The 2012 US Department of Health and Human Services regulations on disclosing and reporting conflicts of interest for researchers funded via its Public Health Service (which includes the NIH) include the following requirements:
- Investigators must complete training related to the regulations and their institution’s financial conflict of interest policy.
- Investigators must disclose to their institutions annually all of their significant financial interests (SFIs) related to their institutional responsibilities. Please note that SFIs include (but are not limited to) consultancy payments, honoraria, paid authorship, equity interests (including any stock, stock option, or other ownership interest) and reimbursed travel. Institutional responsibilities are defined as teaching/education, research, outreach, clinical service, training and University and public service, on behalf of their institution and directly related to those credentials, expertise and achievements upon which the Investigator’s institution position is based.
- Significant financial interests of $5,000 and above must be disclosed.
- Institutions must report to the NIH additional information on identified financial conflicts of interest and how they are being managed.
- Institutions are required to make certain information accessible to the public concerning identified financial conflicts of interest held by senior/key personnel.
Frequently Asked Questions about the new regulations.
Oxford researchers are asked to note the following:
- The regulations apply to all investigators funded by the NIH (or via a sub-contract with a university, where the research in question is funded by the NIH). The regulations define an 'investigator’ as project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include, for example, collaborators or consultants.
- A significant financial interest need not necessarily represent a financial conflict of interest, but must be disclosed by the investigator to the relevant head of department or faculty to determine whether this presents any possible conflict of interest which needs to be reported to the NIH.
- There is no requirement to make a 'nil return’ if an Investigator does not hold any significant financial interests.
- Each investigator must complete an online training module prior to engaging in research related to any NIH-funded grant or contract and at least every four years. NIH-funded investigators are also required to familiarise themselves with their own university’s policy on conflict of interest.
- The procedure at Oxford for making a declaration internally is set out in this flow diagram:
In summary, a declaration of a 'significant financial interest’ should be made initially to the researcher’s head of department or faculty (or in the case of a head of department or faculty, to the head of division) via the annual declaration of significant financial interests form:
If, in the view of the head of department or faculty (or division), this could present a financial conflict of interest, this should then be submitted to the Secretary of the University’s Committee on Conflict of Interest together with a plan for how the conflict can be reduced, eliminated or managed. The Secretary of the University’s Committee on Conflict of Interest will then liaise with Research Services, who will submit the plan to the NIH via their electronic Research Administration (eRA) Commons financial conflicts of interest module. The Investigator is required to produce annual updates on how the conflict is being managed.
- Significant financial interests do not include (1) payments made by the University (salary, royalties, honoraria, expense reimbursement or any other remuneration) or (2) income from seminars, lectures, or teaching engagements sponsored by a federal, state or local government agency, an institution of higher education, an academic teaching hospital, a medical centre, or a research institute that is affiliated with an institution of higher education or (3) an investment by a mutual fund, pension fund or other investment fund over which the investigator or their immediate family member does not exercise management of fund investment.