clinical researchers received a bioethics kit for Christmas, and some may be afraid to open it. He arrived this month in the form of a draft report of the National Bioethics Advisory Commission (NBAC) President calls for tighter controls on research on stored samples of blood and tissue. NBAC says its goal is to protect donor privacy.
The "matter tissue", as bioethicist Robert Yale Levine called, has become a hot topic. Stored tissue may contain a goldmine of information for researchers tracking the spread of the disease, hunting, disease genes and the study of human genetic variation. And it is a huge resource: NBAC calculates that American institutions hold more than 282 million samples of archived human tissue. People who have donated the equipment probably gave general consent for its use, but ethicists argue that the more specific consent may be needed now
CCNB -. A group of 17 members, lawyers, ethicists and health professionals chaired by Princeton President Harold Shapiro of the University - suggests that, in many cases, the identity of the samples secretly encoded by a third party to make them truly anonymous . If a researcher does not want to do, NBAC said, research should go to a local ethics panel, or the Institutional Review Board for approval. NBAC also said that researchers may need to get a new donor consent, particularly for certain genetic studies that provide more than minimal risk to economic or psychological harm.
These are among the 16 recommendations in the draft report of CCNB, which is drawing mixed reactions from the research community. Pathologist John Trojanowski, a specialist in Alzheimer's disease at the University of Pennsylvania, objected that the proposed new notice and consent requirements are so onerous that they "bring research to the judgment." But others were more accepting. Judith Greenberg, who oversees the operations of a large collection of human tissue for the National Institute of General Medical Sciences, said the new report "appears to have reached a fairly reasonable balance." NBAC has set a deadline of 17 January for public comment and may vote on a final report early next year.
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