It has been 15 years since the promulgation of the existing regulations on the responsibility of applicants for promoting objectivity in research (42 CFR Part 50 Subpart F and 45 CFR Part 94). These regulations, commonly known as the financial conflict of interest regulations, established standards to ensure that there is no reasonable expectation that the design, conduct or reporting of research funded by the Public Health Service (which includes the NIH) will be biased by any conflicting interest on the part of the investigator.
Since the existing rules were implemented, the growing complexity of biomedical and behavioral research; the increased interaction among Government, research institutions, and the private sector in attaining common public health goals while meeting public expectations for research integrity; as well as increased public scrutiny, all have raised questions as to whether a more rigorous approach to investigator disclosure, management of financial conflicts, and Federal oversight is required. Because it is of paramount importance to all of us that biomedical research be conducted with the highest standards of integrity and be free of bias, we have proposed changes to the regulations which I am now happy to be able to share with you.
After reviewing and analyzing your comments on last year’s Advanced Notice of Proposed Rulemaking, which asked questions about all aspects of the regulations to help determine how best to move forward, we have published a Notice of Proposed Rulemaking, and I look forward to your comments.
One major proposed change to the regulations concerns the financial interests that investigators are required to disclose to their institutions. The proposed regulations expand investigator disclosure requirements to include all significant financial interests related to the investigator’s institutional responsibilities, thus moving the responsibility for determining the connection of a significant financial interest to NIH-funded research from the investigator to the institution.
We also propose that in all cases where an institution identifies a financial conflict of interest, the institution be required to develop a management plan, which could include reduction or elimination of the conflict. Under the proposed new regulations, the institutions would be required to report additional information on any identified financial conflicts of interest to the NIH, including, but not limited to, the nature of the financial interest (e.g., equity, consulting fees, travel reimbursements, and honoraria), the value of the financial interest, a description of how the financial interest relates to the NIH-funded research, and key elements of the institution’s management plan.
Finally, the proposed regulations include a requirement for disclosure of investigators’ significant financial interests to the public. Specifically, the institution would be required, before expenditure of any funds under a NIH-funded project, to make available, via a publicly accessible Web site, information concerning any significant financial interest that meets the following three criteria: (1) the significant financial interest was disclosed and is still held by the PD/PI or any other investigator who has been identified by the institution as senior/key personnel for the NIH-funded research; (2) the institution determines that the significant financial interest is related to the NIH-funded research; and (3) the institution determines that the significant financial interest is a financial conflict of interest.
NIH is committed to pursuing research that advances public health, while at the same time ensuring that our endeavors remain worthy of public trust. We believe these proposed regulations would do just that. We look forward to your thoughts and insights regarding the proposed changes and anticipate promulgation of final regulations later this year.