NUMBER / DATE / AUTHOR / APPROVED BY / PAGE
HRP-050 / 1/29/16 / L. Carroll / G. Martin / 1 of 2
1PURPOSE
1.1This procedure establishes the process by which IRB members disclose financial interests, and to identify and manage Conflicting Interest of IRB members.
1.2The process begins when an IRB member is asked to make an annual disclosure of financial interests.
1.3The process continues each time an IRB member is asked to review a protocol.
1.4The process ends when an IRB member has completed his/her annual disclosure and has either identified a Conflicting Interest and notified IRB staff, or when an IRB member has determined that he or she does not have a Conflicting Interest, when asked to review a protocol.
2REVISIONS FROM PREVIOUS VERSION
2.1Added procedures regarding annual disclosure of financial interests.
3POLICY
3.1Institutional policy requires all IRB members disclose their financial interests related to research to the FCOIRC and members recuse themselves from review, discussion or vote on any research related to a financial interest.
3.2IRB members are responsible to know the definition of Conflicting Interest and self-identify when they have a Conflicting Interest.
4RESPONSIBILITIES
4.1IRB members follow these procedures.
5PROCEDURE
5.1By March 31, or within 3 months of joining the Board, IRB members make their annual disclosure of financial interests through Mount Sinai’s COI disclosure procedure.
5.2Before reviewing research IRB members are to determine whether they have a Conflicting Interest with research.
5.3If an IRB member has a Conflicting Interest for review outside a meeting (e.g., the expedited procedure, or upon receiving an assignment of a protocol to review for a board meeting), he or she is to notify the IRB staff and return all materials.
5.4If an IRB member has a Conflicting Interest for review of research at a meeting, he or she is to notify the IRB chair, and recuse his/herself from the review, discussion and voting, staying in the meeting room only to answer questions about the research, at the request of the IRB chair.
6MATERIALS
6.1Annual FCOI disclosure form
6.1Definition of Conflicting Interest: An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s Immediate Family have any of the following:
6.1.1Involvement in the design, conduct, or reporting of the research.
6.1.2Ownership interest, stock options, or other ownership interest Related to the Research of any value exclusive of interests in publicly-traded, diversified mutual funds.
6.1.3Compensation Related to the Research of any amount in the past year or of any amount expected in the next year, including compensation for costs directly related to conducting research.
6.1.4Proprietary interest Related to the Research including, but not limited to, a patent, trademark, copyright or licensing agreement.
6.1.5Any other reason for which the individual believes that he or she cannot be independent.
7REFERENCES
7.121 CFR §56.107(e).
7.245 CFR §46.107(e).