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Research With Stored Biological Samples
What Do Research Participants Want?
Donna T. Chen, MD, MPH;
Donald L. Rosenstein, MD;
Palaniappan Muthappan, BS;
Susan G. Hilsenbeck, PhD;
Franklin G. Miller, PhD;
Ezekiel J. Emanuel, MD, PhD;
David Wendler, PhD
Arch Intern Med. 2005;165:652-655.
Background There is widespread disagreement about the type of consent needed for research with stored biological samples. Many believe consent for each future use is required to respect individuals. Others worry this approach may block important research.
Methods We analyzed 1670 consent forms signed by research participants at the Warren G. Magnuson Clinical Center, National Institutes of Health, between January 1, 2000, and May 31, 2002, that offer options for future research with participants’ biological samples. The research participants were healthy volunteers, family members of affected individuals, and individuals with a broad range of medical conditions enrolled in clinical research studies with and without the prospect of direct medical benefit.
Results Overall, 87.1% of research participants given the option chose to authorize future research on any medical condition. More than 85% permitted unlimited future research with their stored biological samples regardless of sex, age, geographic location, or whether the individual was affected by the disease being studied or a healthy volunteer. Only 6.7% of those given the option to refuse all future research did so. Although African Americans were less likely to permit future research, 75.0% of African Americans still authorized unlimited future research with their samples.
Conclusions Most research participants authorize the unlimited future research use of their biological samples when given the opportunity to do so. These findings suggest that providing research participants with a simple binary choice to authorize or refuse all future research might allow individuals to control use of their samples, simplify consent forms, and allow important research to proceed.
Author Affiliations: Department of Clinical Bioethics, Warren G. Magnuson Clinical Center (Drs Chen, Miller, Emanuel, and Wendler and Mr Muthappan), and National Institute of Mental Health (Drs Chen and Rosenstein), National Institutes of Health, Bethesda, Md; and Breast Center, Baylor College of Medicine, Houston, Tex (Dr Hilsenbeck). Dr Chen is now with the Departments of Health Evaluation Sciences and Psychiatric Medicine and the Center for Biomedical Ethics, University of Virginia, Charlottesville.
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