Cloning without Prior Approval: A Response to Recent Disclosures of Noncompliance

Editor's note: 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.

My article, "Splitting Embryos on the Slippery Slope: Ethics and Public Policy" (KIEJ, September 1994), included a brief assessment of the ethics of the Hall-Stillman embryo-splitting experiment conducted at George Washington University (GWU). The article reviewed the researchers' stated purpose ("to help infertile couples by reproducing nature's ability to reproduce twins"), the features of the research itself (splitting embryos that never could become viable and with no plan to implant either the original or the split embryos), and the review procedures surrounding the experiment. I said that the researchers might be faulted for not waiting until embryo research guidelines had been established at the national level; on the other hand, they surely could not fail to conform to such national guidelines when none existed.

My conclusions were based on information that had been reported in the print media. Dr. Robert J. Stillman's statement that the experiment "had been approved by the university's formal review committees and peer reviewed by colleagues" was reported in the Washington Post on October 25, 1993, (Sawyer 1993). However, in light of the recent disclosure that the researchers had not obtained approval from George Washington University's IRB before proceeding with the research (Schwartz 1994), I now draw a sharply different conclusion about the ethics of the researchers' behavior.

The most glaring flaw was the researchers' failure to submit a protocol to their institution's IRB in advance of embarking on the research. Following an investigation of the matter, the Office for Protection from Research Risks (OPRR) made the further determination that "the failure on the part of GWU research investigators and administrators to notify the IRB promptly about noncompliance in this research constitutes additional serious noncompliance" with research regulations (J. Thomas Puglisi, Chief of the Compliance Oversight Branch, Division of Human Subject Protections, OPRR, letter to Stephen J. Trachtenberg, President of George Washington University, 23 August 1994). Is it reasonable to suppose that these researchers were unaware of their obligations (a) to obtain prior review and approval from the IRB and (b) to notify the IRB promptly about their noncompliance? Regarding the latter item, Dr. Puglisi's letter to the President of GWU states that "the notification requirement has been a longstanding element of the GWU MPA [multiple project assurance], which should have been familiar to all members of the GWU research community." I shall concentrate on the researchers' more glaring ethical omission, failure to obtain prior review and approval from the IRB.

Did either or both of these researchers contend that they were unaware of any review requirements for their research? Hall blames Stillman, Director of the Division of Reproductive Endocrinology, Fertility, and IVF Programs, for not making the requirement...