Human Research Protection Program

The purpose of this SOP is to set forth the procedures to be followed by investigators in the identification of actual, potential or apparent conflicts of interest in their human subjects research. Institutional review board members remain subject to HRPP SOP 208: IRB Member Conflict of Interest.

This SOP applies to all human subjects research conducted under the auspices of Brandeis University.

• Ad hoc disclosures: Disclosures of actual, potential or apparent conflicts of interest made via modification request after the initial protocol has been submitted and within 30 days of acquiring the interest.

• Conflict management plan: An agreement that sets out limits and restrictions on the investigator for the purpose of reducing or eliminating a conflict of interest that could directly and significantly affect the design, conduct or reporting of institutional research.

• Conflict of interest: A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.

It is the standard operating procedure of Brandeis University that all investigators are required to disclose all actual, potential or apparent conflicts of interest prior to initiating human subjects research conducted under its auspices and within 30 days of the development of a new conflict.

All investigators and collaborators are required to outline, in the initial protocol (or through a modification request for ad hoc disclosures), all interests that could be construed as being a conflict of interest with the human subjects research they plan to conduct.

Conflicts of interest may necessitate otherwise exempt research to be reviewed as expedited or by the full board, as well as research which otherwise qualifies for expedited review to be reviewed by the full board. During their administrative review of the protocol or modification, HRPP staff will determine the level of review necessary for the reported interests.

If a conflict of interest is believed by the Institutional Review Board to exist, the IRB may request additional information from the principal investigator in order to determine whether a conflict does exist, as well as the significance of the conflict and possible strategies for its mitigation.

If a conflict of interest is determined to exist, the investigator may be required to abide by a conflict management plan to mitigate the conflict of interest. If required, the conflict management plan must be in place prior to the initiation (for new protocols) or continuation (for ad hoc disclosures) of the human subjects research. Some common strategies required by a conflict management plan include, but are not limited, to:

• Disclosure on the informed consent form of the conflict.

• Reconsenting subjects with an updated informed consent form disclosing the conflict.

• Public disclosure of the conflict.

• Independent monitoring and oversight of the research.

• Removing the conflicted investigator from participation in all or a portion of the research.

• Divestiture of interests.