Congress To Forge Ahead With Misconduct Hearings

WASHINGTON—Although many scientists may wish otherwise, the political debate over scientific misconduct is not likely to end anytime soon. Despite the decidedly mixed reviews of last month’s two-day grilling by Rep. John Dingell (D-Mich.) of MIT biologist David Baltimore and others involved in investigating allegations of error stemming from a 1986 Cell paper, Congress seems eager to extend the discussion. Two more congressional panels have scheduled hearings this month on the topic, and legislation is being drawn up that would require universities and other institutions to improve their procedures to root out and prevent misconduct. At the same time, federal regulations are expected to appear shortly on how universities and other institutions must respond to allegations of misconduct. The rules, now being polished in last-minute negotiations between NIH and the Office of Management and Budget, are the final steps in fleshing out legislation passed in 1985. And scientists have not heard the last word on the question posed by biologist Margot O’Toole about the Cell paper written by Baltimore, O’Toole’s laboratory chief Thereza Imanishi-Kari, and others. O’Toole maintains that a central claim in the paper, which relates to the expression of antibodies in transgenic mice, has not been proven by the published data. The case had been closed in January with a report by a three-member panel that errors had been made but that no misconduct had occurred. But NIH Director James Wyngaarden has reopened the investigation, citing new evidence that questions the validity of some of the data in the original experiments. The first entrant in this month’s misconduct sweepstakes is expected to be Rep. Ted Weiss (D-N.Y), chairman of the human resources and intergovernmental relations subcommittee of the House Committee on Government Operations. This week Weiss plans to hold the third in a series of hearings on the responsibilities of federal research grantees, covering NSF as well as NIH. Among other issues, the panel is expected to explore further the problems arising from various types of financial conflicts of interest by scientists, a topic it examined in April and September 1988 hearings. “We realize that many scientists would prefer that Congress not be involved at all in these issues,” notes a subcommittee staffer. “And it’s true that a lot of them can be handled by the individual ‘agency. But we’re hearing a growing consensus that these are important issues, and our goal is to help those agencies in carrying out that task.” On June 28 a new player enters the fray. Rep. Robert Roe (D-NJ.), chairman of the House Science, Space, and Technology Committee, plans hearings by his oversight and investigations subcommittee, which will take a broad view of the problem of investigating allegations of misconduct. Aides note that the panel, under then-Rep. and now Sen. Al Gore (D-Tenn.), first broached the subject in 1981 hearings, but that several cases in the intervening years have raised new questions. “We want to find out where the weaknesses are in the current system, and what we can do to help solve those problems,” explains a subcommittee staffer. “We hope to answer some of the more general questions posed by Mr. Dingell and Mr. Weiss, and also hear from some new voices.” Many observers feel that the most far-reaching event of the next several weeks will he the long-awaited publication of federal regulations on how institutions should handle allegations of misconduct. Those rules will require that any applicant for federal funds must have a written, well-defined procedure for handling allegations, which includes an administrative structure to examine the charges, timetables on how quickly an investigation should be handled and when sponsoring federal agencies must be notified, protections for the rights of whistle-blowers as well as the accused, and adequate record keeping. Helping Schools Comply The rules were proposed in September, and this winter NIH sent to administration officials a final draft that incorporated comments from the scientific community. The document was returned last month with comments, and NIH officials predicted it would be at least mid-June before final details were worked out. NIH’s new Office of Scientific Integrity (see The Scientist, May 15, 1989, page 1) will have the job of helping institutions comply with the new rules, although a separate Office of Scientific Integrity Review within the Department of Health and Human Services will actually be responsible for reviewing the procedures established by each applicant and determining if they meet the federal guidelines. Brian Kimes, the acting head of the new NIH office, emphasizes that the regulations are intended to help universities do a better job in handling allegations of misconduct and fraud. The goal, he says, is a system thai works for everybody. “We don’t want to use it as a club,” he says about the regulations. “We want to use the universities procedures to detect problems that might hinder them in conducting an investigation that will stand up to the scrutiny of an outside, third party. A lot of these institutions haven’t gone through a full investigation into alleged misconduct, and we want to make sure that they have the best possible procedures in place.” Even institutions with some experience in these matters may have to change their policies once the new rules are published, however. At last month’s hearing, for example, Tufts University biomedical sciences dean Louis Lasagna distributed a copy of his school’s newly adopted guidelines to demonstrate its heightened awareness of the issue. But the Tufts guidelines, among other things, say that the sponsoring agency will be notified only after the institution has determined that misconduct has occurred and at the time punishment is being meted out. This is in contrast to the pending requirement that agencies must be provided detailed information as soon as the school decides there is sufficient evidence for a full investigation. That discrepancy is understandable, says Carol Scheman of the Association of American Universities, which represents many of the nation’s largest research universities. “For