Protection of Vulnerable Human Subjects during Research

Protection of Vulnerable Human Subjects during Research

Conducting research projects while ensuring the protection of human subjects is necessary. What are some methods to protect personal rights of someone in one of the groups that is labeled as vulnerable? Justify your rationale.


Involving the vulnerable people in research raises many ethical concerns mainly because of autonomy and their competences in receiving the informed consent compared to the other populations. According to (Melnyk et al., 2014) The vulnerable population includes the children, women of childbearing potential, prisoners, mentally ill, employees, and the students. Obtaining full consent from the vulnerable groups, primarily the cognitive impaired after the assessment of the projects if it is beneficial to the vulnerable individual or it increases the risk of the vulnerable group. Besides the interim analyses of the project that is yet to be conducted in the research should be brought openly in public so that the public can appraise the integrity of the study thus increasing the trust of the public on the research.

The second method of ensuring the rights of the vulnerable groups while conducting research is by developing a plan that enhances comprehensive safety (Breault, 2016). Besides, coming up with a Data Safety Monitoring Committee that will ensure consistent supervision of the safety and confidentiality of the data collected. The team will be involved in the early and the late trial phases that involve the vulnerable individuals to ensure safety, integrity, timeliness, lucidity, documentation, quality of data and to contribute to the recommendations that are required by the scientific caliber.

The involvement of the ethical review board and governmental agencies that will advocate for the norms and ensure continuous monitoring of ethical adherence is crucial in the research while dealing with the vulnerable subjects (Kahn,  Mastroianni & Sugarman, 2018). The research proposal should also undergo vigorous and thorough scientific review before the proposal proceeds to the IRB for the ethical review. Any research that is to be conducted should undergo a rigorous risk and benefit calculation.


Breault J. L. (2016). Protecting human research subjects: the past defines the future. The Ochsner            Journal, 6(1), 15–20. DOI:10.1043/1524-5012(2006)006[0015:PHRSTP]2.0.CO;2

Melnyk, B. M., Fineout-Overholt, E., Gallagher-Ford, L., & Kaplan, L. (2014). The state of evidence-based practice in US nurses: Critical implications for nurse leaders and      educators. Journal of Nursing Administration, 42(9), 410–417.

Kahn, J. P., Mastroianni, A. C., & Sugarman, J. (Eds.). (2018). Beyond consent: Seeking justice in research. Oxford University Press.