An unprecedented "debarment" regulation under which scientists, companies, universities or hospitals can be denied federal grants or other aid was issued yesterday by the Department of Health and Human Services.
The new penalty provision was put forwar two days after public disclosure that a University of California at Los Angeles scientist tried to insert new genes into two patients in Israel and Italy. He did it while his own institution's committee for protection of human subjects was deciding whether to grant him permission. It ultimately decided not to.
The UCLA committee said the experiment by Dr. Martin J. Cline would be unethical without more work first on animals.
The timing of the sweeping HHS regulation, which appeared in yesterday's Federal Register, is unrelated to the California case, Dr. Charles McCarthy of the National Institutes of Health said in an interview, but it is an example of the kind of case the regulation could cover. NIH funds the bulk of the nation's medical research.
"From what I've read," said McCarthy, who heads the NIH's Office of Protection from Research Risks, Cline probably did not violate HHS ethical rules. He said he understood that na Israeli ethics committee approved the experiment there, and that "there was a similar if less formal process" in Italy.
"But we will have to see the evidence," said McCarthy. NIH expects a full report from UCLA and Cline next week.
Meanwhile, McCarthy and other HHS officials said the new debarment regulation gives the agency as set of rules under which individuals or institutions who do legal or civil wrong, or who fail to obey HHS rules, can be temporarily or permanently barred from HHS grants, fellowships, loans or several other kinds of financial aid.
HHS said the penalties night apply to those guilty of fraud or other crimes, those "in serious violation of the condition of a previous award," those with "a record of unsatisfactory performance" on federal contracts or awards and those who do virtually anythig else "that seriously affects [their] responsibility."
Anyone notified of a proposed debarment would be given 30 days to request a hearing. But a suspension of up to six months could be ordered without a hearing.
Until now, McCarthy said, HHS has had no administrative procedure for dealing with a flagrant violator of medical ethics or other transgressors. The new regulation will take effect in 30 days.