Deadline for public input is July 20
Scientists funded by the National Institutes of Health (NIH) may soon be required to disclose more information about their financial ties to industry.
On May 21, NIH proposed substantial revisions to its current regulations governing financial disclosures. The proposed rule is open for public comment for 60 days, and the NIH plans to issue a final rule before the end of the year.
Under existing regulations, which date back to 1995, the responsibility for disclosing conflicts of interest to the NIH rests largely in the hands of individual investigators. Under new regulations, much of that responsibility would be shifted to the institution supporting the investigator. The institution would be required to have a process in place to review reports submitted by researchers to determine those that need to be reported as financial conflicts of interest.
Investigators would also be required to disclose substantially more information about their relationships with private industry, including all financial interests of $5,000 or more, a lower threshold than the current minimum of $10,000.
Finally, the new regulation would require institutions to develop a publicly accessible website that will display significant financial relationships reported by their faculties and other institutional members.
“The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias,” said Dr. Francis Collins, director of the NIH, in a commentary on the proposed rules. He acknowledged that partnerships between NIH-funded scientists and industry are often essential to the process of translating discoveries into patient therapies, but emphasized that the existing regulations need to be strengthened and clarified to uphold the public’s trust and the integrity of the research enterprise.
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