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June 5, 2015

Carl Elliott, MD, PhD
Professor, Center for Bioethics
N504 Boynton
410 Church Street
Minneapolis, MN 55455
Dear Professor Elliott:
I am writing to respond to questions raised in your letter of May 11, 2015, and to the issue discussed in your
subsequent e-mail of May 27, 2015.
Question #1: Is it true that the investigation teams did not meet with the former research subject, and if so, is
this standard practice for investigating complaints about mistreatment of research subjects?
Standard practice for investigating complaints about mistreatment of research subjects allows for but does not
require the interview of witnesses. Since the events complained of occurred seven years in the past, the IRB
investigation panel and FTI Consulting chose to rely primarily on the information reflected in the research and
medical records rather than on the memories of the former research subject and Dr. Olson.
Question #2: Were other subjects informed that bifeprunox had been rejected for marketing approval by the
FDA, and if not, do you plan to inform them now?
An effort is underway to identify and inform subjects who were active in all bifeprunox studies at the University
of Minnesota open on or after August 10, 2007.
Question #3: Was the ethical permissibility of issuing a statement from the Communications Office about a
research subject’s medical history part of your investigation?
No, this question was not a part of the investigation.
The IRB may investigate allegations of researcher non-compliance with IRB policies and procedures.
Investigation of actions by the communications office will not be conducted by the IRB. I understand the Health
Information Compliance Officer has responded to the HIPAA complaint that you filed regarding this issue.
Question/Comment #4: Given the passage of Dan’s Law in 2009, how could the IRB have found in this case
that consent was completely voluntary and there was no evidence of coercion?
The IRB and FTI Consulting found that the former research subject had the capacity to consent and was not
coerced into enrolling in the study. These findings were based on a review of the individual’s research and
medical records, which included interactions with and assessments by clinical staff not involved in the research.

Dan’s Law was not in effect in 2007 and therefore does not apply to these events. Dan’s Law applies to a stay of
commitment order by a judge following a judicial commitment hearing. It does not prohibit research consenting
during a stay of commitment but requires certain extra steps to ensure voluntary informed consent in those
circumstances. A stay of commitment is different than a 72 hour hold. There is no law, regulation or IRB policy
(effective in 2007 or now) that presumes a person is incapable of consent while on a 72 hour hold or prohibits
an investigator from recruiting or consenting a subject during this time frame.
However, as the IRB investigation report states, the IRB has determined that the issue of recruiting subjects
while on a medical hold merits further consideration. The Executive Committee will evaluate whether new IRB
rules should be adopted to refine or restrict research consent under these circumstances.
I hope the answers to these questions will be helpful to you. Thank you for writing.
Sincerely,

Debra
Dykhuis

Digitally signed by Debra Dykhuis
DN: c=US, st=Minnesota, l=Minneapolis,
ou=Human Research Protection
Program, email=dykhu001@umn.edu,
o=University of Minnesota, cn=Debra
Dykhuis
Date: 2015.06.05 19:46:46 -05'00'

Debra A. Dykhuis
Executive Director
C:

Terri Bonoff, Minnesota Senator
James Nobles, Office of Legislative Auditor
Joel Alter, Office of Legislative Auditor