America’s Oldest National Monthly IRB Newsletter
TM
PROTECTING RESEARCHERS AND RESEARCH
RESEARCH SUBJECTS SUBJECTS
AND RESEARCHERS
Volume 38, No. 2 ISSN 0885-0615
Using Single IRBs in
FDA-Regulated Research (#4)
We continue this month with more of FDA’s
many proposals to change existing regulations
and to add new ones on the protection of human
research subjects.
FDA is currently reviewing the many comments
it received following its recent major announce-
ment which we covered previously.
We will continue presenting highlights of these
proposals as a way of assisting IRBs to prepare
for possible future changes to the ways in which
they now review research protocols.
We resume our coverage by examining more
details on ways that FDA may be planning to
change how single IRBs handle the review and
monitoring of multisite trials.
In the past, of course, such studies were typically
reviewed by several IRBs located at the various
involved study sites.
Possible Exceptions to “Single IRB Review”
We begin with FDA’s reference to a proposal
that we presented in last month’s HRR regarding
special challenges posed by research with preg-
nant women at one site, with follow-up research
with neonates planned at a separate site.
“In these instances, utilizing an IRB with
obstetrical expertise and a separate, pediatric
IRB that has extensive experience in neona-
tal research may be in the best interest of
the two populations of research subjects.
We request comment on whether a single
IRB of record would generally be able to sup-
plement its members’ knowledge and expe-
rience with additional information or expertise
to account for these situations, examples of
FDA-regulated research in which these circum-
stances would apply, and any data on the fre-
quency of how often this situation may occur.
FDA is also requesting comment on includ-
ing an exception for cooperative research with
a small number of investigational sites.
Published monthly by The Deem Corporation, P.O. Box 451117, Omaha, NE 68145.
Editor and Publisher: Dennis M. Maloney, Ph.D. Copyright 1986-2023 by The Deem
Corporation. No copyright claim to public domain or otherwise copyrighted materials.
February, 2023
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SACHRP [the Secretary’s Advisory Com-
mittee on Human Research Protections]
recommended that research involving five
or fewer investigational sites should be
considered as potentially appropriate for
exception to the single IRB review require-
ment.
NOTE #1: Quoted materials in this newsletter appear exactly as
originally published in source documents, including any misspell-
ings, grammatical errors, or missing words. However, we will on
occasion insert words or edit text and/or formating in brackets [ ]
to make the material easier to read.
NOTE #2: Emphases are added to articles by HRR by underlining
or adding bold/italics to selected text, unless stated otherwise.
NOTE #3: Articles To Be Continued in subsequent issues are
marked at the end of the article with {TBC}.
ALSO IN THIS ISSUE Page
IRBs and Developing New Drugs for “CDI” .... 3
IRBs and Requirements for Expanded Access ... 4
IRBs and Research With Children .................... 4
IRBs and Comments on Federal Regulations ... 5
IRBs and New Clinical Outcome Assessments ... 5
IRB Recommendations By the SACHRP .......... 6
OHRP Investigation of IRBs and Researchers ... 8
FDA Warning To: Mississippi IRB ................... 9
In Court: Wade v. Oregon Health Sciences Univ. .. 10
IRB Compliance Comment Deadlines & Notices .. 11
IRB Compliance Conferences & Courses ......... 12
Licensing Rights for This Subscriber ................ 12
No portion of this publication may be reproduced in any form without a license to do so
or permission in writing from the publisher. Reference or citation to material in this
publication must include the name and address of the publisher.
Volume 38, No. 2
FDA is requesting feedback on whether an
exception from single IRB review might be
warranted for a multisite study with a small
number of sites, what the benefits and burdens
are for a multisite study with a small number of
sites, and what the appropriate threshold
should be for the number of sites involved.
In addition, we request any specific data
that can be provided on the relationship be-
tween the number of sites and the value of
single IRB review” (87 Fed. Reg. 58759,
September 28, 2022).
When Single IRB Review Can Be
Used Even If Exceptions Apply
“In addition, FDA recognizes that situations
may arise in which a federally conducted or
supported FDA-regulated clinical investigation
would qualify for an exception from single IRB
review under this proposed rule but would
not qualify for an exception determination
issued by a Common Rule Department or
Agency pursuant to 45 CFR 46.114(b)(2)(ii)
of the revised Common Rule (or vice versa).
Both the revised Common Rule and FDA’s
proposed rule still permit use of single IRB
for review and approval of cooperative re-
search even if an exception applies.
However, we are requesting public com-
ment on any impact that such differences in
exceptions from the single IRB review re-
quirement may have on stakeholders, and
on possible approaches to avoid or minimize
any potential negative effects of such differ-
ences for stakeholders, such as whether ad-
ditional exceptions from the proposed single
IRB review requirement should be included
or whether providing guidance on the appli-
cation of FDA’s proposed exceptions might
help avoid or minimize any differences in
exceptions” (supra at pp. 58759-58760).
Are More IRB Exceptions Warranted?
“We also specifically request comment on
whether there are unique challenges to use of
a single IRB review model for FDA-regulated
cooperative research that could not be ad-
dressed by FDA’s proposed exceptions.
For any challenges identified, we seek
comment on whether additional exceptions
should be included to address them.
For example, should FDA consider in-
cluding an exception analogous to the re-
Published
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month
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Page 2 February, 2023
vised Common Rule’s exception at 45 CFR
46.114(b)(2)(ii)?
