I’m very pleased to announce that the Department of Health and Human Services is issuing a final rule in the Federal Register revising the regulations on financial conflicts of interest of extramural investigators. The regulations, one of which applies to grants and cooperative agreements and the other to contracts, were first published in 1995, and with your input we have been working on revising them for the past several years.
The impetus for revising the regulations stemmed from many sources. We recognized that biomedical and behavioral research and the resulting interactions among government, research institutions, and the private sector have become increasing complex. While these interactions are often essential to the process of moving discoveries from the bench to the bedside, it can be challenging to manage the resulting financial relationships when federal funds are also involved so as to assure the public that they can trust in the objectivity of the research.
At the same time, there has been increased scrutiny of investigators’ financial relationships from Congress and the public, as well as the general principle of providing increased transparency and accountability in the use of all federal funds.
These factors highlighted the need to revisit the 1995 regulations. The process began with an Advance Notice of Proposed Rulemaking (ANPRM) in May 2009 asking the community whether the rule should be revised, and if so, how it might be strengthened. After considering these comments, we published a Notice of Proposed Rulemaking (NPRM) in May 2010 that proposed specific revisions to the regulations and again asked for your input.
The community provided numerous and very thoughtful comments. We considered them carefully when preparing the revised regulations. The same general framework of the 1995 regulation has been maintained:
- Institutions are responsible for implementing the regulations by their financial conflict of interest policy, evaluating their investigators’ significant financial interests, determining and managing financial conflicts of interest, and reporting financial conflicts of interest to the NIH.
- Investigators are responsible for complying with the institution’s policy, disclosing their significant financial interests, and complying with the institution’s management of any financial conflicts of interest.
- NIH’s role remains to provide guidance and oversight.
However, the revised regulations do institute a more rigorous approach to the management of investigator significant financial interests and resulting financial conflicts of interest to enhance the objectivity and integrity of the research process. These include changes to address investigator disclosure, institutional management of financial conflicts of interest, and federal oversight. In particular, the regulations:
- Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities as opposed to only those that they see as related to Public Health Service (PHS)-supported research.
- Lower the monetary threshold for disclosure of significant financial interests, generally from $10,000 to $5,000.
- Require institutions to report to the PHS awarding component more comprehensively on identified financial conflicts of interest and how they are being managed.
- Require institutions to make certain information concerning identified financial conflicts of interest held by senior/key personnel accessible to the public.
- Require investigators to be trained on the regulations and their institution’s financial conflict of interest policy at designated times.
For more information on the major changes to the regulations, see the Financial Conflict of Interest website for a side-by-side comparison of the 1995 and 2011 regulations.
We recognize that it will require commitment and careful deliberation by both investigators and institutions to comply with these changes. Therefore, we have provided an implementation period of up to one year (see final rule for the exact language). Until your implementation is complete, you should continue to comply with the 1995 regulations. We are developing training materials for the community, including frequently asked questions and a tutorial. These will be posted on the Financial Conflict of Interest website in the coming weeks.
Looking back over the long road we’ve taken to get to this point, I am very grateful for the substantive and thoughtful comments you provided to both the ANPRM and the NPRM. They were invaluable in our efforts to draft regulations that provide greater transparency and accountability, are not overly burdensome, and that allow those so important relationships between NIH-funded researchers and industry to continue in a venue of integrity and objectivity.
Whew! And we’ll see you on the implementation side.