Ethical Principles and Guidelines for Research Involving Human Subjects
The importance of distinguishing between biomedical and behavioral research involving human subjects, and the practice of accepted therapy, is absolutely necessary to determine which activities should undergo ethical review to protect human subjects. Although there are strict protocols in place for this requirement today, there are still some gray areas that require further analyses. To this end, the purpose of this paper is to provide a review of the relevant literature concerning ethical principles and guidelines for research that involves human subjects, including the publication of the Belmont Report in 1978 and what steps have been taken since that time. Finally, a summary of the findings that emerged from the literature review concerning ethical principles and guidelines for research involving human subjects are presented in the papers conclusion.
Review and Discussion
Published in 1978, the Belmont Report was a seminal document that established ethical principles and guidelines for the protection of human subjects involved in biomedical and behavioral research. Its purpose was to address ethical concerns that arose from notorious cases of research misconduct, such as the Tuskegee Syphilis Study. In this regard, Adashi et al. (2018) emphasize that, It was the summer of 1972 when a stunned nation first learned of the infamous Tuskegee Syphilis Study, during which hundreds of poor, disease-stricken black men from Macon County Alabama, had been deliberately left untreated for 40 years, all in the name of scientific research (p. 1345).
In sum, the Belmont Report outlined...
These principles have had far-reaching implications, shaping the ethical framework for research involving human participants and leading to increased oversight and safeguards to protect the rights and welfare of...…Belmont Report of 1978 laid the groundwork for ethical principles and guidelines to protect human subjects involved in biomedical and behavioral research. Its three core principles of respect for persons, beneficence, and justice have become cornerstones for ensuring the rights and welfare of research participants. While groundbreaking, the report has faced criticism for not fully addressing the breadth of ethical issues that can arise in any research enterprise involving human subjects. The research also showed that distinguishing between research activities that require oversight and accepted therapeutic practice is crucial. Though boundaries can blur, any activities deemed research or experimental should undergo ethical review. Institutional review boards and medical practice committees play a vital role in upholding these ethical standards. As research involving human subjects continues to evolve, ongoing refinement of guiding ethical principles remains essential to navigate the complex ethical terrain while facilitating critical scientific advancements that benefit individuals and…
References
Adashi, E. Y., Walters, L. B., & Menikoff, J. A. (2018). The Belmont Report at 40: Reckoning with Time. American Journal of Public Health, 108(10), 1345–1348.
Institutional Review Board Guidebook. (n.d.). BioTech Law. Retrieved from https://biotech.law. lsu.edu/research/fed/ohrp/gb/irb_chapter5.htm.
Resnik, D. B. (2019). Institutional Review Board Oversight of Citizen Science Research Involving Human Subjects. American Journal of Bioethics, 19(8), 21–23.
Siddiqui, W., & Sharp, R. R. (2021). Beyond the Belmont Report. American Journal of Bioethics, 21(10), 1–4.
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. (1978).
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