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Human subject protection entails the ethical and regulatory measures brought into practice to ensure that safety, rights, and welfare are assured in research studies involving human subjects (White, 2020). This paper consists of a discussion on the history and evolution of safeguarding the rights, dignity, and welfare of people to be involved in research activities. The paper identifies relevant events that are responsible for the standards and guidelines followed today, particularly the activities and roles of Institutional Review Boards (IRBs) and informed consent. The evaluation encompasses safeguards for at-risk populations as well as the requirements for ethical review. It aligns science with humanity and respect for human dignity.
Over the last century, human rights protection has greatly evolved to safeguard the participant’s safety, dignity, and rights. This is basically because of harmful studies that resulted from unethical research; early research exploited vulnerable subjects, such as children and inmates, who seldom received informed consent and awareness of research studies. One of the early landmark achievements in the field of ethics in research is probably the Nuremberg Code of 1947, written as a response to the atrocious experiments carried out by Nazi physicians during World War II. These experiments conducted at concentration camps included unethical medical practices that caused impairment, disease, and death.
The Nuremberg Code focused on voluntary participation, informed consent, and the development of making sure that there would be minimal suffering done unnecessarily (White, 2020).One of the most significant cases in the record of human subject protection was the Tuskegee Syphilis Study performed from 1932 to 1972. In this study, syphilis was deliberately not treated in 399 African American men with syphilis. At the time when penicillin became available in the 1940s, the disease was allowed to progress without treatment for studying its full span.
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
These participants were forbidden to give their own informed consent and were paid only for free checkups, food, and funeral coverage. What was expected to last for six months actually lasted for forty years, which demonstrated an ugly disregard for the well-being of the subjects (Spellecy & Busse, 2021). Public outcry about ethical misconduct led to the National Research Act of 1974. It mandates that IRBs lead and give permission to oversee human subject research.
The Stanford Prison Experiment of 1971 exemplified psychological harm as the participants lacked adequate protection, illustrating how lapses in regulation lead to enormous damage. This highlights the significance of protecting human subjects in light of ethical research practices. The key concepts of such frameworks are, however, respecting persons, beneficence, and justice, which, starting from the Belmont Report, continue to guide their design in balancing scientific progress against the welfare of participants (White, 2020).
Research Activities
From time to time, the art of researching human subjects has evolved, and with this evolution comes the need to protect participants’ safety as well as their rights. A human subject is defined as the Health and Human Services Policy for the Protection of Human Research Subjects in 45 CFR Part 46, which is a living individual who may be involved in an investigation where a person’s identifiable private information or biological material will be gathered.
The National Institutes of Health also distinguishes between interventional and observational study approaches. Observational studies follow subjects without applying specific treatments and are based on potential causes of illness and disease progression changes. For instance, cohort studies track smoking behavior to assess the impact on lung cancer rates (National Institute of Dental and Craniofacial Research, 2022).
NURS FPX 5005 Assessment 1 Protecting Human Research Participants
On the other hand, interventional studies involve the manipulation of one or more natural or psychological variables. For instance, clinical trials have been used to test the safety and efficacy of new treatments or drugs. Under this category fall the Phase III clinical trials assessing the effectiveness of a new cancer drug when compared to the conventional therapies of volunteer patients. Interventional studies also fall under behavioral research, whereby researchers study human behaviors, cognition, and emotions under controlled conditions.
For instance, studies on mindfulness techniques for measuring anxiety level cha
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