As explained above, we do not believe it is
practicable to rely on a broad exemption that
would provide for FDA to make case-by-
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case determinations that use of single IRB
review is not appropriate for the particular
context as the only means for excepting FDA-
regulated cooperative research -- other than
research for which more than single IRB
review is required by law -- from the proposed
new requirement” (supra at p. 58760).
FDA Will Update Single IRB Guidance
“The agency also believes that situations
in which use of a single IRB might not be
appropriate and in which none of FDA’s
proposed exceptions apply would be rare.
However, we seek comment on whether
including an exception that provides for
FDA to determine and document that single
IRB review is not appropriate for the par-
ticular context, in addition to the exceptions
FDA has proposed, could help address any
such situations and any negative impacts of
differences between FDA’s proposed excep-
tions and exceptions available under the re-
vised Common Rule to a Common Rule
Department or Agency supporting or con-
ducting cooperative research.
Lastly, FDA is requesting comment on the
proposed exceptions and any other criteria
that should be considered when assessing
whether an exception to the use of single
IRB review might be warranted.
We also encourage the public to provide
examples of any additional types of FDA-
regulated clinical investigations that they be-
lieve should qualify for such an exception.
To help stakeholders comply with these
proposed requirements, if finalized, FDA in-
tends to update our guidance on using a cen-
tralized IRB review process in multicenter
clinical trials” (ibid). © {TBC}
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©©1986-2023
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byThe
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DeemCorporation
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law
Volume 38, No. 2 Page 3
IRBs and Developing New
Drugs to Treat “CDI” (#1)
As we briefly described in the December 2022
HRR’s section titled “IRB Compliance Com-
ment …,” research on CDI (Clostridioides dif-
ficile) infection poses special problems for re-
searchers and the IRBs that review the relevant
protocols.
CDI is difficult to treat, and potentially fatal.
CDI research requires careful subject selection
and trial design, among other typical issues to
be assessed in IRB reviews.
The FDA’s recent guidance on CDI research,
for which the agency is now reviewing compli-
ance community comments, addresses such is-
sues as selection and design, as follows:
“Sponsors developing drugs for CDI indi-
cations should consider enrolling the follow-
ing clinical trial populations:
• Trials for treatment: Subjects with CDI7
[FN #7: McFarland LV, Elmer GW,
and Surawicz CM, 2002, Breaking the
Cycle: Treatment Strategies for 163 Cases
of Recurrent Clostridium Difficile Dis-
ease, Am J Gastroenterol, 97(7):1769-
75.]” (“Clostridioides difficile Infection:
Developing Drugs for Treatment, Re-
duction of Recurrence, and Prevention,”
October, 2022, p. 2; on the Web at http
s://www.fda.gov/media/162692/downl
oad).
Meaning of “Prevention” for
This Type of Human Research
“• Trials for treatment and reduction of re-
currence: Subjects with CDI.
• Trials for reduction of recurrence only:
Subjects immediately after resolution of a
CDI episode with an SOC [standard of care]
regimen.
• Trials for prevention: Subjects at risk of
developing CDI.5
[FN #5: In this guidance, prevention
refers to prevention of CDI in subjects
with or without a history of CDI who
are at risk for CDI (e.g., subjects on anti-
bacterial therapy in the context of other
predisposing factors such as increased
age or immunosuppression).
For subjects with a history of CDI, the
sponsor should discuss with FDA the time
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February, 2023
between resolution of the previous epi-
sode and enrollment in a prevention
trial.]” (supra at p. 3).
Details of “Trial Design” Can
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Affect Research Subject Safety
“• Trials for all CDI indications should in-
clude older adults and immunosuppressed
subjects and those with varying severity of
illness, comorbidities, and concomitant
medications, including antibacterial drugs
and proton-pump inhibitors, among others.
The representation of polymerase chain
reaction (PCR) ribotypes in the trial popu-
lation should reflect current CDI epidemiol-
ogy” (ibid).
The issue of “trial design” has traditionally posed
special challenges for IRBs reviewing certain
types of experiments. Aspects of experimental
design can be at the core of weighing how risk
vs. benefit assessments are affected by the over-
all adequacy of the design.
For CDI research in particular, because of in-
herent risks for subjects, FDA is recommending
several approaches, as follows.
Agency Presents Different Types of
Trial Designs for Minimizing Risks
“• Trials should be randomized, double-
blinded, and controlled.
• Sponsors use an active control in trials
for CDI treatment and treatment and reduc-
tion of recurrence. Sponsors can use a pla-
cebo or active control in trials for preven-
tion or reduction of recurrence only.
• In trials for treatment and reduction of
recurrence, the initial CDI episode should
be treated with the investigational or com-
parator drug.
In trials for reduction of recurrence only,
the investigational and comparator drug (ac-
tive or placebo) should be started as soon as
possible after resolution of the initial CDI
episode with an SOC regimen.
• A noninferiority (NI) or superiority find-
ing of the investigational drug to SOC is ac-
ceptable to support approval of a drug for
treatment of CDI .... As there are currently
no suitable active comparators for CDE pre-
vention trials, superiority trials are most ap-
propriate for drugs developed for prevention
of CDI” (ibid). © {TBC}
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
month forbidden by law
Volume 38, No. 2 Page 4
IRB Requirements for
Expanded Access (#3)
We continue this month with more key sections
of FDA’s recently revised draft guidance for IRBs
and others that is titled “Expanded Access to In-
vestigational Drugs for Treatment Use: Questions
and Answers.”
