The Nuremberg trials were a turning point in history, setting limits for research that would be conducted on humans. This trial occurred after World War II in reaction to the criminal experiments in the German concentration camps (White, 2020). The result of these proceedings was the establishment of The Nuremberg Code (White, 2020). This code stipulated ten principles to which physicians must adhere while conducting experiments on human subjects, but it was insufficient for dealing with complex situations (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978). A more comprehensive range of moral guidelines will help establish, analyze, and understand specific regulations (White, 2020).
The Belmont Report was released in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (CITI Program, n.d.) The three guiding concepts of this report are respect for persons, beneficence, and justice (CITI Program, n.d.). The Belmont report is one of the most influential studies on ethics and medical research because it safeguards human participants in clinical trials and other scientific investigations (White, 2020). According to respect for persons, everyone has the right to autonomy, and those who lack competence must be protected (White, 2020). Two requirements govern the concept of beneficence: do no harm, optimize potential benefits, and limit possible harms (White, 2020). The justice principle covers the issue of who should reap the rewards and shoulder the research obligations (White, 2020). The Belmont Report’s last section discusses three crucial aspects of human subject research: informed consent, risk assessment, and subject selection (White, 2020). •The informed consent procedure includes providing prospective research participants with information, assisting them in comprehending it, and encouraging their voluntary choice to join the study (CITI Program, n.d.). Performing research where risks to participants are appropriately compared to expected benefits is the aim of risk assessment (CITI Program, n.d.). The element of subject selection requires that the advantages and drawbacks of research are shared fairly (CITI Program, n.d.). This means that no one or group is put in jeopardy of harm while others reap the rewards (CITI Program, n.d.)
Before releasing the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research produced Institutional Review Boards report (White, 2020). An Institutional Review Board is a body explicitly authorized to review and oversee biomedical research involving human beings in compliance with federal and institutional standards (White, 2020). An Institutional Review Board can demand changes be made for research acceptance or rejection (US Food and Drug Administration, 2019). This group review safeguards human research participants’ rights and well-being (US Food and Drug Administration, 2019). Furthermore, the Institutional Review Board verifies that the participant selection method is unbiased and that informed consent is secured (US Food and Drug Administration, 2019).
The federal regulations for protecting human research subjects issued by the Department of Health and Human Services include protections that help vulnerable populations (US Department of Health & Human Services, 2020). The first portion, subpart A of 45 CFR 46 of the Department of Health and Human Service’s federal guidelines for protecting human research participants, is commonly referred to as the Common Rule (US Department of Health & Human Services, 2020). The Common Rule mandates that researchers get institutional review board permission and informed consent from subjects enrolled in human research (US Department of Health & Human Services, 2020). Groups of people who are regarded as vulnerable are protected by three additional subparts (US Department of Health & Human Services, 2020). Subpart B contains regulations safeguarding pregnant women, human fetuses, and neonates (CITI Program, n.d.). Since there is a possibility of unidentified dangers to pregnant women, human fetuses, and newborns in research, it is necessary to provide additional protective measures (Williams, 2005). Subpart C contains regulations that protect prisoners. Inmates are a particularly susceptible demographic because of their limited freedom and limited opportunities, making it difficult for them to provide informed co
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