National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape
bioethics
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, m ...
policy in the
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ...
.
Formed in the aftermath of the
Tuskegee Experiment scandal, the Commission was created in 1974 as Title II of the
National Research Act. It was part of the
United States Department of Health, Education, and Welfare
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
(DHEW) until 1978.
Goals
The Commission had four goals that it needed to analyze:
1) the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were
2) assessing the risks and benefits of the appropriateness of research involving human subjects
3) determining appropriate guidelines for how human subjects can be chosen for the participation in such research
4) defining what informed consent is in each research setting.
Work
The Commission also had the task of making recommendations to the
Secretary of Health, Education, and Welfare and
Congress
A congress is a formal meeting of the representatives of different countries, constituent states, organizations, trade unions, political parties, or other groups. The term originated in Late Middle English to denote an encounter (meeting of ...
for the protection of Human subjects. The commission produced their Reports and Recommendations on the following areas of research:
*Research on the
Fetus
A fetus or foetus (; plural fetuses, feti, foetuses, or foeti) is the unborn offspring that develops from an animal embryo. Following embryonic development the fetal stage of development takes place. In human prenatal development, fetal dev ...
(1975
*Research Involving
Prison
A prison, also known as a jail, gaol (dated, standard English, Australian, and historically in Canada), penitentiary (American English and Canadian English), detention center (or detention centre outside the US), correction center, corre ...
ers (1976
*Research Involving
Children (1977
*
Psychosurgery Report and Recommendations (March 1977
*Disclosure of Research Information Under the
Freedom of Information Act (United States), Freedom of Information Act (April 1977
*Research Involving Those Institutionalized as Mentally Infirm (1978
*Ethical Guidelines for the Delivery of Health Services by DHEW (1978
*Appendix to Ethical Guidelines for the Delivery of Health Services by DHEW (1978
*
Institutional review board, Institutional Review Boards (1978
*Special Study Implications of Advances in Biomedical and Behavioral Research (1978
*The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1979
These reports contained their recommendations, the underlying deliberations and conclusions, a dissenting statement and additional statement by commission members and summaries of materials presented to the Commission. An appendix was also included which contained complete text reports and papers prepared for the commission on the ethical, legal and medical aspects of the different research areas examined and other material reviewed by the commission in its deliberations.
The commission established limits on Biomedical research such that pregnant women and their fetuses were not harmed by researchers or exposed to any form of risk. The commission further established that the health of a pregnant woman or her fetus could not be compromised under any circumstance for the purposes of research no matter how minute the perceived risk may be. Furthermore, the commission suggested lifting the
moratorium (law), moratorium imposed on abortion research at that time under the condition that no inducements were offered to subjects to undergo an abortion for the purpose of research. However research on a dead fetus or dead fetal tissue was approved. Lastly, non-therapeutic research upon a pregnant woman or fetus was approved only under the extenuating circumstance that important biomedical knowledge could not be obtained through any other means and that permission was granted to researchers by the subject.
[The Hastings Center. "Commission Recommendations." The Hastings Center Report 5.3 (1975): 45-46. JSTOR. Web. 19 Mar. 2012.]
The Commission was succeeded by the
.
See also
*
Human experimentation in the United States
Humans (''Homo sapiens'') are the most abundant and widespread species of primate, characterized by bipedalism and exceptional cognitive skills due to a large and complex brain. This has enabled the development of advanced tools, culture, a ...
*
Advisory Committee on Human Radiation Experiments
*
National Bioethics Advisory Commission
*
President's Council on Bioethics
References
External links
THE HISTORY OF THE HUMAN SUBJECTS PROTECTION SYSTEMFormer Bioethics Commissions
{{DEFAULTSORT:National Commission For The Protection Of Human Subjects Of Biomedical And Behavioral Research
Human subject research in the United States
United States national commissions
Ethics commissions
Clinical research ethics
1974 establishments in the United States