We resume coverage here with the guidance’s
Q&A #10.
“Q10. Is a physician participating in
an expanded access protocol sponsored
by another entity (e.g., manufacturer of
the drug) required to obtain local IRB
review and approval?)
[A10]. If the sponsor of the expanded access
protocol (e.g., manufacturer of the drug) has
obtained IRB review and approval of the pro-
tocol, the physician may not be required to
obtain local IRB review and approval.
A physician associated with the institution
should verify that the sponsor has obtained
IRB approval of the protocol, and the physi-
cian should consult their institution on their
policy in these situations.
Some institutions may require that their
physicians obtain approval from the insti-
tution’s IRB as well” (guidance, p. 13 of
37; on the Web at https://www.fda.gov/me
dia/162793/download).
Role for Prior IRB Review and Approval
“Q11. Can the same drug be used in an
emergency situation at the same institu-
tion more than once?
If so, is prospective IRB review re-
quired for the subsequent expanded
access emergency use?
[A11] There can be more than one ex-
panded access emergency use of the same
drug at the same institution.
For expanded access use authorized under
the emergency procedures, the emergency
use must be reported to the responsible
IRB within 5 working days of initiation of
treatment (§56.104(c)).
Generally, once an investigational drug is
used in an emergency situation without prior
IRB approval, any subsequent uses of the
investigational drug at that same institution
would require prior IRB review and approval
(§56.104(c)).” © {TBC}
Published each month
since January, 1986 HUMAN RESEARCH REPORTTM
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February, 2023
IRBs and Research
With Children (#4)
We continue this month with more highlights
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from the FDA’s new draft guidance titled “Ethi-
cal Considerations for Clinical Investigations of
Medical Products Involving Children.”
“Assent means a child has provided affir-
mative agreement to participate in a clinical
investigation; mere failure to object should
not be construed as assent (21 CFR 50.3(n)).
Unless the IRB waives the requirement,
adequate provisions must be made for solic-
iting assent from the children if the IRB
determines that the children are capable of
providing assent (21 CFR 50.55(a)).
Children 7 years of age and older are often
considered capable of assent; however, the
age, maturity, and psychological state (men-
tal capacity and developmental stage) of the
child involved in the research must be con-
sidered (21 CFR 50.55(b))” (guidance, Sep-
tember, 2022, pp. 9-10; on the Web at https://
www.fda.gov/media/161740/download).
When Child’s Assent is Not Required
“Assent of the children is not a necessary con-
dition for a clinical investigation to proceed if
the IRB finds either 1) that the children’s ca-
pability is so limited [that] they cannot reason-
ably be consulted or 2) that the intervention or
procedure involved in the clinical investiga-
tion holds out a prospect of direct benefit that
is important to the health or well-being of the
children and is available only in the context of
the clinical investigation (21 CFR 50.55(c)).
Even if the IRB determines that the children
are capable of assenting, assent may be waived
under 21 CFR 50.55(d) if the IRB finds and
documents that all of the following criteria
are met:
• The clinical investigation involves no
more than minimal risk to the subjects;
• The waiver will not adversely affect
the rights and welfare of the subjects;
• The clinical investigation could not
practicably be carried out without the
waiver; and
• Whenever appropriate, the subjects will
be provided with additional pertinent in-
formation after participation” (supra at
p. 10). © {TBC}
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
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Volume 38, No. 2 Page 5
IRBs and Comments on
Current Federal Regulations
Comments are due by February 21st on the
FDA’s current regulations on the protection of
human research subjects (21 CFR Part 50, “Pro-
tection of Human Subjects”). This is one of the
few occasions when the compliance community
has a clear opportunity to seek any changes in
the protection requirements.
Most of the recent FEDERAL REGISTER announce-
ment reiterates the main requirements for IRBs
and others, which we shall skip (see 88 Fed. Reg.
3415, January 19).
However, the agency’s estimates of the time
burdens placed on IRBs for compliance may be
the most useful portions warranting input for
potential revisions.
For the 2,520 IRBs cited by FDA as the ones
overseeing FDA-regulated research, FDA esti-
mates the time burdens for record keeping re-
quirements to be a total of 1,522,104 hours an-
nually for all applicable IRBs combined.
FDA estimates that each IRB meets an average
of 14.6 times per year, with about 40 hours spent
per meeting of person-time to fulfill IRB record
keeping requirements.
Estimated Time for IRBs to
Comply With Specific Requirements
FDA estimates that the average annual time
burden per IRB, for each record keeping or re-
porting event that we have selected, to be:
• for §56.113 (suspension or termination
of research) = 30 minutes
• for §50.27 (documentation of informed
consent) = 30 minutes
• for §56.109(e) (written notification to ap-
prove or disapprove research) = an average
of 40 such disclosures per year for each IRB
at approximately 30 minutes per IRB =
annual combined total of 50,400 hours
• for §56.109(d) (written statement about
minimal risk research when documentation
of informed consent is waived) = 2 disclo-
sures per IRB each year at approximately
30 minutes per disclosure = annual com-
bined total of 2,520 hours
For more information, including how to com-
ment on these estimates, contact: Domini Bean
at 301-796-5733 or send email to PRAStaff@fd
a.hhs.gov. ©
Published each month
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February, 2023
IRBs and New Clinical
Outcome Assessments (#2)
We continue here with more highlights from
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FDA’s new draft guidance titled “Patient-Focused
Drug Development: Selecting, Developing, or
Modifying Fit-for-Purpose Clinical Outcome
Assessments [COAs].”
