and resource from which significant potential for research and advances in medical care will result” (p. 8). However, the report counseled the DoD “to consider the legal issues that may arise in situations where non-DoD entities may have access to and utilize some of these assets,” stating (DHB, 2008, p. 5) that
it is essential that the plan clearly delineate the access and usage limits of the resources available through the Tissue Repository. The Board advises DoD to thoroughly define the route of access to specimens for civilian sector research and include a direct communication mechanism to ensure a facilitated process for interagency and civilian avenues of approach.
A number of National Academy of Sciences reports have addressed topics relevant to the issues under consideration here. Salient publications are summarized below.
Monitoring Human Tissues for Toxic Substances (NRC, 1991) described the benefits of using tissue specimens to evaluate the health effects of exposures to chemicals in the environment. The report described the need for quality control in maintaining biospecimens in the short term and the long term. It noted that “access to specimens in an archive must be carefully controlled” and that “in each case, it must be determined whether a projected use will provide useful data and its value must be balanced against the need to maintain specimens for future studies” (p. 106).
Effect of the HIPAA Privacy Rule on Health Research (IOM, 2006), the proceedings of a workshop, evaluated the rule’s impact on research, including considerations regarding the bureaucracy, informed consent, and clinical trials. A participant observed that the Common Rule has been interpreted to permit broad research consents whereas the Privacy Rule requires study-specific consents and that this often led to confusion in the research community. A resulting suggestion was to allow both broad and specific consent of biospecimen preservation, maintenance, and use under HIPAA.
Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research (IOM, 2009) assessed whether the HIPAA Privacy Rule was having an effect on health research and offered recommendations to promote efficient health research while maintaining the privacy of personally identifiable health information. The report stated that the Privacy Rule did not protect privacy as well as it should and that it was hindering effec-