New NIH Conflict Rules and Their Impact on CIRM

The NIH today unveiled proposed new conflict-of-interest rules that will reach deep into stem cell research circles in California, touching the state's stem cell agency and affecting 40,000 scientists nationwide.

Francis Collins, director of the NIH, said the rules are aimed at preserving public trust in research ethics and the “integrity of the scientific enterprise.”

According to a report on GenomeWeb News, Collins said,

"As the NIH director, I think I can say with great sincerity that the public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process."

Rob Stein of the Washington Post wrote,

“Among other changes, the new guidelines will reduce from $10,000 to $5,000 the minimum payment that researchers will be required to report and mandate that universities, colleges, research institutes, businesses and other entities that employ researchers who receive NIH funding monitor compliance with the new reporting requirement. Funding information would have to be posted on a publicly accessible Web site. Violators could be subject to losing their funding.”

The rules would require recipient institutions to create a Web site that would display the statements of economic interests filed by their faculty. Some institutions, such as Stanford, already do that. Stanford labels the pages as “industry relationships.”

The NIH announcement focuses new attention on a recommendation last January that CIRM post on the Internet the statements of economic interest filed by members of its board of directors. A sister organization to CIRM, the Citizens Financial Accountability Oversight Committee, said that CIRM should follow the example of California Gov. Arnold Schwarzenegger. He requires his appointees to file their economic interests online along with their monthly expense claims. State Controller John Chiang, the state's top fiscal officer and chairman of the oversight committee, said the postings and other changes were needed to improve transparency and accountability at CIRM.

Last Friday, the California Stem Cell Report asked Don Gibbons, CIRM's chief communications officer,  whether the agency intended to act on the recommendation for online postings. We have received no response.

The NIH requirement is also likely to raise questions about CIRM's policy of secrecy concerning the economic interests of the scientists who make the de facto decisions on CIRM grants. Currently grant reviewers only have to disclose their interests to a select group within CIRM. Applicants (and the public) have no way of knowing the economic or professional interests of scientists who review their applications. However, with the new NIH rule, virtually all of those scientific reviewers, given the likelihood they hold an NIH grant, will have to post their economic interests at their home institutions but not at CIRM.

Some influential groups have taken positions indicating the proposed NIH rules are not strict enough. Jocelyn Kaiser of Science magazine wrote,

“Although these are big changes, they fall short of advice from an Institute of Medicine panel and the Association of American Medical Colleges (AAMC). Both think that researchers should report all potential financial conflicts to their institutions, with no minimum dollar threshold.”