Vulnerability is central to the ethics of human subjects research. Researchers are responsible for the rights and welfare of study participants and are required to include additional safeguards when working with vulnerable populations based on the Common Rule, the US Department of Health and Human Services’ Policy for Protection of Human Subjects, and any state, city, or local regulations. Reflecting the principle of respect for persons from the Belmont Report written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, individuals with diminished autonomy are entitled to protection (Gordon, 2020). Justifying the involvement of vulnerable populations in research can be complex as the degree of risk and vulnerability increases. Institutional Review Board (IRB) administrators engage in the method of inquiry with the primary researcher for subject identification and recruitment to ensure that accessing a vulnerable population is ethically and legally acceptable.
IRB administrators consider several factors when making their human subjects research protocol review determination including the study population age, setting, environment, and if the study materials are appropriate for the context and with these individuals. For example:
- A researcher intends to engage adolescent females recently removed from violent domestic situations.
- The researcher is interested in topics of resilience and recovery in the context of an educational setting, as many of these adolescent females had never (or rarely) attended school.
- The researcher’s topic was centered around learning and education, however, because of their situation, the females were still dealing with their past adverse experiences.
- The researcher planned to interview the adolescent females in a private room and ask questions about their schooling.
Given this unique situation, an IRB reviewer will consider the researcher's qualifications, the risks and benefits involved, and how the researcher intends to interact with this population. In this example, the IRB administrator may ask the researcher to consider asking the adolescent females to choose a room or quiet space they felt comfortable in for the interview, rather than being led by the researcher. Additionally, an IRB administrator may ask the researcher to include a safety plan in the event that the adolescent females diverts from the study topic about education and delves into sensitive topics concerning their previous domestic situation. The researcher can provide a plan on how to handle sensitive topics, how best to respect the adolescent females’ perspective, and offer safeguards to pause or stop the study, and resources if the adolescent females needed additional support.
Vulnerability as a Spectrum
Vulnerable and marginalized populations represent a diverse population beyond what typical definitions may imply. Vulnerability can be understood as a spectrum rather than a categorical construct. Following a categorical perspective, the Code of Federal regulation (Title 45, Code 46) that university Institutional Review Boards (IRBs) typically follow lists the following groups as vulnerable:
- Prisoners,
- Children,
- Pregnant women,
- Fetuses,
- Cognitively impaired persons, and
- Economically-and-educationally-disadvantaged persons. (Gordon, 2020)
It is important to recognize that vulnerable and marginalized populations are not limited to a specific set of groups defined by traditional categories. Instead, vulnerability should be understood as a spectrum that can affect individuals in different ways. However, it is important to recognize that this list is not exhaustive and that vulnerability can affect individuals from a wide range of backgrounds and circumstances.
However, some advisory committees recommend interpreting vulnerability as an intrinsic or situational condition that places some participants at increased risk of being ethically harmed during the research process. This contextual framework characterizes vulnerability in situational terms, highlighting specific reasons a person may be vulnerable. This approach leads to a more nuanced understanding of vulnerability and a more focused approach to safeguards. The categorical approach is less than optimal for situations in which an individual has multiple vulnerabilities, such as a pregnant minor. Due to intersecting vulnerabilities, researchers should expand their understanding of vulnerability to include a broader range of circumstances and populations that face potential harm during the research process (Lake, Majic, & Maxwell, 2019; Gordon, 2020).
Circumstantial Forms of Vulnerability (Gordon, 2020)
Deferential vulnerability includes persons who are under the authority of others. This authority is informal rather than overtly hierarchical and arises due to power imbalances based on race, gender, and class. An example of this is the doctor-patient relationship. Deference may occur out of fear of offending the authority figure or a desire to please a respected other, especially in instances when an individual may have concerns about loss of access or resources. In this situation, there is a risk of exploitation and an inability to make truly autonomous decisions. To mitigate this risk, researchers can implement clear consent procedures for potential participants with statements that the study is voluntary and nothing bad will happen if the individual chooses not to participate.
