The NIH is inviting comments on proposed rules to amend its regulations regarding financial ties and conflicts of interest among clinical investigators who apply for or receive research funding from the U.S. Public Health Service, of which the NIH is a part.
The rules aim to expand and add transparency to researchers' disclosures of financial interests and to enhance regulatory compliance and oversight by institutions, according to a notice of proposed rulemaking(www.gpo.gov) in the May 21 Federal Register.
According to a commentary(www.nih.gov) on the proposed rules co-written by NIH Director Francis Collins, M.D., Ph.D., in the May 24 Journal of the American Medical Association, the proposed changes focus on three areas:
- NIH-funded investigators would be required to disclose to their institutions all significant financial interests related to their institutional responsibilities. Thus, the responsibility for determining whether an investigator's significant financial interests are related to NIH-supported research would move from the investigator to his or her institution.
- Institutions would be required to develop a management plan for every identified financial conflict of interest and to provide the NIH with additional information on identified conflicts and their management.
- Every NIH-funded institution would be required to post, on a publicly accessible website, information on certain significant financial interests that the institution has determined are related to NIH-funded research and that constitute a conflict of interest.
In a May 20 telebriefing on the proposed changes(ocplmedia.od.nih.gov), Collins said, "The way science is moving forward, to be successful, partnerships between NIH researchers and industry are essential. But we need to be clear to have the public trust. Research must be conducted without bias and with the highest ethical standards."
During the telebriefing, NIH officials pointed to a particularly important proposed change that would expand the definition of "significant financial interests" that investigators would be required to disclose. For disclosure purposes, certain monetary thresholds would be lowered from $10,000 to $5,000.
In the notice of proposed rulemaking, the NIH acknowledged that the lower thresholds would require more work from administrators but contended that the revisions would strengthen federal and institutional oversight.
"We recognize that incorporating a lower monetary threshold is likely to lead to increased administrative burden on (i)nvestigators and (i)nstitutions because more financial interests are likely to be subject to disclosure and review," said the NIH notice.
According to the notice, comments on all aspects of the significant financial interests definition are welcome, including comments regarding the balance between the costs associated with the change versus the potential benefits.
Other proposed changes would
- modify the types of interests that would be specifically excluded from the significant financial interests definition, such as seminars, lectures and teaching engagements;
- broaden the regulations to include Small Business Innovation Research/ Small Business Technology Transfer Research Phase I applications; and
- create or revise various other definitions related to the proposed regulations to enhance clarity and ensure internal consistency.
Interested parties may comment on the proposed rule changes through July 20. The rules will be finalized later this year.