How to write a nursing paper on Human Subjects Protection (Answered)

Historical background of human subjects protection? (10 points)

The history of human subjects research protection can be traced to the early 1940s during the second world war. During this period, Nazi German physicians conducted human experiments on thousands of people without their consent (Spellecy & Busse, 2021). Most subjects in the prisons died or were permanently crippled and in 1946, the American military tribunal opened court cases against 23 identified physicians and administrators (Spellecy & Busse, 2021). To resolve issues in human subject research, it was proposed that the all human subjects must consent before conducting any research.

Find and discuss at least one historical incident of human subjects abuse in research and what human right was violated. (10 points)

One of the historical events involving the abuse of human subjects was the Tuskegee Study involving patients with syphilis. The US Public Health Service and

Tuskegee institute monitored 400 African-American males diagnosed with syphilis for 40 years without intervention (Spellecy & Busse, 2021). The participants were denied treatment even after penicillin was approved in the 1950s leading to disability and death. This research violated the human right to health that entitles one to treatment, prevention, and control of diseases.

What steps will you take to minimize risks on human subjects? (10 points)

One of the initial steps taken to reduce harm to human subjects during research involves using procedures that align with research designs. For example, the research design should have a meaningful objective, and the procedures used should achieve the desired outcome (White, 2020). To minimize risks during procedures, I will use the minimum number of participants possible and obtain a certificate of consent. Eliminating unnecessary procedures will ensure the use of data elements that can positively contribute to the analysis plan.

What populations are considered vulnerable populations and why? (10 points)

Vulnerable populations represent groups that cannot fully consent to participate in a study. These populations include expectant mothers and fetuses, prisoners, children, and individuals with mental health issues.

What are appropriate ways to recruit subjects? (10 points)

The recruitment and selection of human subjects must be equitable within the confines of the research. One of the best ways to recruit participants involves obtaining a separate IRB-approved recruitment protocol (White, 2020). These participants usually provide consent for future research studies. Secondly, the researcher can use advertisements, notices, or media. Other mechanisms may involve using the UCIMC Clinical Trial website to post information and attract potential subjects.

How would you properly obtain consent? (10 points)

Consent should be obtained before the participant enters the research and it involves education and information exchange. I would abide by the federal regulations and obtain consent that is documented (Manti & Licari, 2018). I will verbally explain to the participant the study procedures, purpose, benefits, and risks involved. I will answer any questions asked and assess for subject comprehension to ensure the participant fully understands the research.

What are the elements of a properly executed consent? (10 points)

A good consent contains three major elements which include disclosure of information, the patient’s competence to make decisions, and the voluntary nature of the decision. Disclosure of information entails a discussion of the procedures, risks, and benefits of the study (Manti & Licari, 2018). The ability of the participant to make a decision entails subject comprehension assessment (Manti & Licari, 2018). The other element is the voluntary nature of the decision which protects the individual’s freedom of choice and reduces the chances of exploitation.

What committees are responsible for monitoring the protection of human subjects? (10 points)

Conducting research on humans requires approval by a committee established to protect human subjects. In the US, the Institutional Review Boards (IRBs), also known as Ethics Review Committees guide researchers on the involvement of human subjects (White, 2020).  IRB functions to ensure all research on human subjects meet the federal requirements of ethical research.

References

Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe (Sheffield, England), 14(2), 145–152. https://doi.org/10.1183/20734735.001918

Spellecy, R., & Busse, K. (2021). The history of human subjects research and rationale for Institutional Review Board Oversight. Nutrition in Clinical Practice : Official Publication of the American Society For Parenteral And Enteral Nutrition, 36(3), 560–567. https://doi.org/10.1002/ncp.10623

White M. G. (2020). Why human subjects research protection is important. The Ochsner Journal, 20(1), 16–33. https://doi.org/10.31486/toj.20.5012

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