Wellcome Rules Widen the Net

Reposted from Science magazine,Vol. 293 No. 5534

The U.K.'s biggest biomedical charity has filled a void by proposing its own guidelines and procedures for handling allegations of scientific misconduct. While generally winning high marks, the draft rules from the Wellcome Trust are likely to spark controversy by broadening the definition of misconduct beyond the U.S. government's standard and by offering relatively little protection to whistleblowers.

The draft guidelines, circulated late last month, would apply only to institutions receiving Wellcome funds. Even so, they could be a tonic

for a scientific community that has been left to police itself without widely accepted definitions of both misconduct and good scientific practices. "Everyone in the U.K. seems to agree that something needs to be done, but no one seemed to be willing to take action," says Wellcome's Robert Terry.

"This is an extraordinarily positive development," says ethics expert C. Kristina Gunsalus, associate provost of the University of Illinois, Urbana-Champaign. "The most important thing is that someone in the U.K. has finally taken the initiative."

The Wellcome document gives a fuller--and perhaps more contentious--definition of misconduct than parallel regulations governing U.S. federal funding developed by the Office of Science and Technology Policy (OSTP) (see table on the left). While approving Wellcome's overall approach, some experts quibble with the details. Although both the trust's and OSTP's definitions include plagiarism, fabrication, and falsification of data, the Wellcome language "moves away from the clarity of the U.S. definition by reintroducing deviation from accepted practices as misconduct rather than as the basis for finding misconduct," argues Fred Grinnell, director of the Ethics in Science and Medicine program at the University of Texas Southwestern Medical Center in Dallas. Adds ethics expert Howard K. Schachman, a biochemist at the University of California, Berkeley, "The definition of scientific misconduct presented in the Wellcome Trust document contains words and ideas that I think should be eliminated."

According to Chris B. Pascal, director of the U.S. Office of Research Integrity, Wellcome's definition of what constitutes misconduct-- including "deliberate, dangerous or negligent deviations from accepted practices"--"is considerably broader" than the OSTP's definition. "In theory, it would be easier to show misconduct under Wellcome's definition than under the U.S. definition," says Pascal, who notes that the OSTP rules are likely to go into effect at several--but not all--U.S. departments by the end of this year.

One shortcoming in the Wellcome guidelines, contends microbial geneticist Herbert Arst of Imperial College in London, is their lack of strong provisions for protecting whistleblowers and ensuring that universities don't conduct cursory "whitewash inquiries" of misconduct allegations. Terry defends Wellcome's whistleblower section, explaining that its wording is limited partly by the U.K.'s strict libel laws, which make it easier for accused parties to win a defamation case.

Such concerns could be addressed in final guidelines set to go into effect in the fall of 2002. In addition to providing comments on the existing draft, due next month, the trust has asked organizations to describe how they deal with misconduct allegations. Oxford University's 2-year-old integrity code, for example, offers a relatively broad definition of misconduct and a set of procedures to pursue allegations. According to Wellcome, sanctions against a researcher found guilty of misconduct could range from a letter of reprimand to barring the individual from receiving trust funds "for a given period."

The Wellcome guidelines could trigger a rush among U.K. research outfits to follow suit, predicts Drummond Rennie, deputy editor of The Journal of the American Medical Association. Nor are the guidelines intended solely for biomedical scientists: "We're hoping that this also can become the template for guidelines in other fields of science," says Terry. In addition, Britain's research councils are weighing whether to require universities to adhere to "good practice" as outlined by the Medical Research Council. Although Wellcome does not have the power of a government agency, it does wield a sword of Damocles over universities and research institutes hesitant to enforce its planned rules: the threat of making them ineligible for Wellcome grants.

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