More IRBs now are being faced with review-
ing protocols where some portion of the COAs
are based on reports from human subjects them-
selves about the investigational products’ effects.
Our excerpt this month is from the guidance’s
subsection titled “3. Special Considerations for
Selecting or Developing COAs for Pediatric Pop-
ulations.”
“If the concept of interest can be reliably
measured across the age spectrum of the
trial patient population, we recommend us-
ing one simple version of a COA for pa-
tients of all ages in a study.
Including multiple versions of a COA
for different age groups in the same trial is
generally not recommended because it may
introduce unwanted measurement vari-
ability” (June, 2022, p. 22; on the Web at
https://www.fda.gov/media/159500/downl
oad).
If a Child’s Self-Reporting
Is Feasible, Then ….
“However, depending on the concept of
interest, at times it may be necessary to use
multiple versions of a COA and/or different
COA types to measure a concept, because
assessment of the target concept may differ
substantially across the age and develop-
ment spectrum (e.g., gross motor function-
ing in infants and adolescents).
Using multiple COAs to measure a con-
cept in a trial impacts statistical analysis
plans and trial power ….
When pediatric self-administered COAs
are feasible, the COAs should be completed
by the child independently, without any
assistance from caregivers, investigators,
or anyone else, to avoid influencing the
child’s responses.
Computer-administration, including auto-
mated reading of items, using a touch screen,
or games, may make it easier for children to
self-report” (supra at pp. 15-16). © {TBC}
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
month forbidden by law
Volume 38, No. 2 Page 6
IRB Recommendations
By the SACHRP
The federal Secretary’s Advisory Committee on Human
Research Protections (SACHRP) is the leading national
body that develops recommendations for IRBs and others
on better ways to protect human research subjects.
SACHRP’s work has led to many new and revised reg-
ulations and practical tips for protecting human subjects.
Here are more of their IRB recommendations.
* * * cussion of the Policy’s stance on data de-
Document Title: “Attachment A -- NIH Data
Sharing Policy” - HRR Article #2
Document Source: Letter to Alex Azar II, Sec-
retary, Department of Health and Human
Services
Document Date: August 12, 2020
Available at: https://www.hhs.gov/ohrp/sachrp-
committee/recommendations/august-12-2020-
attachment-a-nih-sdata-sharing-policy/index
.html
* * * trol of Data by Human Participants
IRBs and Human Subject Privacy
With this “catch up” article we resume cover-
age of the policy titled “Implications of the NIH
Draft Policy for Data Management and Sharing
on Data Derived from Human Participants.”
We will focus on the primary impacts of that
NIH policy on IRBs and researchers.
We last presented a sample highlight from this
SACHRP set of recommendations in our October
2020 HRR issue as a way of alerting readers
about what was, at that time, a new SACHRP
proposal on human subject protections.
We resume coverage of this document with
SACHRP’s important reminder to the compliance
community about what NIH has, and has not,
done to explain the policy’s impact on human
subjects research.
A key item for HRR readers is the impact on
human subject privacy and what IRBs can and
cannot do to help ensure that privacy.
Not Enough Consideration of Data-Sharing
“The FEDERAL REGISTER publication of the
Policy is followed by supplemental draft
guidance on elements of an NIH data man-
agement and sharing plan that outlines ad-
ditional elements that investigators should
consider as they develop their Plans.
Published each month
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February, 2023
Under the supplemental draft guidance, in-
vestigators are advised to consider, among
other things, the rationale for decisions about
which data to share, plans for providing ap-
propriate protections of privacy and confi-
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dentiality for scientific data derived from
human participants, and whether data gener-
ated from humans will be available through
restricted or through unrestricted access.
Though many experts provided thoughtful
input on the Policy, there has been little dis-
rived from human participants.
Our intent in this letter is to examine the
ways in which the Policy may better protect
such data and precautions that SACHRP be-
lieves should be implemented to protect the
interests of human participants.”
The Crucial Role of Informed Consent
“II. Potential Issues Created by the
Policy; Recommendations
A. Consent to Data Sharing and Con-
As drafted, the Policy includes little to no
discussion of informed consent, despite the
fact that under the federal Common Rule,
the Food and Drug Administration regula-
tions on human subjects research, as well as
general common law principles of consent
to treatment, the data of human participants
are typically collected pursuant to some form
of informed consent.
Investigators generally should comply
with any limitations on future uses and shar-
ing of data derived from human participants
that are set forth in the relevant consent
document.”
Do We Need Multiple New
Requirements for Consent?
“Though human participants may consent
to use and disclosure of their data as part of
a clinical trial or other research study, such
consents often do not contemplate broad
sharing of the collected data with the re-
search community and the public.
Moreover, even when the consent does
discuss the possibility of future research, the
consent document may not define future
uses to include sharing [of] the consenting
patients’ data as broadly as is contemplated
by the Policy.
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
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Volume 38, No. 2 Page 7
SACHRP recommends that the Policy
require that investigators carefully craft
consents so that they accommodate sub-
sequent uses of data derived from human
participants; that investigators using pre-
viously-collected data sets pay close atten-
tion to any specific data use limitations in
the terms and conditions (including con-
sents) under which those data were col-
lected; and that investigators, as part of
their Plans, must ensure compliance with
any such data use limitations by subse-
quent data requestors.”
