IRB Executive Committee Meeting April 14, 2014

Members Present: Susan Berry (chair), Joanne Billings, Robert Haight, Darlette Luke, Margaret MacMillan,

June Nobbe, Michael Oakes (vice-chair), Don Quick, Sarah Jane Schwarzenberg (arrived at 1:55pm)

Ex Officio/Non-Voting Members: Adrienne Baranauskas, Brian Herman, Barbara Shiels, Sarah Waldemar

Staff: Debra Dykhuis, Cynthia McGill, Patrice Webster, Linnea Anderson, Andrew Allen, Christina

Dobrovolny, Jeffery Perkey, Felicia Mroczkowski, Laura Conger

Members Absent: Scott Crow, Michael Steenson, Joyce Trost

Discussion Items

1. Review of 2014.03.10 IRB Exec meeting recap (Berry)

2. CMRR (Oakes, Mroczkowski)

Michael Oakes met with Cheryl Olman, faculty representative for CMRR and IRB medical panel

member, to discuss the outstanding issues detailed in correspondence between HRPP Post-

Approval Review staff and CMRR, following from the IRB Executive Committees discussion at its March 10, 2014 meeting. These issues included: CMRR compliance with IRB tracking

requirements for tesla levels above 3T and a second scientific opinion on the safety of repeat

exposure to magnets at 3T and above.

Response was received from a second scientific source regarding the safety of magnets 3T and

above. The committee agreed that this response satisfies their concerns regarding that issue.

Clarification was also provided during the meeting between Oakes and Olman regarding the

outstanding requirements. Oakes clarified that the IRB requirement is for tracking subjects so that

number of exposures can be documented. Oakes will continue working with Dr. Olman and

other CMRR faculty/staff to develop a proposal on how CMRR will comply regarding tracking

subjects for tesla levels 3T and above. This proposal will be brought back to the IRB Executive

Committee for further discussion.

3. Research concern raised by Leigh Turner (received March 4, 2014; discussion started March 10, 2014) (Berry/Dykhuis)

This issue was initially brought to the committee on the March 10, 2014 meeting, but due to lack

of quorum the committee was unable to make an official determination. The committee agreed, as

a duly-convened IRB, that an investigation into the issues raised by Dr. Turner will not be opened

at this time. The UMN IRB has two open investigations in the conduct of research in the

Department of Psychiatry. The committee will reconsider Dr. Turners request in the future.

The discussion surrounding issues raised by Dr. Turner generated a question concerning the

training of research coordinators. Due to time restrictions, this issue was tabled until a later date.

4. University investment in support for investigators holding INDs or IDEs (Herman)

The University has agreed to fund an FDA regulatory expert position, effective as of July 1,

2014.Plansare to house this position within HRPP. It will function independent of, but cooperate

with the IRB and IBC as an integral part of the Human Research Protection Program. Debra

Dykhuis will be organizing a search committee to locate suitable candidates to fill this role.

Policy regarding IND/IDE management is in development. IND/IDE assistance service will

continue to be provided by CTSI to support institutional knowledge of IND/IDE activities,

information about INDs and IDEs will be gathered and reported by the FDA regulatory expert.

As part of the work surrounding recommendation for the IND/IDE regulatory specialist position,

the workgroup assigned to researching this role discovered that the University does not have a

consistent definition of what constitutes clinical research. This workgroup has therefore put forth

the suggestion of adopting the University of Michigans definition, which is as follows:

A prospective, biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, biologics, treatments, devices, or new ways of using

known drugs, biologics, treatments, or devices). Behavioral interventions are intended to prevent or treat an acute or

chronic disease or condition.

5. Update on external evaluation of current IRB policies and processes (Herman)

OVPR has received 3 responses to RFP for management of a process to evaluate IRB procedures

and policies, especially those related to diminished capacity to consent. . It is hoped that an

independent review of HRPP by one of these firms, in combination with AAHRPP re-

accreditation and the two active investigations, will satisfy the concerns that initially prompted

this resolution from the faculty senate.

6. Investigations update (Webster)

Two official investigations have now been approved by the IRB Executive Committee to look into

issues raised regarding studies associated with research being done by the Department of

Psychiatry. The two investigations are being conducted by separate sub-committees and address

separate issues.

The initial investigation sub-committee on Olson bifeprunox studies has met and requested further

information from medical records, which will be provided. The sub-committee will meet again on

April 23, 2014 to discuss the new information. More information will be reported to the IRB

Executive Committee as it is available.

The second investigation sub-committee on Fairview concerns will have its initial meeting on

April 14, 2014, immediately following the IRB Executive meeting. Information on this

investigation will be reported to the IRB Executive Committee as it becomes available.

