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NIH's Collins Introduces Conflict-of-Interest Changes

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Along with several enhancements being considered for its policy on dealing with financial conflicts of interest, the National Institutes of Health is making plans that will shift much of the responsibility for transparency away from the individual and to the institutions they work for, NIH Director Francis Collins said today.

In a conference call with reporters, Collins outlined several planned changes that he said are aimed at safeguarding the public's trust in federal research ethics. Collins said a notice of proposed rulemaking in the Federal Register tomorrow will list the changes and will mark the beginning of a public comment period of 60 days for the proposals.

Collins said that the rules will provide "a substantial change in the way in which NIH seeks to oversee potential conflicts of interest," as well as "differences for investigators in universities and institutes and small businesses that are being supported by NIH."

He explained that "even though these proposed new rules may provide some burden… in terms of additional reporting requirements, we believe that it is essential to tighten up this situation in order to be sure that we are obtaining and maintaining the public trust and the integrity of the scientific enterprise."

According to the director, there will be several broad new rules. Under one of the rules, the financial threshold for amounts that NIH will not worry about will be reduced from $10,000 to $5,000.

The new rules will now cover those receiving Small Business Innovation Research and Small Business Technology Transfer grants, which were not covered under the rules instituted in 1996.

The responsibility for deciding whether a particular relationship is a financial conflict of interest will now rest upon the institution as opposed to the investigator, Collins said. In addition, Institutions now will be required to set up a process to review potential conflicts of interest, to identify those that may be an intervention, and to report to NIH those that may need an intervention, he continued.

The rules will exclude income gained from seminars, lectures, teaching, and service on advisory or review panels for government agencies or institutions of higher education.

The new policy also will have a disclosure component under which institutions will now be required to develop a publicly accessible website that will display significant financial interests of their faculty and other institutional members so that the public can have a clear way for identifying what kinds of arrangements have been made so that there is more transparency in the process, he added.

"We believe that in the past the process that has been followed has, for the most part, been successful… [and] I don't mean to imply in these things that I'm saying that there has been a widespread problem in terms of financial conflicts of interests," said Collins. "But there clearly have been a few examples uncovered in the last few years where investigators were involved in financial conflicts that could be at least pierced as coloring their judgments and perhaps affecting publications that they were involved in."

He added, "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."

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