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 or contexts that demonstrate nuanced vulnerabilities. In the previous article, “Interpreting Respect for Persons through a Culturally Sensitive Lens,” we explored the significance of autonomy, and how researchers may interpret autonomy through the “respect for persons” principle in the Belmont Report and ensure that this guiding principle aligns with the beliefs and identities of their population of interest. This article explores the principle of justice and examines who should bear the burden in research. Specifically, this article focuses on populations with nuanced vulnerabilities, who may have a history of neglect, or exploitation, and how researchers can frame studies to consider the benefits of participation in research.
Foundational Principles in the Belmont Report
One guiding principle of the Belmont Report is concerned with the timeless and weighty question of justice: “Who ought to receive the benefits of research and bear its burdens?” Benefits of research entail research participants’ desired outcome (e.g., an intervention (medical, behavioral, or other) that they would not otherwise receive), whereas burdens constitute discomfort, inconveniences, and psychological, physical, legal, social, or economic risks that are experienced by participants in any given study.
These formulations are:
- to each person an equal share
- to each person according to individual need
- to each person according to individual effort
- to each person according to societal contribution
- to each person according to merit
Benefits in research are always considered in relation to the risks associated with the study. Direct benefits to subjects can never be guaranteed.
Past Significance of “Justice”
Preceding unethical research serves as a perpetual reminder that in the past, the burdens of research were often imposed upon groups with limited autonomy (e.g., minority status or low economic means) without consideration for participants’ direct or potential benefits. For instance, the Tuskegee experiment intended to track the course of syphilis and observe the effects of the venereal disease when it remained untreated, even after a treatment became available. Investigators recruited African American males, primarily sharecroppers with sparse financial autonomy and who had limited access to a doctor. The Tuskegee experiment violated the principle of justice outlined in the Belmont Report and the conceptualization of risks and benefits in various ways.
- Vulnerable populations: First, fair procedures in the selection and recruitment of participants were non-existent. Participants were likely selected due to their manipulability and susceptibility to coercion as they were often unable to afford medical attention otherwise. Researchers omitted information because individuals were not informed when a treatment for syphilis became available.
- Benefits did not outweigh risks: Moreover, the proposed benefits of study participation (free medical exams, meals, and burial insurance) were not commensurate with the immense burdens and risks (severe health problems or death) they endured. There is no evidence of “distributive justice” in this Tuskegee experiment, as benefits and burdens were not fairly distributed.
- Exacerbated risk: Lastly, the principle of justice also asserts that the burdens of research should not be added to groups who are already burdened by socioeconomic conditions, diseases, etc.
The Tuskegee experiment was an abhorrent example of the absence of justice in research ethics and exemplified the necessity for the creation of ethical principles underlying research and the existence of IRB committees. The legacy of the Tuskegee experiment has endured, as it has historically contributed to minority community’s distrust of research institutions, which may influence an individual's willingness to participate in research, specifically medical research.
Present Significance of “Justice”
The historical outcome of the Tuskegee experiment, along with other unethical research studies (Nuremberg War Crime Trials, Henrietta Lacks, Stanford Prison Experiment, etc.) imparted invaluable lessons and the necessity to develop ethical guiding principles. It was due to this exigency, that the multifaceted ethical principle of justice was stipulated.
As a principle, justice encompases fair treatment of human subjects across domains such as equitable distribution of the risks and benefits of research, a representative potential subject pool, and appropriate recruitment practices.
Thus, the principle of justice should guide researchers to ensure that participants bearing the burdens of research will receive benefits commensurate with the experienced burdens. It is necessary to appeal to and respect the concept of distributive justice in all research studies, even in some of the most extreme or high-risk cases in research. For example, if subjects are suffering from a terminal illness, they may choose to participate in a study examining the efficacy of an experimental treatment if there is a notable likelihood that it will improve their life expectancy or quality of life. The potential benefit of study participation in this context may justify the risk.
There are a lot of complexities embedded in the concept of justice, related to the distribution of risks and benefits and the selection of research subjects, which highlight the necessity for investigators and IRB administrators to approach and review participant selection with the highest scrutiny. IRBs are federally mandated to ensure that research subjects are not being systematically selected because of their accessibility, manipulability, or convenience for researchers. Instead, sample populations should be selected based on population characteristics directly related to the questions being investigated in the study, such as the patients with a terminal illness participating in a study examining an experimental treatment for that particular illness (OHRP, 1979).
Consideration of Disparities
A research community is susceptible to an imbalance of distributive justice and an unethical selection of the recipients of the benefits of research because of added pressures like funding deadlines, publication expectations, and achievement-based promotions. For instance, in the United States, people from Western, educated, industrialized, rich, and democratic (WEIRD) groups “represent as much as 80 percent of study participants, but only 12 percent of the world’s population” (Azar, 2010). These groups tend to receive direct and indirect research benefits because they are an accessible population (e.g., flexible work schedules, access to transportation, etc.), familiar with the research process, and may exhibit mainstream views, which may create fewer outliers. Investigators should consider the consequences of convenience sampling, or in other words, recruiting participants based on their ease of availability.
Mitigating Barriers to Promote Fair Selection & Recruitment of Participants
Equitable and diverse representation in research is crucial. However, it is not always a facile accomplishment. Researchers may face barriers when accessing populations with both unambiguous and nuanced vulnerabilities. IRB administrators are a resource for researchers when considering impediments to equity in research.
It is important to think of ways that researchers may engage underserved populations in an appropriate manner. For example, during the COVID-19 pandemic, many education researchers chose to make their evidence-based, online educational curriculum available to any schools in need, rather than just their partner research schools. Additionally, if a researcher at a four-year university is interested in investigating the effectiveness of a new therapy in reducing symptoms in emerging adults with chronic psychological disorders, the researcher should consider extending their recruitment beyond student participants exclusively from their university. Underserved communities may lack access to behavioral healthcare and may benefit from the refinement of therapeutic interventions.
Furthermore, populations with nuanced vulnerabilities have been often overlooked in research due to constraints such as limited access to privacy and communication means, lack of transportation, and limited schedules. Therefore, it is important for investigators to implement practical procedures to be more accommodating for their participants and ensure that the direct benefits of a study outweigh the costs of participating in research. For instance, if a clinical trial requires participants to commute to a research site (e.g., a hospital or lab) and will provide a free neuropsychological evaluation to the participant as part of the study activities, the distance, lack of a personal vehicle, or cost of transportation may outweigh the direct benefit and deter participation. In order to address this barrier, the researcher may provide a travel voucher to compensate for the inconvenience. Another barrier may be timing of appointments, so the researcher may offer extended evening and weekend time slots for those participants who work during the day. This is a pragmatic example of how researchers can make their study more accessible, introduce flexibility into their research, and ensure that all those who are qualified for the study have access.
Conclusion
The principle of justice requires an equitable distribution of risks and benefits for research participants and fair recruitment practices yielding an impartial subject pool. It is essential for investigators to provide benefits that are commensurate with the risks or burdens of participating in a research study or in low-risk studies, specify there is no direct benefit. For those researchers working with groups with nuanced vulnerability, it is especially important to mitigate risks and barriers due to a history of exploitation and neglect and introduce elements of flexibility and cooperation within their research. Investigators should thus approach the principle of justice with a comprehensive understanding of cultural sensitivity. The IRB can guide investigators and propose solutions so that researchers stay within federal guidelines, and introduce accommodations within their research so that they are not withholding benefits from marginalized communities.