three years people have been asking me when the regulations are going to come out,” she says. “It’s a long, slow process for a university to adopt a policy on misconduct, and many administrators have said that they plan to wait until the regulations are out so they only have to go through it once.” Kimes’ measured comments about how NIH plans to work with its constituents reflects the concern of many researchers that the federal government will place them in a bureaucratic straitjacket in order to ensure that their institutions respond properly to allegations of misconduct. They fear that congressional intervention could lead to a teamof “science police” that would destroy a thriving and productive biomedical community. “Of course there could be improvements,” says Robert Weinstein, an MIT biologist and member of the Institute of Medicine committee that recently issued a ‘report on what it termed “the responsible conduct” of research. “But whatever happens, you’ve got to start with the basic premise that American biomedical research has been fabulously successful. And you don’t want to do anything to mess it up.” Another piece in the misconduct puzzle is legislation being drafted by Dingell in his role as chairman of the House Energy and Commerce Committee, which oversees NIH. That bill, says a legislative staffer, isn’t going to frighten anyone worried about the heavy hand of Congress. “There’s not a lot of contrast between what the NIH regulations contain and our proposal,” says the aide. “There’s no data police, and there’s nothing about this legislation that is particularly chilling.” According to several sources, the prospective bill requires institutions seeking NIH funds to have a process for dealing with allegation of misconduct, as well as a process for educating faculty and students on how to ensure high standards for the conduct of research. Such an effort could include information on effective data collection and storage techniques, responsible policies on authorship, adequate supervision of graduate students, and other ethical issues. “There’s some question about how much universities have actually done toward achieving these goals in the past few years,” says the Dingell aide, “and how much is just talk. We just want to make sure that what we want to happen, happens.” However, some observers question whether the legislation will ever be introduced. “Misconduct is still a volatile issue,” notes one science policy analyst, “but I don’t see a strong consensus for legislation as the answer.” Adds another House aide familiar with the issue, “If I were Dingell, I certainly wouldn’t be in any hurry to introduce this bill. J think I’d wait until the situation improves a little.” Tactics Backfired That last comment is a reference to the general view that Dingell’s conduct in examining how Tufts, MIT, and NIH handled their investigations of the Cell paper was heavy-handed and unfair to the researchers involved. Dingell insists that the hearings were intended to look at the process of investigating fraud, not whether the science was done and reported accurately. He stresses his strong support for biomedical research in general and for NIH in particular, and believes that his actions will strengthen science by making it more responsive. But after two full days of hearings, there were few scientists taking his side. Even those who have strongly criticized their colleagues for moving too slowly on the issue say that Dingell’s tactics backfired and that his pursuit of the case may make it more difficult to find permnent solutions. “Of course Congress has the right to look at how public funds are being spent m research,” says Drummond Rennie, deputy editor of the Journal of the American Medical Association, “and it’s done a good job at reminding scientists about their duties in such important areas as the treatment of human subjects, laboratory animals, and responsible conduct. Fraud is a legitimate problem, and I’m certainly no admirer of how universitites have responded. “But I don’t see how persecuting David Baltimore will advance IDingell’s] cause,” adds Rennie, who has suggested that a random audit be conducted to determine the extent of research fraud. “People understand his point that the research community acts in a self-serving fashion, that it often tries to crush the whistle-blower, and that it’s too slow to deal with allegations of misconduct. But the Baltimore case doesn’t convince scientists that they have a problem with fraud. Rather, it tells them that they have a problem with Congress. Not surprisingly, the Republicans on Dingell’s committee agree that the exercise was a futile one. “America is becoming a science-poor nation,” Rep. Norman Lent (R-N.Y.) declared in an opening statement, “If we allow leading-edge scientific work to suffer because of misguided attacks and public efforts to discredit our best and brightest, instead of encouraging sound research and informed debate we will soon find ourselves with no scientists and nothing to debate.” But arguments over Dingell’s tactics won’t change the fact that NIH has begun another investigation into the Cell paper. The new probe will take several months, Kimes estimates, and will include a data audit by outside forensic experts and possibly a new round of interviews with the principal characters, including O’Toole, Imanishi-Kari, and Walter Stewart, the NIH researcher who has been helping Dingell with the investigation. Kimes hopes at least some of the three original panel members will agree to serve on the new committee. But he says he would understand if they decline. “I just hope that we’re not gong to scare off good people from being willing to participate because of the hardships involved,” Kimes says about the process of investigating alleged misconduct. “But I can tell you that it’s a stressful experience.” [ Ed. note: This is the first of a two part series on research misconduct. Next a look at some of the scientific issues that defy easy solutions. ]

Congress To Forge Ahead With Misconduct Hearings

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Jeffrey Merivs

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June 1989

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