New IRB Record Keeping Requirements
“SACHRP further recommends that
NIH consider implementing a means to
track such limitations or require down-
stream users to enter into data use agree-
ments so that subsequent data requesters
are made aware of sharing limitations
and held accountable for unauthorized
future uses of data derived from human
participants.
Further, upon the adopting of the Policy,
investigators and institutions will need to
undertake the burden of harmonizing exist-
ing consent documents and privacy notices
to accommodate the type of data sharing
contemplated by the Policy.
For example, if there is an original consent
associated with medical treatment, the con-
sent often may not state or indicate that the
data collecting during standard of care pro-
cedures may be used subsequently in a re-
search study.”
Subjects’ Data May Be Used and
Reused Without Specific Consent
“Also, the Health Insurance Portability
and Accountability Act of 1996 (‘HIPAA’)
Privacy Rule requires ‘covered entities,’
which include health plans and most U.S.
health care providers, to provide individuals
a ‘notice of privacy practices’ explaining
how such entities may use and disclose indi-
viduals’ protected health information that
are gathered in the course of medical care
and health insurance payment.
Even though data disclosed pursuant to the
Policy may be de-identified and thus no long-
er subject to HIPAA standards, consideration
of medical and research ethics should lead
Published each month
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covered entities to inform patients and ben-
eficiaries in these notices that their clinical
data may be de-identified or anonymized and
re-used for future research, and the privacy no-
tices should describe subsequent data sharing.
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These disclosures should be made not only
in the context of the data sharing contemplated
by the Policy, but also for data sharing pursu-
ant to other contractual obligations, regula-
tory requirements (e.g., European Medicines
Agency Clinical Trial Regulation), publica-
tion requirements (e.g., BMJ transparency
policy), and institutional commitments.”
Committee Wants New Consent Templates
“SACHRP recommends that the Policy
promote transparency in notices of pri-
vacy practices and in similar statements
of institutional practices regarding subse-
quent research uses of clinical data, so
that patients may be aware of data sharing
for future research purposes, even in ad-
vance of any participation in a primary
research study, as many data used in pri-
mary studies are themselves previously
gained during delivery of standard of care
or previous research.
SACHRP further recommends that
NIH, in collaboration with the HHS Of-
fice for Civil Rights, provide additional
guidance in the form of standard text or
templates that would assist investigators
and institutions in developing updated
consent and notice documents that con-
form to the Policy’s expectation for data
sharing, and that these templates be
crafted to respect health literacy limita-
tions that often characterize the public
at large.”
Many Research Subjects Lack
Control Over Their Own Data
“The above discussion of informed con-
sent raises the issue of the level of control
that human participants have over their data
and how to ensure that participants’ rights
and preferences are protected as their data
are being shared downstream.
In general, under HIPAA standards as well
as under accepted research practices, data sub-
jects do not exercise control over the down-
stream research uses of any of their de-iden-
tified or anonymized data.” © {TBC}
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
month forbidden by law
Volume 38, No. 2 Page 8
OHRP Investigation of
IRBs and Researchers
Project Title: Human Research Protections Under
Federalwide Assurance 07xxx (HRR Article #2)
Investigating Agency: Office for Human Research
Protections (OHRP) of the Department of Health
and Human Services (HHS)
Allegation: Exemption of studies from application
of federal human subject protection regulations
when said studies should not have been exempted
Reference: OHRP response letter of February 28,
2022, to Denver, Colorado, health system
* * *
Local IRB Is Disbanded and
Outside Firm Hired Instead
As we saw last month, the investigated institu-
tion in this case decided to disband its IRB, fol-
lowing multiple noncompliance problems un-
earthed by the OHRP investigation.
In so doing, the health system went through a
transition phase in order to not incur additional
problems and face possible OHRP sanctions
(although those have been noticeably absent).
OHRP’s report described how an outside con-
sulting firm took over the disbanded IRB’s duties
and responsibilities, as follows.
“An initial assessment of the IRB records
received by the external IRB was completed
to ensure the records were in order.
a. The external IRB [then] conducted a
continuing review, comparable to an
initial review, for transferred studies.
b. For studies in which modifications
were submitted to the external IRB for
review right after transfer, but before
continuing review was due, the external
IRB reviewed the modifications while
concurrently completing a review com-
parable to an initial review.”
IRB Reviews Resumed “From Scratch”
“c. For the remaining studies, qualified
external IRB staff completed an adminis-
trative review of each transferred study
to evaluate regulatory compliance and
determine whether the external IRB
should undertake IRB review sooner
than the next continuing review date.”
d. A review comparable to an initial re-
view was completed sooner than the next
Published each month
since January, 1986 HUMAN RESEARCH REPORTTM
Web: www.IRBusa.com Emailed to subscribers between the 7th and 11th of each
February, 2023
continuing review date for studies for
which the administrative review indi-
cated the need to document IRB deter-
minations that were perhaps not clearly
documented within the records trans-
This newsletter is copyright protected and sold with a limited license. See p. 12 for details.
ferred from the prior IRB.
e. An initial review was conducted by
the external IRB for transferred studies
that had an initial review by [the health
system] … IRB, and the study was either
deferred by, or received contingent ap-
proval from, [the health system] … IRB
and was transferred to the external IRB
before the conditions of IRB approval
were determined to be satisfied.
f. For each transferred study requiring
consent from the subject or the subject’s
legally authorized representative, the ex-
ternal IRB provided the researcher with
an IRB-approved consent form adden-
dum to use to notify subjects of the change
in IRB contact information.”
