The development of the United States regulatory framework for research, including Institutional Review Boards (IRBs), was motivated by violations of human research participants. An individual can see the direct connection between the abuses and the regulations, including ethical principles outlined in the Belmont report, through understanding the history. The paper provides a brief history of human subjects’ protection, instances of abuse in the historical past, ways of minimizing risks, vulnerable populations, and other critical elements of human subjects (Durdella, 2022). The present systems of protection of human subjects have evolved over the last decades. Human research principles were first established in Nuremberg Code to try criminals of the Nazi War. Key components of the Nuremberg Code were a positive risks/benefits analysis, explicit authorization from participants, and withdrawal options with no repercussions (Schmidt et al., 2020). In 1964, the World Medical Association (WMA) issued the Helsinki Declaration, which laid the foundation for the Nuremberg Code.
Several studies in the US led to congressional debates concerning the overview of human subject research. The National Research Act of 1974 was the first law approved by Congress to safeguard the rights and safety of research participants (Durdella, 2022). It established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which is accountable for the publication of the Belmont Report. Primary principles of the Belmont report include; justice, respect for individuals, and beneficence. The human research protection office directs Title 45, part 46 of the Code for Federal Regulations on research on human subjects (Schmidt et al., 2020). Similarly, the office is indirectly in charge of studying human subjects via local IRB.
Experiments conducted by the Nazis, the Milgram Obedience Studies of the 1960s, and the Tuskegee Syphilis Study are among the historical cases covered in this section. Nazi doctors conducted Nazi experiments during WWII in concentration camps. It involved thousands of prisoners, including Gypsy children, Dwarfs, and persons with abnormalities who were infected on purpose leading to dangerous illnesses (Schmidt et al., 2020). The victims’ informed consent was violated since they were forced to participate in the research. The defendants were charged with torture, murder, and other killings under the pretense of medical science.
Milgram Obedience studies by Stanley Milgram tested Obedience. Sixty percent of instructors were persuaded to administer the maximum level of shocks despite learners having lost awareness, and they excused their conduct by claiming they were following orders (Durdella, 2022). The right to withdrawal of the participants was violated since the experiment only encouraged them to continue even after they showed signs of being under tension. At the same time, the right to protection was violated due to exposure to stressful situations.
Another experiment was the Tuskegee Study of Untreated Syphilis in the Negro male in Macon County, Alabama, from 1932-1972. The subjects were tested for the illness, and those positive were not told they had it (Schmidt et al., 2020). Penicillin was widely available and accepted treatment for syphilis but was withheld from infected men. Rights violated included informed consent and lack of protection from the risk of harm.
Risks on human subjects can be physical, social, psychological, or legal. The first instance entails being injured, and in the second, someone finds out about an issue they do not want to be disclosed (Schmidt et al., 2020). Researchers should avoid any known risk of harm to subjects. As a researcher, I would avoid unnecessary procedures that may raise the risk of injury to study subjects—for instance, gathering the bare minimum of data required for the study. I would take measures to reduce the danger, suffering, discomfort, stress, and other adverse effects of study on individuals. For instance, I might use topical anesthetics, painkillers, or tranquilizers to alleviate pain. Equally, I would adhere to the strictest norms of confidentiality while dealing with research participants. I would additionally integrate research and clinical practices.
Vulnerable populations describe a part of the community that requires ultimate care and protection during research. Specific vulnerable groups listed by Common Rule include; children, expectant mothers, fetuses, educationally or economically disadvantaged people, and mentally disabled people (Schmidt et al., 2020). They are considered vulnerable since their capability of safeguarding their interests as research participants via an informed consent process or withdrawal is compromised.
The recruitment process entails making the final decision concerning whether participants meet the exclusion and inclusion criteria of the research. Appropriate ways include finding and inviting the right persons to participate in the research. According to Durdella (2022), finding the right person for the research ensures that the needed findings are obtained. It should be based on the eligibility criteria of exclusion and inclusion. Requirements such as sex, health, age, and locality should be defined. Lastly, only individuals who meet standards should be invited. The recruitment process should ensure respect, fairness, and beneficence.
Obtaining consent typically involves explaining the research and evaluating subject comprehension using a consent form, usually a data sheet or written consent approved by IRB. Informed consent basics ought to be considered to obtain permission properly. First, all information has to be provided; secondly, ensuring the possible participant understands what they are getting involved in; and lastly, voluntariness (not forcing the participant into the research) (Durdella, 2022). Volunteer participation is the base for any consent. In other words, participants must be willing to participate.
A properly executed consent should inform and protect research subjects by discussing and disclosing relevant data. It should state that it is an invitation to the research and must have a clearly stated purpose, involved procedures, and study duration. Additionally, known benefits or risks and actions are taken to ensure confidentiality of the information stated (Schmidt et al., 2020). Lastly, the voluntary nature of participation includes who to be contacted when questions arise.
There are various bodies mandated to monitor the protection of human subjects. One of them is IRBs which were formed to protect and trust. Even though, at times, it appears to be an oppressive body with several regulations, in reality, it is a federal government attempt to ensure the rights and welfare of human research participants are protected. It assists researchers in addressing and recognizing issues of human subjects in their research (Durdella, 2022). Similarly, it advocates for fairness and autonomy and acts like a public watchdog and scientific merit arbiter. Other bodies include Federal Regulations and Policy; under it, there is (45 CFR 46) approved in 1974, and Federal Policy for the Protection of Human Subjects (The Common Rule) was adopted in 1991 (Schmidt et al., 2020). The bodies ensure that vulnerable populations are protected during the research process.
References
Durdella, N. (2022). Conducting research with human participants: An IRB guide for students and faculty. SAGE Publications.
Schmidt, U., Frewer, A., & Sprumont, D. (Eds.). (2020). Ethical Research: The declaration of Helsinki, and the past, present, and future of human experimentation. Oxford University Press.