How would you feel if your biological materials – blood, skin cells, or the like – were used to develop sperm in a lab? What if it were conducted without your knowledge or consent? Most Americans likely are unaware that their biological materials have been stored and been made available for research. Federal regulations permit existing specimens to be used in research without consent of the individuals who provided the materials. Such materials are an important resource for biomedical research and have been responsible for many scientific advances. However, some may object to at least some uses of their biological materials. Most recently, the case of Catalona v. Washington University drew attention to some of the legal and ethical issues that arise in research involving stored biological materials. The case arose from a dispute between, Dr. Catalona, an internationally known prostate cancer researcher and his former academic institution regarding who should have control of the biological materials collected over decades and stored for use in research. Several research participants who donated their biological materials and wished their materials to go to Dr. Catalona, rather than staying at Washington University joined the lawsuit, asserting that they should have a right to control how their biological materials were used. As has been the case in other cases, the Catalona court showed little sympathy to the research participants’ claims, particularly when those interests may impede medical research that may benefit society. Consistent with the federal regulations regarding such research, the Catalona court saw little harm in using the research participants’ stored biological materials in research, even though, in this instance, the research participants were objecting to the continued use, at least at Washington University. The underlying assumptions of the federal regulations are that there are few risks and that most people would agree to such participation. However, those assumptions may no longer be valid in an era of whole genome sequencing and large DNA databases, especially as genomic research is increasingly being done on sensitive issues such as IQ, ancestry, and personality traits. Moreover, those assumptions are not reasonable in the face of objections. In this article, I argue that it is time to reconsider our regulatory approach to research involving stored biological materials to better reflect the risks presented by such research and the concerns that some people have about use of their materials. In the first section, I analyze the court cases that address research with stored biological materials to identify how courts’ have characterized research participants’ interests in their materials. In the second section, I analyze how the federal regulations governing human subjects research protect those interests, and the limitations of those protections. In the third section, I present empirical data from a national survey of IRB Chairs that demonstrates that IRB Chairs often are reluctant to apply the approaches available under the federal regulations to allow research on stored materials without consent when the proposed use is different from the purpose for which the materials were originally collected and empirical data regarding investigator practices in such research. I also evaluate empirical data from the literature concerning participant preferences regarding consent and control over their donated biological materials. The combination of these data suggests a preference for recognizing donor choice over the materials that is not fully represented in the court opinions and in the federal regulations. In the final section, I make recommendations for changing the federal regulations and guidance to take into account the changing scientific landscape, risks to participants, and preferences expressed in practices, without unnecessarily impeding research involving stored biological materials
