pants’ rights; and heightened concerns about legal liability on the part of organizations that hold or study human genetic material and health records (Cambon-Thomsen et al., 2007; Hoeyer, 2008).
The changes have also been driven by a series of events that have captured the attention of the public and prompted examination by various professional and government bodies. Dramatic and troubling cases tend to galvanize public attitudes, thereby altering the social and cultural context of research. Much as the notorious U.S. Public Health Service syphilis study at Tuskegee, the Jewish Chronic Disease Hospital case, the Willowbrook hepatitis study, and other such events in the United States from the 1930s to the 1970s transformed approaches to research involving human subjects (Katz, 1972), recent attention to problematic uses of human biologic materials in research have altered the ethical, legal, and regulatory landscape of biorepositories. Some examples are the Havasupai tribe’s lawsuit against the Arizona Board of Regents for unapproved secondary uses of tribal members’ biologic samples (Harmon, 2010); the legal actions against Texas A&M University’s use of bloodspots from newborn screening in genetic research and the Texas Department of Health exchange of such material for money and services, all without parental knowledge or consent (Beleno v. Texas Department of Health Services1; Higgins v. Lakey2); the derivation of the HeLa cell line, a highly important research resource, from tissue clinically removed from a patient without notice to or consent from the patient for research use (Skloot, 2010), and the dispute between a researcher and his institution over ownership of a cell repository (Washington University v. Catalona3). Those cases have focused attention and debate on the adequacy of the federal regulations on humansubjects research (principally the Common Rule, at 45 CFR Part 46) to address the use of archived biospecimens, especially because—under some circumstances—research use of such specimens is not considered research on human subjects under the regulations.
One essential task for the committee has been to identify and assess the crucial changes in this landscape to make it possible to offer recommendations for JPC governance of, policies for, and practices at its repository. This section maps the challenges posed by the changing landscape, identifies important normative trends for biobanking, and examines some specific decisions facing the JPC to lay the groundwork for responding to the questions that the committee has been asked to address. The committee’s task is complicated by a lack of broad public consensus on the meaning of
1SA-09-CA-188-FB (W.S. Tex., September 17, 2009).
2SA-10-CV-990-XR (W.D. Tex., July 7, 2011).
3437 F. Supp. 2d 985 (E.D. Mo. 2006), aff’d, 490 F.3d 667 (8th Cir 2007), cert. denied, 128 S. Ct. 1122 (2008).