity for any in-person part, the Privacy Act, the Freedom of argument in person, by telephone, or by
proceeding, and the ALJ may review Information Act, or other Federal law or audio-visual communication;
and decide the case on the basis of the regulation. (17) Take action against any party for
administrative record. The ALJ may failing to follow an order or procedure
§ 93.506 Authority of the Administrative
grant a respondent’s request that waiver Law Judge.
or for disruptive conduct.
of the in-person proceeding be (c) The ALJ does not have the
(a) The ALJ assigned to the case must authority to—
conditioned upon the opportunity for conduct a fair and impartial hearing,
respondent to file additional pleadings (1) Enter an order in the nature of a
avoid unnecessary delay, maintain directed verdict;
and documentation. ORI may also order, and assure that a complete and
supplement the administrative record (2) Compel settlement negotiations;
accurate record of the proceeding is (3) Enjoin any act of the Secretary; or
through pleadings, documents, in- properly made. The ALJ is bound by all (4) Find invalid or refuse to follow
person or telephonic testimony, and oral Federal statutes and regulations, Federal statutes or regulations,
presentations. Secretarial delegations of authority, and Secretarial delegations of authority, or
§ 93.504 Grounds for dismissal of a applicable HHS policies and may not HHS policies.
hearing request. refuse to follow them or find them
invalid, as provided in paragraph (c)(4) § 93.507 Ex parte communications.
(a) The ALJ must dismiss a hearing
request if the respondent— of this section. The ALJ has the (a) No party, attorney, or other party
(1) Does not file the request within 30 authorities set forth in this part. representative may communicate ex
days after receiving the charge letter; (b) Subject to review as provided parte with the ALJ on any matter at
(2) Does not raise a genuine dispute elsewhere in this subpart, the ALJ issue in a case, unless both parties have
over facts or law material to the findings may— notice and an opportunity to participate
of research misconduct and any (1) Set and change the date, time, in the communication. However, a
administrative actions, including schedule, and place of the hearing upon party, attorney, or other party
debarment and suspension actions, in reasonable notice to the parties; representative may communicate with
the hearing request or in any extension (2) Continue or recess the hearing in DAB staff about administrative or
to supplement granted by the ALJ under whole or in part for a reasonable period procedural matters.
§ 93.501(d); of time; (b) If an ex parte communication
(3) Does not raise any issue which (3) Hold conferences with the parties occurs, the ALJ will disclose it to the
may properly be addressed in a hearing; to identify or simplify the issues, or to other party and make it part of the
(4) Withdraws or abandons the consider other matters that may aid in record after the other party has an
hearing request; or the prompt disposition of the opportunity to comment.
(b) The ALJ may dismiss a hearing proceeding; (c) The provisions of this section do
request if the respondent fails to provide (4) Administer oaths and affirmations; not apply to communications between
ORI with notice in the form and manner (5) Require the attendance of an employee or contractor of the DAB
required by § 93.501. witnesses at a hearing; and the ALJ.
(6) Rule on motions and other
§ 93.505 Rights of the parties. procedural matters; § 93.508 Filing, forms, and service.
