Disclosure of Interest: IRB

1. Disclosure of Interest: IRB Daniel R. Vasgird, PhD Office of Research Integrity & Compliance 304-293-6094 drvasgird@mail.wvu.edu

2. Bayh - Dole Act (1980) The act permits recipients of federal funds to obtain title to the inventions developed under the federally funded projects and have a stake in the resultant products. If the university elects title, it is necessary to: file patent applications, seek commercial opportunities, and report back to the funding agency on efforts to obtain utilization of their inventions.

3. Conflicts of Interest The core issue is the change in external perception by the public and interested parties (reasonable person standard) and the internal reference points of researchers and their sponsoring institutions when the researchers and the institutions have an ownership stake in the results.

4. Conflicts of Interest Potential for bias in: • Choice of design or protocol • Selection of research participants • Collection, analysis, interpretation of data • Sharing of results Lack of public trust when COIs are not disclosed and/or managed. Not talking about scientific misconduct

5. Federal Conflict of Interest Regulations (PHS/NSF1995) Regulations apply to investigators An investigator is any person who is responsible for the design, conduct, or reporting of research Includes spouses and dependent children

6. Conflict of Interest Policies Each investigator must provide to an institutional official a listing of his/her known financial interests that would reasonably appear to be affected by the research. It is always better to report and let the institution make decision on management. All financial disclosures must be updated during the award period or as new significant financial interests are obtained.

7. Disclosure of Interests Anything of monetary value, including, but not limited to - • Salary, consultancy, speakers fees or other payments for services from an outside institution • Equity interests • Intellectual property rights

8. Oversight The institution determines if the interest is substantial enough to merit oversight. For human research IRB is key.

9. 2004 HHS Guidance • In general, Belmont Principles (respect form persons, beneficence, justice) should not be undermined by financial interests • IRBs should determine if COIR management is sufficient or further action required; • IRBs should determine level of detail to be provided to subjects regarding sources of funding, funding arrangements, financial interests of parties, COI management actions.

10. Managing a Conflict of Interest Institutions designate an “institutional official” to solicit and review disclosures of interests. The Official determines which disclosed financial interests could directly and significantly affect the design, conduct, or reporting of the research. Official acts tomanage, reduce, or eliminate the conflict. However, for HR IRB can supersede.

11. Disclosure of Interest • Log in to WVU ORIC COIR • http://oric.research.wvu.edu/conint • Select “Conflict of Interest in Research Certification Form” & follow directions • Select “Conflict of Interest in Research Certification Form” & follow directions