Cloning without prior approval: a response to recent disclosures of noncompliance.

In September 1994, the Kennedy Institute of Ethics Journal published a special issue on the ethics of embryo splitting or "cloning," which included papers originally prepared for a workshop on embryo splitting sponsored by the National Advisory Board on Ethics in Reproduction (NABER) and NABER's report, Human Cloning through Embryo Splitting. The impetus for the project was embryo-splitting research conducted by Drs. Jerry L. Hall, Robert J. Stillman, and others, at George Washington University and presented in October 1993 at a joint meeting of the American Fertility Society and the Canadian Fertility and Andrology Society. Media coverage at the time reported that the research had been approved by the university's formal review committees. However, it came to light in December 1994 that the researchers had not obtained approval from the university's institutional review board prior to conducting the research. Following a university investigation, the researchers were disciplined and instructed to destroy their data. The university also voluntarily forwarded the records of the incident to the Office for Protection from Research Risks at the National Institutes of Health. Dr. Hall resigned from George Washington University in September 1994. In the following postscript to her article on the ethics of embryo splitting (KIEJ, September 1994), Ruth Macklin discusses these events. The letters and memoranda that she cites were obtained from NIH through the Freedom of Information Act.