IRB History and Ethical Principles

IRB/URR

The Belmont report is the foundational document for the current human subjects testing protections and protocols in the United States. Created in 1979 as a response to the many unethical research practices on fellow humans in the US and worldwide, the Belmont report lays out three key ethical principles to follow when conducting human subjects research: respect for persons, beneficence, and justice.

Respect for persons states that human participants are autonomous beings entitled to protection. The core belief of the principle is that individuals can make decisions concerning their own wellbeing. In the context of research, this means that potential participants are free to choose to participate or withdraw from a research study and are permitted to know all the necessary information of the study in order to make that choice. In what is known as informed consent, researchers are required to inform participants of the purpose of the study, what the individual is expected to do, and the potential risks of harm that may occur due to the study. Informed consent must be presented in a simple and clear manner so that any individual who is not familiar with research is able to understand. Additionally, respect for persons argues that some individuals may not be capable of making these decisions. These vulnerable populations, such as children or prison inmates, should be provided with extra protections.

Beneficence refers to the idea of harm reduction. Even though most social science and humanities research does not directly benefit the participants and cause minimal harm, researchers should do their best to maximize possible benefits of the research while minimizing the potential risks involved. This means that the potential harm must be reasonable in comparison the the expected benefits of the information learned. Some of the most common risks of harm in a research study are psychological distress or embarrassment and breaches of privacy and confidentiality. The use of deception in research studies is allowed if the researcher provides adequate justification that it is necessary for the research question. Additionally, safe data management and storage procedures are included in harm reduction, meaning that steps should be taken to reduce data mining and re-identification.

Finally, the principle of justice argues that the burden of research must be equally distributed and certain populations should not have to endure the harm for others to benefit from. Many studies in the past have ignored this principle. Some notable historical examples of this are the Nazi experiments on those in concentration camps and the US government syphilis experiments on members of the African American community. These experiments were conducted on specific populations who were unable to say no, while the effects of the knowledge learned have impacted much larger populations. Because of these studies, and many others, researchers are discouraged from conducting research convenient populations, such as students in their own classroom or prison inmates.

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