Consent for Research With Biological Samples: One-Time General Consent Versus a Gift Model

Technological advances have dramatically increased thescientific value of the hundreds of millions of human tissue and blood samples that are currently stored in labo-ratories and the tens of millions of new samples that are obtained each year (1, 2). These advances have led to con-tinuing debate over what consent process should be used to obtain and store human biological samples for future re-search (3). Some commentators argue that, as with other types of research with humans, donors should consent to the spe-cific 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 con-sent repeatedly for studies that often vary in minor detail