US National Institutes of Health proposes new rules on researchers’ ties to industryBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c2923 (Published 04 June 2010) Cite this as: BMJ 2010;340:c2923
Senior figures at the US National Institutes of Health (NIH) have proposed new, stricter rules for funded researchers on showing their ties with industry.
Francis Collins, who heads the agency, and Sally Rockey, head of its office of extramural research, wrote in a commentary in the Journal of the American Medical Association that the existing 1995 rules “need to be clarified and strengthened to ensure greater transparency and accountability” (doi:10.1001/jama.2010.774).
Members of Congress, in particular Republican Senator Chuck Grassley of Iowa, have been investigating undisclosed ties between researchers and industry.
In their JAMA commentary Drs Collins and Rockey say that as the NIH tries to speed up discoveries from the laboratory to the clinic, “already complex relationships between NIH funded researchers and industry will likely become more complicated, even as they become more exciting and more productive.”
One problem with the present system, they write, is that it puts the responsibility for disclosing financial conflicts of interest on individual investigators—not their institutions.
The proposed new rules would require funded researchers to disclose to their institutions all their significant financial interests, including those that may not appear to be related to research funded by NIH, thus shifting responsibility for determining possible conflicts of interest to the institution.
Under the proposals, the threshold for reporting financial interests would fall from $10 000 (£6900; €8200) to $5000. Reporting the transfer of certain discoveries made by government funded researchers to private industry would also become a requirement.
Researchers will have to provide much more detailed information than is required at present. This would include the value of the financial interest, the nature of the potential conflict of interest (for example, consultancy fees, travel reimbursements, or honoraria), and a description of how the possible conflict of interest is related to the funded research.
A management plan would have to be produced for every identified conflict of interest, which “may include reduction or elimination of the FCOI [financial conflict of interest],” write Drs Collins and Rockey. And institutions would have to provide “significant additional information on identified FCOI and their management.”
All the conflict of interest information would have to be posted on a publicly available website before the institution could spend any NIH money on research.
The proposed rules would also require researchers to undergo training in financial conflicts of interest before they undertake any research funded by the institutes and every two years thereafter.
The proposals have been published in the Federal Register (http://www.thefederalregister.com/d.p/2010-05-21-2010-11885). After 60 days of public comment, ending on 20 July 2010, they will be implemented, subject to revision.
Cite this as: BMJ 2010;340:c2923