Conflict of Interest Issues for the Research Administrator

1. Conflict of Interest Issues for the Research Administrator NCURA August 5, 2013 Policy/Compliance

2. Today’s Presenters • Lois Brako (lbrako@umich.edu) – Assistant Vice President for Research, Regulatory and Compliance Oversight • Terri Maxwell (tmax@umich.edu) – Senior Project Representative, Office of Research and Sponsored Projects • Cathy Handyside (chandys@umich.edu) – Senior Product Manager, Information and Technology Services • Lori Deromedi (lderomed@umich.edu) – Compliance Change Management, Office of the Vice President for Research

3. U-M by the Numbers 2012 data • 3: Campuses - Ann Arbor, Dearborn, Flint • 19: Schools and colleges (Ann Arbor campus) • 7,141: Total regular faculty • 36,710: Total staff and supplemental faculty • 60,798: Total enrollment • $1,274,000,000: Research volume What’s at stake for U-M

4. COI Regulations • Public Health Service (PHS/NIH) • 1995 Regulation – Responsibilities of the Investigator • 2011 Revised Regulation – Responsibilities of the Institution • http://grants.nih.gov/grants/policy/coi/ • National Science Foundation (NSF) • 2005 Grant Policy Manual – Responsibilities of the Institution and Investigator • http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp • Food and Drug Administration (FDA) • 2013 Guidance documents (e.g., Financial Disclosure by Clinical Investigators) • http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

5. COI Regulations: Commonalities • Common regulatory points: • Definitions: • Investigator • Outside interest • Conflict of interest • Significant financial conflict of interest • Institutional policy requirements: • Disclose outside interests to institution • Report significant conflicts

6. COI Compliance: Who’s Involved? Discloses outside interests Facilitates disclosure process Provides structure Ensures compliance

7. Why Should We Care about COI? COI policies provide researchers and the institution a way to manage actual or perceived conflicts of interest; safeguarding objectivity in research… • Investigator Point of View • Undue influence on professional judgment • Balance between primary obligations to the university vs. outside interest • Research Administrator Point of View • Research objectivity/integrity • Open publication of research results • Appropriate use of funds • Projection of human subjects • Proper transfer of intellectual property • Maintain relationships with/fulfillobligations to colleagues, students, andtrainees …and avoiding negative news headlines.

8. Institutional Responsibilities • What do research institutions look for to determine COI? • Commitment to the home institution • Outside activities do not negatively impact institutional responsibilities • Outside activities do not exceed institutional policy limit for time and effort • Publication is credited to institution • Use of institutional resources is approved by the institution • Impact on objectivity of their research (real or perceived) • Impact on human subject rights • Loss of trust in physician/patient relationships • Impact on students and trainees • Student progress is not affected • COI Office

9. Common COI Situations • Investigator serves on a Board of Directors, Scientific Advisory Board, or consults for a company that is sponsoring research or is involved in human subject research • Investigator holds equity in a start-up company and is collaborating on a SBIR or STTR award with the company • Investigator wants to use institutional facilities or resources for work on behalf of an outside entity (e.g., equipment, lab space) • PI wants to have graduate students or other trainees work on projects for an outside entity with which the PI has an FCOI • Investigator want to buy research supplies/software from acompany with which he/she has a relationship • COI Office

10. Managing COI for Research Activity • RA • Policies and procedures: • Disclosure • Annual • Changes reported within 30 days (PHS) • Review • Unit • Central Office • Person • Project • Management • Reporting • COI Office

11. Discloser’s Responsibilities • Investigator • RA • Main outside interest considerations: • Activity related to institutional responsibilities • Consulting/Advising • Leadership roles • Board roles • Ownership/Equity • Intellectual Property • Travel (PHS) • Disclosers need to be aware of changes: • Timing • Thresholds • Travel (PHS) • Research Administrators (RAs) assist faculty and staff in units: • Disclosure Policies • Disclosure System • Resources for help

12. Sponsored Projects Office Role • Sponsored Projects (pre-award office) ensures COI compliance through proposal and award management processes • At time of proposal submission, checks whether PHS FCOI regulations apply • YES: • Verifies all Investigators at all sites must have disclosed • Verifies who will manage COI for sub-award Investigators (your institution or theirs) • NO: follows applicable federal regulations and institutional COI review procedures • Sponsored Projects Office

13. COI Check at Award • For NIH awards, U-M Sponsored Projects uses the “Just-In-Time” (JIT) point to alert the COI Office that an award is likely • COI Office: review and management • Reviews Investigators’ outside interests in context of the research activities to be conducted • If a conflict of interest is determined, establishes a management plan and creates the FCOI report for Sponsored Projects to submit to the sponsor • Sponsored Projects Office: reporting • Reports to the sponsor BEFORE any funds are drawn down. • Submits via Commons • Key elements are entered in text boxes or radio buttons • Uploads actual FCOI Plan • Or, submits FCOI report directly to the sponsor per their instructions • COI Office • Sponsored Projects Office

14. COI Check for Sub-Awards • RA • At time of application: management • Investigator/RA obtains sub-award institution’s PHS COI policy attestation • Own policy or listed on the FDP Clearinghouse demonstrates compliance (policy and disclosure “trust model”) • No policy or not on FDP Clearinghouse? Subcontractor investigators disclose to the awardee institution. Research Administrators obtain completed forms. • Sponsored Projects/Contracts Office records attestation • At time of award: management, review, reporting • RA requests up-to-date disclosures, if needed • Contracts Administration (post-award office) verifies sub-award institution’s PHS COI policy attestation via the draft agreement • If applicable, COI Office reviews disclosures • If FCOI Report (from COI Office or sub-award institution) included, Sponsored Projects reports to the sponsor • Sponsored Projects Office • Contracts Office

15. Subcontract COI Terms Paraphrased from FDP forms • By signature, Subcontractor certifies that they: • Have an up-to-date, written and enforced administrative process to identify and manage FCOI which complies with 42 CFR Part 50 for PHS research projects; or follow the awardee institution’s process • Promote and enforce Investigator compliance with requirements including disclosure of significant financial interests • Make information about Investigators’ disclosures and Subcontractor’s reviews (regardless of COI determination) available to the awardee institution • Report any FCOI to the awardee institution and PHS within 45 days of any identified FCOI and before expenditure of authorized funds • Fully comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors • Contracts Office

16. Changes/Annual Review • Annual disclosure required by PHS and/or institution • COI Office reviews annually or when change reported • A new outside interest creating an FCOI in the course of a project requires notification to Sponsor within 60 days • If change is not reported within 60 days, a retrospective review of Investigator’s activities is required to determine if there was any bias to the research • A lengthy report of that review has to be submitted to the sponsor including the reason for the retrospective review • COI Office • Sponsored Projects Office

17. Information Technology Role • Tools and Automation • Disclosure • Review • Management • Reporting • Information Technology

18. Performance Support Role • RA • Research Administrators assist with unit communication: • Unit procedures • Resources for help • Change Management • Plan • Coordinate with campus • One voice for compliance • Audience evaluation • Methods • Targeted communications • E-mail • Web • Job aids • Web pages design • Simplify • Resources • Not all text • Performance Support