HHS Issues Final Conflict of Interest Rules for PHS-Funded Research That Increases Burden to Institutions and Investigators

By Nisha P. Shah –

The U.S. Department of Health and Human Services recently revised conflict of interest rules for Public Health Service ("PHS") related grants and research (i.e., the National Institutes of Health (“NIH”)) in response to congressional and public concerns over potential conflicts between investigators and companies, such as drug and medical device manufacturers.  The final rules implement changes to regulations issued in 1995 on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is South and Responsible Prospective Contractors (42 C.F.R. Part 50 and 45 C.F.R. Part 94).  Below are some of the highlights of the final rules that will result in increased monitoring, disclosure, and reporting requirements for institutions and investigators.

Definitions (42 C.F.R. § 50.603, 45 C.F.R. § 94.3)

The most significant changes to the definitions are the changes to the definition of significant financial interest ("SFI") and the inclusion of a definition of financial conflict of interest ("FCOI").

• For SFI, the minimum threshold decreases from $10,000 to $5,000 for payments and/or equity interests, including non-publicly traded entities, related to their institutional responsibilities.  SFI also now includes certain intellectual property rights and interests and most reimbursed or sponsored travel.  Under the final rules, SFI excludes income from investment vehicles and income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education.
• An FCOI is an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.  In this context, HHS explained that “significantly” means that the financial interest would have a material effect on the research.

Responsibilities of Institutions Regarding Investigator Financial Conflicts of Interest (42 C.F.R. § 50.604, 45 C.F.R. § 94.4)

• While the 1995 regulations required an institution to maintain a conflict of interest policy, the new rules add that an institution must make such policy available via a publicly accessible website.  If an institution does not have a presence on a website, the institution must make the policy available in writing within 5 business days of any request.
• The 1995 rules did not have a training requirement; the new rules require each institution to train each investigator on the institution’s conflicts of interest policy and the new regulations prior to engaging in research related to any PHS-funded grant or contract, at least every 4 years, and under specific circumstances, such as when the investigator is new to an institution. 
• Each investigator who is planning to participate in the PHS-funded research must disclose to the institution the investigator’s SFI (and those of the investigator’s spouse and dependent children) no later than the date of submission of the institution’s proposal to the NIH, and thereafter, the investigator must update disclosure within 30 days any newly discovered or acquired SFI and at least annually of any unreported SFI. 

Management and Reporting of Financial Conflicts of Interest (42 C.F.R. § 50.605, 45 C.F.R. § 94.5)

• While the 1995 rule did not require public disclosure of SFI, the new rules now require an institution to either post on a publicly accessible website or make available in a written report within 5 days of a request information concerning any SFI disclosed to an institution that meets the following 3 criteria: (1) the SFI was disclosed and is still held by senior/key personnel; (2) the institution determines that the SFI is related to the PHS-funded research; and (3) the institution determines that the SFI is a FCOI.  Information that must be made publicly available include (but is not limited to): the investigator’s name, the investigator’s title and role regarding the research project, the nature of the SFI, and the approximate dollar value of the SFI (ranges are permissible).  The institution must update this information at least annually and within 60 days of the institution’s receipt or identification of information concerning any additional SFI.
• While institutions implemented a “management plan” under the 1995 rules, the final rules now require that an institution must review all investigator disclosures of SFIs, determine whether a SFI is a FCOI, and, if so, develop and implement a management plan that specifies the actions that will be taken to manage such FCOI.  Examples of actions under a management plan include: public disclosure of FCOI when presenting or publishing research, disclosure of FCOI to participants in a research project involving human subjects, modification of the research plan, and change of personnel or personnel responsibilities.
• The number of requirement elements in the FCOI report submitted to the NIH has increased and now includes (but is not limited to): the name of the investigator with FCOI, the nature of the financial interest, the value of the financial interest, a description of how the financial interest relates to the PHS-funded research, and a description of the key elements of the institution’s management plan.
• If an investigator does not disclose a SFI in a timely manner, the institution must implement a management plan within 60 days and within 120 days must complete and document a retrospective review as to whether any portion of the PHS-funded research was biased.  If bias is found, the institution must notify and submit a mitigation report to the NIH.

The effective date of the final rule is September 26, 2011, and the compliance date is no later than August 24, 2012 and immediately upon making its FCOI policy publicly accessible.