1. Conflict of Interest Issues for the Research Administrator NCURA August 5, 2013 Policy/Compliance 08/05/131

2. Today’s Presenters  Lois Brako (lbrako@umich.edu) – Assistant Vice President for Research, Regulatory and Compliance Oversightlbrako@umich.edu  Terri Maxwell (tmax@umich.edu) – Senior Project Representative, Office of Research and Sponsored Projectstmax@umich.edu  Cathy Handyside (chandys@umich.edu) – Senior Product Manager, Information and Technology Serviceschandys@umich.edu  Lori Deromedi (lderomed@umich.edu) – Compliance Change Management, Office of the Vice President for Researchlderomed@umich.edu 08/05/132

3. U-M by the Numbers  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 08/05/133 What’s at stake for U-M 2012 data

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/ 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 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 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ UCM341008.pdf 08/05/134

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 08/05/135

6. 6 COI Compliance: Who’s Involved? Regulatory Compliance Investigator Research Administrator COI Office Sponsored Projects Office Contracts Office Information Technology Performance Support Discloses outside interests Ensures compliance Provides structure Facilitates disclosure process

7. Why Should We Care about COI?  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/fulfill obligations to colleagues, students, and trainees 08/05/137 COI policies provide researchers and the institution a way to manage actual or perceived conflicts of interest; safeguarding objectivity in research… …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 08/05/138 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 a company with which he/she has a relationship 08/05/139 COI Office

10. Managing COI for Research Activity  Policies and procedures:  Disclosure  Annual  Changes reported within 30 days (PHS)  Review  Unit  Central Office  Person  Project  Management  Reporting 08/05/1310 COI Office RA

11. Discloser’s Responsibilities 08/05/1311  Main outside interest considerations:  Activity related to institutional responsibilities  Consulting/Advisi ng  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 Investigato r RA

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 08/05/1312 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 08/05/1313 Sponsored Projects Office COI Office

14. COI Check for Sub-Awards  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 08/05/1314 Sponsore d Projects Office Contracts Office RA

15. Subcontract COI Terms  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 08/05/1315 Contracts Office Paraphrased from FDP forms

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 08/05/1316 Sponsore d Projects Office COI Office

17. Information Technology Role  Tools and Automation  Disclosure  Review  Management  Reporting 08/05/1317 Information Technology

18. Performance Support Role  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 08/05/1318  Research Administrators assist with unit communication:  Unit procedures  Resources for help Performance Support RA