By Lisa Seachrist
BETHESDA, Md. — Long before Dolly and the human cloning debate entered into the picture, the National Bioethics Advisory Commission (NBAC) was charged with evaluating the ethical issues found in experimenting on human beings and managing the explosion of genetic information.
While the potential to clone a tribe of Hitlers or team of Michael Jordans is a much sexier topic, establishing a policy by which researchers can have access to the vast number of tissues samples stored in hospitals around the country could have a profound effect on the way biomedical research is conducted today.
In considering issues ranging from medical privacy to community stigmatization, the NBAC's genetics subcommittee is devising a framework that it expects will provide researchers the access they need to the stored tissue samples while at the same time providing appropriate levels of informed consent to the people whose tissues are being used.
The subcommittee members met Sunday at the National Institutes of Health (NIH), in Bethesda, Md., to continue their dialogue with an eye to having a report in February 1998.
For decades, stored tissue obtained from biopsies and other surgical and diagnostic procedures has served as the raw material for investigations into diseases ranging from cancers to neurological disorders. Typically, researchers need certain types of tissues, but have no interest in identifying from whom they came. And federal law allows such research without any institutional oversight when the samples are anonymous.
Samples Contain Vast Amounts Of Information
However, the advent of genetic technologies means a gold mine of information — unimaginable at the time many of the samples were taken — can be retrieved from every sample.
While a boon to academic and industry researchers alike, the problem is many people haven't the foggiest notion their tissue is being kept and used for research, despite the fact that in order to have the procedure performed, patients sign a release which informs them their tissue may be used for research and educational purposes.
This scenario is, in effect, "hidden investigations," said Robert Weir, a professor of bioethics at the University of Iowa, who has been commissioned to provide the subcommittee a paper describing ethical issues surrounding tissue research. Weir detailed anecdotes to the commission where patients were told — in form letters — research on their tissues had been conducted.
"When you said hidden investigations, my blood began to boil," said Ezekiel Emanuel, commission member and professor of medical ethics at Harvard Medical School. "This isn't underground, classified research. Your characterization is descriptively inaccurate."
In order to gauge how people around the country felt about their tissues being used for research, the commission is holding a number of mini-hearings.
James Wells, a researcher with the NIH who has conducted the hearings, reported that the number one issue for most people was they wanted to be sure their insurance companies couldn't identify them from research conducted on their tissue samples.
"While they wanted assurances of confidentiality, they didn't in general trust anyone to provide it," Wells said.
"I think it is important to note here we've identified the bogeyman: the insurance companies," Emanuel said. "People aren't objecting to the research."
But the concern over privacy, especially genetic privacy, has spawned a plethora of state and federal bills to prevent the misuse of these tissues. Because the federal government has yet to weigh in on the subject, the states have tried to step into the void, sometimes with potentially disastrous consequences.
State Legislation Potentially Damaging
In New Jersey, Gov. Christine Todd Whitman was prepared to sign a bill into law that would have granted ownership rights to a person's genetic code. The move would have halted biomedical research in the state. Intensive lobbying by the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America convinced Whitman to veto the legislation.
David Korn, former vice president of Stanford University and chairman of the Stanford University Medical School's department of pathology, has urged policy makers to allow NBAC to weigh in on the subject before hastily passing legislation.
For stored tissues that already exist, the subcommittee is in near unanimous agreement that research conducted on the samples, which have been stripped of all identifiers, should be permitted without additional consent. However, the method by which the identifiers are removed should be impermeable to attempts to identify the people from whom the samples came.
"Researchers may want to go back and tell people that they have a predisposition for a certain disease after conducting a genetic study," said Steve Holtzman, commission member and chief business officer at Millennium Pharmaceuticals Inc., in Cambridge, Mass. "Except if you consider the issue of consent, if you can identify the source of the tissues, you will need to get consent."
The subcommittee is also looking into ways to strengthen consent for patients undergoing biopsies, but it has yet to determine what those requirements are likely to look like.
In addition to individual consent, the commission is considering a requirement for some sort of community consent when the results of research on a particular ethnic group could prove stigmatizing.
For example, recently a group at Johns Hopkins University, in Baltimore, identified a gene for colon cancer in Ashkenazi Jews. The research was conducted on stored blood samples that were originally taken for testing for Tay-Sachs disease carrier status. Under the common rule, the researchers conducted the study without institutional review board (IRB) oversight.
"That study has raised concern in the Jewish community," said Karen Rothenberg, a professor at the University of Maryland School of Law, in Baltimore, who attended the Sunday meeting. "The NIH and members of the Jewish community have scheduled a meeting to address this issue." *