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Biobanking Human Biological Materials

Issues Surrounding the Collection of Samples for Use in Future Research

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Abstract

The practice of collecting and storing human biological materials for use in future biomedical research protocols engenders a wide variety of complex legal, ethical and social concerns. In recent years these concerns have received an enormous amount of attention, both in the US and internationally, in public and professional discourse and literature. This article reviews, on a broadly inclusive but inevitably selective basis, the most significant professional literature published in this arena during the last several years.

The literature documents tremendous diversity in clinical practice, policy advocacy and lay perceptions concerning informed consent for research participation by the human sources of biological materials, the privacy implications of collection and storage of biological materials for future research purposes, and questions pertaining to tissue ownership and the possibility of lucrative commercialization of the products of molecular genetics research conducted with human biological materials. Despite this lack of uniformity heretofore, there appears to be consensus emerging (which this article endorses) in the professional literature and public opinion around the position that it is in the long-term prudential self-interest of researchers, medical clinicians, policy makers and the public for both policy and practice in this area to respect and protect to the greatest extent reasonably feasible the dignity, autonomy and privacy rights of those persons who are actual or potential sources of human biological materials for research purposes, even if that approach may occasionally result in impeding the conduct of a particular research project in the short term.

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Notes

  1. 42 Code of Federal Regulations Part 46.

  2. 21 Code of Federal Regulations Parts 50, 56, 312 and 812.

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Acknowledgements

No external funds supported the preparation of this article. The author has no conflicts of interest regarding the writing of this article.

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  1. Southern Illinois University School of Law and School of Medicine, 1150 Douglas Drive, Carbondale, MC 6804, IL, 62901, USA

    Marshall B. Kapp (Garwin Distinguished Professor of Law and Medicine)

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  1. Marshall B. Kapp
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Kapp, M.B. Biobanking Human Biological Materials. Pharm Med 22, 75–84 (2008). https://doi.org/10.1007/BF03256687

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