New rules drive off NIH researchersBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7496.864 (Published 14 April 2005) Cite this as: BMJ 2005;330:864
Tough new rules on ethics and on competing interests have caused four top researchers at the US National Institutes of Health (NIH) to quit and a prospective new head of one of the institutes to reconsider taking up the position. Meanwhile, the director of the NIH, Elias Zerhouni, told a Senate committee on 6 April that the rules had had a “deleterious impact” on the institutes and that he would consider changes.
The most senior of the top researchers to leave is James Battey, chairman of the NIH's stem cell task force and head of its National Institute on Deafness and Other Communication Disorders, who will retire in September. He has applied to be president of the new California Institute for Regenerative Medicine.
Preceding him out the door were the pathologist Lance Liotta of the National Cancer Institute and his colleague Emanuel Petricoin of the Food and Drug Administration, who are moving to George Mason University to set up a centre for proteomics (the study of the complete complement of proteins that can be expressed within an organism), and H. Brian Brewer of the National Heart, Lung, and Blood Institute, who is joining a research institute in Washington, DC.
David Schwartz, who was to head the National Institute of Environmental Health Sciences, moving from Duke University with his team, postponed taking the job.
Leading NIH scientists said the rules should be relaxed so as not to discourage scientists from working at the institutes (BMJ 2005;330:559).
The new rules ban consulting and require many NIH employees to sell shares in pharmaceutical and biotechnology companies. They were published in February 2005 (www.nih.gov/about/ethics/020105COIsummary.pdf) after debate in Congress about a Los Angeles Times article that reported that some of the NIH's 17 000 employees had received millions of dollars from outside sources (BMJ 2004;329:10).
Scientific organisations have criticised the rules, among them the Federation of American Societies for Experimental Biology, which has 65 000 members, and the American Association of Immunologists, with 6500 research scientists and physicians.
The federation said the rules should be tailored to the different roles and responsibilities of institute scientists and complained that service to professional societies and single presentations by institute scientists as guest lecturers should not be banned, that the administrative process for approving outside activities should be simplified, that the issue of prohibited financial interests should be reconsidered, because sometimes no conflict of interest exists, and that the rules about awards be clarified.
The immunologists complained that the rules were “overly strict” and “too broad” and had already had a “negative effect” on NIH staff members, “the vast majority of whom have had no conflicts of interest or engaged in even the appearance of impropriety.” The rules “will undoubtedly decrease scientific communication between NIH scientists and industry, a clearly undesirable consequence if NIH's goal is to advance research 'from the bench to the bedside.'”
Already changes have been made, said Holli Beckerman Jaffe, director of the NIH ethics office. She said that the deadline for employees' reporting of their stock holdings has been postponed to July and that the deadline for divestiture has been postponed to 3 October. About 1500 clinical and research fellows, who work temporarily at the NIH for up to four years, must disclose their holdings but may not need to sell their shares. The issue of awards will also be clarified.
The Department of Health and Human Services, the NIH's parent body, will evaluate the more than 1000 comments it has received, and rules may be changed.
“The ethics programme had deficiencies. We are committed to improvement, but perhaps some regulations went too far,” Ms Jaffe said.