Blood banks, biobanks, and the ethics of donation

T he studies by Scott and coworkers and Rice and coworkers, included in this issue of TRANSFUSION, are part of a growing body of research that broaches the question of—and, to some extent, implicitly advocates for—the use of stored blood bank blood for medical research projects not directly related to blood safety. As noted below, this interest in piggybacking research studies on existing methods of biospecimen collection and storage is not specific to blood banks. It is, rather, part of a much more general attempt to locate and capitalize on what are increasingly understood as biospecimen “resources. ” However, precisely because blood banking both depends on and helps to create a community-oriented ethic of donation, blood banks are different from many of the other institutions to which researchers are turning in their search for biospecimens. On the one hand, blood bank administrators interested in making their stored blood samples available for research uses beyond that of blood safety cannot necessarily apply the ethical considerations developed for other kinds of institutions in the health care and health research landscape. On the other hand, the unique role played by blood banks means that they may be especially well positioned to play a central role to formulate a new social contract that explicitly links the ethic of donation with the goal of medical research. Although medical research has long relied on human biospecimens, the completion of the Human Genome Project (HGP) in 2003 has encouraged a widespread consensus among health care professionals, medical researchers, and policy makers that we are at the cusp of a revolution in medicine, a sea change in the relationship between medical research and medical care that is often captured in phrases such as “personalized medicine” and “reclassification of diseases. ” These various groups are also generally in agreement that fulfilling these promises of the genetics and genomics revolutions (as well as the other -omic revolutions) will require that medical researchers gain access to large collections of human tissues or fluids and associated clinical—and, if possible, lifestyle and environmental—data. While much smaller and more specific collections of biospecimens were adequate for research on Mendelian diseases, these earlier collections are generally deemed insufficient for research that seeks to establish correlations among genotypes, environmental exposures, and risks for a variety of medical conditions. There is less agreement on precisely how large such biospecimen collections must be in order to be useful, and determinations of size depend to some extent on particular research goals. In general, commentators are agreed that the bigger such collections, or “biobanks,” can be, the better. Francis Collins (the current director of NIH), for example, has been particularly vocal about the need for a national collection that draws samples and data from at least half a million people, and others have echoed his call for collections that draw biospecimens from hundreds of thousands of subjects. It is by no means clear how, precisely, such biospecimens and associated data can or ought to be collected, especially in the United States. In European countries such as Iceland, Austria, Denmark, and Sweden, national health care systems have allowed medical researchers access to large volumes of biospecimens and data that have been collected and stored in a relatively uniform manner. Although only a small number of European countries have directly drawn on their national health care systems in this way, projects such as the UK Biobank are able to draw upon the generally perceived legitimacy of the state-citizen relation by encouraging research subjects to think of their participation in a national biobank as an act of civic virtue. US researchers are neither able to draw on a national collection nor can they rely on an ethic of nationally oriented blood or tissue donation. Thus, although tens of millions of biospecimens are collected by different US groups every year, it is not clear whether this decentralized process of biospecimen collection can result in accessible large-scale collections. This discrepancy between the large volume of biospecimens collected yearly in the United States and the very small number of samples to which any particular researcher has access has produced something like a “prospector mentality” among medical researchers, encouraging a sometimes fevered search for ways of gaining access to a resource that seems to remain tantalizingly just out of reach. At least three different strategies have been developed to gain access to biospecimen resources. Some researchers have advocated the creation of de novo/biobanks, arguing that a viable biospecimen resource can be established only if it is planned as such from the start (e.g., Collins’s proposal for 500,000-person collection). Largescale de novo collections are, however, quite expensive, and currently there seems to be little Congressional support for this kind of proposal. Others have advocated networking together existing smaller tissue and blood sample collections to create a large-scale collection. TRANSFUSION 2010;50:1866-1869.