Passing the Baton …
“g. The HRPP office, which had four
full-time staff, had only a single HRPP
Administrator as of September 2020.
Staff changes led to reconsideration of
how to best administer the HRPP.
While a search for a new human pro-
tections administrator was occurring, an
HRPP consulting firm provided tempo-
rary staffing for the position of HRPP
Interim Director.
A consultant began serving as [the
health system’s] … Interim HRPP Di-
rector on March 30, 2020, and remains
in place as of the date of this letter.
h. This HRPP Office provided regula-
tory and local context support for all re-
searchers and coordinators regardless of
study type or funding source.
This support had previously been pro-
vided by the HRPP staff but in Septem-
ber 2020, it became the responsibility of
the new Interim HRPP Director.
The Interim Director was the liaison
between researchers, coordinators, and
the primary external IRB, as well as with
other external IRBs.”
This concludes our coverage of this unusual
case where the organization decided it was best
to disband its own IRB. ©
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
month forbidden by law
Volume 38, No. 2 Page 9
FDA Warning
Warning Letter to: Pascagoula, Mississippi
IRB (Part 3)
Investigation Period: Ended on July 23, 2012
Warning Letter Date: February 1, 2013
Noncompliance: IRB failure to follow four
different federal regulations on protecting
human subjects
* * * “3. The IRB failed to review proposed
Is There a Doctor in the House?
We continue this month with more noncom-
pliance findings made in FDA’s investigation of
a Mississippi IRB and its parent organization.
We resume with more of what FDA found when
it studied background information on the IRB’s
members and their qualifications, or the lack
thereof, for IRB duties.
“We wish to emphasize that without having
a physician member present at these meet-
ings, the IRB lacked the experience and
expertise to review the oncology research
activities.
During the inspection, the IRB Chairper-
son indicated that a new physician member,
Dr. …, had been recruited and would begin
participating as a voting member at the Au-
gust 2012 IRB meeting.
We note that Dr. … has been added to the
IRB membership list. We find this correc-
tive action to be adequate.”
When Is a Claimed IRB
Not Really an IRB?
“We note that the IRB’s written response
asserts that the IRB possessed expertise
adequate to review all presented and ap-
proved studies because scientific review
was conducted by individuals or organiza-
tions other than the IRB, such as the medi-
cal staff of the Regional Cancer Center (RCC)
and …’s IRB.
We recognize that it is possible to rely on
the review of another qualified IRB under
certain circumstances (see 21 CFR 56.114).
However, review by the medical staff of the
RCC does not constitute review by another
qualified IRB.
Published each month
since January, 1986 HUMAN RESEARCH REPORTTM
Web: www.IRBusa.com Emailed to subscribers between the 7th and 11th of each
February, 2023
Additionally, the IRB’s ‘Policy and Proce-
dures Guidebook’ does not discuss coopera-
tive review of research, or contain procedures
that would allow the … IRB to rely on the
This newsletter is copyright protected and sold with a limited license. See p. 12 for details.
… [a separate organization’s] IRB for cer-
tain aspects of the review.
Therefore, any reliance of the … IRB on
the scientific review conducted by the RCC
medical staff or the … IRB does not satisfy
the requirements of 21 CFR 56.107.”
When Numbers Do Matter
research at convened meetings at which a
majority of the members of the IRB are
present, including at least one member
whose primary concerns are in nonscien-
tific areas (21 CFR 56.108(c)).
Except when an expedited review procedure
is used, the IRB may only review proposed re-
search at convened meetings at which a ma-
jority of the IRB members (i.e., a quorum) is
present, including at least one member whose
primary concerns are in nonscientific areas.
Our inspection revealed that the IRB re-
viewed research at meetings at which a ma-
jority of the IRB members was not present.
For example:
a. Minutes of the August 9, 2011, IRB
meeting indicate that the IRB had twelve
members.
Therefore, in order to review research,
at least seven members needed to be
present (including a nonscientist).
The minutes indicate that [only] six
members were present when FDA-
regulated research was reviewed.
b. Minutes of the October 11, 2011,
IRB meeting indicate that the IRB had
thirteen members.
Therefore, in order to review research,
at least seven members needed to be
present (including a nonscientist).
The minutes indicate that [only] six
members were present when FDA-regu-
lated research was reviewed.
We acknowledge the IRB’s written response,
which indicates that meeting minutes will re-
flect the presence of a majority of IRB mem-
bers. The response is inadequate because it
does not include a description of any train-
ing provided to IRB staff ....” © {TBC}
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
month forbidden by law
Volume 38, No. 2 Page 10
In Court
Case: Amy Cordy, et al., v. Oregon Health and Science
University (OHSU); aka Wade v. OHSU (Part 61)
Key Issue(s): Possible IRB failure to protect human subjects,
lack of informed consent, negligence, and violation of
personal privacy by school officials (including by
IRB members)
Research Focus: Various effects of mandatory drug testing
of student athletes compared to no drug testing (“Stu-
dent Athletic Testing Using Random Notification” or
SATURN study)
Court: U.S. District Court, District of Oregon (Portland
(3))
Reference: Civil Case 02-CV-877-KI, June 28, 2002
Date: Case closed on April 22, 2004
* * * Nuremberg Code or the Declaration of Hel-
“Right to Dignity” Is Basic Claim
We continue here with more of the former
high school athlete’s argument that she had a
constitutional right to human dignity which, as
she previously claimed, was violated by alleg-
edly unethical researchers.
