How the Belmont Report Shaped Research Involving Human Subjects

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 paper’s 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 three fundamental ethical principles for research involving human subjects: 1) respect for persons, 2) beneficence, and 3) justice (The Belmont Report, 1978). 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 research subjects (The Belmont Report, 1978).

Notwithstanding the importance of the ethical framework established by the Belmont Report, many authorities today maintain that it failed to address the broad range of issues that are invariably involved in research involved human subjects. For instance, according to Siddiqi and Sharp (2021), “For decades, the Belmont Report—and the associated regulatory framework it inspired—has been a corner-stone in the ethical conduct of research involving human subjects. Despite its canonic status, there are many reasons to view the protections articulated in the Belmont Report as insufficient for managing the ethical challenges of biomedical research” (p. 1).

In the context of the Belmont Report, research is defined as an activity designed to test a hypothesis, draw conclusions, and contribute to generalizable knowledge, often described in a formal protocol. In contrast, the practice of therapy aims to enhance the well-being of an individual patient or client using interventions with a reasonable expectation of success. For example, according to the Institutional Review Board Guidebook, “Most of the research reviewed by IRBs falls within the broad categories of biomedical or behavioral research. IRBs should be sensitive to specific aspects of biomedical and behavioral research in their review of protocols” (chap. V). At their core, both biomedical and behavioral research share the overarching goal of establishing a robust, replicable foundation of facts and theory that can advance human understanding and help address the multiple problems that are faced by individuals and society (Institutional Review Board Guidebook).

While research and professional practice may overlap, such as in evaluating the safety and efficacy of a given therapeutical intervention, the general rule is that any activity involving an element of research should undergo review for the protection of human subjects. The boundaries between research and practice can be blurred, though, most especially when significant departures from standard practice are termed “experimental” (Belmont Report, 1978) Therefore, it is the fundamental responsibility of medical practice committees and internal review boards to ensure that major innovations are incorporated into formal research projects to assess their safety and effectiveness (Resnik, 2019).