Commission head talks tough on misconduct - Chemical

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GOVERNMENT

Commission head talks tough on misconduct At the first meeting last month of the new Commission on Research Integrity of the Department of Health & Human Services (HHS), commission chairman Kenneth J. Ryan made it clear he is deeply troubled by the scientific community's half-heart­ ed response to the problem of miscon­ duct in science. It is time, the Harvard Medical School professor said, to clear up once and for all the perennially con­ tentious issues of the definition of scien­ tific misconduct and the role of individ­ uals, of universities, and of government in policing scientists' behavior. "Scientists are supposed to control the kinds of biases they have so they can get to the truth," Ryan said. "I think we have a right to ask scientists how they expect to control [scientific misconduct]. If they don't know how, we will have to figure out ways to help them." Before the meeting, Ryan had met with Rep. John D. Dingell (D.-Mich.), chairman of the House Energy & Commerce Com­

mittee, whose Subcommittee on Over­ sight & Investigations has held a series of heated hearings addressing the research community's inadequate response to sci­ entific misconduct. Most recently, Dingell has focused on data falsifications in a breast cancer study funded by the Nation­ al Institutes of Health (NIH) (C&EN, April 18, page 7). Ryan said Dingell told him that "the commission ought to find out whaf s wrong and fix it." Two decades ago, Ryan chaired the National Commission for the Protec­ tion of Human Subjects in Biomedical & Behavioral Research. He sees paral­ lels between issues considered by that commission and scientific misconduct. "We are at a point where we were with human research back in the 1970s," he said. "A lot of things were going wrong— some of them awful—and yet scientists came back and said, Trust us.' They even ridiculed the informed-consent process." The new commission, whose 12 mem­

bers were appointed by HHS Secretary Donna E. Shalala in late May, was man­ dated by Congress in the NIH Revitalization Act of 1993. That law requires the group to develop a definition of research misconduct and recommendations on procedures for HHS's Office of Research Integrity (ORI) to use in dealing with al­ legations of misconduct. A report of the commission's recom­ mendations is due to Shalala and Con­ gress within 120 days of the commis­ sion's establishment—a deadline mem­ bers are not even pretending they will make. Ryan, however, has insisted on meeting once a month for the next year, a pace that took his busy fellow com­ missioners by surprise. The NIH Revitalization Act spelled out the composition of the commis­ sion—three scientists, three people with experience in investigating misconduct allegations, three university representa­ tives, and three others including at least one attorney and one ethicist. Commis­ sion members include Judith P. Swazey, president of the Acadia Institute, Bar Har-

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The main accomplishment of the old ORI advisory committee the commission is replacing was to limit ORFs reach. Based on the old panel's advice, ORI is allowing individuals found guilty of misconduct to argue their cases in a trial-like hearing before HHS's Departmental Appeals Board. ORI has lost two high-profile cases in which the appeals board held that ORI had to prove intentional misconduct in the face of claims of "honest error." The old advisory committee also recommended that ORI narrow its definition of scientific misconduct to fabrication, falsification, and plagiarism and exclude the controversial phrase "other practices Ryan: concerned by cool response that seriously deviate from those that are commonly accepted within the scientific bor, Me., who has surveyed scientists on community." ORI had been set to follow their perceptions of misconduct; Drum- that advice but has put that action on mond I. Rennie, deputy editor of the Jour- hold since its appeals losses and the creation of the new commission. nal of the American Medical Association; and Thomas M. Devine, legal director of the At the meeting, ORI attorney Marcus Government Accountability Project, a H. Christ Jr. asked the commission to Washington, D.C., organization active in address the difficulties the office has whistle-blower protection. faced with proving intentional miscon-

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duct. 'This commission should establish if intent should be required and who has the burden of proving lionest error,' " Christ said. "Should it be ORI who has to show [a falsification] wasn't honest error? Or is it up to the individual to bear the burden of demonstrating he has all the data that support what he reported in the paper?" Ryan immediately replied that "when scientists present material as being new, it is their responsibility to convince colleagues or the world. It is not the responsibility of anyone else to prove it wrong. They either have the data and it's correct or they don't." The commission will continue to debate Christ's questions at its next meeting July 25. Other issues it has decided to address in subsequent meetings include the appeals hearing process, a statute of limitations on allegations of scientific misconduct, sanctions for those found guilty, the prevalence of scientific misconduct, and fostering research integrity. Pamela Zurer

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