A US presidential commission is likely to recommend soon that researchers should lose the liberal access to anonymous tissue samples that they now enjoy for genetic studies whose outcomes could affect whole groups of people.
The National Bioethics Advisory Commission (NBAC) is drawing up recommendations on informed consent and the ethical use of tissue samples that are due to be made public within a few months. It is likely to recommend that researchers be required to carry out ‘community consultation’ before initiating a trial that could put groups at risk.
The move follows the identification last year of a genetic mutation that predisposes to colon cancer and is carried in 6 per cent of Ashkenazi Jews — Jews of European descent who make up nearly all American Jewry. During the study, 766 archived, anonymous blood samples were used that were originally collected during screening for Tay Sachs disease.
The samples are among at least 283 million archived tissue samples that US scientists rely on for their work in genetics, epidemiology, pathology and other fields.
But critics are claiming that the findings, by a team headed by Bert Vogelstein of Johns Hopkins University in Baltimore, Maryland (see Nature Genetics 17, 79-83; 1997), have created job and insurance risks for Ashkenazim. The findings follow the earlier identification of the most common mutation that predisposes to breast and ovarian cancer. That mutation in the BRCA2 gene, also identified using Tay Sachs samples (see Nature Genetics 14, 188; 1996), is carried in just over 1 per cent of Ashkenazi Jews.
“The community is being clearly pinpointed,” says Ezekiel Emanuel, a former member of NBAC, who heads the department of clinical bioethics at the National Institutes of Health.
Local ethics boards, known as institutional review boards, which approve research protocols before scientists are allowed to proceed, would probably be the enforcers of ‘community consultation’ introduced at the urging of the NBAC. Alternatively, tissue banks might set up panels to identify protocols requiring such consultation, an approach proposed by the National Action Plan on Breast Cancer.
The community consultation recommendation emerged from the genetics subcommittee of NBAC, and is to be debated — along with other proposals about informed consent for the use of tissue samples — by the full commission at a meeting in Los Angeles on 5 and 6 February. The commission tentatively plans to post its tissue sample recommendations on the Internet in interim form next month (www.bioethics.gov).
The commission's recommendations would not be binding. But its advice has in the past carried weight. Last spring, for example, its suggestions on cloning were immediately written into a bill sent to the Congress by President Bill Clinton.
Researchers have reacted warily to the latest proposal. “This is a Pandora's box unless they very carefully define what a community is, because it could easily be misinterpreted by regulators,” says Mark Sobel, chief of the molecular pathology section at the National Cancer Institute and president-elect of the Association for Molecular Pathology. “And then it would be a major burden on researchers.”
Sobel argues that there would be difficulties in defining a ‘community’ — ought bald men, for example, be consulted before the launch of a study on the role of androgen receptors in baldness? Questions would also arise as to who legitimately represents such a community. For example, do Orthodox, Conservative or Reform rabbis speak for Jews? “We don't need an extra official layer” of protection, says Sobel, who argues that review boards are already sensitive to issues such as community risk. “These things do not get done without time, people and money.”
Kenneth Offit, chief of clinical genetics at Memorial Sloan-Kettering Cancer Center in New York, and a member of the team that identified the most common mutation that predisposes to breast and ovarian cancer, says that community consultation before experiments is unrealistic for researchers in population genetics. In the course of their careers, researchers may look at dozens of mutations, not all of which yield significant results.
It would be “hard to imagine” how in practice to hold a community conference before each experiment for a mutation “which is of unclear significance”, says Offit, who was also a member of Vogelstein's team. In the worst case, he adds, onerous new requirements “could shut down a very important aspect of genetic epidemiological research: population genetics”.
But others argue that the recent explosion of genetics research has changed the moral landscape, making individual consents for the use of tissues in research inadequate in cases in which groups such as the Ashkenazim are so keenly affected by discoveries.
“Every time we change our ethical standards, somebody says ‘This is going to be more red tape’,” says Patricia Barr, a lawyer who headed a subcommittee that drafted tissue sample recommendations for the National Action Plan on Breast Cancer. But “the way we now think about these issues, the individual's consent is not always sufficient”.
Community consultation “upholds other important social values, so I don't see the same risk” as the researchers, says Lori Andrews, a law professor at Chicago-Kent College of Law. “There are other very important values — not least of which is the trust in the research enterprise — at stake here.”
The NBAC would not be alone in invoking ‘community consultation’, which is now used, for instance, by the Food and Drug Administration for trials in emergency situations in which individuals are unable to consent. And the National Heart, Lung and Blood Institute relies heavily on community consultation for genetic studies in African American and Native American communities, says Teri Manolio, who manages community-based studies of genetic risk for the institute.
“You can't go back to the community after you have the results and say ‘Oh, by the way, we'd like to consult with you'. It has to start from the very beginning.”