Belmont Report - History

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) 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 released, and it was published in 1979 in the Federal Register. It was named the Belmont Report, for the Belmont Conference Center, where the National Commission met when first drafting the report. The Belmont Report is one of the leading works concerning ethics and health care research. It allows for the protection of participants in clinical trials and research studies.

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):

1. 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;
2. Beneficence: The philosophy of "Do no harm" while maximizing benefits for the research project and 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 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 (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.

The Bellemont Report, published in 1978 was 20 pages doubles spaced and outlined the ethics involved in research pertaining to human subjects.

Outlined by Jennifer Sims in her article A Brief Review of the Belmont Report, she states 7 things nurses, as primary caregivers for individuals participating in a study, must do to insure the rights of the participant is met. 1. They must make sure the study is approved by an IRB 2. Get informed consent from the patient 3. Be sure that the patient understands the full extent to the experiment, and if not contact the study co-ordinator 4. Make sure the patient wasn't coerced into doing the experiment by means of threatening or bullying 5. Be careful of other effects of the clinical trial that was not mentioned, and report it to the proper study coordinator 6. Support the privacy of the patients identity, their motivation to join or refuse the experiment. 7. Ensure all patients get at the least, minimal care needed