The University Record, February 18, 1998

National Conference on 'Managing Research Integrity': Shapiro details National Bioethics Advisory Commission's work in national policy formulation on human cloning

Harold Shapiro told his Rackham Amphitheater audience that coming up with a recommendation on cloning for President Clinton required some finessing of issues and forced decisions based on political expediency by the National Bioethics Advisory Commission. Photo by Bob Kalmbach

By Jane R. Elgass

The fear, concern and anxiety that arose last year following the announcement of the cloning of a sheep "had an extraordinary impact on our ability to deal with [the issue] in a thoughtful way," Princeton University President Harold T. Shapiro told those attending the conference on "Managing Integrity in Research" last week. He delivered the keynote address at the Feb. 10­11 event in the Rackham Building.

Shapiro chairs the National Bioethics Advisory Commission, which was charged shortly after the announcement of Dolly's birth with advising President Clinton within 90 days on the ethical and legal issues surrounding the possible cloning of human beings.

He used the Commission's work on cloning to illustrate the challenges and frustrations encountered when bioethical issues intersect with public policy issues. He also underscored the difficulties encountered by a group that was comprised largely of academics, who are accustomed to applying rigorous standards to their work over long periods of time. He even thought about rejecting the charge, knowing that the work wouldn't survive normal academic review, that it would require finessing some issues, ignoring others and compromising on yet others.

There was "a lot of angst" when Dolly was announced, Shapiro noted, and legislation was being introduced that "was very scary." He hoped that the work of the Commission would provide a cooling-off period and help focus public debate on the issue.

To tackle the complex issue, the group accessed the knowledge that was available from the scientific community; the legal arena, because constitutional issues are involved; and two groups with expertise in ethics-religious faiths and philosophers.

And even the approach became controversial. Shapiro said some felt that just asking for input from religious groups was unconstitutional and inappropriate, because of the constitutional issue of separation of church and state.

The Commission ultimately decided to redefine the original problem to a smaller scale, finessing and ignoring some issues even if they were central to the issue at hand. Legal considerations were left to the courts. Animal rights issues had no direct impact. Embryo research, perhaps the most controversial related issue, was put aside. Shapiro knew that if this issue were included, the report would be "dead on arrival."

The final focus of the group's work was "using the somatic cell nuclear transfer technique for the purpose of creating an infant." Shapiro explained that this allowed the group to remain silent on the embryo research issue, and provides a good example of the necessity of compromise and making political judgments.

The Commission then was able to agree that at the time attempting to clone a human being was scientifically and clinically premature, unsafe and unethical, and recommended a five-year ban on attempts to clone a human being.

Shapiro also briefly touched on another complex issue that will be on the Commission's agenda-the use of human subjects who have impaired decision-making capacity.

The answers to this dilemma are not so clear as were those with human cloning. The treatment of human subjects in medical experiments has gradually improved since World War II, he noted, with the institution of informed consent and institutional review boards. And while there have recently been provisions made that cover children, there are none for those who are "decisionally-impaired."

This is an unusual dilemma, he said, because the needs of this population are extraordinary, and many could likely benefit from test medications. "But how do you get them into experiments when informed consent, one of the rocks on which research ethics rests, is gone? You need human subjects eventually."

It's possible to use the approach used with children, which requires the consent of a parent or guardian. Individuals who are at risk for Alzheimer's disease might be asked to prepare advance directives. "But what is the ethical content of that decision?" Shapiro asked. "Can you understand now how you might feel in a different state?

"We need to have a way of determining someone's decision-making capacity. It's a shame we don't have guidelines. They are much needed."