(a) The parties to the hearing are the (7) Require the production of (a) Filing. (1) Unless the ALJ provides
respondent and ORI. The investigating documents and regulate the scope and otherwise, all submissions required or
institution is not a party to the case, timing of documentary discovery as authorized to be filed in the proceeding
unless it is a respondent. permitted by this part; must be filed with the ALJ.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28397

(2) Submissions are considered filed or legal holiday observed by the Federal (2) Stipulations and admissions of fact
when they are placed in the mail, government, in which case it includes including the contents, relevancy, and
transmitted to a private delivery service the next business day. authenticity of documents;
for the purpose of delivering the item to (b) When the period of time allowed (3) Respondent’s waiver of an
the ALJ, or submitted in another manner is less than 7 days, intermediate administrative hearing, if any, and
authorized by the ALJ. Saturdays, Sundays, and legal holidays submission of the case on the basis of
(b) Forms. (1) Unless the ALJ provides observed by the Federal government the administrative record as provided in
otherwise, all submissions filed in the must be excluded from the computation. § 93.503(d);
proceeding must include an original and (c) Where a document has been filed (4) Identification of legal issues and
two copies. The ALJ may designate the by placing it in the mail, an additional any need for briefing before the hearing;
format for copies of nondocumentary 5 days must be added to the time (5) Identification of evidence,
materials such as videotapes, computer permitted for any response. This pleadings, and other materials, if any,
disks, or physical evidence. This paragraph does not apply to a that the parties should exchange before
provision does not apply to the charge respondent’s request for hearing under the hearing;
letter or other written notice provided § 93.501. (6) Identification of the parties’
under § 93.405. (d) Except for the respondent’s witnesses, the general nature of their
(2) Every submission filed in the request for a hearing, the ALJ may testimony, and the limitation on the
proceeding must include the title of the modify the time for the filing of any number of witnesses and the scope of
case, the docket number, and a document or paper required or their testimony;
designation of the nature of the authorized under the rules in this part (7) Scheduling dates such as the filing
submission, such as a ‘‘Motion to to be filed for good cause shown. When of briefs on legal issues identified in the
Compel the Production of Documents’’ time permits, notice of a party’s request charge letter or the respondent’s request
or ‘‘Respondent’s Proposed Exhibits.’’ for extension of the time and an for hearing, the exchange of witness
(3) Every submission filed in the opportunity to respond must be lists, witness statements, proposed
proceeding must be signed by and provided to the other party. exhibits, requests for the production of
contain the address and telephone documents, and objections to proposed
number of the party on whose behalf the § 93.510 Filing motions. witnesses and documents;
document or paper was filed, or the (a) Parties must file all motions and (8) Scheduling the time, place, and
attorney of record for the party. requests for an order or ruling with the anticipated length of the hearing; and
(c) Service. A party filing a ALJ, serve them on the other party, state (9) Other matters that may encourage
submission with the ALJ must, at the the nature of the relief requested, the fair, just, and prompt disposition of
time of filing, serve a copy on the other provide the legal authority relied upon, the proceedings.
party. Service may be made either to the and state the facts alleged. (c) The ALJ may schedule additional
last known principal place of business (b) All motions must be in writing prehearing conferences as appropriate,
of the party’s attorney if the party is except for those made during a upon reasonable notice to or request of
represented by an attorney, or, if not, to prehearing conference or at the hearing. the parties.
the party’s last known address. Service (c) Within 10 days after being served (d) All prehearing conferences will be
may be made by— with a motion, or other time as set by audio-taped with copies provided to the
(1) Certified mail; the ALJ, a party may file a response to parties upon request.
(2) First-class postage prepaid U.S. the motion. The moving party may not (e) Whenever possible, the ALJ must
Mail; file a reply to the responsive pleading memorialize in writing any oral rulings
(3) A private delivery service; unless allowed by the ALJ. within 10 days after the prehearing
(4) Hand-delivery; or (d) The ALJ may not grant a motion conference.
(5) Facsimile or other electronic before the time for filing a response has (f) By 15 days before the scheduled
means if permitted by the ALJ. expired, except with the parties’ consent hearing date, the ALJ must hold a final
(d) Proof of service. Each party filing or after a hearing on the motion. prehearing conference to resolve to the
a document or paper with the ALJ must However, the ALJ may overrule or deny maximum extent possible all
also provide proof of service at the time any motion without awaiting a outstanding issues about evidence,
of the filing. Any of the following items response. witnesses, stipulations, motions and all
may constitute proof of service: (e) The ALJ must make a reasonable other matters that may encourage the
(1) A certified mail receipt returned effort to dispose of all motions fair, just, and prompt disposition of the
by the postal service with a signature; promptly, and, whenever possible, proceedings.