“In arguing that there is no constitutional
right to be treated with dignity, defendants
rely on Robertson v. McGee, No. 01-CV-60,
at 5 (N.D. Okla. Jan. 28, 2002) and Wright v.
The Fred Hutchinson Cancer Research Cen-
ter, No. C01-5217L (W.D. Wash. Filed Aug.
8, 2002)” (“Plaintiff’s Memorandum in Re-
sponse to Defendants’ Motions to Dismiss,”
December 9, 2002, Docket Document #27,
p. 22).
Who Cares Who Represented
Which Defendant Back Then?
“Wade’s [the plaintiffs in the present case
include Wade] counsel, as defendants have
informed this Court, is counsel in Robertson
and Wright.
Those trial court opinions are unpublished
and, under the Rules of this Circuit, unpub-
lished decisions in the Ninth Circuit have no
precedential value. See U.S. Ct. of App. 9th
Cir. R. 36-3, Hart v. Massanari, 266 F.3d
1155 (9th Cir. 2001).
In any event, the courts in Robertson and
Wright based their decisions on disputed find-
ings of fact that the plaintiffs gave informed
consent to participate in those therapeutic
medical studies (ignoring the fact that the in-
Published each month
since January, 1986 HUMAN RESEARCH REPORTTM
Web: www.IRBusa.com Emailed to subscribers between the 7th and 11th of each
February, 2023
formed consent process was so flawed as to
render it void).”
“Coercive” Informed Consent
Is Not True Informed Consent
This newsletter is copyright protected and sold with a limited license. See p. 12 for details.
“Here, the experiment was non-therapeu-
tic, meaning [that] the subjects were to re-
ceive no potential benefit from participating.
Moreover, because the informed consent
was coercive, this case is more analogous
to In Re Cincinnati Radiation than it is to
Wright and Robertson.
As stated above, this Court need only decide
that dignitary harm in the context of a human
experiment may be an element of damages.
Moreover, the damages for dignitary harm
claimed by Wade are not based upon the
sinki but [on] the fundamental right to pri-
vacy and to be free from unreasonable gov-
ernment searches and seizures and the right
to bodily integrity and liberty under the
Fourteenth Amendment.”
A Right By Extension to Other Rights
“The rights to privacy, bodily integrity,
liberty[,] and freedom from unreasonable
searches and seizures are clearly established
rights under the Constitution.
The interest in being treated with dignity
is only an extension of the right to bodily
integrity.
2. Defendants violated Wade’s Constitu-
tional right to privacy and to be free from
unreasonable government searches and
seizures under 42 U.S.C. §1983.
The Fourth Amendment to the United States
Constitution states:
The right of the people to be secure in
their persons, homes, papers, and effects,
against unreasonable searches and sei-
zures, shall not be violated ….
It applies to the conduct of state govern-
ment actions through the Due Process Clause
of the Fourteenth Amendment. Mapp v. Ohio,
367 U.S. 643, 655 (1961).
As the Supreme Court has stated, ‘The ba-
sic purpose of the Amendment … is to safe-
guard the privacy and security of individuals
against the arbitrary invasions by govern-
ment officials’ Camara v. Municipal Court,
387 U.S. 523, 528 (1967).” © {TBC}
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
month forbidden by law
Volume 38, No. 2 Page 11
In Compliance
IRB Congress: Research
Comment
Ethics & Regulations
Deadlines & Notices
• Food and Drug Administration. Comments
are due by February 13 on a new draft guidance
that contains tips for IRBs and researchers in-
volved with research on tuberculosis. The guidance
is titled “Pulmonary Tuberculosis: Developing
Drugs for Treatment.”
“.... this draft guidance provides FDA’s
current recommendations regarding the
overall development program and clinical
trial designs for a new investigational drug
or drugs to be used in combination with
approved drugs or a new treatment regimen
that includes one or more investigational
drugs to support an indication for the treat-
ment of pulmonary TB ….
Since the 2013 final guidance was issued
[see 78 Fed. Reg. 66744], there have been
improvements in nonclinical models and
further interest in streamlined clinical devel-
opment programs as well as consideration
for combination regimens with treatment-
shortening regimens with improved safety
and efficacy.
Thus, in this revised draft guidance more
detail is provided for nonclinical models,
early phase studies and trial design consider-
ations, including the demonstration of effi-
cacy using superiority or noninferiority
(NI) trial designs ....” (87 Fed. Reg. 76629-
76630, December 15, 2022).
For more information, contact: Mr. Ramya
Gopinath of FDA’s CDER at 240-402-5328.
• Food and Drug Administration. Comments
are due by February 21 on the guidance “M11
Clinical Electronic Structured Harmonised Proto-
col (CeSHarP)” and related documents titled “M11
Template” and “M11 Technical Specification.”
“The draft guidance, template, and techni-
cal specification were prepared under the
auspices of the International Council for
Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use (ICH)
…. The draft guidance provides recommen-
dations for a harmonized clinical trial pro-
tocol including the organization of standard-
ized content and formatting ….
Published each month
since January, 1986 HUMAN RESEARCH REPORTTM
Web: www.IRBusa.com Emailed to subscribers between the 7th and 11th of each
February, 2023
The intent of the draft guidance and sup-
porting documents is to create an interna-
tional standard for the content and exchange
of clinical trial protocol information facili-
tating review and assessment by regulators,
This newsletter is copyright protected and sold with a limited license. See p. 12 for details.
sponsors, ethical oversight bodies, investi-
gators, and other stakeholders” (87 Fed. Reg.
