IRB Executive Committee Minutes April 2014

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Minutes of the University of Minnesota IRB (Institutional Review Board) Executive Committee, April 2014, with discussion of ongoing and future investigations of problems with psychiatric research

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<ul><li><p>IRB Executive Committee Meeting April 14, 2014 </p><p>Members Present: Susan Berry (chair), Joanne Billings, Robert Haight, Darlette Luke, Margaret MacMillan, </p><p>June Nobbe, Michael Oakes (vice-chair), Don Quick, Sarah Jane Schwarzenberg (arrived at 1:55pm) </p><p>Ex Officio/Non-Voting Members: Adrienne Baranauskas, Brian Herman, Barbara Shiels, Sarah Waldemar </p><p>Staff: Debra Dykhuis, Cynthia McGill, Patrice Webster, Linnea Anderson, Andrew Allen, Christina </p><p>Dobrovolny, Jeffery Perkey, Felicia Mroczkowski, Laura Conger </p><p>Members Absent: Scott Crow, Michael Steenson, Joyce Trost </p><p>Discussion Items </p><p>1. Review of 2014.03.10 IRB Exec meeting recap (Berry) </p><p>2. CMRR (Oakes, Mroczkowski) </p><p>Michael Oakes met with Cheryl Olman, faculty representative for CMRR and IRB medical panel </p><p>member, to discuss the outstanding issues detailed in correspondence between HRPP Post-</p><p>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 </p><p>requirements for tesla levels above 3T and a second scientific opinion on the safety of repeat </p><p>exposure to magnets at 3T and above. </p><p>Response was received from a second scientific source regarding the safety of magnets 3T and </p><p>above. The committee agreed that this response satisfies their concerns regarding that issue. </p><p>Clarification was also provided during the meeting between Oakes and Olman regarding the </p><p>outstanding requirements. Oakes clarified that the IRB requirement is for tracking subjects so that </p><p>number of exposures can be documented. Oakes will continue working with Dr. Olman and </p><p>other CMRR faculty/staff to develop a proposal on how CMRR will comply regarding tracking </p><p>subjects for tesla levels 3T and above. This proposal will be brought back to the IRB Executive </p><p>Committee for further discussion. </p><p>3. Research concern raised by Leigh Turner (received March 4, 2014; discussion started March 10, 2014) (Berry/Dykhuis) </p><p>This issue was initially brought to the committee on the March 10, 2014 meeting, but due to lack </p><p>of quorum the committee was unable to make an official determination. The committee agreed, as </p><p>a duly-convened IRB, that an investigation into the issues raised by Dr. Turner will not be opened </p></li><li><p>at this time. The UMN IRB has two open investigations in the conduct of research in the </p><p>Department of Psychiatry. The committee will reconsider Dr. Turners request in the future. </p><p>The discussion surrounding issues raised by Dr. Turner generated a question concerning the </p><p>training of research coordinators. Due to time restrictions, this issue was tabled until a later date. </p><p>4. University investment in support for investigators holding INDs or IDEs (Herman) </p><p>The University has agreed to fund an FDA regulatory expert position, effective as of July 1, </p><p>2014.Plansare to house this position within HRPP. It will function independent of, but cooperate </p><p>with the IRB and IBC as an integral part of the Human Research Protection Program. Debra </p><p>Dykhuis will be organizing a search committee to locate suitable candidates to fill this role. </p><p>Policy regarding IND/IDE management is in development. IND/IDE assistance service will </p><p>continue to be provided by CTSI to support institutional knowledge of IND/IDE activities, </p><p>information about INDs and IDEs will be gathered and reported by the FDA regulatory expert. </p><p>As part of the work surrounding recommendation for the IND/IDE regulatory specialist position, </p><p>the workgroup assigned to researching this role discovered that the University does not have a </p><p>consistent definition of what constitutes clinical research. This workgroup has therefore put forth </p><p>the suggestion of adopting the University of Michigans definition, which is as follows: </p><p>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 </p><p>known drugs, biologics, treatments, or devices). Behavioral interventions are intended to prevent or treat an acute or </p><p>chronic disease or condition. </p><p>5. Update on external evaluation of current IRB policies and processes (Herman) </p><p>OVPR has received 3 responses to RFP for management of a process to evaluate IRB procedures </p><p>and policies, especially those related to diminished capacity to consent. . It is hoped that an </p><p>independent review of HRPP by one of these firms, in combination with AAHRPP re-</p><p>accreditation and the two active investigations, will satisfy the concerns that initially prompted </p><p>this resolution from the faculty senate. </p><p>6. Investigations update (Webster) </p><p>Two official investigations have now been approved by the IRB Executive Committee to look into </p><p>issues raised regarding studies associated with research being done by the Department of </p><p>Psychiatry. The two investigations are being conducted by separate sub-committees and address </p><p>separate issues. </p><p>The initial investigation sub-committee on Olson bifeprunox studies has met and requested further </p><p>information from medical records, which will be provided. The sub-committee will meet again on </p><p>April 23, 2014 to discuss the new information. More information will be reported to the IRB </p><p>Executive Committee as it is available. </p></li><li><p>The second investigation sub-committee on Fairview concerns will have its initial meeting on </p><p>April 14, 2014, immediately following the IRB Executive meeting. Information on this </p><p>investigation will be reported to the IRB Executive Committee as it becomes