Mapping Public Policy for Genetic Technologies

Appendix F. A Short History of Bioethics

Information Contained in this Chapter

Committees and Institutions in the United States
	National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978)
	President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-1983)
	Biomedical Ethics Advisory Committee (1988-1989)
	National Bioethics Advisory Commission (1995-present)
	National Institutes of Health/Department of Energy—Ethical, Legal and Social Impacts (ELSI) Program
	Office of Technology Assessment (OTA)
	Institute of Medicine (IOM)
Reports

Committees and Institutions in the United States

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978)

This national commission was created (over the strenuous objections of the research community) in response to abuses of human research subjects: the Tuskeegee syphilis trials, the Willowbrook hepatitis experiments, the Jewish Chronic Disease Hospital cancer tests, the Department of Defense whole-body irradiation experiments and others.

The national commission issued 10 reports, many of which were used as a basis for federal regulation of research involving human subjects. It established institutional review boards to evaluate experiments involving human subjects, and established some cornerstones of human experimentation: respect for people, beneficence, justice and autonomy (of which informed consent is the key provision). The commission recognized the special vulnerability of certain populations (children, prisoners, the retarded and the mentally ill) and the need to protect them.

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-1983)

The president’s commission issued 11 reports, several of which became the foundations of new standards that have been widely adopted worldwide. Among these were Defining Death (1981), the standards of which became the basis of law and was a prerequisite of developing organ transplantation techniques; and Deciding to Forego Life-Sustaining Treatment (1983), which set out the rationale for living wills and durable powers of attorney. Splicing Life (1982), an early and influential consideration of the potential of biotechnology, was one of the first studies to focus on the practical application of human genetics, especially gene therapy. It cleared the way for progress by establishing the vital distinction between somatic and germ-line therapy. Other reports, like the contentious Securing Access to Health Care (1983), were largely ignored.

Biomedical Ethics Advisory Committee (1988-1989)

The committee represented an attempt to continue a U.S. ethics advisory mechanism that foundered on special interest politics, specifically fetal tissue research and the politics of abortion.

National Bioethics Advisory Commission (1995-present)

This national body was formed to continue the work of the national commission and the president’s commission. The group’s charter "specifies two prospective areas of inquiry: issues in the management and use of genetic information and protection of the rights and welfare of research subjects. Discrete issues that fall under these two broad topics include: issues of genetic privacy, screening for genetic disorders, intellectual property rights, access to research data or materials developed with public funding, current views on informed consent, adequacy and implementation of Federal human subject research guidelines, and the concept of ‘minimal risk.’ In addition, several other potential issues for consideration by the Commission have been raised in discussions to date including: adequacy and implementation of Federal human subject research guidelines, recommendations on requirements to maintain research data, and the ethical aspects of access to costly health care technology."

National Institutes of Health/Department of Energy—Ethical, Legal and Social Impacts (ELSI) Program

Saying that, "Some very real dilemmas exist already about the privacy of DNA," James Watson single-handedly set up the ELSI program within days of becoming the first director of the U.S. National Center for Human Genome Research (part of NIH), setting 3 percent of the fledgling agency’s budget for the purpose. This feature of the NIH program particularly caught congressional imagination, and queries about the ethical implications of new biological science have been a persistent feature of the congressional oversight and appropriations process ever since.

In its determination to examine the implications of genomics, the NIH/DOE program has poured millions of dollars into programs for ethical research. This had the desired effect of ensuring thorough consideration of high-priority ELSI issues. It had the secondary effect, however, of magnifying their importance, as potential consultants added new expertise and the academic centers added new programs in the ethics of the human genome program.

Office of Technology Assessment (OTA)

An agency of the U.S. Congress disbanded in 1994, OTA assembled lay analyses of emerging technologies and summaries of possible policy options. Although it was not OTA’s job to make policy, its reports have been instrumental in the development of biotechnology and related disciplines.

Institute of Medicine (IOM)

An arm of the U.S. National Academy of Sciences, IOM coordinates studies by distinguished academics on important issues.

Reports

ELSI
Genetic Information and Health Insurance (1993)

Office of Technology Assessment
Biomedical Ethics in U.S. Public Policy (1992)

Institute of Medicine
Assessing Genetic Risks: Implications for Health and Social Policy (1993)

President’s Commission
Securing Access to Health Care (1983)
Splicing Life (1982)

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