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Unrelated hematopoietic stem cell donors as research subjects

Bone Marrow Transplantation volume 46, page 14 (2011)Cite this article

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The paper by King et al. is a useful reminder that unrelated hematopoietic stem cell donors are often research subjects and that the international transplant community should do all it can to develop processes that both ensure donor rights and at the same time remove undue burdens from the conduct of clinical care and clinical research. The paper does a good job of describing when a donor is or is not a research subject, a distinction that is not always clear. If cells are collected in the usual way, no research is done on those cells and no additional information is requested from the donor for research purposes, then the donor is not a research subject even if the patient is on a clinical trial. If, however, there is an intervention or interaction with the donor for research purposes (for example, a study of an alteration in the usual method of stem cell collection, or a questionnaire seeking additional information beyond that routinely provided), then the donor is clearly a research subject. Perhaps slightly less obvious is the fact that if the research requires any link between the recipient and the individual source of stem cells, even if material and data are coded, then the donor is a research subject. In the United States, the approach to this last situation is that the donor center presents the National Marrow Donor Program research consent form, which describes research on donor samples and data in broad strokes. To access the data or research samples, local IRB approval and approval from the NMDP are required. Developing an international system that works similarly would be ideal. The paper strays a bit from its general theme when it briefly discusses the ethics of related donor consent. Although one can understand the argument that there is a possible benefit in separating the counseling and consenting of the donor from the physician caring for the patient, there is also a price to be paid in having different physicians involved, in that the physician caring for the patient will be best informed about unique patient and family circumstances that might affect the timing or other specifics of the donation. Certainly, the donor consenting process should be conducted without other members of the family being present to reduce possible coercion. Some of the challenges going into the future are left unanswered by this document; for example, how to handle the inevitable discovery of genetic polymorphisms in donor cells that could impact the future health of the ‘normal’ donor.

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  1. FHCRC Transplantation Biology Department, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

    F R Appelbaum

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  1. F R Appelbaum
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Correspondence to F R Appelbaum.

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Appelbaum, F. Unrelated hematopoietic stem cell donors as research subjects. Bone Marrow Transplant 46, 14 (2011). https://doi.org/10.1038/bmt.2010.269

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