Research with blood donated to blood banking organizations.

• Author: Ries, Nola M.

Introduction

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." (7) Archived donor specimens are used principally for hemovigilance activities, including investigations of possible transfusion-transmitted infections and look-back testing. (8) Stored samples may also be used for research in most of the countries surveyed. Research typically requires approval of a research ethics committee and donor consent. The nature of consent varies among blood service agencies, from seeking informed consent for a specific study (e.g. research testing for West Nile virus), to a general consent for use of stored samples for future research aimed at improving blood safety and blood system operations. In some countries, de-identified samples may be used for research without individual donor consent.

Some specific examples of biorepositories and research with banked blood donor samples are described in the literature. (9) In the United States over the past several decades, blood donor and recipient samples have been collected "to investigate specific infectious risks that were of concern at the time the studies were launched." (10) Samples were collected for a defined time period for the purpose of a particular study. These collections now amount to three million cryopreserved samples, with the earliest samples dating to the mid- to late 1970s. The National Heart, Lung and Blood Institute, part of the National Institutes of Health, maintains the samples and is described as "strongly endors[ing] data sharing and facilitat[ing] access to resources for scientific research." (11) Investigators may apply for access to biosamples, as well as demographic and infectious disease test results for blood donors and recipients.

As an example of a specific study, the Transfusion-Transmitted Viruses Study in the United States collected matched donor-recipient samples, along with samples from a control group of surgical patients who had not received a transfusion. These blood samples were collected in the 1970s and individuals gave consent to future testing. De-identified samples were recently used to investigate whether human herpesvirus-8 is transmissible via blood transfusion. (12)

The Scottish National Blood Transfusion Service has maintained a blood donor sample archive since the early 1970s. (13) This repository now amounts to over 7 million samples. Access to the samples is generally limited to investigations into possible transfusion-transmissible infections and screening stored samples with new tests. A National Medical Director must approve other requests for access.

While blood service agencies commonly store samples for at least some period of time, donors may have little knowledge about the retention and future use of their donated blood, including for research purposes.

Donors' Knowledge of and Attitude toward Use of Donated Blood for Research Purposes

Literature about blood donors has focused predominantly on factors that motivate and deter people from donating blood. (14) This literature indicates that issues related to research use of donated blood are not reported as either encouraging or discouraging donation. That is, the potential benefits of having one's blood used in research that advances medicine is not cited as a motivator for donation, nor are fears about unknown or non-consensual future research uses cited as a deterrent for donating. (15) The absence of these factors from existing survey data may be attributable to lack of awareness among donors of potential research uses of donated blood.

Indeed, few studies have asked blood donors about their knowledge of and attitudes toward research uses of donated blood. In Great Britain, Busby interviewed persons who donated blood to the National Blood Service (NBS) and reported findings from interviews with 26 donors. (16) She asked donors "about their views on research, beginning with a question about whether they would see giving blood for research differently from giving blood to help people directly." (17) Interestingly, she explains that she did not pursue this topic with detailed questions "if interviewees did not seem comfortable with discussing them." The author did not wish "to intervene in people's understanding of blood systems," (18) suggesting that they had little understanding of research uses and, as the interviewer, she was not in a position to answer questions that might arise about how the NBS uses blood for research. Busby points out that "when donors spoke about how the blood was...