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Following HHS Final Rule, Researchers Face Changes to Conflict-of-Interest Reporting Rules in 2012

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National Institutes of Health-funded researchers will face more rigorous rules for reporting potential conflicts of interest beginning in August 2012, as a result of the US Department of Health and Human Service's recently issued final rule on the subject.

While HHS has maintained the general framework of its 1995 conflict-of-interest regulations, notable changes reflect its commitment to providing "greater transparency and accountability," NIH's Sally Rockey noted at her Office of Extramural Research blog.

Among changes made to its 1995 regulations, the department amended what it considers "significant financial interests" — which now include all of the investigator's institutional responsibilities, rather than only those deemed related to the federally funded work — as well as the threshold for their disclosure — $5,000 instead of $10,000.
In addition, the August 2011 final rule requires researchers to complete conflict-of-interest training prior to engaging in public health service-funded research and at least every four years thereafter. They must also make certain conflict-of-interest information available to anyone who requests it within five days.

"The NIH is committed to safeguarding the public's trust in federally supported research that is conducted with the highest scientific and ethical standards," NIH Director Francis Collins said in a statement. "Strengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds."

Hamilton Moses III, chairman of the Virginia-based Alerion Institute and adjunct professor of neurology at Johns Hopkins School of Medicine, says he doesn't expect these conflict-of-interest changes will affect biomedical research substantially.

"I think the changes are minimal, and [it's] very likely the change in the disclosure threshold — and most of the others — will have very little effect on interactions between researchers and companies," Moses says. "It's possible that others would draw different conclusions, but as I read them, the changes are so minimal — the difference between $5,000 and $10,000 is not great — that the need to have the ties disclosed, the need for the institutions to redisclose them to others, those are all fairly straightforward."

If anything, Moses says the changes could have an impact on clinical research. "I don't think the changes that have been propagated are going to affect basic research very much," he says. But since the final rule changes "don't address clinical research explicitly, they leave open what is to be expected of the clinical researcher."

Overall, "the most vulnerable area is in the space between ... basic research and clinical research," Moses says. It is early-stage translational research, he adds, that "is a very gray area."

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