NIH has announced revised regulations on conflicts of interest in research (the Final Rule on Financial Conflict of Interest Regulations) that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (.pdf) (45 CFR Part 94). The new regulations go into effective no later than August 24, 2012. For answers to frequently asked questions on the new regulations visit the NIH FAQ website.
The revised regulations require mandatory investigator training regarding financial conflicts of interest in research at least every four years. All faculty who are recipients of funding from the Public Health Service (PHS) including AHRQ, ATSDR, CDC, FDA, HRSA, IHS, NIH, and SAMHSA are required to take the training at least every four years.
New Reporting Requirements For Significant Financial Interests
All investigators must report significant financial interests of themselves, their spouses, and dependent children that are in any way related to their institutional responsibilities (e.g., teaching, research, administrative) on an annual basis and thereafter within 30 days of acquiring a new financial interest.
A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
- intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
- any ownership interests in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization
- income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education;
- income from service on advisory committees or review panels for a federal, state, or local government agency, or an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Investigators will therefore be asked to provide their opinion as to whether any of their disclosed significant financial interests could directly and significantly affect the design, conduct or reporting of the NIH-funded research. Each response will thereafter be reviewed by a member of the Review Panel on Conflict of Interest in Research and may include additional discussions with the investigator. If it is determined that a FCOI exists then several things will happen: 1) Princeton will have to report each occurrence to the sponsor; 2) Princeton will have to implement a conflict of interest management plan; and 3) Princeton will have to make certain information regarding the FCOI available to the public (see below).
The Rules require that starting August 23rd, each investigator must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to the investigator’s institutional responsibilities and within thirty (30) days of the travel. However, the disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
- a federal, state, or local government agency,
- an Institution of higher education as defined at 20 U.S.C. 1001(a) (which does not include foreign academic institutions),
- an academic teaching hospital,
- a medical center, or
- a research institute that is affiliated with an Institution of higher education.
Public Accessibility of Certain Information Regarding All FCOIs
For all those investigators that are deemed to have a FCOI, Princeton is required to make public disclosure of such information including the name of the investigator, the conflicted company, and the amount of the financial interest through either a website or by written request. Princeton University intends to respond in writing on a case-by-case basis to requests for this information and will not maintain a website to report such interests. Affected faculty will be notified in advance of the release of this information in response to any such requests