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, med ...

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 territorie ...

. Formed in the aftermath of the

Tuskegee Experiment The Tuskegee Study of Untreated Syphilis in the Negro Male (informally referred to as the Tuskegee Experiment or Tuskegee Syphilis Study) was a study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Cente ...

scandal, the Commission was created in 1974 as Title II of the

National Research Act The National Research Act was enacted by the 93rd United States Congress and signed into law by President Richard Nixon on July 12, 1974, after a series of congressional hearings on human-subjects research, directed by Senator Edward Kennedy. The ...

. It was part of the United States Department of Health, Education, and Welfare (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 The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is ...

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 a ...

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 deve ...

(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, correc ...

ers (1976

*Research Involving

Child A child ( : children) is a human being between the stages of birth and puberty, or between the developmental period of infancy and puberty. The legal definition of ''child'' generally refers to a minor, otherwise known as a person younger ...

ren (1977

*

Psychosurgery Psychosurgery, also called neurosurgery for mental disorder (NMD), is the neurosurgical treatment of mental disorder. Psychosurgery has always been a controversial medical field. The modern history of psychosurgery begins in the 1880s under th ...

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

President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was a bioethics organization in the United States. Purposes This Congressionally mandated group was formed in November 1978, by Public ...

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

Goals

Work

See also

References

External links