The Health and Human Services Policy for Protection of Human Research Subjects in 45 CFR Part 46 describes a human subject as a live person whom a researcher investigates by gathering personal data and biological samples for utilization, examination, and evaluation (National Institute of Dental and Craniofacial Research, 2022). A human subject is also someone whose private information or biospecimens a researcher utilizes, examines, and evaluates (National Institute of Dental and Craniofacial Research, 2022). According to the National Institute of Health, there are two types of human subject research: observational and interventional (National Institute of Dental and Craniofacial Research, 2022). In an observational study, the researcher monitors subjects and collects data without designating participants to a particular treatment or therapy (National Institute of Dental and Craniofacial Research, 2022). These studies concentrate on observing potential causes of disease, the manifestation of illness, and changes in disease development (National Institute of Dental and Craniofacial Research, 2022). In an interventional study, one or more biological or cognitive systems are changed by altering the participant or the participant’s surroundings (National Institute of Dental and Craniofacial Research, 2022).
Since the early days of research, human subjects have often been exposed to risks with little understanding of the potential consequences (White, 2020). In many cases, these subjects were not given a choice in whether to participate and were not adequately informed of the risks they were taking (White, 2020). As a result, numerous instances of research experiments have resulted in harm to the participants (White, 2020). In response to this, strategies have been implemented to minimize the risks to research participants.
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 R
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