Human Subjects Protection

This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. 

Evidence based research involving human subjects requires that researchers be cognizant of and adhere to the important tenets necessary to protect subjects from abuse, harm, injury, and/or other undesirable outcomes resulting from the research process.  Based on this fact, write a minimum of 2 pages (Title page and Reference not included in page count) of an APA formatted paper answering the following questions with a minimum of 3 “short” sentences for each question:

 

Historical background of human subjects protection? (10 points)

Human subjects’ protection entered the limelight in 1974 following significant research misconduct in the previous decades (the 1930s to 1970s). For example, the Tuskegee Syphilis Study of 1932 to 1972 violated various rights and entitlements of human subjects. Consequently, the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research (National Commission) conceptualized the Belmont Report of 1978 (Nagai, Nakazawa & Akabayashi, 2022). The report emphasized three bioethical principles and guidelines for human subject research: respect for persons, beneficence, and justice.

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

The Tuskegee Syphilis Study (1932-1972) is one of the historical incidents that grossly violated human rights. According to the Centers for Disease Control and Prevention [CDC] (2021), this study involved “Negro Males” (600 Black men-399 with syphilis and 201 without the disease). Researchers did not obtain informed consent from the participants and deceived them that the purpose of the study was to treat them for “bad blood.” During that time, bad blood described various diseases, including anemia and syphilis. Another deceptive behavior in the study involved free medical exams, free meals, and burial insurance in exchange for participating in the study (Centers for Disease Control and Prevention, 2021). Although penicillin was the preferable treatment option for syphilis, the researchers did not offer treatment to the participants, leading to deaths and poor quality of life. Based on the inappropriateness of this study, it is possible to argue that the researchers violated various rights, including the right to self-determination, informed consent, and safety.

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

Researchers must minimize risks when conducting research involving human subjects. In this case, risks may include the likelihood of manipulating participants, exploitation, and potential harm. According to Buchanan (2023), it is possible to minimize these risks by obtaining consent to uphold the right to self-determination, practicing appropriate data collection and storage to avert the inadvertent or voluntary violation of data privacy protocols, planning for undesirable or unexpected events, and avoiding deceptive and coercive acts like tricking or forcing participants to participate in research.

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

Pregnant women, minors, incarcerated people, people with diminished mental capacity, and the economically or educationally disadvantaged are often vulnerable. In research endeavors, researchers must understand the level of susceptibility to protect human subjects. These populations are vulnerable because they are susceptible to undue influence from researchers, may not understand the components of informed consent, and are often incapable of making informed decisions and providing consent.

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

Proper recruitment of human subjects can safeguard their rights, enhance their participation, and improve the quality, validity, and reliability of the findings. Appropriate ways of recruiting participants include avoiding pressure and undue influence, designing inclusion criteria consistent with the study’s objective, accurately describing the study, and adopting open and transparent advertisement approaches, including online adverts, emails, and social media. Also, obtaining approval from relevant ethical boards or committees and obtaining informed consent before recruiting participants is essential.

How would you properly obtain consent? (10 points)

Obtaining informed consent entails educating the potential participants about the risks, benefits, and alternatives of a particular procedure or intervention (Shah et al., 2022). In this case, participants must be competent in making a voluntary decision regarding their participation in the study. Therefore, obtaining informed consent includes providing written information sheets to the potential participants and verbally explaining various elements of the research.

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

Notably, informed consent should include a written information sheet and verbal explanations of various elements of the imminent research. Shah et al. (2022) argue that informed consent should include elements like the nature of the procedure or intervention, risks and benefits of the procedure, reasonable alternatives, risks and benefits of the alternatives, and the assessment of the participant’s understanding of the consent elements. Also, it is essential to document the subject selection criteria, the study’s purpose, cost, compensation, and all procedures relevant to participants.

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

International Review Boards (IRBs) monitor biomedical research involving human subjects. These committees protect the rights of human subjects by assuring that appropriate steps are in place to ensure the welfare of humans participating as subjects in research. Also, they have the authority to approve, require modification in research, and disapprove biomedical research that does not protect the participants’ rights and welfare (US Food and Drug Administration, 2019). International Review Boards are also known as Ethics Review Committees.

 

References

Buchanan, D. (2023). How can a researcher minimize causing harm when conducting interviews with particularly vulnerable children in longitudinal research? Children & Society. https://doi.org/10.1111/chso.12704

Centers for Disease Control and Prevention. (2021). Tuskegee study – timeline. https://www.cdc.gov/tuskegee/timeline.htm

Nagai, H., Nakazawa, E., & Akabayashi, A. (2022). The creation of the Belmont Report and its effect on ethical principles: A historical study. Monash Bioethics Review, 40(2). https://doi.org/10.1007/s40592-022-00165-5

Shah, P., Thornton, I., Hipskind, J. E., & Turrin, D. (2022, June 11). Informed consent. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK430827/

US Food and Drug Administration. (2019). Institutional Review Boards (IRBs) and protection of human subjects in clinical trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials#

 

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