(2) An official record of the postal dispose of all outstanding motions
§ 93.512 Discovery.
service or private delivery service; before the hearing.
(3) A certificate of service stating the (a) Request to provide documents. A
method, place, date of service, and § 93.511 Prehearing conferences. party may only request another party to
person served that is signed by an (a) The ALJ must schedule an initial produce documents or other tangible
individual with personal knowledge of prehearing conference with the parties items for inspection and copying that
these facts; or within 30 days of the DAB Chair’s are relevant and material to the issues
(4) Other proof authorized by the ALJ. assignment of the case. identified in the charge letter and in the
(b) The ALJ may use the initial respondent’s request for hearing.
§ 93.509 Computation of time. prehearing conference to discuss— (b) Meaning of documents. For
(a) In computing any period of time (1) Identification and simplification of purposes of this subpart, the term
under this part for filing and service or the issues, specification of disputes of documents includes information,
for responding to an order issued by the fact and their materiality to the ORI reports, answers, records, accounts,
ALJ, the computation begins with the findings of research misconduct and any papers, tangible items, and other data
day following the act or event, and HHS administrative actions, and and documentary evidence. This
includes the last day of the period amendments to the pleadings, including subpart does not require the creation of
unless that day is a Saturday, Sunday, any need for a more definite statement; any document. However, requested data

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28398 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

stored in an electronic data storage (5) The party seeking discovery has section is considered authentic, relevant
system must be produced in a form the burden of showing that the ALJ and material for the purpose of
reasonably accessible to the requesting should allow it. admissibility at the hearing.
party. (e) Refusal to produce items. If a party
refuses to provide requested documents § 93.514 Amendment to the charge letter.
(c) Nondisclosable items. This section
does not authorize the disclosure of— when ordered by the ALJ, the ALJ may (a) The ORI may amend the findings
(1) Interview reports or statements take corrective action, including but not of research misconduct up to 30 days
obtained by any party, or on behalf of limited to, ordering the noncompliant before the scheduled hearing.
any party, of persons whom the party party to submit written answers under (b) The ALJ may not unreasonably
will not call as witness in its case-in- oath to written interrogatories posed by deny a respondent’s motion to postpone
chief; the other party or taking any of the all or part of the hearing to allow
actions at § 93.515. sufficient time to prepare and respond
(2) Analyses and summaries prepared
to the amended findings.
in conjunction with the inquiry, § 93.513 Submission of witness lists,
investigation, ORI oversight review, or witness statements, and exhibits. § 93.515 Actions for violating an order or
litigation of the case; or (a) By 60 days before the scheduled for disruptive conduct.
(3) Any privileged documents, hearing date, each party must give the (a) The ALJ may take action against
including but not limited to those ALJ a list of witnesses to be offered any party in the proceeding for violating
protected by the attorney-client during the hearing and a statement an order or procedure or for other
privilege, attorney-work product describing the substance of their conduct that interferes with the prompt,
doctrine, or Federal law or regulation. proposed testimony, copies of any prior orderly, or fair conduct of the hearing.
(d) Responses to a discovery request. written statements or transcribed Any action imposed upon a party must
Within 30 days of receiving a request for testimony of proposed witnesses, a reasonably relate to the severity and
the production of documents, a party written report of each expert witness to nature of the violation or disruptive
must either fully respond to the request, be called to testify that meets the conduct.
