University probe faults 'cloning' research.

In October 1993, two researchers created a stir when they announced that they had "cloned" human embryos. At the time, many ethicists denounced the work, saying it could lead to scores of duplicate humans. Last week, a National Public Radio report broke the news that the researchers had failed to obtain timely approval for their controversial experiments.

Robert J. Stillman and Jerry L. Hall of George Washington University (GW) in Washington, D.C., remain at the center of this lingering saga. The duo first presented their work on Oct. 13, 1993, at the annual meeting of the American Fertility Society, held in Montreal. Their research involved separating two- to eight-cell human embryos into their constituent cells (SN: 10/30/93, p.276;2/5/94, p.92).

In theory, the method, which the two researchers referred to as "cloning," could create identical twins or triplets. But the Hall-Stillman experiments relied on abnormal human embryos that could not develop properly and had been slated for disposal because they were not suitable for in vitro fertilization.

Throughout the whirlwind of publicity, the researchers noted again and again

that their work had won the university's ethical okay. For example, in an October 1993 press statement, Stillman said the experiment was approved by the Institutional Review Board (IRB) and the Ethics Committee of the Medical Center." The IRB is a group of professionals that reviews all requests to conduct research related to human subjects at GW.

Last week, a spokesperson for the GW medical center's office of public relations refused to answer any questions about the affair. The office did, however, release a statement saying that after the two researchers presented their results in Montreal, the IRB, as well as an independent three-member panel, went back and conducted an investigation. That probe found that Stillman and Hall had violated university policy by obtaining IRB "approval" after they had already completed the controversial experiment.

The statement says, "The IRB was never told that its approval was being sought for work that had already been performed." Furthermore, the IRB had granted its approval on the condition that the researchers obtain informed consent from the people who had donated the embryos. At the time Stillman and Hall received the university's okay, consent was not possible: They had already finished the work, using anonymous embryos.

The GW inquiry concluded that the researchers had submitted their work without full disclosure of the facts, a violation of university policy. GW President Stephen Joel Trachtenberg has directed Hall and Stillman to discard all data from this experiment. In addition, the university says it will monitor Stillman's research for a period of 2 years. (Hall left GW early this fall.)

The IRB's conclusions are based on errors of fact, contends Washington, D.C., attorney Ronald Goldfarb in a March 15, 1994, letter to the Office for Protection from Research Risks at the National Institutes of Health (NIH) in Bethesda, Md. Goldfarb has been retained by Stillman, who contends that informed consent was "impossible" and probably unnecessary, since the human embryos were grossly abnormal.

Although the experiment was not conducted with federal funds, GW (as well as other universities that receive a mix of private and federal money) complies with federal guidelines for the protection of research subjects, points out Gary Ellis of the Office for Protection from Research Risks. GW informed NIH of its investigation and the corrective measures taken. "We accepted their findings," Ellis says.