Battle Heats Up Over Who Owns Research Data

WASHINGTON -- University of Utah administrator Jean Nash began to wonder two years ago whether her institution or the individual scientist owns research data generated in the laboratory. As the director of the Utah Resource for Genetic and Epidemiological Research, Nash was trying to develop management guidelines for the burgeoning amounts of information flowing out of her center and its affiliated medical school. But she discovered that, in her words, "there were no university guidelines. And we thought that in the future there was potential for problems." Little did she know how many others share her concerns. In the wake of heightened efforts nationally to resolve allegations of scientific misconduct, the issue of who should keep the original data in his possession has become a hot topic for university administrators, government officials, and bench scientists alike. Heated debate at two recent meetings suggests that the issue is far from simple, however, and that any quick resolution is unlikely. Last month, at a two-day, government-sponsored workshop devoted to the subject, a Public Health Service (PHS) lawyer declared that institutions are responsible for all records, both financial and scientific ones, that are generated from federally funded research. At another April meeting, this one cosponsored by the National Institutes of Health and the American Association of Medical Colleges, a lawyer for Johns Hopkins Medical School took a similar view of what's needed at her institution. Both statements immediately evoked a cry of protest from scientists and other university administrators. They argue that the data historically have belonged to the investigator, as well as that any change would constitute an unwarranted and unnecessary intrusion into the laboratory. Many scientists take great pride in maintaining detailed records of their work, which in common practice they carry around with them from one laboratory position to the next. They say universities -- many of which do not have clear ownership and access policies -- should have no fear of lost or inaccessible records and express astonishment that universities would try to wrest control away from them. "First you'll have to build a new building to house the 35 boxes stored in my attic," says Barbara Hansen, a professor of physiology and vice president of graduate studies and research at the University of Maryland School of Medicine. "I have some samples that are 10 years old. After I publish, my data may be subjected to many more analyses and mined for many more papers before they are no longer useful." After two years of canvassing other medical schools and of monitoring discordant opinions within her own university, Nash still doesn't know when the guidelines will appear. "If you have good management policies then dealing with fraud and misconduct problems becomes mechanical," says Nash, who believes much of the current anxiety arose from the celebrated hearings by Rep. John Dingell (D-Mich.) into how NIH handled allegations that a 1986 Cell paper on gene expression, coauthored by Nobel laureate David Baltimore, contained serious errors. Speaking at a "Workshop on Data Management in Biomedical Research" in Washington, D.C., last month, PHS chief counsel Richard Riseberg confirmed some scientists' worst fears when he stated publicly that PHS will hold the university responsible for the maintenance of - and government access to - all research records. Until now scientists and administrators have been uncertain what the government expects of them. Eleanor Shore, dean for faculty affairs at the Harvard Medical School, says she has heard informally from an NIH official that the institution owns the biological data. But that [policy] exists only in common law. I've been hunting for [federal] documents saying the university owns the data . . . If you find a statement I wish you would call me first." Her frustration is understandable, according to Robert Lanman, legal adviser to the NIH Office of Scientific Integrity (OSI). "It is not written down as a rule anywhere that the university owns the data," he explains. Instead, he says, the code of federal regulations relating to the administration of extramural grants directs the university to maintain "records." In the past, those records have been construed to mean financial information. The PHS general counsel's office apparently wants to broaden that definition. An unsigned paper circulated at the PHS meeting on data management states "research data developed under a PHS grant is owned by the grantee institution . . . PHS has the right of access to any records of the grantee which are pertinent to the PHS grant, including research data." Says Riseberg, "The record retention language [in the paper] is significantly broad enough to cover more than financial records." Data ownership has always been a fuzzy part of PHS policy. The paper is an attempt, according to Lyle Bivens, director of the Office of Scientific Integrity Review, "to get a clear and explicit reading out on the table." The new federal regulations on scientific misconduct, published last August in the Federal Register (The Scientist, Sept. 4, 1989, page 1) do not specifically address retention of laboratory data. But OSI's Suzanne Hadley says that her office already expects universities to retain "primary responsibility" for research records. "When we are investigating an allegation of misconduct," says Hadley, "we say to them: Go do your duty. It's not a credible answer to say that [you] don't have the data." Riseberg's statement appears to be an attempt to clear up confusion over the issue. But judging from the reaction, he may have gotten into more than he bargained for. "Riseberg thinks this is just a little legal issue," says Hansen. "But it's a big science issue, and it's going to catapult him into the headlines, because we're just not going to let him get away with this." But others regard comments like Hansen's as an overreaction. "Such arguments are emotional, but not rooted in law," says Estelle Fishbein, general counsel for the Johns Hopkins Medical School. In a talk on "The Promotion of Integrity and Responsible Practice in Biomedical Research," sponsored jointly by the American Association of Medical Colleges and NIH in Arlington, Va., last month, Fishbein says that she "made some recommendations for the adoption of a university policy." With more than a note of understatement in her voice, she adds, "It turns out to be a very controversial issue." "I said that in the policy [to be distributed July 1, 1990] the university should assert its right to ownership of primary data," she explains. "The scientist would have access, but he or she must request permission to remove certain data. Permission would be based on a promise to return it or allow [the university] access . . . After that, the fur began to fly [at the meeting]." As Hansen recalls, "The majority of people there said she shouldn't be allowed to say such things. Her proposal was burdensome, unnecessary, costly, totally unjustified, and a complete overresponse to a nonproblem." It is too soon to know how the new interpretation will apply to the next case of alleged misconduct that NIH investigates. Stung by the discovery that universities may be pressured into becoming custodians for their data, many scientists are waiting anxiously to see if, and how, such a policy is actually enforced.

Battle Heats Up Over Who Owns Research Data

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