IRB Executive Committee Meeting

July 13, 2015, 1:30-3:00pm

Members Present: Michele Biros (vice-chair), Michael Oakes (phone), Debra Dykhuis, Don Quick, Robert
Haight, Ebony Ruhland, Sarah Jane Schwarzenberg, Keith Horvath
Members Absent: Joanne Billings, Sue Berry, Scott Crow, Darlette Luke, Margaret MacMillan, June Nobbe
Ex Officio/Non-Voting Members Present: Brian Herman, Barbara Shiels, Joyce Trost, Sarah Waldemar, Jill
Cordes
Ex Officio/Non-Voting Members Absent: none
Guests: none
Staff Present: Patrice Webster, Cynthia McGill, Andrew Allen, Clinton Dietrich, Felicia Mroczkowski, Melissa
Nowicki, Jeffery Perkey, Linnea Anderson, Sarah Wanserski, Milana Solganik,
Informational Items and Notifications
1. Review of Recap from May 11, 2015 IRB meeting
The recap from the May 11, 2015 IRB meeting was accepted.
2. AAHRPP Site Visit/Work Plan Update/IRB Outsourcing
The Committee was provided with a status update on current IRB projects. The report from
AAHRPP was received in June, with an IRB response to the findings due July 13th. It was noted
that findings were generally in line with those laid out previously in the external review of the
Universitys human research protection program. The IRB response included proposed changes
to policy and a copy of the work plan to address recommendations made by the external panel.
A decision regarding reaccreditation will be made when the AAHRPP council meets in
September.
The work plan created by the implementation team has been accepted. The items listed in the
work plan have been assigned to their responsible parties. These activities will be completed at
three, six, and twelve month timelines.
It was noted that one of the recommendations suggested by an AAHRPP site visitor was to
outsource Business and Industry (B & I) trials to an independent IRB. Doing so could help
improve turn-around time and lighten the review load of our members. The Committee
discussed potential issues with this approach, such as a loss of skill evaluating B & I protocols
and the potential for lax or inconsistent review outcomes for protocols undergoing review by

another IRB. These concerns notwithstanding, it was determined that outsourcing these
protocols is worthy of investigation, and is a practice used by some other universities.
Information will be gathered from other institutions that employ this practice, and the results
communicated at a future Exec meeting.
Items for Discussion
3. Recruitment of patients under involuntary medical hold
The Committee discussed the practice of recruiting psychiatric patients for studies while they
are under an involuntary medical hold. The statute Dans Law, passed in response to the
suicide of Dan Markingson, prohibits some patients from participating in a psychiatric clinical
drug trial unless several conditions are met. However, Dans Law applies only to patients under
a stay of commitment order which is not the same as a 72 hour medical hold and would occur
later in the process after a commitment hearing is held. Because of the potential for coercion or
undue influence of subjects, the committee determined it is appropriate to prohibit
recruitment while under an involuntary medical hold. Draft updates to policies 501, 506 and
Appendix I were presented to address these concerns.
Several attendant issues were discussed. Of especial concern was that if patients decide to be
voluntarily admitted, the 72 hour hold is lifted, making that patient eligible for recruitment. At
the time of voluntary admission, the patient is informed that they have right to leave the facility
within 12 hours of making a request. During this period, a doctor determines whether it is
appropriate for the patient to leave the facility, or if they should be put back on an involuntary
72 hour hold after the voluntary 12 hour intent to leave hold. Reinstituting the 72 hour hold
would render them ineligible for the study. To mitigate these complications, the committee
determined that policy should indicate that patients cannot be recruited while on either a 72
hour hold, or a12 hour intent to leave.
It was also noted that as residents rotate, they may switch from being part of a patients
therapeutic team to belonging to their research team. The role of the residents should be
clarified to the patients to avoid coercion or undue influence. It was further discussed that the
policies should be updated to include psychiatric clinical device trials (i.e. electrodes, ECT, etc.)
and biologics, as it currently addresses only drug studies.
The policies will be modified accordingly to address the above concerns.
4. Paying Human Subjects

The Committee was updated on changes made to the financial systems handling of human
subjects payments. The recently implemented PeopleSoft Upgrade resulted in the potential for
human subjects names to display on financial reports, which would violate confidentiality.
Modifications were implemented to address this concern. It was further noted that the
University is considering adopting debit cards as a method of payment for subjects, which
would eliminate payment by check and cash and further safeguard subject confidentiality.
5. CMRR Operational Safety & Consent Form Template Update
In response to ongoing concerns regarding the management of the safety of subjects using their
facilities, the Center for Magnetic Resonance Research (CMRR) submitted a proposal to clarify
the roles and responsibilities for the safe use of magnetic resonance in research.
The training of technicians operating the machines was of particular concern; the Committee
feels that these technicians should be trained to the same standard of clinical techs working for
Fairview, while CMRR maintains that online courses could provide adequate training. The
Committee will determine the additional actions needed to bridge these concerns, and provide
CMRR their response.
An updated consent form template (version 18 June 2015) for studies involving research use of
MRI devices at the CMRR was also presented. Primary revision to the template includes
enhancement of the Risks section to ensure appropriate disclosure of all reasonably
foreseeable risks associated with MRI. The Committee was asked to review this form and
provide feedback to Felicia Mroczkowski by the end of this week.
6. Schulz Protocol 1408M53023
The Committee reviewed a report form on Dr. Schulzs protocol 1408M53023, Clozapine for
Cannabis Use in Schizophrenia (CLOCS). This study was approved by our IRB on 12/18/14, but
Quorum, to whom the UMN IRB transferred oversight of this study, deemed the submitted
protocol inadequate. Quorum indicated that they would not approve the study, and requested
Dr. Schulz withdraw it.
In the period of time after it was approved by the UMN IRB and before enrollment was
suspended on 3/18/15, one person was enrolled.
Dr. Schulz will be told to send an inactivation request on this protocol.