Belmont Report

The Belmont Report is a simple report created by the former United States Department of Health, Education, and Welfare (which was renamed to Health and Human Services) entitled "Ethical Principles and Guidelines for the Protection of HumanSubjects of Research" and is an important historical document in the field of medical ethics. The report was created on April 181979 and gets its name from the Belmont Conference Center where the document was drafted. 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.

History

Prompted in part by problems arising from the Tuskegee Syphilis Study (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) [HEW was split into the Department of Education and the Department of Health and Human Services in 1979. See http://www.hhs.gov/about/hhshist.html] revised and expanded its regulations for the protection of human subjects 45 CFR part 46 in the late 1970's and early 1980's. 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. [ [http://ohsr.od.nih.gov/guidelines/belmont.html Office of Human Subjects Research ] ]

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:

• (1) respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent;
• (2) beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and
• (3) justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits.)

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.

ummary

The summary, from the top of the Report:

On July 12, 1974, the National Research Act (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.” "Office for Human Research Protections (OHRP)" was established within HHS [ [http://www.hhs.gov/ohrp/ Office for Human Research Protections (OHRP)] ] .

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.

References

ee also

*Clinical trial
*Informed consent
*Tuskegee Syphilis Study

External links

* [http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm The Belmont Report] - U.S. Health & Human Services website
* [http://www.belmontconferencecenter.com/ Belmont Conference Center home page]