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HHS Guidance on COI

NCURA 2008. Conflict of Interest . Regulatory BackgroundHHS Guidance on Financial Relationships and Interests Resources. NCURA 2008. . HHS Regulations for Protection of Human Subjects at 45 CFR part 46. NCURA 2008. Conflict of Interest. No definition under 45 CFR part 46 P

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HHS Guidance on COI

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    1. NCURA 2008 HHS Guidance on COI Freda E. Yoder Division of Education & Development Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) NCURA National Harbor, MD November 5, 2008

    2. NCURA 2008 Conflict of Interest Regulatory Background HHS Guidance on Financial Relationships and Interests Resources

    3. NCURA 2008 HHS Regulations for Protection of Human Subjects at 45 CFR part 46

    4. NCURA 2008 Conflict of Interest No definition under 45 CFR part 46 PHS Regulations define Conflict of Interest (COI) as: a Significant Financial Interest [that] could directly and significantly affect the design, conduct, or reporting of research

    5. NCURA 2008 Regulatory Citation re: IRB Member COI No IRB member may participate in the initial or continuing review of an project for which the member has a conflicting interest - 46.107(e) OHRP strongly recommends that conflicted IRB members absent themselves from the meeting room during IRB deliberations and voting

    6. NCURA 2008 Other Regulatory Considerations Risks & benefits considerations 46.111(a) & (b) Additional protections for vulnerable subjects - 46.111(b) Informed consent process 46.116 minimize possibility of coercion & undue influence

    7. NCURA 2008 HHS Guidance

    8. NCURA 2008 HHS Guidance Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protections http://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf

    9. NCURA 2008 HHS Guidance, Contd Identify COI Manage COI

    10. NCURA 2008 Considerations for Identifying COI Procedures for determining what financial relationships and interests might cause potential or actual COI Procedures for collecting and evaluating information re: COI Identify from whom information should be collected

    11. NCURA 2008 Managing COI Ensure that the financial interests do not compromise the rights and welfare of human research subjects

    12. NCURA 2008 Considerations for Managing COI Eliminate or Mitigate Impact What actions necessary to protect subjects Oversight procedures, e.g., advisory/oversight committees, or individuals Educational programs re: COI Other considerations Composition and administrative positioning of IRB to ensure its independence from institutional pressures

    13. NCURA 2008 Resources

    14. NCURA 2008 Other Federal COI Laws/Regulations/Policies HHS Public Health Service regulatory requirements (42 CFR part 50, subpart F, and 45 CFR part 94) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-040.html FDA regulatory requirements re: sponsors responsibilities to disclose certain financial interests of investigators to FDA in marketing applications (21 CFR part 94) http://www.fda.gov/oc/guidance/financialdis.html The NSF conflict of interest policy appears at http://www.nsf.gov/bfa/cpo/gpm95/ch5.htm#ch5

    15. NCURA 2008 OHRP Resources & Contact Information OHRP Web page: http://www.hhs.gov/ohrp Join Listserv: http://www.hhs.gov/ohrp/news/distributionlist.html Contact OHRP: Phone: (240) 453-6900, (866) 447-4777 E-mail: ohrp@hhs.gov

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