Ethics Panel Backs New Controls on Tissue Research

Clinical researchers have received a bioethics package for Christmas, and some may be afraid to open it. It arrived this month in the form of a draft report from the president's National Bioethics Advisory Commission (NBAC) arguing for tighter controls over research on stored samples of human blood and tissue. NBAC says its goal is to protect the donors' privacy.

The "tissue issue," as Yale bioethicist Robert Levine calls it, has become a hot topic. Stored tissue can contain a gold mine of information for researchers tracking the spread of disease, hunting disease genes, and studying human genetic variation. And it's a huge resource: NBAC calculates that U.S. institutions hold more than 282 million samples of archived human tissue. People who donated the material probably gave general consent for its use, but ethicists argue that more specific consent may be needed now.

NBAC--a 17-member group of lawyers, ethicists, and medical professionals chaired by Princeton University President Harold Shapiro--is proposing that in many cases the identity of samples be secretly encoded by a third party to make them truly anonymous. If a researcher didn't want to do this, NBAC says, the research should go to a local ethics panel, or institutional review board, for approval. NBAC also says researchers may need to obtain new consent from donors, particularly for some genetic studies that pose more than a minimal risk of doing economic or psychological harm.

These are among the 16 recommendations in NBAC's draft report, which is drawing mixed reactions from the research community. Pathologist John Trojanowski, an Alzheimer's disease specialist at the University of Pennsylvania, objected that the proposed new reviews and consent requirements would be so burdensome that they "would bring research to a standstill." But others were more accepting. Judith Greenberg, who oversees the operation of a large human tissue collection for the National Institute of General Medical Sciences, says the new report "seems to have achieved a pretty reasonable balance." NBAC has set a deadline of 17 January for public comment and may vote on a final report early next year.