submit a written objection to the requirements of Federal Rule of Civil (b) The actions may include—
discovery request, or seek a protective Procedure 26(a)(2)(B), and copies of (1) Prohibiting a party from
order from the ALJ. If a party objects to proposed hearing exhibits, including introducing certain evidence or
a request for the production of copies of any written statements that a otherwise supporting a particular claim
documents, the party must identify each party intends to offer instead of live or defense;
document or item subject to the scope direct testimony. If there are no prior (2) Striking pleadings, in whole or in
of the request and state the basis of the written statements or transcribed part;
objection for each document, or any part testimony of a proffered witness, the (3) Staying the proceedings;
that the party does not produce. party must submit a detailed factual (4) Entering a decision by default;
(1) Within 30 days of receiving any affidavit of the proposed testimony. (5) Refusing to consider any motion or
objections, the party seeking production (b) A party may supplement its other action not timely filed; or
may file a motion to compel the submission under paragraph (a) of this (6) Drawing the inference that
production of the requested documents. section until 30 days before the spoliated evidence was unfavorable to
(2) The ALJ may order a party to scheduled hearing date if the ALJ the party responsible for its spoliation.
produce the requested documents for in determines:
§ 93.516 Standard and burden of proof.
camera inspection to evaluate the merits (1) There are extraordinary
of a motion to compel or for a protective circumstances; and (a) Standard of proof. The standard of
order. (2) There is no substantial prejudice proof is the preponderance of the
to the objecting party. evidence.
(3) The ALJ must compel the
(c) The parties must have an (b) Burden of proof. (1) ORI bears the
production of a requested document and
opportunity to object to the admission burden of proving the findings of
deny a motion for a protective order,
of evidence submitted under paragraph research misconduct. The destruction,
unless the requested document is—
(a) of this section under a schedule set absence of, or respondent’s failure to
(i) Not relevant or material to the provide research records adequately
by the ALJ. However, the parties must
issues identified in the charge letter or documenting the questioned research is
file all objections before the final
the respondent’s request for hearing; evidence of research misconduct where
prehearing conference.
(ii) Unduly costly or burdensome to (d) If a party tries to introduce ORI establishes by a preponderance of
produce; evidence after the deadlines in the evidence that the respondent
(iii) Likely to unduly delay the paragraph (a) of this section, the ALJ intentionally, knowingly, or recklessly
proceeding or substantially prejudice a must exclude the offered evidence from had research records and destroyed
party; the party’s case-in-chief unless the them, had the opportunity to maintain
(iv) Privileged, including but not conditions of paragraph (b) of this the records but did not do so, or
limited to documents protected by the section are met. If the ALJ admits maintained the records and failed to
attorney-client privilege, attorney-work evidence under paragraph (b) of this produce them in a timely manner and
product doctrine, or Federal law or section, the objecting party may file a the respondent’s conduct constitutes a
regulation; or motion to postpone all or part of the significant departure from accepted
(v) Collateral to issues to be decided hearing to allow sufficient time to practices of the relevant research
at the hearing. prepare and respond to the evidence. community.
(4) If any part of a document is The ALJ may not unreasonably deny (2) The respondent has the burden of
protected from disclosure under that motion. going forward with and the burden of
paragraph (d)(3) of this section, the ALJ (e) If a party fails to object within the proving, by a preponderance of the
must redact the protected portion of a time set by the ALJ and before the final evidence, any and all affirmative
document before giving it to the prehearing conference, evidence defenses raised. In determining whether
requesting party. exchanged under paragraph (a) of this ORI has carried the burden of proof

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations 28399

imposed by this part, the ALJ shall give § 93.518 Witnesses. or upon motion by a party as permitted
due consideration to admissible, (a) Except as provided in paragraph under FRE 201 (Judicial Notice of
credible evidence of honest error or (b) of this section, witnesses must give Adjudicative Facts).
difference of opinion presented by the testimony at the hearing under oath or (1) The ALJ may take judicial notice
respondent. affirmation. of any other matter of technical,
(3) ORI bears the burden of proving (b) The ALJ may admit written scientific, or commercial fact of
that the proposed HHS administrative testimony if the witness is available for established character.
actions are reasonable under the cross-examination, including prior (2) The ALJ must give the parties
circumstances of the case. The sworn testimony of witnesses that has adequate notice of matters subject to
respondent has the burden of going been subject to cross-examination. judicial notice and adequate
forward with and proving by a These written statements must be opportunity to show that the ALJ
preponderance of the evidence any provided to all other parties under erroneously noticed the matters.
mitigating factors that are relevant to a § 93.513. (f) Evidence of crimes, wrongs, or acts
decision to impose HHS administrative (c) The parties may conduct direct other than those at issue in the hearing
actions following a research misconduct witness examination and cross- is admissible only as permitted under
proceeding. examination in person, by telephone, or FRE 404(b) (Character Evidence not
by audio-visual communication as Admissible to Prove Conduct;
§ 93.517 The hearing. permitted by the ALJ. However, a Exceptions, Other Crimes).
