Research with Blood Donated to Blood Banking Organizations
Ries, Nola M., Health Law Review
A vast amount of literature examines the legal, ethical and social issues involved in the collection and use of blood and other biological samples for research purposes. For example, a recent study analyzed nearly 600 papers on consent and biobank research. (1) Some literatuAre focuses on the prospective collection of blood or other biological materials for the purpose of creating biobanks as a resource for biomedical research. Other literature addresses the secondary research use of stored samples that were initially collected for clinical purposes.
In contrast with the wealth of literature addressing these topics, comparatively little has been written about the research use of blood that is collected by blood service agencies to meet blood supply needs in the health care system. Public communication intended to motivate people to donate blood emphasizes the use of blood as a precious resource to sustain and save lives. Yet, blood that is collected primarily for medical care purposes may also be stored and used for research.
Some recent literature underscores the potential benefits of creating and using repositories of donated blood for research purposes. In an editorial in Transfusion, Allain and Busch argue "we feel strongly that research repositories are key to advancing the field [of transfusion medicine] and should be established and maintained." (2) They also suggest that such repositories can support broader research inquiries beyond those directly related to transfusion medicine, that "repository samples need to be made widely available to the scientific community" and should be linked with other biobanking initiatives. (3) Other researchers discuss opportunities for using blood donation repositories as a resource for genetic studies. (4)
Another scholar cautions, however, that broader research use of blood collected by blood banks raises questions about linking "the ethic of donation with the goal of medical research." (5)Indeed, in any efforts to expand research uses of blood collected by blood service agencies, it is critically important not to undermine the trust that donors have in these organizations. And while Allain and Busch advocate for wide research access to biorepositories of donated blood, they also acknowledge that "to make these resources powerful research tools it is important to address ethical and/or informed consent considerations when the specimens are collected to allow for their future use...." (6)
This article explores issues concerning the research use of blood donated to blood banking organizations. It begins with an overview of practices of these organizations in retaining samples and creating biorepositories. Next, the article examines donors' knowledge of and attitudes toward use of donated blood in research. Available research shows that donors express trust in blood banks to make appropriate choices for how donated blood is used, however donors may give little thought to research use and focus, instead, on use for medical care purposes.
Whatever their level of awareness about research uses, donors maintain a privacy interest in retained samples. The article discusses relevant privacy aspects, then turns to a discussion of consent challenges and options. Blood service organizations that wish to store, use and share donated samples for research should ensure that consent for research is addressed in a manner than sustains the trust relationship between blood bank and donor. The concluding section of the article suggests several areas for further research to inform policy options for consent to research use of donated blood.
Blood Service Organizations and Retention and Use of Stored Samples
A survey of practices among blood service agencies in more than 15 countries found that most store samples for some period, ranging from several days to indefinite storage. A distinction is noted between "donation specimens retained primarily for [the blood agency's] operational purposes" and "collections of donor and/or recipient biospecimens that are made available to the research community. …