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The Ethical Concerns of Vulnerable Populations in Clinical Research

When reflecting upon the global history of clinical research, there is an obvious, dark trend of the exploitation of vulnerable populations - from the inhumane testing of Jewish prisoners by Nazi Germany to the Tuskegee syphilis experiment on Black American men. “Vulnerable” populations are defined as “groups of people who can be harmed, manipulated, coerced, or deceived by researchers because of their diminished competence, powerlessness, or disadvantaged status.” [1] Those unable to protect themselves with informed consent are vulnerable. [2] Thus, vulnerable populations can include: prisoners, racial and ethnic minorities, the elderly, the poor, children, and those with cognitive impairments. [3] Upon widespread realization of the horrors of such treatment, ethical ordinances, such as the Nuremberg Code and Declaration of Helsinki, were enacted, globally, to protect vulnerable populations from future abusive medical treatment. Institutional review boards (IRBs) are one type of body that works to eliminate such mistreatment by maintaining that research proposals meet federal guidelines for ethical research. Thus, any researcher that seeks to work with vulnerable populations must first be approved by their setting’s IRB. [4]

A major aspect of “vulnerable” status is the inability of an individual to provide informed consent. Whereas, in some instances, vulnerable individuals have loved ones available to behave as their surrogate decision makers for informed consent, in other instances,\ this consent is provided by the individual’s healthcare providers. Such healthcare providers view their decision as necessary by virtue of the principle of beneficence, which requires them to mull over a cost-benefit analysis of the scenario. [1] Oftentimes, however, vulnerable populations are not recruited for clinical studies because of a preemptive fear of mistreatment.

An odd paradox arises due to the hesitancy of the clinical research community in utilizing vulnerable populations to avoid any potential exploitation. If vulnerable populations are seldom studied, the ability to understand and treat medical issues prevalent in such populations decreases dramatically. [1] Research funding is far more likely to be awarded to study the issues that are currently cited in research; without funding, research is not possible. Thus, if the health issues faced by vulnerable populations are rarely studied because they are not engaged in scientific studies, then these issues are thereby less likely to receive funding. This has the potential to create a vicious cycle in which vulnerable populations will remain vulnerable because the issues that plague them are not studied, and thereby not understood. Further, the avoidance of vulnerable populations for research and data analysis contributes to a non-representative sample of our populations. Additionally, the avoidance of such populations for clinical research does nothing to address or alleviate the understandable mistrust certain populations hold towards researchers, namely African Americans after the Tuskegee syphilis study in the 1930s. [5]

It is certainly true that extra efforts must be taken by clinical researchers to ensure that medical exploitation of defenseless populations ceases to exist. However, it is also crucial that, in worrying about the potential exploitation of groups, we do not alienate them from necessary research. Researchers must think of ways to mutually protect vulnerable populations from exploitation, as well as, recruit them into their studies. While recruiting for studies, eligible volunteers of vulnerable status must be provided with all information necessary to decide on their participation in a study. The necessary provided information includes: a description of the study, potential risks/benefits, the right to give voluntary consent, the right to withdraw from the study at any time, anonymity, confidentiality, and any modes to lessen risks. [6] However, simply providing this information to potential study volunteers is not enough; potential volunteers must also perceive that they are fully informed in their decision. This can be made easier by collaboration and open dialogue between researchers, healthcare providers, ethicists, potential volunteers, and their family members. [1]


1. Quinn, C. R. (2015). General considerations for research with vulnerable populations: Ten lessons for success. Health & Justice, 3(1).

2. Ulrich, C. M., Wallen, G. R., & Grady, C. (2002). Research vulnerability and patient advocacy: Balance-seeking perspectives for the clinical nurse scientist. Nursing Research, 51, 71.

3. Martin, P. A. (1995). Recruitment of research subjects. Applied Nursing Research, 8, 50-54.

4. Anderson, D. G., & Hatton, D. C. (2000). Accessing vulnerable populations for research. Western Journal of Nursing Research, 22(2), 244–251.

5. Park, S. S., & Grayson, M. H. (2008). Clinical research: Protection of the “vulnerable”? Journal of Allergy and Clinical Immunology, 121(5), 1103–1107.

6. Miracle, V. A. (2010). Vulnerable populations in research. Dimensions of Critical Care Nursing, 29(5), 242–245.



Author: Aseelah Saiyed

Editor: Lauryn Agron

Health scientist: Aseelah Saiyed

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