ANALYSIS : Problems of Fraud in the Science Lab

Scientists and government officials are increasingly concerned by reports of irregularities in biomedical research but are deeply divided over what sort of corrective measures are necessary.

Some congressman are contemplating new laws to regulate and to punish data-fudging researchers who are often supported by large federal grants.

But many biomedical researchers are aghast at such proposals. While conceding that there was “some truth” to the charge that the research community has been “stonewalling” the fraud problem, two editors of the prestigious New England Journal of Medicine argued in a recent editorial that a strengthened federal oversight role would only make matters worse by “jeopardizing the freedom that is required for research to flourish.”

The editorial suggested that the research community had finally been jolted out of its complacency and is “willing and able to police itself.” Examples of this willingness include new policies from the International Committee of Medical Journal Editors on the retraction of erroneous or fraudulent research findings and new guidelines on fraud prevention at such medical schools as Harvard and UCLA.

In the months ahead, a number of prestigious groups will hold conferences on scientific misconduct, including the Institute of Medicine and the Council of Biology Editors. Further congressional hearings and a internal U.S. Department of Health and Human Services review are likely as well.

Regardless of whether this call for congressional restraint prevails, leading scientists as well as their chief source of funds, the U.S. National Institutes of Health, have clearly been put on the defensive.

In 1986, after four years of planning, the NIH implemented procedures for dealing with misconduct, including guidelines for conducting investigations, requirements that institutions receiving federal funds more closely monitor their scientists and safeguards for the rights of those accused. These procedures have been widely praised as a significant step forward.

But the NIH has been criticized for inadequately enforcing its own regulations. For example, it has an annual budget of more than $6 billion and supports the work of about 50,000 scientists a year. But it has only a handful of staff members whose primary responsibility is to monitor scientific misconduct. The agency’s probes often drag on for years.

The NIH has also been criticized for forsaking an activist role in ferreting out unreported instances of fraud. It has not commissioned research to accurately determine the extent of research irregularities, ranging from poor record-keeping to more serious violations. Nor does it perform spot audits of investigators who receive federal funds. By contrast, the U.S. Food and Drug Administration routinely uses such audits to ascertain the accuracy of tests of new drugs and uncovers “serious deficiencies” more than 10% of the time.

The perception that the agency’s probes lack vigor and timeliness is illustrated by the highly publicized allegations of misconduct against a group of Massachusetts Institute of Technology and Tufts researchers, including Nobel Laureate David Baltimore, one of America’s best-known scientists. The charges involve the verity of a complicated immunology paper published in the prestigious journal Cell on April 25, 1986.

The allegations of irregularities--which the Boston researchers deny--were first publicized within the research community in early 1987. Soon thereafter, Baltimore suggested that the dispute be arbitrated by a group of independent immunologists assembled by the NIH. But the federal probe did not get under way in earnest until the matter was aired at two congressional hearings in April. Now, a final report is expected within “weeks, not months,” according to Mary L. Miers, the NIH’s misconduct policy officer.

Moreover, NIH officials initially appointed a former postdoctoral student of Baltimore’s and his co-author on a textbook to the three-member review panel. The two later had to be replaced when this apparent conflict of interest became widely known.

Consensus on the best approach to quash scientific misconduct is unlikely, but the recent developments make it more likely that stronger corrective measures will emerge. If not, observers fear that a continuing series of revelations is likely.