Financial Conflict of Interest
Administrative Process and Guidance for Handling Certain Voluntary Disclosures
Purpose:
This Administrative Process and Guidance addresses the situation (“Relevant Scenario,” hereafter) in which an Investigator files a project specific disclosure with the BUMC or CRC Advisory Committee on Investigators’ Conflicts of Interest in which he/she reports solely that he/she has rights to receive future royalties, if any, on Intellectual Property owned by the institution, whether licensed or not, and that this Intellectual Property is proposed to be used, studied or involved in non-exempt human subjects research. (Note: The Relevant Scenario does not cover disclosure of actual receipt of royalties.)
Background:
The Relevant Scenario does not involve a “significant financial interest” as defined under current federal regulations or under Boston University and Boston Medical Center Policies on Investigators’ Conflicts of Interest. (Note: Actual receipt of royalties in excess of $10,000 in a 12 month period is a “significant financial interest” under current policies.)
Administrative process and guidance:
Under current policies (referenced above), Investigators are not required to disclose the Relevant Scenario and the CRC and BUMC Advisory Committees on Investigators’ Conflicts of Interest will not review disclosures involving the Relevant Scenario. If the Committee has previously reviewed a disclosure falling under the Relevant Scenario, the investigator will be sent this Administrative Process and Guidance and his/her management plan, if any, will no longer be monitored by the Committee.
However, if the Office of Research Compliance receives such disclosures or request for guidance as to the Relevant Scenario, the Office will provide a copy of this Administrative Process and Guidance document to the Investigator.
Non-exempt human subjects research:
All Investigators are advised that best practices in the case of a Relevant Scenario involving non-exempt human subjects research generally include that management be put in place to protect against the appearance or actuality of research bias. At a minimum, it is advised that the disclosing clinical Investigator should consider ensuring:
- that his or her colleagues on the research, and the audience or readers of any of his/her publications or presentation of the research, are informed by the Investigator of his/her right to potential royalties on the Intellectual Property;
- that other measures are adopted, as the Investigator deems appropriate, for minimizing appearances or effects of possible bias. Such measures may include, for example:
- involvement of non-conflicted co-investigators
- independent monitoring investigators or data safety monitoring boards
- blinding of disclosing investigator as to all aspects of the research in which he/she participates.
The CRC or BUMC IRB, as applicable, will be informed of any such disclosure and may impose requirements as they see fit for the protection of human subjects and for disclosure to human subjects. The CRC and BUMC Advisory Committees on Investigators’ Conflicts of Interest will not, however, monitor these adopted measures all of which are, under current policy, left to the discretion of the Investigator.
Important caveat:
Investigators whose initial disclosures relate solely to the Relevant Scenario, must understand that they remain subject to the requirement to supplement their Project Specific Disclosures upon any material change. Such material change includes, without limitation, the licensing of the relevant Intellectual Property to an entity in which the Investigator holds an equity interest of any magnitude or earns income in excess of $10,000 over any twelve month period.
This Administrative Process and Guidance does not exempt any Investigator from any requirement of the institutional policies referenced above.
