1. Conflict of Interest Presented by Barbara L. Shiels Associate General Counsel February 2009

2. I.Source of Rules u Federal Regulations  Public Health Service  National Science Foundation  FDA u Minnesota Statutes § 15.43 u Agency and Professional Society Guidelines  AAU/AAMC Reports  HHS Guidelines u University of Minnesota Policies and Procedures on Conflicts of Interest (Individual and Institutional)

3. II.Purpose of Rules on Individual Conflicts 1 2 4 3 To assure that a researcher’s financial or business interests do not compromise the objectivity and integrity of research conducted at the University To assure that a researcher’s financial or business interests do not compromise the safety/welfare of human participants in research To assure that a researcher’s financial or business interests do not compromise the ability of a University student to meet legitimate academic goals To assure that University/public resources are not misused to further a researcher’s financial or business interests

4. III.Changing Landscape u Congress and the public are increasingly concerned about conflicts in medical research and practice u NIH is expected to issue tougher conflict of interest regulations in the near future u Conflict of interest at institutional level has emerged as an important issue u Focus of conflict review may expand beyond research to encompass other University activities

5. IV.What is exempt? $ Seminars or lectures for public/non-profit entities $ Review activities for public/non-profit entities $ Private practice income under Regents Policies $ Royalties through the University, if researcher has no other financial interest and no clinical trials or other development research with royalty granting entity Income, regardless of amount, from

6. V.Policy Triggers $ Financial Interest, by researcher and immediate family members or associated entity ¢ Consulting, royalty or other income of $10,000 or more annually ¢ Equity interest in a business of 5% ownership or value of $10,000 or more ¢ Promise or expectation of above OR $ Business Interest, by researcher or immediate family member ¢ Executive position ¢ Member of board of directors or advisory board

7. V.Policy Triggers Cont. u Examples of relationships : $ Researcher receives $10,000 consulting income from company which sponsors his University research $ Researcher and faculty colleagues start up company, each holding equity and executive positions, and company contracts with OTC to develop technology u Examples of no relationship : $ Physician researcher earns $10,000 from home carpentry business $ Biologist researcher invests in medical device corporation, earning $10,000 in stock dividends, but has no consulting or research relationship with company Must be relationship between financial or business interest and University duties

8. VI.University of Minnesota Approach to Individual Conflicts u Potential conflicts are reviewed on an individual basis to determine if they can be managed effectively u Research involving human subjects is subject to greater scrutiny u Management of potential conflicts is in researcher’s best interest u University will support employees who "play by the rules" if controversy arises

9. VII. How to Play by the Rules u University of Minnesota when completing a REPA on external professional activities u Department head/dean when submitting PRF research application u OTC when participating in patent or licensing activities u IRB/IACUC when submitting research subjects application u Department head/dean when receiving gift of $1,000 or more for research activities u Outside sponsors of research u Journals when submitting paper for publication Researcher fully disclose relevant financial or business interests to:

10. VII."Playing by the Rules" cont. u When in doubt, researcher should err on the side of disclosure u Researcher provides complete and accurate information via REPA u Researcher completes ROC on Outside Consulting for consulting that will average one day or more per month u Researcher follows requirements of approved conflict plan for managing, reducing or eliminating conflict

11. VIII.What Happens After Disclosure? u Department head makes recommendation to dean if activity has low potential for conflict of interest  E.g., researcher assigns students to work on research project sponsored by company from which researcher is entitled to receive royalties u Dean approves department head’s recommendation or refers matter to Conflict Review Committee (CRC)

12. VIII. "After Disclosure" Cont. uDean refers matter to CRC with or without recommendation if activity has moderate to high potential for conflict  E.g., researcher participates in research involving clinical trials sponsored by company in which she has equity interest of $10,000  Researcher receives consulting income of $10,000 from company which sponsors his research at University  Researcher holds equity of 5% and executive position in start-up company which engages in same or related research as individual performs at University uCRC makes recommendation back to dean

13. IX. Structure of Individual Conflict Review Committees u CRC’s are organized by area  AHC has CRC covering all AHC colleges  Provost’s Office has CRC for rest of University u Each CRC is comprised of:  Faculty from area colleges representing 3/4 of voting membership  Faculty from other colleges and representatives outside University representing 1/4 voting membership  Ex-officio members from SPA/OTC, Office of General Counsel, IRB and area administration

14. X.Role of CRC u Review activities involving potential conflicts of interest referred by deans u Obtain input from employee whose activities are under review u Evaluate whether a potential or actual conflict of interest exists u If so, recommend actions to dean to manage or eliminate such conflicts

15. XI.Input from Researcher Under Review u Researcher may appear at CRC meeting personally or by telephone conference u CRC gives draft report to researcher for review and comment before transmittal to dean u CRC reviews researcher’s disclosures on REPA, ROC, PRF, IRB forms, etc. u CRC may send researcher correspondence asking specific questions

16. XII.Prohibited Activities  Participate in or influence University purchasing decisions for contracting with a business in which employee has financial, business or personal interest  Prohibited by Minn. Stat. 15.43  Make professional referrals in course of University duties to business in which employee, immediate family member or associated entity has financial or business interest  Possible exception when function is not available from other sources and employee discloses interest

17. XIII.Examples of Managing Potential Individual Conflicts u Researcher must disseminate research results publicly before sharing data with outside company u Ad hoc committee or individual is appointed to review research for objectivity u Research data is managed by existing multi-center data oversight committee u Researcher is replaced as PI or Co-I by independent non-conflicted researcher u Researcher plays no role with human subjects u Researcher removes self as student’s primary advisor u Researcher discloses financial interest to affected students u Researcher discloses financial interest to human subjects in research consent form u Researcher divests financial interest or reduces to <$10K u Researcher resigns from board or executive position u Researcher recuses self from board deliberations involving own research

18. XIV. Institutional Conflicts of Interest u U of M Regents established policy in 2005 u Institutional conflict means a situation where U mission/activities may be compromised based on external financial/business relationships of institution or its senior officials u A separate conflict committee reviews these matters; high level conflicts are acted upon by Regents