(a) The ALJ will conduct an in-person respondent must always appear in- (g) Methods of proving character are
hearing to decide if the respondent person to present testimony and for admissible only as permitted under FRE
committed research misconduct and if cross-examination. 405 (Methods of Proving Character).
the HHS administrative actions, (d) The ALJ may exercise reasonable (h) Evidence related to the character
including any debarment or suspension control over the mode and order of and conduct of witnesses is admissible
actions, are appropriate. questioning witnesses and presenting only as permitted under FRE Rule 608
(b) The ALJ provides an independent evidence to— (Evidence of Character and Conduct of
de novo review of the ORI findings of (1) Make the witness questioning and Witness).
research misconduct and the proposed presentation relevant to deciding the (i) Evidence about offers of
HHS administrative actions. The ALJ truth of the matter; and compromise or settlement made in this
does not review the institution’s (2) Avoid undue repetition or action is inadmissible as provided in
procedures or misconduct findings or needless consumption of time. FRE 408 (Compromise and Offers to
ORI’s research misconduct proceedings. (e) The ALJ must permit the parties to
Compromise).
(c) A hearing under this subpart is not conduct cross-examination of witnesses.
(j) The ALJ must admit relevant and
limited to specific findings and (f) Upon request of a party, the ALJ
material hearsay evidence, unless an
evidence set forth in the charge letter or may exclude a witness from the hearing
objecting party shows that the offered
the respondent’s request for hearing. before the witness’ own testimony.
hearsay evidence is not reliable.
Additional evidence and information However, the ALJ may not exclude—
(1) A party or party representative; (k) The parties may introduce
may be offered by either party during its witnesses and evidence on rebuttal.
case-in-chief unless the offered evidence (2) Persons whose presence is shown
by a party to be essential to the (l) All documents and other evidence
is— offered or admitted into the record must
(1) Privileged, including but not presentation of its case; or
(3) Expert witnesses. be open to examination by both parties,
limited to those protected by the unless otherwise ordered by the ALJ for
attorney-client privilege, attorney-work § 93.519 Admissibility of evidence. good cause shown.
product doctrine, or Federal law or (a) The ALJ decides the admissibility (m) Whenever the ALJ excludes
regulation. of evidence offered at the hearing. evidence, the party offering the
(2) Otherwise inadmissible under (b) Except as provided in this part, the evidence may make an offer of proof,
§§ 93.515 or 93.519. ALJ is not bound by the Federal Rules and the ALJ must include the offer in
(3) Not offered within the times or of Evidence (FRE). However, the ALJ the transcript or recording of the hearing
terms of §§ 93.512 and 93.513. may apply the FRE where appropriate in full. The offer of proof should consist
(d) ORI proceeds first in its (e.g., to exclude unreliable evidence). of a brief oral statement describing the
presentation of evidence at the hearing. (c) The ALJ must admit evidence evidence excluded. If the offered
(e) After both parties have presented unless it is clearly irrelevant, evidence consists of an exhibit, the ALJ
their cases-in-chief, the parties may immaterial, or unduly repetitious. must mark it for identification and place
offer rebuttal evidence even if not However, the ALJ may exclude relevant it in the hearing record. However, the
exchanged earlier under §§ 93.512 and and material evidence if its probative ALJ may rely upon the offered evidence
93.513. value is substantially outweighed by the in reaching the decision on the case
(f) Except as provided in § 93.518(c), danger of unfair prejudice, confusion of only if the ALJ admits it.