78696, December 22, 2022).
For more information, contact: Veronica Pei
of CDER at 240-402-7091 or send an email to
Yangveronica.Pei@fda.hhs.gov.
• Food and Drug Administration. Comments
are being accepted on a now final guidance titled
“Studying Multiple Versions of a Cellular or
Gene Therapy Product in an Early-Phase Clini-
cal Trial.”
“Sponsors have expressed interest in gath-
ering preliminary evidence of safety and
activity using multiple versions of a cellular
or gene therapy product in a single clinical
trial, where each version of the product is
distinct and is generally submitted to FDA
in a separate investigational new drug appli-
cation (IND).
The guidance provides recommendations
for conducting such studies, including how
to organize and structure the INDs, submit
new information, and report adverse events.
The guidance announced in this notice fi-
nalizes the draft guidance of the same title
dated September 2021” (87 Fed. Reg. 67046,
November 7, 2022).
The 10-page guidance itself is on the Web at
https://www.fda.gov/media/152536/download.
For more information, contact: Jessica Gillum
of FDA’s CBER at 240-402-7911.
• Government Accountability Office. A recent
GAO report found that:
“Despite more than 3 decades of govern-
ment policies to improve diversity in clini-
cal cancer trials, certain groups remain
underrepresented, including some racial
and ethnic groups, women, and low-income
individuals.
Diversity in clinical trials aims to ensure
safe and effective treatments for any patient
likely to use them” (in “Fast Facts” section
of “Cancer Clinical Trials: Federal Actions
and Selected Non-Federal Practices to Fa-
cilitate Diversity of Patients,” December 19,
2022, 73 pgs.; on the Web at https://www.ga
o.gov/assets/gao-23-105245.pdf). ©
© 1986-2023 by The Deem Corporation
Unauthorized duplication is
month forbidden by law
 Volume 38, No. 2 Page 12 February, 2023
IRB Compliance Conferences & Courses
Readers unable to attend may still access available conference/course materials
COVID-19 UPDATE: Conferences may be postponed or cancelled. Please check with Conference Contacts to verify latest schedule.
• February 16-17, 2023, in Miami Beach, Florida: “Pediatric Clinical Inc. (MSMR) and cosponsored by the North Carolina Association for Bio-
Trials Conference.” The topics will include: regulatory considerations in medical Research, the FBI Weapons of Mass Destruction Directorate, and
pediatric research; special ethical challenges in pediatric research; moni- the Maine Regulatory Training and Ethics Center. The meetings will be
toring, auditing, and compliance; and successful recruitment, enrollment, held at The Carolina Inn. The topics will be announced. Contact: Lynne
and retention of human subjects in pediatric studies. Contact: Conference Walsh, Massachusetts Society for Medical Research, 73 Princeton Street,
Registrar, SoCRA, at 800-762-7292, or send an email to Office@SoCRA. Suite 311, North Chelmsford, MA 01863 at 978-251-1556, or send email
org, or see their Web site at www.SoCRA.org. to lynne.walsh@msmr.org.
• March 30-31, 2023, in San Diego, California: “Oncology Clinical • April 27-28, 2023, in Scottsdale, Arizona: “16th Annual Device
Trials Conference.” Topics include: the role and function of a central Research & Regulatory Conference.” The meetings will be held at
IRB; the role and function of a data safety monitoring board; the process the Embassy Suites by Hilton Scottsdale Resort. The topics include:
of reporting adverse events; and risk minimization through good clinical the ethics and regulations of medical device research -- are you treat-
practices. Contact: Conference Registrar, SoCRA, at 800-762-7292, or fax ing a patient or experimenting on a human subject?; medical device
to 215-822-8633, or send email to Office@SoCRA.org, or see their Web adverse event reporting and federal requirements; risk categories in IDE
site at www.SoCRA.org. studies; the use of real-world data; and COVID-19 and compliance with
• April 24-26, 2023, in Chapel Hill, North Carolina: “The Three I’s human subjects research. This conference is presented by the Society of
(IACUCs, IBCs, IRBs) Research Integrity & Biosecurity: Promoting Clinical Research Associates (SoCRA). Contact: Conference Registrar,
the Responsible Conduct of Research, Partnership, Ethics, and Best SoCRA, 530 West Butler Avenue, Chalfont, PA 18914 at 800-762-7292,
Practices and the Exploration of Current Trends.” This annual confer- or fax to 215-822-8633, or send email to Office@SoCRA.org, or see their
ence will be presented by the Massachusetts Society for Medical Research, Web site at www.SoCRA.org. ©
Dennis Maloney, Ph.D., is Editor of the Kathleen Maloney, M.Ed., is the Associate
Human Research Report. He earned his Editor of the Human Research Report. Her
degree in Experimental Psychology (with degree is in Computers in Education and she is
Honors). He has authored or edited over a former Honors English teacher. She has pub-
200 works (reference book, textbook lished nationally, won competitive grant awards,
chapters, newspaper column, academic and received a special award from the Alice
journal articles, etc.), and won over $20 B. Buffet Foundation (a Warren Buffet Foun-
million in grant awards. More of his works dation). Also a mixed media artist, a selection
are available on the Web at FocusSurveys. of some of her works is available on the Web
com and at MyLuckyPenny.com. at KathleenMaloney.net.
MEMBER The HUMAN RESEARCH REPORT is designed to provide accurate and authoritative information in Newsletter
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