In response to unethical research techniques, the strategy for protecting human subjects has changed throughout the past century (White, 2020). In the past, vulnerable populations, including children and prisoners, have been utilized as research subjects without their knowledge or consent being obtained (White, 2020). The Tuskegee Experiment and tests carried out in German concentration camps during World War II are two prominent examples of research exploitation (White, 2020). Informed consent and treatment were refused to 201 uninfected controls and 399 syphilis patients participating in the Tuskegee Experiment (White, 2020). German concentration camps exposed its prisoners to unethical medical treatment, which caused injury, illness, and even death (White, 2020).
Human subjects are defined as people whose biological samples and personal information are studied, analyzed, or assessed by researchers under the Health and Human Services Policy for the Protection of Human Research Subjects (National Institute of Dental and Craniofacial Research, 2022). In addition, those whose biospecimens or private information is used in research are considered human subjects (National Institute of Dental and Craniofacial Research, 2022). There are two categories of research using human subjects: observational and interventional (National Institute of Dental and Craniofacial Research, 2022).
Observational studies focus on the causes of disorders and how they progress by gathering data without prescribing particular treatments (National Institute of Dental and Craniofacial Research, 2022). On the other hand, by participant or environmental modifications, interventional research modifies biological or cognitive processes (National Institute of Dental and Craniofacial Research, 2022).
Human study subjects have always been exposed to risks without sufficient knowledge or choice (White, 2020). There have been initiatives put in place to lessen these dangers. In response to unethical research conducted in German concentration camps, the Nuremberg trials produced the Nuremberg Code, which established guidelines for research involving human subjects (White, 2020). Informed consent, risk assessment, and subject selection were the main topics of the 1979 Belmont Report, which established the concepts of beneficence, justice, and respect for people (CITI Program, n.d.). (White, 2020)
Institutional Review Boards (IRBs) were established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research prior to the Belmont Report to supervise and evaluate biomedical research involving humans (White, 2020). IRBs are accredited organizations tasked with monitoring adherence to institutional and government regulations while defending the rights and welfare of participants. As of 2019, the US Food and Drug Administration.
Vulnerable populations in human research are protected by federal regulations, such as the Common Rule published by the Department of Health and Human Services (USDepartment of Health & Human Services, 2020). Subparts of these regulations safeguard children, inmates, the CITI Program, n.d., human fetuses, neonates, and pregnant women (USD Department of Health & Human Services, 2020).
Institutional review boards (IRBs) are mandated to guarantee that disadvantaged populations receive special consideration during the research approval process, in addition to these protections. The rules place a strong emphasis on reducing the risks to vulnerable groups and guaranteeing informed, voluntary participation. Additionally, in order to ensure that the potential benefits of research are divided fairly and that vulnerable volunteers are not taken advantage of, researchers must take special precautions to prevent coercion or undue influence (USD Department of Health & Human Services, 2020). These actions seek to further scientific understanding while upholding moral principles.
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