available. </p><p>7. Research at the State Fair (Webster/Dykhuis) </p><p>There is now an independent building at the state fair for UMN research, in an effort to increase </p><p>the pace and diversity of enrollment in research. </p><p>A committee, headed by Logan Spector, is reviewing requests from researchers to use the space. </p><p>Only studies that are determined as minimal risk will be considered. </p><p>Issues of concern for the IRB include: capacity to consent (particularly in regard to potential </p><p>intoxication), use of incentives to participate, timing of giving of consent, potentially including </p><p>collection of blood for genetic testing (and the safety issues surrounding the physical practice of </p><p>blood draw in the venue). </p><p>The committee agrees that reviews for the studies requesting to conduct research at the State Fair </p><p>should be consistent. IRB Chairs and senior members will act as the reviewers for this committee. </p><p>Review tools will likely include, but not be limited to a checklist for pertinent regulatory issues, as </p><p>well as issues associated specifically with the local venue (access, safety, etc). </p><p>It was also suggested that, to help encourage public engagement surrounding ethics in research, </p><p>the IRB/HRPP have a presence at the State Fair as well, in the form of a poster, booth, and/or live </p><p>in-person. </p><p>8. Stem Cell Research review (Dykhuis/Shiels) </p><p>HRPP will be assuming responsibility for the reinvigoration of the stem cell research committee. </p><p>The proposed goal is to have a functioning committee by July1, 2014. More information will be </p><p>coming on this issue and what influence this will have on IRB, as it is available. </p><p>9. New Social and Behavioral application (Anderson/McGill) </p><p>A draft of the new Social and Behavior Sciences IRB application has been sent to members of the </p><p>Faculty and Student Social IRB committees, with a request for feedback and input. </p><p>10. Assuring Stipulations are related to criteria for approval (all) </p><p>The committee is reminded that communications to researchers regarding IRB review of </p><p>submissions are meant to be substantive and related to criteria for approval. In correlation with </p><p>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 </p><p>the researcher, then it should be stipulated. Stipulations made regarding wording should be related </p><p>to risk and/or criteria for approval. Another way to address further issues related to wording is to </p><p>include a summary comment that spelling and grammar should be reviewed for correctness. </p><p>Reviewers may give examples, if desired. It is hoped that this re-focus on criteria for approval </p><p>will minimize inconsistency between stipulations given by separate committees and improve the </p><p>process by which stipulated issues are resolved. </p></li><li><p>Items Carried Over from a Previous Agenda </p><p>11. Proposed process for allowing PIs in-person opportunity to answer Committee questions (Dykhuis) </p><p>The committee is asked to review the proposal and provide feedback before or at the next IRB </p><p>Executive Committee meeting on May 12, 2014. However, in discussion it was specifically noted </p><p>and agreed upon that if a request is submitted to address the IRB in person, the Investigator must </p><p>attend personally, not send another research team member as proxy. </p><p>12. Full committee review for studies involving genetic testing (Webster) </p><p>As more information is now collected on studies involving genetic testing, via Appendix G, the </p><p>question was raised regarding what level of IRB review is necessary for these studies (expedited </p><p>or full committee). For the short term, it was noted that all studies submitted with an </p><p>appropriately-completed Appendix G will be sent for full committee review. HRPP will continue </p><p>developing further review guidance for the future. More information will be provided as it is </p><p>available. </p><p>Standing Agenda Items </p><p>13. PAR update (Mroczkowski) </p><p>None. </p><p>14. Subject Advocate Update (Mroczkowski/Baranauskas) </p><p>12 inquiries were submitted to the Subject Advocate Line in the previous month, all handled </p><p>appropriately with no further issues. </p><p>Adrienne Baranauskas reported that Fairview has seen a spike in calls over the last quarter, but </p><p>most were related to a single study and these issues are being addressed by Fairview </p><p>administration. </p><p>UMN HRPP, Fairview and Gillette are continually working together to coordinate how feedback </p><p>regarding complaints is shared between these entities. </p><p>15. AAHRPP Reaccreditation Policy Review (HRPP Staff) </p><p>For review: HRPP Policy 202 - Management of IRB Members and Consultant Conflict of Interest </p><p>In association with preparation for AHRPP Re-accreditation, HRPP is making minimal changes to </p><p>its policies, so a large volume will not be brought back to Exec for review. Exec has been asked to </p><p>review the proposed changes to HRPP Policy 202 Management of IRB Members and Consultant Conflict of Interest and provide any feedback. </p><p>HRPP has a total of 113 IRB-related policies that require review as part of the AAHRPP Re-</p><p>accreditation process. We have committed to provide all policies to our AAHRPP Accreditation </p></li><li><p>consultant, Western IRB, by June 1. That gives us just over 17 weeks to complete the internal </p><p>review process. </p><p>Progress as of 4/11/14: </p><p>Scheduled for HRPP Internal Review 56 policies </p><p>Still in HRPP Internal Review process 12 policies </p><p>HRPP Internal Review complete 44 policies </p><p>Total 113 policies </p><p>Already sent to Western IRB for </p><p>consultation </p><p>40 policies </p><p>16. IRB Membership Update (Webster) </p><p>None. </p><p>Next Meeting: May 12, 2014 at 1:30 p.m. D-528 Mayo </p></li></ul>

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