NIH Investigators Face Increased Scrutiny of Financial Conflicts of Interest

Last August, the US Department of Health and Human Services adopted new Financial Conflict of Interest (FCOI) regulations that apply to NIH-funded investigators.  The rules must be implemented by Institutions receiving public health service funds by August 24, 2012, which means many Institutions are rolling out new conflict of interest policies this summer.  While all Institutions have to meet the new requirements, they can implement stricter rules.  BPS members have reported a variety a range of ways in which their institutions are implementing the policy.

Here are the most relevant changes to the FCOI regulations to BPS members:

  •  Investigators must disclose to their universities all of their significant financial interests related to their institutional responsibilities.  This includes financial interested related to the research that could be affected by the research, or is an entity whose financial interest could be affected by the research.
  •  Investigators must report significant financial interests of their spouse and dependent children.
  • The threshold to be considered a “significant financial interest” requiring disclosure is being lowered from $10,000 to $5,000, and in some cases, eliminates the threshold all together.
  • 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, are excluded.
  •  Institutions must make information related to identified financial conflicts of interest publicly accessible via a website or by a written response.  This includes the investigator’s name, title, role with respect to the research project, name of the entity in which the significant financial interest is held, the nature of the significant financial interest, and the approximate dollar value of that interest.
  • Requires investigators to undergo FCOI training at least every four years
  • Investigators must disclose any reimbursed or sponsored travel.  That includes travel 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.  There is no minimum for disclosure; all reimbursed or sponsored travel must be reported to the investigator’s institution, unless it was sponsored by a university, medical school, or government agency.

The NIH Office of Extramural Research has made materials related to the updated FCOI regulations available on their website, http://grants.nih.gov/grants/policy/coi/. The rules apply to all individuals receiving NIH funding through grants or cooperative agreements.  Additional rules apply to investigators receiving NIH funds for clinical trials.

Please share in the comments how your institution is implementing the new financial conflict of interest regulations.

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