Economic vulnerability includes persons who are disadvantaged regarding social goods and services such as income, housing, or healthcare. Monetary incentives for this population may be considered inducements to participate since autonomy is limited to the extent that such individuals participate against their own wishes due to economic conditions. Although providing monetary incentives is the most tangible and effective incentive impacting an individual's likelihood to participate, the monetary amount must be appropriate to what the study requires of participants to avoid coercion of economically vulnerable populations.
Social vulnerability refers to persons who are members of undervalued or disadvantaged social groups, such as racial or ethnic minorities, the homeless, and the elderly. ocial vulnerability arises from the negative, discriminatory, and stereotypical perception of certain individuals. These perceptions may devalue the welfare and societal contributions of such groups. Since these groups are considered less important than a more valued group, the risks they face in a research study may be deemed less threatening. Researchers may consider including members of these groups in the design, decision-making, and oversight processes, or pilot testing of the study. Involving the target group in the research process from the outset can be instrumental in reducing stereotyping and stigmatization.
Some salient reasons why individuals may be vulnerable in research are due to potential difficulty in providing voluntary, informed consent (due to limitations in decision-making capacity or situational circumstances) which may lead to increased risk for exploitation; likelihood of being coerced, or unduly influenced by researchers.
Under-representation of Vulnerable Populations
Members of vulnerable populations are underrepresented in social science and medical research studies. Some social groups are consistently excluded from social research, such as women, sexual minorities, and ethnic minorities (Ellard-Gray, Jeffrey, Choubak, & Crann, 2015), whereas other populations oversaturate research (e.g., Western, educated, industrialized, rich, and democratic societies). Despite the NIH Revitalization Act of 1993 mandating appropriate representation of minorities in clinical trials, there is still inadequate representation compared to non-minority groups (UyBico, Pavel, & Gross, 2007).
Understand the Risks and Benefits of Working with Vulnerable Populations
Investigators and members of the IRB can work together to understand the risks and benefits of working with vulnerable populations and what motivates these populations to participate in research. The next blog in this series, Barriers to Recruitment of Vulnerable Populations at a Participant and Researcher Level provides insights into subject selection and recruitment, and populations most at risk of harm.
Resources
Ellard-Gray, A., Jeffrey, N. K., Choubak, M., & Crann, S. E. (2015). Finding the Hidden Participant: Solutions for Recruiting Hidden, Hard-to-Reach, and Vulnerable Populations. International Journal of Qualitative Methods, 14(5), 1609406915621420. https://doi.org/10.1177/1609406915621420
Gordon, B. G. (2020). Vulnerability in Research: Basic Ethical Concepts and General Approach to Review. The Ochsner Journal, 20(1), 34–38. https://doi.org/10.31486/toj.19.0079
Lake, M., Majic, S., & Maxwell, R. (2019). Research on Vulnerable and Marginalized Populations (SSRN Scholarly Paper No. 3333511). https://doi.org/10.2139/ssrn.3333511
Sutton, L. B., Erlen, J. A., Glad, J. M., & Siminoff, L. A. (2003). Recruiting vulnerable populations for research: Revisiting the ethical issues. Journal of Professional Nursing, 19(2), 106–112. https://doi.org/10.1053/jpnu.2003.16
Park, S. S., & Grayson, M. H. (2008). Clinical research: Protection of the “vulnerable”? Journal of Allergy and Clinical Immunology, 121(5), 1103–1107. https://doi.org/10.1016/j.jaci.2008.01.014
UyBico, S. J., Pavel, S., & Gross, C. P. (2007). Recruiting Vulnerable Populations into Research: A Systematic Review of Recruitment Interventions. Journal of General Internal Medicine, 22(6), 852–863. https://doi.org/10.1007/s11606-007-0126-3
Van Wijk, E. (2014). Recruitment and Retention of Vulnerable Populations: Lessons Learned from a Longitudinal Qualitative Study. The Qualitative Report, 19, 1–21.