This TC IRB blog series, “Fostering Ethical Research in Contexts with Nuanced Vulnerability” presents the three core principles identified in the Belmont Report and explores how to conceptualize these ethical guidelines when conducting research with populations with nuanced vulnerability. Specified vulnerable populations, or according to the revised Common Rule subjects who are vulnerable to coercion or undue influence (45 CFR 46.111(a)(3)) include: 

  • Children
  • Prisoners
  • Economically disadvantaged persons
  • Educationally disadvantaged persons
  • Individuals with impaired decision-making capacity

Children  - “By regulatory definition, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research... Generally, the law considers any person under 18 years old to be a child” (OHRP, 2016).

When reviewing research with children as subjects, IRB administrators consider “….the potential benefits, risks, and discomforts of the research to children and assess the justification for their inclusion in the research.” Included in this consideration are the “...circumstances of the children to be enrolled in the study…” (health status, age, and ability to understand what is involved in the research) (OHRP, 2016).

Prisoners - “A Prisoner means any individual involuntarily confined or detained in a penal institution” (OHRP, 2021).

A prisoner representative with appropriate background and experience will review the research study. IRB administrators consider any potential benefits of research participation afforded are not of such great magnitude that they may inspire participation. Researchers should demonstrate fair subject recruitment, clearly described study procedures to ensure understanding, and sound privacy/confidentiality standards.

Economically & Educationally Disadvantaged Persons - Economically and/or educationally disadvantaged persons may have a difficult time meeting the demands associated with sustaining themselves and their families. Additionally, educationally disadvantaged persons may have educational deficits or learning disabilities that hinder the communication of their needs or concerns surrounding their participation in research.

  • Due to the unique concerns of that population, researchers should incorporate additional safeguards to mitigate potential vulnerability to undue influence or coercion.
  • These individuals may have issues understanding the consent process or may have issues that prevent them from completing the study activity or from performing written instructions. Educational challenges may not be immediately apparent to researchers. As such, researchers should explore the cultural, social, and engagement norms of the population to ensure an understanding of their needs.

Individuals with impaired decision-making capacity - “….The term ‘consent capacity’ describes an adult’s ability to understand information relevant to making an informed, voluntary decision to participate in research. Several kinds of information are relevant to such decisions, including the purpose of the study, its experimental nature, risks and anticipated benefits, the right to withdraw, alternatives to participation, confidentiality protections, and the safeguards used to minimize risks. A wide variety of diseases, disorders, conditions, and injuries can affect a person’s ability to understand such information, to weigh the advantages and disadvantages of participation in research, and to reach an informed decision regarding study participation” (NIH, 2009).

Impaired decision-making may not be obvious when engaging with a research participant. As such, researchers can develop keen observation skills and mindfulness methods to gauge if the study subject seems distressed, uncomfortable, or distracted. The researcher could weave in periodic check-ins to ask if the individual wishes to stop, needs a break, or has questions. 

Since the vulnerability of human subjects is always contextual (depending on the study, setting, timing, etc.) IRB institutions and Human Research Protection Program (HRPP) will continue to exercise discretion in ensuring that human subjects that may be vulnerable are appropriately enrolled and protected. Populations with nuanced vulnerabilities are groups that may not be listed in the federal guidelines, but who may require augmented protections depending on the context. Therefore, nuanced vulnerability transcends a conventional view concerned with physical location characteristics (e.g., prisoners), cognitive impairments, or limitations (e.g., youth), pregnancy status, etc. Instead, this denomination involves acknowledging that social groups or populations, which are not listed as vulnerable populations in federal regulations may require additional protections when participating in research. 

In this article, we will cover the first ethical principle of the Belmont Report, provide examples of nuanced vulnerable populations, and introduce ideas to ensure that the autonomy associated with the “respect for persons” principle is upheld in accordance with the beliefs and identities of research participants exhibiting nuanced vulnerabilities.

Foundational Principles in the Belmont Report

The Belmont Report of 1979 has laid the groundwork for ethical decision-making in research and continues to serve as an exemplar of the three guiding principles that IRBs rigorously adhere to when reviewing research with human subjects. The first basic principle outlined in the Belmont Report is “respect for persons” which delineates two canons of research ethics: “individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.” This ethical premise describes two requirements that human subjects research must demonstrate and that the IRB must examine: 

  1. the acknowledgment of autonomy 
  2. the obligation to protect individuals with reduced autonomy

Definition and Applications of “Autonomy”

Autonomy is the principle that all individuals “have intrinsic and unconditional worth, and therefore, should have the power to make rational decisions and moral choices, and each should be allowed to exercise self-determination” (Varkey, 2021). Depending on the context, practical applications of autonomy can be fluid and diverse and should be considered as such with regard to the research population. In western societies, individual autonomy is held paramount and thus decision-making revolves around a single person. In collectivistic cultures, collective autonomy is the norm and decision-making is often group-oriented, shared, or designated to a specific individual. Therefore, it is important that before the IRB and researchers seek to acknowledge and secure autonomy from participants, there must be an existing, assiduous understanding of what autonomy means within the cultural and individualistic contexts of the research subjects.  

