There are new rules for financial-conflict-of-interest disclosure for scientific researchers who get grants from the National Institutes of Health. While the “vast majority of academic researchers” are already sensitive to conflicts and act with “the highest standards of integrity,” the system “needs an additional layer of oversight” to protect against potential problems down the line, said Francis Collins , director of the NIH, on a conference call with reporters. The final rule, out from the Department of Health and Human Services today, generally sticks to the same framework as the current 1995 regulations, said Sally Rockey , deputy director of extramural research at NIH, on the call. But there are changes, including a lowering of the threshold at which investigators must report significant financial interests to their university or research institution, to $5,000 from $10,000. A financial interest counts as “significant” if it involves the investigator, his or her spouse or dependent children, and is related to any of the investigator’s institutional responsibilities — not just his or her research. Universities or medical centers are responsible for examining those financial interests and figuring out whether they represent a financial conflict of interest — that is, whether they would impact the design or conduct of research that’s being funded, Rockey said. The new rules also require academic institutions to do more than simply tell the public funding

agency that a conflict exists for a certain investigator but that it’s been managed. Now they must also report the name of the company or entity in which there’s a conflict of interest, the value of the interest, why it’s a conflict and “some key elements” of how the institution plans to manage the conflict, Rockey said. A provision in the proposed rule would have required institutions to post their investigators’ financial conflicts on a publicly accessible website. Sen. Charles Grassley urged the Obama administration earlier this month to include the website requirement in its final rule. Instead, institutions can either post the information online or respond to written requests for that information within five business days, Rockey said. NIH began reviewing the conflict-of-interest rules more than two years ago. It had earlier come under fire from Congress for failing to crack down on undeclared conflicts by federally funded academic researchers. A federal report released in November 2009 found that 90% of the institutions that receive NIH funds “rely solely on researchers’ discretion.” Institutions have a year to implement the new regulations, including training all their investigators about the changes. In the meantime they have to stick to the 1995 rules. Health Blog readers, what do you think? Image: iStockphoto

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New NIH Conflict-of-Interest Rules: Better Than the Old Rules?