Bioethics Panel Mulls Human Research
APO
Oct 25 2000 6:18AM

SALT LAKE CITY (AP) - Federal regulations that cover medical testing on human subjects were written 25 years ago - before cloning and the human genome project were possible. Updating those regulations will be a daunting task, acknowledge the scientists, law experts and other advisers who comprise the National Bioethics Advisory Commission.

``It's an aging system from a philosophical perspective,'' said Eric Meslin, the committee's executive director. ``There are lessons tolearn from history that we don't want to repeat.''

Notorious examples include a 1940s government study in which black men with syphilis were not treated so that the disease's progression could be recorded, and another in which citizens were secretly injected with plutonium or uranium so the effect could be studied.

``In light of this history, oversight is required to ensure these abuses to  not occur again - that research participants are selected fairly, adequately informed and otherwise protected,'' the commission's draft report reads.

The 18-member group met Tuesday and will again Wednesday to draft recommendations for overseeing human research. The 5-year-old commission has already written reports on the ethical questions raised by human cloning, embryo cell research and studies of the mentally impaired.

The test subject project may be its broadest undertaking yet, Meslin said. It covers everything from gene scanning to surveys about drinking habits, from international drug studies to experiments at local medical schools.

The full report should be completed in December and opened up for public comment before being submitted to President Clinton. Federal agencies can then either implement the recommendations, or Congress can draft such legislation.

One topic of debate among the advisers was whether, in these days of gene mapping and medical testing, researchers should protect their subjects' secrets.

``Researchers come to me and ask, '' I'm doing a study on mental illness and I'm finding people who are suicidal. Should I report it?'' said Dr. Bernard Lo, director of medical ethics at the University of California at San Francisco.

Another hotly contested issue during Tuesday's session was how to protect confidential information about subjects.

Privacy ``is without question one of the hot-button issues of today,''  especially as more databases full of personal information go online, said Alta Charo, a University of Wisconsin law and medical ethics professor.

They recognized the value of laws that require a breach of confidence - such as when a researcher uncovers child abuse - but the panel said such incidents can damage the scientific integrity of the study or scare off volunteers.

``Suppose I was solicited to participate in a research project on mental issues,'' said commission member Bette Kramer, president of the Richmond Bioethics Consortium in Virginia. ``I would want to be absolutely certain I know a question that will be asked is how protected this information will be. Will it get out into the hands of others?''

Such questions take time to answer, even as technological advances come faster and faster, said Howard Mann, chairman of an institutional review board for Intermountain Health Care.

``The deliberations that need to occur to help us make use of this change is necessarily slow,'' Mann said ``The technological change far outpaces our ability to consider its ramifications.''

National Bioethics Advisory Commission:
http://www.bioethics.gov

Copyright © 2000 The Associated Press.