News of the WeekBioethics

Panel Proposes Tighter Rules for Tissue Studies

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Science  18 Dec 1998:
Vol. 282, Issue 5397, pp. 2165-2166
DOI: 10.1126/science.282.5397.2165a

Clinical researchers have received a bioethics package for Christmas, and some may be afraid to open it. It appeared on 3 December in the form of a draft report from the president's National Bioethics Advisory Commission (NBAC) (posted on the Web at arguing for tighter controls over research on stored samples of human blood and tissue 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 today. Although those who donated the material probably gave broad consent for its use in research, ethicists believe that more specific consent may be needed for certain studies that could identify and stigmatize donors.

NBAC—a 17-member group of lawyers, ethicists, and medical professionals chaired by Princeton University President Harold Shapiro—began picking its way through this dense thicket 2 years ago. A draft report in late 1997 was withdrawn after it drew flak from clinicians and NBAC members. The new version, completely rewritten, is still likely to be controversial. Even before he had seen the details, pathologist John Trojanowski, an Alzheimer's disease specialist at the University of Pennsylvania, objected that its 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.” And pathologist Jonathan Tait of the University of Washington, Seattle, after a quick reading, said he identified some vague spots, but thinks the report “doesn't have severe problems.”

Today, an investigator often makes biological samples anonymous by stripping off names and other identifiers and replacing them with a code. Because these coded samples are considered to be exempt from normal consent requirements, researchers often share them with colleagues as though they were anonymous, without obtaining new consent from donors. Nor do researchers necessarily seek approval from local panels that monitor the use of human subjects—known as institutional review boards (IRBs)–to conduct research on such samples. But this could change.

To protect against loss of privacy, NBAC is proposing that unidentified samples be coded not by the investigator but by a third party, such as “an encryption service.” This would make it almost impossible for any researcher to identify the source. But if a researcher cannot or doesn't want to make tissues truly anonymous in this way, NBAC says, the research should be approved by an IRB, which might also ask the researcher to obtain specific consent from the donors.

If a study might pose more than a minimal risk of harm to the donors, NBAC says, IRBs should take care to see that the risks are clearly described to donors before consent is sought. This is particularly important for “sensitive” projects such as research on behavioral genetics or for “studies differentiating traits among ethnic or racial groups, or research on stigmatizing characteristics such as addictive behavior.” If the IRB determines that donors of stored tissue samples were not adequately informed in the past, researchers might be required to go back to the donors seek a new consent. In addition, donors at this point would be given a chance to ask that their tissues not be used in this or any future research project.

Even if the IRB finds no need for this kind of renewed consent procedure in a particular study, NBAC recommends that tissue donors should be given a chance to opt out of any research they “might find objectionable on moral or other grounds.” NBAC doesn't explain how: It just says that institutions “should consider the option of making a good faith effort to contact subjects to allow them to 'opt out. …”

Some of these tough requirements were included in earlier drafts. But NBAC is taking a softer line on some issues. For example, it is not including a recommendation that researchers obtain “community consent” for genetic studies that might embarrass a particular ethnic group. Instead, the new draft says researchers should “be mindful” that their research might harm a genetically linked group of people, and minimize the risk. NBAC also suggests—to reduce paperwork—that the requirement for consent be waived when research on identifiable tissues poses a minimal risk of harm.

Many critics of NBAC's earlier draft are likely to agree with pathologist Jeffrey Cossman of Georgetown University, who says, “I think there's been a major advance” in the report's quality, “but this document isn't ready for prime time.” It needs more polishing and another round of editing, he says. But time is running short. NBAC has set a deadline for all public comment of 17 January, and the panel could vote on a final report early next year.

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