Analysis And Comment Ethics

One-time general consent for research on biological samples

BMJ 2006; 332 doi: http://dx.doi.org/10.1136/bmj.332.7540.544 (Published 02 March 2006) Cite this as: BMJ 2006;332:544
  1. David Wendler, staff scientist (dwendler@nih.gov)1
  1. 1 Department of Clinical Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA
  • Accepted 6 December 2005

It is now recognised that people should give informed consent for use of their biological samples in research. The literature on individuals' views supports one-time general consent as the best approach for this purpose

Clinicians and clinical researchers routinely obtain human biological samples and store them for future research. Previously, samples were often stored and used without informed consent. Most investigators thought that the protections in place for research with human participants were not needed for research with human samples.

Recent commentators recognise the importance of informed consent for research with biological samples, but they disagree about when it is required and what types of consent should be obtained. Some argue that people should provide consent for each new study, at the time the study is proposed. Others support prospective consent, but they endorse different sets of options regarding the storage of samples, which investigators can use the samples, and what types of research can be performed.

This profusion of guidance has led to divergent practices,1 2 with one study finding that institutional review boards in the United States recommend “various consent options, all of which are different.”3 Such variation may undermine the scientific value of patients' contributed samples and greatly increase the costs of such research. Assessing whether people's views support one of the recommended options for consent could provide a solution to these problems.

Methods

I searched PubMed (see appendix 1 on bmj.com) for studies published in English that reported the views of individuals on consent for research with human biological samples. This search identified 30 eligible studies.

Results

Individual willingness

The 30 studies provide data on the views of more than 33 000 people (table).432 The studies assessed the views of patients, research participants, family members, religious leaders, and the public. The studies yield consistent …

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