NIH final conflict rule demands more data, but not much better access to it

New federal conflict rules released this week confirmed rumors that the National Institutes of Health had stepped back from stronger public transparency for biomedical researchers who accept industry support. The updates to the rule, last established in 1995, are still an important step forward, lowering the reportable dollar threshold that counts as a potential conflict from $10,000 to $5000 annually, and capturing more info on academic-industry ties both at the university and federal level.

Despite the disappointing retreat on requiring universities to publish investigators' conflict info on a public website--(schools  must only be able to produce it upon request, much like FOIA)--the updated rule retained some major improvements and stated reasons that we supported in comments to the Institutes in 2009, including:

• The definition of a Significant Financial Interest, and therefore what is reported, be changed from its current level – payments above $10,000 – to $5,000, which would mean universities would have to report all such payments to the NIH. (The Association of American Medical Colleges, or AAMC, also backed this change.)
• Reports of Financial Conflicts of Interest (FCOI) to NIH should include more information, specifically the criteria and categories identified in the Physician Payments Sunshine Act.

The new rule will also broaden the types of payments an investigator must report to his or her institution, including sponsored travel, though an institution may not require a dollar amount—but at minimum a destination, sponsor and purpose of the trip. The NIH will also require grantee institutions to train investigators on conflicts of interest and the policies going forward.

As we noted last year, the AAMC and other university associations pushed back hard on many parts of the rule, even questioning in late comments the need for changing the conflict of interest rules:

There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could … erode the trust between the regulators and those being regulated. (AAMC comments on proposed rule, the Federal Register, August 2010)

“Academic medicine revolted against it,” Public Citizen’s Sidney Wolfe told PostScript earlier this month. Wolfe said the public website component of the rule was an important “user-friendly place" for researchers and patients concerned about the potential bias of researchers who take money from drug companies to go.

Other watchdog groups said the rules stopped short of what was needed.

“The take-home message is that these are half steps,” Paul Thacker, a former aide to Sen. Grassley and now at the Project on Government Oversight, told the Washington Post. “[NIH] could have taken steps that ensured the trust of American taxpayers who are funding this research, but they chose not to take those steps.”

Thacker told the JAMA blog that keeping the website rule could have been as simple as 'requiring institutions to add information about management plans and investigators’ conflicts to the NIH’s existing RePORTER database, in which institutions provide information about the use of grant funds.'

In our comments to the agency, we, along with Sens. Grassley and Kohl, stressed that the Physician Payments Sunshine Provisions would be an important tool for auditing disclosures made to NIH institutions. With the rollback on uniform public access to this information, Sunshine’s centralized, public-geared website becomes even more essential, and the agency should take care to preserve it, both in spirit and in letter.

--Kate Petersen, PostScript blogger