U.S. Proposes Rules to Deter Scientific Fraud

The Department of Health and Human Services has proposed tough new measures to prevent and punish scientific fraud, including spot audits of researchers who receive federal funds, the creation of an “office of scientific integrity” and financial sanctions against universities that fail to monitor their scientists adequately.

The department, which has been under criticism for lagging in efforts to ferret out scientific misconduct, has drafted a far-reaching outline of a “rigorous and active program to detect and deter scientific misconduct.” The proposal also suggests that scientists and institutions be required to keep “raw data for a specific period of time” and share the data with other researchers in certain circumstances.

The proposals are being published today in the government publication known as the Federal Register, along with a request for comments from the public and members of the scientific community. After the 60-day comment period, department officials will decide which of the proposed measures to include in more specific regulations. These rules, which do not require congressional approval, eventually would be finalized and go into effect.

“We have tried to flesh out all of the issues concerning scientific misconduct that we thought were significant,” said a senior Health and Human Services official involved in developing the proposals.

“They have a clearly conceived program which is quite different than the one which existed up to now,” said Dr. Martin F. Shapiro, an associate professor of medicine at the UCLA Medical Center who is a member of the Institute of Medicine’s committee on the responsible conduct of research. “It looks to me like they have thought it through quite carefully.”

The Health and Human Services initiative comes at a time of increasing concern by scientists and government officials over reports of irregularities in biomedical research. These irregularities include not only outright fraud and data fabrication but less obvious problems such as sloppy laboratory techniques and poor record-keeping.

There has also been sharp congressional criticism of the National Institutes of Health, which are part of the Department of Health and Human Services, for inadequately enforcing their own scientific misconduct regulations. The NIH support the work of about 50,000 scientists a year throughout the country and have an annual budget of more than $6 billion.

A key element of the new Health and Human Services plan is a proposed office of scientific integrity, which might supersede the current scientific misconduct offices of such agencies as the NIH and the Alcohol, Drug Abuse and Mental Health Administration. A department official said the Food and Drug Administration is less likely to be affected by the proposals.

The office of scientific integrity would have an investigative branch to determine whether misconduct allegations have merit. A pool of scientists would make up the office’s adjudicative branch. The scientists would form committees to review allegations found to have merit. In the past, scientific misconduct investigations have sometimes been delayed by difficulties in finding qualified scientists to conduct the reviews. Federal officials hope to speed up the review process by creating a group of scientists ready to take part.

After formal hearings, the adjudicative branch would have the power “to impose such sanctions as it deems appropriate where scientific misconduct has been established by the evidence,” according to the proposal.

The department said it was also considering a variation on this plan--giving the existing office of inspector general “complete and exclusive authority to investigate allegations of scientific misconduct.”

Controversial Proposal

A proposal that may be controversial is the suggested requirement for retention and sharing of research data, unless it contained proprietary information. This is already required for some research funded by the National Science Foundation. Scientists in favor of this requirement say it would serve as a check against poor record-keeping and shoddy research and encourage scientific progress. Scientists against such a requirement feel enormous amounts of storage space might be necessary; others feel it might give an unfair advantage to competitors.

Another potentially controversial proposal is expanded use of “either routine or random on-site audits” of research data collected under federally funded research projects. The NIH have never performed such spot audits. By contrast, the FDA routinely uses such audits to ascertain the accuracy of tests and uncovers what it considers “serious deficiencies” more than 10% of the time.

The Health and Human Services announcement also proposes to require universities that receive funds from the NIH and other Public Health Service agencies to “inquire immediately” into misconduct allegations and to “deal forthrightly” with misconduct when it is discovered.

Universities are also urged to protect the privacy of those who report apparent misconduct and to guard against real or apparent conflicts of interest in cases where a scientist is asked to review a close colleague.

Funding Cutoff

Failure to comply with Health and Human Services requirements “may result in enforcement action against the institution, including loss of funding,” the draft proposal states. The perception that the NIH’s misconduct probes in the past have lacked vigor and timeliness was strengthened last April at congressional hearings on misconduct allegations against a group of Massachusetts Institute of Technology and Tufts University researchers including Nobel Laureate David Baltimore. The NIH report on these allegations, which were first publicized within the research community in early 1987, has yet to be completed.

At these hearings, some congressmen compared data-fudging researchers to “white-collar” criminals and suggested that new laws might be necessary to regulate and punish them.

Leading scientists said that such congressional action would only make matters worse, perhaps even stifling creativity by casting a shadow over unorthodox research approaches.

“There has been widespread concern within the research community about Congress taking some action that might impinge upon academic freedom,” UCLA’s Shapiro said. These proposed regulations “can be seen as an effort by the Administration to forestall that. Indeed, if they set up an appropriate program, it would be a good thing.”

In a related development, the NIH have increased from two to four the number of professionals whose primary responsibility is to monitor scientific misconduct.

On Oct. 10, Mary Janet Newburgh, described as a “health scientist/administrator” will become director of the NIH’s Institutional Liaison Office, which monitors scientific misconduct, according to Katherine Bick, the NIH’s deputy director for extramural research. Newburgh replaces Mary L. Miers, the former director of the office, who has taken another job within the NIH.