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Breaking the stalemate: a prospective regulatory framework for unforseen research uses of human tissue samples and health information.

The legal and ethical issues raised by new research uses of previously collected human tissues and health information are increasingly important to genetics research. This Article discusses and criticizes current positions on such uses, including the recent report of the National Bioethics Advisory Commission, Research Involving Human Biological Materials. It then proposes a new regulatory framework for tissue and information collected in the future that would better protect the interests of the people who provide them. It ends by suggesting a resolution for the problems of previously collected tissue and information.

Advisory Committees↗

The National Bioethics Advisory Commission: bridging the tension between scientific and public policy analysis.

During the period between the early 1980s to the mid 1990s, the U.S. was distinguished from most other developed countries by its lack of a national-level public body to assist the government in its policy-making on topics of biomedical ethics. While Canada, Denmark, France, Spain, and other countries regularly sought advice from public commissions on issues ranging from reproductive technologies to euthanasia, the U.S. relied on myriad state commissions, court decisions, and academic bodies. The result was a pattern of policy-making that was slower and more unpredictable than that of its peers. With the 1996 appointment of the National Bioethics Advisory Commission (NBAC) by President Clinton, there has been a change in the process of U.S. public policy development. This article provides an overview of the NBAC and highlights recent areas of focus and related recommendations.

Advisory Committees↗

Challenges to human subject protections in US medical research.

United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research-including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself are creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.

Advisory Committees↗