Response of the Department of Health and Human Services to NBAC's Report 'Research Involving Human Biological Materials: Ethical Issues and Policy Guidance'. Introduction


Protection of individuals who participate in research as human subjects is a vital public policy. Volunteers willing to assume the risks associated with participating in research have been the cornerstone of many of the medical advances that we enjoy today. Without the involvement of human subjects, much biomedical research, including a significant share of basic research, would not be possible. While ensuring the scientific community’s ability to pursue its goals of developing new knowledge and more effective means of preventing, diagnosing and treating illnesses and disorders, we also must take measures to protect those who participate in research. A strong ethical foundation should go hand in hand with a robust scientific enterprise. Vigorous human subject protections also help to maintain public confidence in this enterprise; this confidence makes possible the continuous strong support the American public has given to our pursuit of biomedical research.

With the rapid, cutting-edge technological advances that have been made in recent years, ethical issues have emerged in a variety of unexpected areas – requiring scientists, ethicists and the public to examine the sometimes contradictory interplay between the pursuit of scientific goals and respect for society’s values. Research involving human biological materials – a promising and rapidly growing field – is one arena in which a number of important ethical issues have emerged.

The National Bioethics Advisory Commission’s report, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, is a thoughtful and insightful document that will help inform policymaking in the Department of Health and Human Services (DHHS). Much biomedical research involves some degree of risk to study participants. It is not clear to what extent the public is aware that there is sometimes a correlation between what can be learned from research and the level of risk to which participants are exposed. This relationship is especially true in research involving human biological materials. Research based on use of human biological materials can be carried out with virtually no risk to the individuals from whom samples were originally collected when the samples have been divorced from any personal identifiers. In such instances, however, the investigator is then unable to obtain additional information about the sample sources that would help to determine if a research finding correlates with development of disease or with beneficial or adverse response to a new therapy. NBAC’s report speaks to the importance of balancing the protection of human subjects with the pursuit of new biomedical knowledge that may be relevant to safeguarding and strengthening the public’s health and welfare.

NBAC’s recommendations, covering both publicly and privately funded research, are intended for not only DHHS and its component agencies but also broad segments of the scientific community, including researchers, institutions, repositories, institutional review boards and the public. In order to analyze the appropriateness, feasibility and practical implications of those recommendations directed at DHHS, the Office of Science Policy of the Office of the Assistant Secretary for Planning and Evaluation convened a multi-agency Working Group to review and provide a response to NBAC’s report. The Working Group included representatives from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), and the National Institutes of Health (NIH). Also included in the Working Group were representatives of the Office of General Counsel (OGC) and the Office for Human Research Protections (OHRP).

The Working Group agreed with and endorsed almost all of NBAC’s analyses and recommendations. In a few instances, the Working Group foresaw some practical problems that would result from implementation of the recommendations; these difficulties are described below. Whenever appropriate, the Working Group proposed specific actions that could be taken by DHHS to strengthen the oversight of research involving human biological materials.

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