Date of Meeting:
Attendance: Ed Gillan, Bob Kirby, Gary Gussin, Johna Leddy, Alberto Segre, Faryle Nothwehr, Barbara Eckstein, Claire Sponsler, Carolyn Colvin, Cara Hamann, , Ryan Tinnes, Nicholas Borcherding, Patricia Gillette, George Hospodarsky, Paul Soderdahl, Bob Kirby
Others: Cheryl Reardon, James Walker, Grainne Martin
Item 1: Welcome and Updates (Ed Gillan)
Meeting called to order at 1:30 pm
Item 2: Updates on recent OVPRED activities (Cheryl Reardon)
- The call for nomination for 2015 research awards was announced early this week. The nominations are due in Feb 6, 2015. http://ovproperations.research.uiowa.edu/awards-and-recognition-information
- The VPRED office announced the search for an Associate Director of Center of Biocatalysis and Bioprocessing. Nominations are due January 10, 2015.
- Actively working on spring 2015 initiatives (salon dinners, follow up on State of Research talk, etc.)
Item 3: Review and Approval of November 17, 2014.
November 17, 2014 minutes reviewed and approved as amended.
- Minor – 2nd last bullet: The sentence should reflect that Bob talked about previous attempts to provide support for supplies, noting that supplies can be difficult to track. Travel Stipends (for faculty) can be easier to award….
- Font changes throughout the document and “Rationale” …needs an “e”
- For the previous October minutes - attendance needs to be updated - Faryle Nothwehr
Item 4: Vote on final revisions to proposed Research Council charter changes to forward to governance groups. (PDF should be added as a link to the minutes when approved for the website)
A brief Discussion on the final revisions to proposed research council charter.
- Bob Kirby noted that post docs needed to submit a short rationale based on the discussion at the November 17th RC meeting. Ed Gillan received the rationale via email and will send it around to RC members. As appropriate he will incorporate some of the wording into the overview page. In several places postdoctoral researcher terms will be updated in the policy document.
- Kirby also asked whether the idea of non-voting postdoc membership was more appropriate. It was pointed out that this was discussed earlier in the semester and it was agreed to pursue the full voting membership option as a first option.
- Gary Gussin commented on the use of “governance body” in the charter seemed in appropriate as faculty may not regard it as having governance over them. Ed pointed out that this is the appropriate description in the policy and mirrored language in all other charters in the Operations Manual. Also he pointed out that if a policy is formulated and passed by Faculty Senate and then approved by the UI President, all faculty will be “governed” by the new policy.
The motion passed unanimously to move this RC charter revision forward to shared governance groups (Faculty Senate, Staff Council, UISG, etc.) for approval.
Institutional Conflict of Interest Policy in Human Subjects Research Policy (ICOI)
- James Walker, Associate VP for Research Compliance presented the draft policy on Institutional Conflict of Interest policy.
- The purpose of the policy is to meet one of the University of Iowa’s human research protection program accreditation standards. This requirement established by the Association for the Accreditation of Human Subjects Protection Programs [AAHRPP- http://www.aahrpp.org/] obligates the institution to have a policy that addresses human subject protections and promotes objectivity in research by identifying and eliminating/managing potential institutional financial conflicts of interest. This policy can be considered complementary to the existing individual conflict of interest in research policy [http://www.uiowa.edu/~our/opmanual/ii/18.htm#186].
Major Draft ICOI Policy Elements:
- Policy applies to clinical research on drugs, devices, and treatments that is or appears to be affected by Institutional significant financial interests (SFI)
- Defines Institutional SFI as payments/royalties/gifts/public stock ownership interests as >$100,000; any private company equity or ownership interest
- Defines University Official SFI as payments/royalties/gifts/public stock ownership as >$25,000; any private company equity or ownership interest; company fiduciary position
- Oversight review committee operates under the authority of the President
- Oversight committee includes current faculty-based COI Committee members, President’s chair designee and a non-UI affiliated member.
- “Rebuttable assumption” is the core principle for managing ICOI, i.e., conflicted research cannot be conducted at UI unless there are compelling reasons.
- Principle Investigator with assistance from UI Administration is responsible for submitting a compelling justification for why the research can be conducted at UI
- Rebuttable presumption criteria, e.g., unique patient population, PI/inventor with unique expertise; minimal overlap of interest/impact; UI unique capabilities
- ICOI Management Plans can included but not limited to the following:
- Recusal of the conflicted University Official from business decisions related to the project.
- Use of an external monitor; Data & Safety Monitoring Board; external IRB; independent data analysis; review of manuscript.
- Disclosure to research subjects, study team members, students, sponsor, etc.
- Appeals are made directly to Board of Regents
Discussion by the Research Council
- Gary Gussin asked for clarification on the rationale for the 12-month window. Jim noted that the current data analyzed involves a rolling prior 12 month window versus an annual year window.
- Claire Sponsler asked if the policy would remain limited to human subjects research. Jim stated that while this limited ICOI policy only applies to our specific accreditation requirements, by making it a stand-alone policy in the Operations Manual, this left open the possibility of expanding its scope if other external agencies such as NIH require it in the future.
- Alberto Segre asked for clarification on the scope of individuals included (example, CEO of UIHC, Chairs of CCoM, President, etc.). It was clarified that any administrator at UI, including UIHC was covered by this policy down to heads of centers and chairs of departments.
- Gary asked for clarification of the “safe haven” clause and Jim provided several examples where an outside party can provide someone in a research program with advice on concerns with the ICOI or its management.
- Carolyn Colvin asked how transparent is this process? President Mason (or designee) would have knowledge and responsible for ensure a management plan.
- What if the conflict is the President of the University – presumably, this would be managed by the Board of Regents.
- What if the Board of Regents had an ICOI? Not in the scope of the draft policy as our Operations Manual only applies to those employed at the University of Iowa. Jim noted that some private institutions have included their board of trustees in the university policy.
Meeting adjourned at 2:30 pm
Appendix A: Rationale for Postdoc Voting Inclusion on Research Council:
UI Postdoctoral Research Scholars and Fellows are engaged in research and scholarly activities under the mentorship of faculty advisors, as well as often providing mentorship/training to graduate students, undergraduates, and staff in their research groups. They serve the University’s research mission playing a unique role where they are directly engaged as key researchers who act more independently than undergraduate and graduate students, yet are not fully independent, as they are faculty-mentored. Postdocs also differ significantly in terms of policy due to their status as trainees, requiring advanced mentorship that prepares them for independent research positions in academia, the private sector, or government. Their scholarly activities promote funded research at the University and expand the research venture as they begin to develop their own research identities. For these reasons, we believe that postdoctoral researchers can offer new perspectives and input to the dialogue on Research Council matters.