Belmont Report
Encyclopedia
The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The report was issued on 30 September 1978 and published in the Federal Register on 18 April 1979. It took its name from the Belmont Conference Center where the document was drafted in part. The conference center, once a part of the Smithsonian Institution
, is in Elkridge, Maryland
, 10 miles south of Baltimore, and is now operated by Howard Community College
.
(1932–1972) and based on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978), the Department of Health, Education and Welfare (HEW) revised and expanded its regulations for the protection of human subjects 45 CFR
part 46 in the late 1970s and early 1980s. In 1978, the Commission’s report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” was published. It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report.
The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations.
The three fundamental ethical principles for using any human subjects for research are ( as found on http://ohsr.od.nih.gov/guidelines/belmont.html):
These principles remain the basis for the HHS human subject protection regulations.
Today, the Belmont Report continues as an essential reference for institutional review boards
(IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.
Applications of these principles to conduct research requires careful consideration of i)informed consent, ii) risks benefit assessment and iii)selection of subjects of research.
Today the Belmont Report serves as a historical document and provides the moral framework for understanding regulations in the United States on the use of humans in experimental research.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States....
. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The report was issued on 30 September 1978 and published in the Federal Register on 18 April 1979. It took its name from the Belmont Conference Center where the document was drafted in part. The conference center, once a part of the Smithsonian Institution
Smithsonian Institution
The Smithsonian Institution is an educational and research institute and associated museum complex, administered and funded by the government of the United States and by funds from its endowment, contributions, and profits from its retail operations, concessions, licensing activities, and magazines...
, is in Elkridge, Maryland
Elkridge, Maryland
Elkridge is a census-designated place in Howard County, Maryland, United States. The population was 22,042 at the 2000 census. Founded early in the 18th century, Elkridge is located at the confluence of three counties, the other two being Anne Arundel and Baltimore counties...
, 10 miles south of Baltimore, and is now operated by Howard Community College
Howard Community College
Howard Community College is a community college in Columbia, Howard County, Maryland. HCC, in partnership with Prince George's Community College and 5 four year colleges, also has a campus in Laurel that is known as Laurel College Center...
.
History
Prompted in part by problems arising from the Tuskegee Syphilis StudyTuskegee Syphilis Study
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S...
(1932–1972) and based on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978), the Department of Health, Education and Welfare (HEW) revised and expanded its regulations for the protection of human subjects 45 CFR
Code of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...
part 46 in the late 1970s and early 1980s. In 1978, the Commission’s report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” was published. It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report.
The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations.
The three fundamental ethical principles for using any human subjects for research are ( as found on http://ohsr.od.nih.gov/guidelines/belmont.html):
- Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception;
- Beneficence: The philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects; and
- Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally.
These principles remain the basis for the HHS human subject protection regulations.
Today, the Belmont Report continues as an essential reference for institutional review boards
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
(IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.
Applications of these principles to conduct research requires careful consideration of i)informed consent, ii) risks benefit assessment and iii)selection of subjects of research.
Summary
The summary, from the top of the Report:
On July 12, 1974, the National Research ActNational Research ActThe National Research Act was enacted by the 93rd United States Congress. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to oversee and regulate the use of human experimentation in medicine. It was partly a response to the infamous...
(Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.
The Belmont Report Today
In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.” The Office for Human Research Protections (OHRP) was also established within HHS.Today the Belmont Report serves as a historical document and provides the moral framework for understanding regulations in the United States on the use of humans in experimental research.
See also
- Human experimentation in the United StatesHuman experimentation in the United StatesThere have been numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects....
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Informed consentInformed consentInformed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
- Tuskegee Syphilis StudyTuskegee Syphilis StudyThe Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S...
External links
- The Belmont Report - U.S. Health & Human Services website
- Belmont Report, original version, 30 September 1978
- Belmont Report, Federal Register, 18 April 1979
- http://ohsr.od.nih.gov/guidelines/belmont.html - National Institutes of Health website