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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, Cont’d 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: sponsor’s 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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