NIH proposes new funding rules to prevent conflicts of interest

By Rob Stein
Friday, May 21, 2010

The National Institutes of Health proposed new guidelines Thursday to prevent financial conflicts of interest among thousands of researchers who receive federal funding, a move long sought by watchdogs of scientific research concerned about the influence of the drug industry and others.

The move, which will affect more than 40,000 researchers, comes amid rising concern about the influence of the pharmaceutical industry and other private-sector interests on scientific research. In a series of high-profile cases, federally funded researchers have received upward of millions of dollars from companies with a financial interest in the outcome of their work.

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 lose their funding.

"Partnerships between NIH-funded researchers and industry are essential. They have been, and they will be," NIH Director Francis S. Collins said in announcing the guidelines, which will be subject to 60 days of public comment and possible revision before becoming final. "At the same time, we need to be clear that in order to preserve the public trust in the objectivity of biomedical and behavioral research, all research has to be conducted without bias and with the highest scientific and ethical standards."

Collins stressed that, in most cases, the integrity of scientific research has not been compromised by outside funding. But even the appearance of a conflict can undermine public trust, he said.

"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," Collins said.

Universities and professional organizations have been tightening their policies concerning outside funding in recent years to prevent conflicts of interests. The National Academy of Sciences' Institute of Medicine released a scathing report last year urging doctors to stop accepting money, gifts and free drug samples from drug and medical device companies.

Sen. Charles E. Grassley (R-Iowa), who has been investigating conflicts of interest in federally funded research, welcomed the proposed changes, which he said he planned to review.

"Disclosure of financial relationships and the resulting accountability have been sorely lacking in federally sponsored research," Grassley said in a statement. "Letting the sun shine in and making information public is basic to building people's confidence in medicine. And with the taxpayer funding that's involved, people have a right to know. Public trust and public dollars are at stake."

Several groups that had been advocating for tougher rules praised the proposal.

"The leaders of the NIH are finally considering seriously an idea they have rejected for years: public disclosure of grantees' financial arrangements that may create conflicts of interest," said Ned Feder of the Project on Government Oversight.

Allan Coukell, director of the Pew Prescription Project, a consumer advocacy group, said the rules were a step in the right direction, though there were some shortcomings. The rules should require researchers to report any financial interest, even those less than $5,000, he said. The rules also do not require those receiving more than $250,000 to specify the amount any further.

"From the public's point of view of trying to assess someone's financial stake, you'll have no way of knowing whether they have a $250,000 interest or a $1 million interest," Coukell said.

A spokesman for PhRMA, which represents the pharmaceutical industry, said the group was reviewing the proposed rules.

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