Autonomous Decision Making during the Informed Consent Process with Adults

This concept of autonomy defines the ethical conduct of research and is most tangible during the informed consent process, where individuals have the freedom to decide whether they would like to participate in a research study after being informed of the risks, benefits, and procedures. In preparation for the informed consent process, investigators should create a plan of action to ensure they are navigating, respecting, and accommodating the cultural norms of populations with nuanced vulnerability. 

Cultural Contexts

In western culture, informed consent is typically considered an individual decision; however, there are some contexts in which this might vary. For instance, if a researcher is working with women whose rights are limited by cultural or religious constraints, it is essential to approach the situation with cultural humility (Al Subeh & Alzoubi, 2021). Researchers should inquire if it is necessary to contact a designated family member for consultation (e.g., the family patriarch). In this case, this population does not neatly fit into any of the vulnerable populations stipulated in the federal regulations, and there is no evidence of impaired decision-making capacities. However, given the cultural circumstances and context, this population may require additional protections. Therefore, it is important for researchers to critically think about whether certain populations may exhibit subtle vulnerabilities that may impact the informed consent process and participation. With the help of the IRB, researchers can then explore cultural components pertaining to this population to ensure an adequate understanding of what consenting to participate in research means to them and what protections are required to feel at ease. 

Beyond Borders

In a related vein, certain cultural subgroups such as South Asian immigrants may adhere to more collectivist norms and endorse a family-centered approach to decision-making (Chittem & Butow, 2015). This is important for researchers to keep in mind before attempting to recruit potential participants and acknowledge that the informed consent process may require additional considerations. Similarly, when working with indigenous groups or Native Indian tribes, researchers should be cognizant of populations with nuanced vulnerability because indigenous populations are historically disadvantaged groups who may be recognized as economically disadvantaged but also possess a more nuanced vulnerability related to historical exploitation. This is essential when attempting to secure an understanding of the participant’s concept of autonomy and their beliefs regarding consent. In this case with Native Indian tribes and indigenous groups, it may be important to understand that informed consent may operate through kinship or alliances. Therefore, decisions are often deferred to tribal leaders or community gatekeepers. Their understanding and approval of the study often dictate participation (OHRP, 2021). Investigators will be concerned with consenting the group first, then the individual; autonomy may mean that a group is given the information and power necessary to come to an informed, collective decision. It is important for investigators to keep in mind that many times, there are layers to consenting, reflective of the complexity of culture, attitudes, and beliefs. In all of these situations, TC IRB can be contacted for support in determining the best methods of consent.

Consideration of Risks and Barriers for Disempowered Groups

Participating in research might be a momentous event for individuals, especially for populations with nuanced vulnerabilities where mistrust, a history of abuse, or unfamiliarity with the process limits their engagement with research. For instance, Native Americans may deeply value the environmental knowledge, traditions, and stories stored within their community. They may feel the need to protect their cultural patrimony from non-natives who have previously tried to eradicate their history (Harding et al., 2011). Thus, depending on the nature of the study, these populations may feel dubious about sharing their insights. It behooves investigators to provide individuals with all the necessary information written or described in a way to help them make informed decisions that are consistent with their views. 

The informed consent process may also have divergent cultural meanings for some populations, and their signature on a legal document may evoke fear or lack of trust. For undocumented immigrants, the act of signing a consent form might be intrusive and anxiety-provoking. Consequently, in such specific instances, investigators may be able to seek alternatives to obtaining the standard written informed consent and may request to collect verbal consent or a waiver of documentation (e.g., using only checkboxes to indicate consent for low-risk online studies). Investigators should provide the IRB with relevant and pertinent information about the vulnerable group they are working with and the justification for why they are requesting altered consent.

Conclusion

Consideration of cultural context is embedded in the process of conducting ethical research, and it is important for investigators to adopt a culturally sensitive view in all cases, but even more so when working with populations with nuanced vulnerability. Researchers should consider barriers to entering research: keep in mind that autonomy may include collective decision-making and tailor consent forms as needed. The IRB has sample language for obtaining verbal consent and waivers of documentation that can be provided upon request. These practices described in this article should be implemented to ensure that the autonomy referenced in the respect for persons guiding principle of the Belmont Report aligns with the individual’s concept of autonomy.

Resources

— Raquel Queiruga, B.A.

Published Tuesday, Mar 1, 2022