the parties may appear at the hearing in the issues, or by considerations of
person or by an attorney of record in the undue delay or needless presentation of § 93.520 The record.
proceeding. cumulative evidence under FRE 401– (a) HHS will record and transcribe the
(g) The hearing must be open to the 403. hearing, and if requested, provide a
public, unless the ALJ orders otherwise (d) The ALJ must exclude relevant transcript to the parties at HHS’
for good cause shown. However, even if and material evidence if it is privileged, expense.
the hearing is closed to the public, the including but not limited to evidence (b) The exhibits, transcripts of
ALJ may not exclude a party or party protected by the attorney-client testimony, any other evidence admitted
representative, persons whose presence privilege, the attorney-work product at the hearing, and all papers and
a party shows to be essential to the doctrine, or Federal law or regulation. requests filed in the proceeding
presentation of its case, or expert (e) The ALJ may take judicial notice constitute the record for the decision by
witnesses. of matters upon the ALJ’s own initiative the ALJ.

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3
28400 Federal Register / Vol. 70, No. 94 / Tuesday, May 17, 2005 / Rules and Regulations

(c) For good cause shown, the ALJ § 93.523 The Administrative Law Judge’s notification is not provided within the
may order appropriate redactions made ruling. 30-day period, the ALJ’s recommended
to the record at any time. (a) The ALJ shall issue a ruling in decision shall become final. An ALJ
(d) The DAB may return original writing setting forth proposed findings decision that becomes final in that
research records and other similar items of fact and any conclusions of law manner or a decision by the Assistant
to the parties or awardee institution within 60 days after the last submission Secretary for Health modifying or
upon request after final HHS action, by the parties in the case. If unable to rejecting the ALJ’s recommended
unless under judicial review. meet the 60-day deadline, the ALJ must decision in whole or in part is the final
§ 93.521 Correction of the transcript.
set a new deadline and promptly notify HHS action, unless debarment or
the parties, the Assistant Secretary for suspension is an administrative action
(a) At any time, but not later than the Health and the debarring official, if
time set for the parties to file their post- recommended in the decision.
debarment or suspension is under
hearing briefs, any party may file a (c) If a decision under § 93.523(b)
review. The ALJ shall serve a copy of
motion proposing material corrections results in a recommendation for
the ruling upon the parties and the
to the transcript or recording. debarment or suspension, the Assistant
(b) At any time before the filing of the Assistant Secretary for Health.
(b) The ruling of the ALJ constitutes Secretary for Health shall serve a copy
ALJ’s decision and after consideration of
a recommended decision to the of the decision upon the debarring
any corrections proposed by the parties,
Assistant Secretary for Health. The official and the decision shall constitute
the ALJ may issue an order making any
requested corrections in the transcript Assistant Secretary for Health may findings of fact to the debarring official
or recording. review the ALJ’s recommended decision in accordance with 45 CFR 76.845(c).
and modify or reject it in whole or in The decision of the debarring official on
§ 93.522 Filing post-hearing briefs. part after determining it, or the part debarment or suspension is the final
(a) After the hearing and under a modified or rejected, to be arbitrary and HHS decision on those administrative
schedule set by the ALJ , the parties may capricious or clearly erroneous. The actions.
file post-hearing briefs, and the ALJ may Assistant Secretary for Health shall [FR Doc. 05–9643 Filed 5–16–05; 8:45 am]
allow the parties to file reply briefs. notify the parties of an intention to BILLING CODE 4150–31–P
(b) The parties may include proposed review the ALJ’s recommended decision
findings of fact and conclusions of law within 30 days after service of the
in their post-hearing briefs. recommended decision. If that

VerDate jul<14>2003 15:08 May 16, 2005 Jkt 205001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 E:\FR\FM\17MYR3.SGM 17MYR3