7. Research at the State Fair (Webster/Dykhuis)

There is now an independent building at the state fair for UMN research, in an effort to increase

the pace and diversity of enrollment in research.

A committee, headed by Logan Spector, is reviewing requests from researchers to use the space.

Only studies that are determined as minimal risk will be considered.

Issues of concern for the IRB include: capacity to consent (particularly in regard to potential

intoxication), use of incentives to participate, timing of giving of consent, potentially including

collection of blood for genetic testing (and the safety issues surrounding the physical practice of

blood draw in the venue).

The committee agrees that reviews for the studies requesting to conduct research at the State Fair

should be consistent. IRB Chairs and senior members will act as the reviewers for this committee.

Review tools will likely include, but not be limited to a checklist for pertinent regulatory issues, as

well as issues associated specifically with the local venue (access, safety, etc).

It was also suggested that, to help encourage public engagement surrounding ethics in research,

the IRB/HRPP have a presence at the State Fair as well, in the form of a poster, booth, and/or live

in-person.

8. Stem Cell Research review (Dykhuis/Shiels)

HRPP will be assuming responsibility for the reinvigoration of the stem cell research committee.

The proposed goal is to have a functioning committee by July1, 2014. More information will be

coming on this issue and what influence this will have on IRB, as it is available.

9. New Social and Behavioral application (Anderson/McGill)

A draft of the new Social and Behavior Sciences IRB application has been sent to members of the

Faculty and Student Social IRB committees, with a request for feedback and input.

10. Assuring Stipulations are related to criteria for approval (all)

The committee is reminded that communications to researchers regarding IRB review of

submissions are meant to be substantive and related to criteria for approval. In correlation with

this focus, the IRB is trying to move away from suggestions, as we dont have a way to enforce or consistently track such changes. If an issue is important enough to include in communication to

the researcher, then it should be stipulated. Stipulations made regarding wording should be related

to risk and/or criteria for approval. Another way to address further issues related to wording is to

include a summary comment that spelling and grammar should be reviewed for correctness.

Reviewers may give examples, if desired. It is hoped that this re-focus on criteria for approval

will minimize inconsistency between stipulations given by separate committees and improve the

process by which stipulated issues are resolved.

Items Carried Over from a Previous Agenda

11. Proposed process for allowing PIs in-person opportunity to answer Committee questions (Dykhuis)

The committee is asked to review the proposal and provide feedback before or at the next IRB

Executive Committee meeting on May 12, 2014. However, in discussion it was specifically noted

and agreed upon that if a request is submitted to address the IRB in person, the Investigator must

attend personally, not send another research team member as proxy.

12. Full committee review for studies involving genetic testing (Webster)

As more information is now collected on studies involving genetic testing, via Appendix G, the

question was raised regarding what level of IRB review is necessary for these studies (expedited

or full committee). For the short term, it was noted that all studies submitted with an

appropriately-completed Appendix G will be sent for full committee review. HRPP will continue

developing further review guidance for the future. More information will be provided as it is

available.

Standing Agenda Items

13. PAR update (Mroczkowski)

None.

14. Subject Advocate Update (Mroczkowski/Baranauskas)

12 inquiries were submitted to the Subject Advocate Line in the previous month, all handled

appropriately with no further issues.

Adrienne Baranauskas reported that Fairview has seen a spike in calls over the last quarter, but

most were related to a single study and these issues are being addressed by Fairview

administration.

UMN HRPP, Fairview and Gillette are continually working together to coordinate how feedback

regarding complaints is shared between these entities.

15. AAHRPP Reaccreditation Policy Review (HRPP Staff)

For review: HRPP Policy 202 - Management of IRB Members and Consultant Conflict of Interest

In association with preparation for AHRPP Re-accreditation, HRPP is making minimal changes to

its policies, so a large volume will not be brought back to Exec for review. Exec has been asked to

review the proposed changes to HRPP Policy 202 Management of IRB Members and Consultant Conflict of Interest and provide any feedback.

HRPP has a total of 113 IRB-related policies that require review as part of the AAHRPP Re-

accreditation process. We have committed to provide all policies to our AAHRPP Accreditation

consultant, Western IRB, by June 1. That gives us just over 17 weeks to complete the internal

review process.

Progress as of 4/11/14:

Scheduled for HRPP Internal Review 56 policies

Still in HRPP Internal Review process 12 policies

HRPP Internal Review complete 44 policies

Total 113 policies

Already sent to Western IRB for

consultation

40 policies

16. IRB Membership Update (Webster)

None.

Next Meeting: May 12, 2014 at 1:30 p.m. D-528 Mayo