Last year, as part of our human genome 10th anniversary coverage, Science took a long look at the ethical dilemmas facing geneticists when their research on donated DNA unexpectedly turns up a mutation or genetic variation that could affect a person's health, or that of their family. For example, if a researcher sequencing DNA as part of an ancestry study discovers a man has a mutation that promotes Alzheimer disease, should they track down that DNA's owner and let him know?
Yesterday, as part of a special collection of papers in Genetics in Medicine on these so-called incidental findings, a working group convened by the National Institutes of Health released a series of recommendations on how such sensitive information should be handled. The most provocative theme of the report is a strong call for biobanks, the sites where donated DNA are increasingly stored for use by outside scientists, to shoulder increased responsibility for returning such findings. Traditionally, experts had argued that the researcher generating an incidental result, or their institutional review board, should take on that duty.
The working group, headed by Susan Wolf of the University of Minnesota, Twin Cities, a law professor specializing in bioethics , spent 2 years gathering data and feedback on incidental findings. The group doesn't argue that primary researchers bear no responsibility for returning such information. But it does recommend that each biobank set up a multidisciplinary committee for dealing with incidental findings and for the creation of an overall related "Central Advisory Body" that would maintain consistency on the issue across biobanks.
Biobank officials may be reluctant to take on this delicate new duty, neurologist Robert Green of Boston University, told Science last year:
"Ethicists sit around a table and talk about" the importance of returning DNA results, "but if you talk to people like myself who have actually helped run biobanks, you can't imagine how unsuited we are to doing this," says Green. Biobanks would have to reach out to the hundreds of thousands of people who have already shared DNA samples and inquire whether they might want information back; currently, virtually all biobank consent forms say that genetic results will not be returned. Even if informed consent forms change, the banks might then need to interact with researchers uncertain about what to share with a DNA donor and make decisions, often on a case-by-case basis, before recontacting a participant with a potentially upsetting research finding.
In a Nature news story on the new report, Ellen Wright Clayton of the Center for Biomedical Ethics and Society at Vanderbilt University in Nashville, Tennessee, also expressed concern for formalizing a system of returning incidental findings to DNA providers: "It's unfortunate that the authors of the consensus statement didn't discuss the cost implications of what they're proposing, because what they have in mind is going to be expensive and difficult, particularly at a time when funding success is as low as it's ever been."