Belmont Report

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[1] and published in the Federal Register on 18 April 1979.[2] The Report took its name from the Belmont Conference Center where the document was drafted in part. The Belmont Conference Center, once a part of the Smithsonian Institution, is in Elkridge, Maryland, 10 miles south of Baltimore, and until the end of 2010 was operated by Howard Community College.[3]

The Belmont Report[2] summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Three primary areas of application are also stated. They are informed consent, assessment of risks and benefits, and selection of subjects. According to Vollmer and Howard, the Belmont Report allows for a positive solution, which at times may be difficult to find, to future subjects who are not capable to make independent decisions.[4]

History

The Belmont Report was first written by the National Commission for the Protection of Human Services of Biomedical and Behavioral Research.[5] 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)[6] 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.[7] 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.[5]

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:[2]

  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 United States Department of Health and Human Services (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.

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 ensure the rights of the participant is met.

  1. Ensure the study is approved by an IRB
  2. Get informed consent from the patient
  3. Ensure that the patient understands the full extent of the experiment, and if not, will contact the study coordinator
  4. Ensure 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 that all patients at least get the minimal care needed for their condition[5]

Researchers must share the findings of their procedures regardless of them being good or bad results. Also in the case someone did not want to participate in research but would like treatment they cannot be turned away and must be treated with the same standard care.[5]

Summary

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." The Office for Human Research Protections (OHRP) was also established within HHS.[8]

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.

Critique of the Report

In a study by Nancy Shore, community-based participatory researchers were interviewed for their interpretation and critique of the Belmont Report. Interviewees expressed concerns regarding the Belmont Report's ethical principles and interpretations as being one size fits all and advocated researchers to resist the tendency to rely on those principles systematically.[9] It argues that the ethical analysis should be extended to take into account more appropriate factors, such as cultural, gender, ethnic and geographical considerations.[9] Debate continues over the ethics and regulations of research involving human subjects because of discrepancies over the meaning and priority of the Belmont Report's basic ethical principles: respect for persons, beneficence, and justice. Notably, the Belmont Report does not specify how its three ethical principles should be weighted or prioritized. According to Albert R. Jonsen, a member of the National Commission that composed the report, the Institutional Review Board is charged with weighing these principles and deciding how they should be applied. Matters become controversial when deciding if the principles should be interpreted as more or less weighty depending upon the particular circumstances of the research in question, if the principles should be viewed as an obligation that society must undertake on behalf of its members,[4] or if it should be viewed as giving absolute priority to respect for persons’ autonomy over the general good of society.[10]

See also

References

  1. ↑ National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, Education and Welfare (DHEW) (30 September 1978). The Belmont Report (PDF). Washington, DC: United States Government Printing Office.
  2. 1 2 3 Office of the Secretary, United States Department of Health, Education and Welfare (18 April 1979). "Protection of Human Subjects; Notice of Report for Public Comment" (PDF). Federal Register 44 (76): 23191–7. Archived from the original (PDF) on 2011-10-17.
  3. ↑ Carson, Larry (30 September 2010). "HCC to close Belmont Conference Center". The Baltimore Sun.
  4. 1 2 Vollmer, Sara H.; Howard, George (December 2010). "Statistical power, the Belmont Report, and the ethics of clinical trials". Science and Engineering Ethics: 675–91. doi:10.1007/s11948-010-9244-0. PMID 21063801.
  5. 1 2 3 4 Sims, Jennifer (July–August 2010). "A brief review of the Belmont Report". Dimensions of Critical Care Nursing 29 (4): 173–4. doi:10.1097/dcc.0b013e3181de9ec5.
  6. ↑ HEW was split into the Department of Education and the Department of Health and Human Services in 1980. See http://www.hhs.gov/about/hhshist.html
  7. ↑ Office of Human Subjects Research, National Institutes of Health, United States Department of Health and Human Services. "Regulations and Ethical Guidelines: The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research". Archived from the original on 2004-04-05.
  8. ↑ "OHRP Home". Office for Human Research Protections (OHRP), United States Department of Health and Human Services. Retrieved 2014-06-28.
  9. 1 2 Shore, Nancy (2006). "Re-conceptualizing the Belmont Report: A community-based participatory research perspective". Journal of Community Practice 14 (4): 5–26. doi:10.1300/J125v14n04_02.
  10. ↑ Vanderpool, Harold Y. (1996). The Ethics of Research Involving Human Subjects: Facing the 21st Century. Frederick, MD: University Pub. Group. ISBN 9781555720360.

External links

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