2009 managing coi in research

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  • 1. Managing Conflict of Interest in Research
    • January 27, 2009
  • UHCMC Department of Surgery
  • Research Conference
  • Maureen Landies, M.A.
  • Conflict of Interest Administrator Office of Outside Interests
  • Case Western Reserve University
  • Philip A. Cola, M.A.
  • Vice President Research and Technology
  • University Hospitals of Cleveland

2. Outside Interests Committeeof Case Western Reserve University

  • Membership :
  • Faculty investigators (SOM, CSE, CAS, SON)
  • Case officials: Spons Proj, TTO, IRBs, IACUC
  • Hospital officials (also representing IRBs)
  • Responsibilities
  • Collect Financial Interest reports (faculty, research)
  • Develop, monitor COI management plans
  • Work to develop, harmonize policy, procedure
  • Participate in national dialogue regarding COI

3. Topics of Presentation

  • Conflict of Interest in the news
  • Overview of changes under new Case policy
  • COI management by the Outside Interests Committee
  • Case study
  • Examples of informed consent language

4. COI in the News: Public Web Sites

  • Kohl-Grassley reintroduced "Physician Payments Sunshine Act" (drugs, devices, biologics) in early 2009
    • DHHS will maintain public website
    • Companies to report payments >$100, gifts honoraria, travel awards, purpose, date, what was received in exchange
  • Similar laws in MN, VT, DC, ME, WV
  • Eli Lilly, Merck, Medtronic to post in 2009
  • CCF website posts physician interests>$5000
  • In 2007, Department of Justice required five orthopedic device manufacturers to post payments to physicians on public web sites

5. Congressional Investigations

  • 20 universities investigated (Psychiatry, Orthopedic, Cardiology researchers--Harvard, Stanford, 22 cardiologists at Columbia, U. Cincinnati).
  • NIH grant stopped (Emory); PI left the university
  • Amounts reported by Universities compared with amounts reported by industry
  • Concerns regarding industry influence:
    • --Physician payments drive up cost of drugs
    • --Prescribing brand-name vs. generic drugs
    • --Inducements in medical device selection
    • --Bias in research and medical education

6. PHS, FDA COI Regulations

  • 42 CFR 50 Subpart F Responsibility of Applicants for PromotingObjectivity in Researchfor which PHS Funding is Sought (PHS 1995)
  • 45 CFR 94 Responsible Prospective Contractors (PHS revised 2004)
  • 21 CFR 54 Financial Disclosure by Clinical Investigators" (FDA revised 2000)

7. NIH: Manage ,reduce ,eliminate

  • Financial conflicts of interest must be reported by the grantee institution to the NIH.
  • NIH must be informed whether the COI is being managed, reduced or eliminated.
  • 1995 NIH Financial COI - Workgroup Report

8. NIH, FDA Reporting Thresholds

  • NIH definition of " significantfinancial interest"
    • Salary > $10,000
    • Equity > $10,000 or 5% (publicly traded company)
  • FDA definition of " significantpayments, equity"
    • Salary > $25,000
    • Equity > $50,000 (publicly traded company)
  • Most Universities previously:
    • Used reporting threshold (variant of NIH, FDA)
    • Not required by law to ask exact amounts
  • New NIH regulations expected in 2009:
  • "zero threshold"

9. Academic Medical Center Initiatives

  • The Cornell University Institute on Medicine as a Profession (IMAP) reported after conducting a 2007 survey that, "many schools are in the process of revising and adding to their policies, a result that is not surprising with consideration to the increased attention to transparency."

10. CasePolicies on Individual Conflicts of Interest and Institutional Conflicts of Interest will be finalized in 2009 (revision of 2001 COI policy) 11. What's new in 2009?

  • 2009 draft COI policy makes explicit the following:
  • Report any "financial interest"
  • "Special" (not full-time) facultyif paid by Caseare required to report
  • Covered individual reports financial interest of self, spouse, dependent children,domestic partner, or any other person living in the same household as the individual ."
  • Deans receive COI management plans of their faculty
  • Clarification in the policy of "institutional conflict of interest," e.g., a financial interest held by an institutional official can create an institutional conflict of interest.
  • 2008 COI procedures addressed items not specified in policy:
  • For COIs related to research: reported> $10,000 annual compensation, and/or> $10,000 or 5% in a publicly held company.
  • "Special" faculty were not required to report (except researchers).
  • Individual reported financial interest of self, spouse, dependent children
  • Deans received a list of names, and could request COI plans for their faculty.
  • COIs were managed where institutional official had an interest related to research.

12. How to Report a COI

  • Annual "Outside Financial Interest Report for Faculty and Investigators" - annually and update, as needed
  • Report to grants/contracts officer: Case University Review Form; UHCMC Proposal Information Form (checkbox)
  • Report to IACUC
  • Report to IRBs (on New Protocol application, at Continuing Review or once a COI exists)

13. Report what?

  • Investigator'sindividualfinancial interest, e.g.
  • Paid consulting
  • Equity
  • Officer or Board member
  • Intellectual Property (IP) rights (listed as inventor on licensed IP)
  • Non-research COIs: Purchases, vendor relationships (to Case or to hospital)
  • Institutionalfinancial interest (Case or affiliate)
  • Institution owns equity
  • Institution has IP rights (licensor of IP)
  • Institutional official has anindividualCOI

14. Research COI Management: Considerations

  • Human subjects research?
  • Animal research?
  • NIH sponsorship?
  • Supervision of staff or academic advisees?
  • Will publications be generated?
  • Who will analyze the data?
  • Is there independent data review?
  • Is there an institutional conflict of interest?
  • Precedent decisions, AAMC, AAU guide OIC

15. COI Management template: Basic, animal, human subjects research

    • Disclose to sponsor if NIH
    • Data Integrity (individual, institutional COIs)
        • --Disclosure on publications / presentations
        • --Disclosure to research staff / advisees
        • --Disclosure to IACUC for animal research
    • Conflicts of mentoring
        • --Designate non-conflicted advisee supervisor
        • --Protect student thesis work, inventions

16. COI Management Template: Human Subjects Research

  • Determination of "compelling circumstances" for participation of conflicted investigator (AAMC)
  • Delimit investigator role (surgery, lab etc).
  • Recuse from subject selection, informed consent
  • Recuse from primary data analysis/interpretation
  • Designate non-conflicted PI / RI
  • Designate monitor or DSMB
  • For institutional COI, designate monitor(s) from outside Case and affiliates

17. OIC-IRB Collaboration in COI Management

  • IRB, OIC conduct concurrent review
  • IRB asks that IRB Protocol and consent document address the conflict of interest.
  • IRB can be more stringent than the OIC, not less so. The IRB may require:
    • Disclosure of annual income