How to write a nursing research essay on human Subjects Protection Assignment

Historical Background: Human subjects protection is a term that is collectively used to describe policies, procedures, and ethical considerations when conducting research on people. Over the past five decades, oversight and protection of human subjects during research have evolved. In the early 1940s, Nazi German physicians conducted research on people without their approval (Spellecy & Busse, 2021). Because of the adverse outcomes observed including death and permanent injuries, about 23 physicians and administrators were charged.

The Nuremberg Code was among the first actions to try and regulate research on human subjects. This code contained three key elements to guide research and they included voluntary informed consent, favorable risk/benefit analysis, and the right to withdraw anytime (Spellecy & Busse, 2021). Later, congress approved the first legislation in 1974 which created a commission for the protection of human subjects. Today, the Office of Human Research Protections oversees all research and the use of institutional review boards (IRBs) ensures all research on human subjects meets the required standards.

Historical Incident

The Tuskegee experiment is recognized as one of the most brutal incidents in American history. This study represented an experiment to observe the natural history of untreated syphilis. Conducted between 1932 and 1972, the researchers failed to collect informed consent from the participants and they did not provide a cure for syphilis even when it became available (Centers for Disease Control and Prevention, (CDC), 2022). In the year 1932, 400 African American men from Alabama were recruited for the study by the United States Public Health Service (USPHS). The primary goal of the experiment was to observe how untreated syphilis progressed among African American subjects based on the estimates that 35% of the population had syphilis (CDC, 2022). During the experiment, individuals were told that they were receiving treatment for bad blood. The researchers also recruited 200 control subjects without syphilis. Even after the discovery of penicillin as the first treatment for syphilis in 1947, the affected individuals were not treated. Until its completion in 1972, the Tuskegee study led to the death of many patients.

Minimizing Risks on Human Subjects

Minimizing the risk of harm during research begins at the first stage of conducting research which deals with the purpose and objectives of the study. During the research, I will ensure to use of procedures that align with the research design and those that target the desired outcome. Involving the Institutional Review Boards will be an important step to ensure that the research meets the required standards (White, 2020). The second step that can minimize harm is using the least number of participants possible. I will ensure to use of the approved methods to calculate the sample size and obtain informed consent for every procedure. In other circumstances, performing prescreening to identify and eliminate high-risk patients can be a good step toward minimizing harm. Lastly, I will ensure to eliminate unnecessary procedures during research and use data elements that can positively influence outcomes.

Vulnerable Populations

Vulnerable populations represent the disadvantaged sub-segment of the community that requires special care and specific considerations during the research (Shivayogi, 2013). These populations require assiduous attention during recruitment for research and monitoring during experiments. These individuals include minors, prisoners, pregnant mothers and unborn children, and those who are mentally challenged (Shivayogi, 2013). For example, by legal definition, minors are those aged below 18 years and they are not permitted to give consent during research. These individuals are believed to have limited cognitive ability from ethical and legal perspectives to understand what research entails. During research involving subjects from these groups, the IRB approves studies that demonstrate sensitivity to the needs of the participants and minimize unnecessary risks.

Ways to Recruit Subjects

Recruiting subjects for research is a process that requires following guidelines and using the right approaches to reach people. One of the ways to recruit participants is using the IRB-approved protocol. The protocol contains people who have participated in research and consent for future recruitment in other studies. The second way is to form a team that can help to set up live intercepts. The use of social media is an acceptable strategy to recruit people for research.

Properly Obtaining Consent

Informed consent is a legal and ethical requirement for research involving human subjects. A properly executed consent should be obtained before the research begins and it involves giving detailed information to patients (Spellecy & Busse, 2021). To properly obtain consent, I will ensure to verbally explain the research purpose, potential benefits, risks involved, and the right to withdraw without consequences to the participant.

Elements of a Consent

Properly executing consent will involve obtaining a written agreement from the participant to be involved in research. The key elements of good consent include disclosure of information, making sure the participant is competent to make the decision, and the voluntary nature of decision-making (White, 2020).

Committees

Currently, the United States policy requires research involving human subjects to be approved by committees called Institutional Review Boards (IRBs). These committees ensure that the research meets the federal requirements for ethical research.

 

 

References

Centers for Disease Control and Prevention. (2022). The U.S. Public Health Service Syphilis Study at Tuskegee. https://www.cdc.gov/tuskegee/index.html

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

Shivayogi, P. (2013). Vulnerable population and methods for their safeguard. Perspectives in Clinical Research, 4(1), 53–57.

https://doi.org/10.4103/2229-3485.106389

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

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