Consent for Research With Biological Samples: One-Time General Consent Versus a Gift Model
Cet article compare deux modèles de consentement proposés aux patients pour le don d'échantillons biologiques à des fins de recherche
Technological advances have dramatically increased the scientific value of the hundreds of millions of human tissue and blood samples that are currently stored in laboratories and the tens of millions of new samples that are obtained each year (1, 2). These advances have led to continuing debate over what consent process should be used to obtain and store human biological samples for future research (3).
Some commentators argue that, as with other types of research with humans, donors should consent to the specific studies for which their samples will be used when the studies are proposed (4). This approach allows people to know the details of the studies for which their samples will be used. However, it also requires investigators to keep track of donors (sometimes for decades) and to obtain consent repeatedly for studies that often vary in minor details only (5).
Given these shortcomings, an Advance Notice of Proposed Rulemaking, issued on 26 July 2011, considered the endorsement of one-time general consent for research with human biological samples. Specifically, it raised the possibility of incorporating into U.S. federal regulations a general rule requiring individuals to give consent for “research use of their biospecimens, though that consent need not be study-specific, and could cover open-ended future research” (6).
Some commentators have suggested that a gift model may be better than one-time general consent for research with human biological samples (7). To assess this claim and to evaluate the possibility of incorporating one-time general consent into U.S. regulations, this article compares how well a gift model and one-time general consent address 5 challenges that investigators face when obtaining and storing human biological samples for future research.
Annals of Internal Medicine , résumé, 2012