By Stacey Kusterbeck
As an advocate and refugee ethics scholar, Julie M. Aultman, PhD, personally has observed unethical conduct in human subjects research involving persons seeking asylum. “Designing a study that lacks proper resources to minimize risks can place undue burdens on a community, exacerbate known risks, and disrespect participants,” says Aultman.
The federal government recognizes vulnerable and marginalized populations, such as prisoners and children, in research and has created special protection guidelines for investigators to follow when working with these populations. However, refugee populations do not have specific special protections, observes Aultman, former co-chair and current member of the ethics subcommittee for the Society of Refugee Healthcare Providers. Aultman and colleagues developed recommendations for best practices in conducting human subjects research with refugee and asylum-seeking populations.1 “We wanted to illustrate some unique features of refugees and asylum-seeking persons for investigators to be mindful of when working with these populations in research,” says Aultman. The authors applied the National Institutes of Health Guiding Principles for Ethical Research to address the unique needs, experiences, and values of refugees.
“The trauma refugees and those seeking asylum have experienced, and often relive from day to day, is very important for investigators to recognize and understand,” says Aultman. Participating in some research studies can trigger or exacerbate emotional and psychological trauma. Investigators must be prepared to minimize these harms in the initial study design, such as by arranging for counseling as needed for study participants. “Resettled refugees I have personally worked with in academic, clinical, and advocacy capacities have described repetitive physical and sexual violence, having to witness the deaths of family and friends in their countries, and long stays in refugee camps without essential resources to survive,” says Aultman. Additionally, there are language and cultural differences, the emotions involved in having to relocate to a new country, and the prevalence of stigma, racism, and discrimination in some host countries. “The vulnerability of refugee and asylum-seeking populations is significant,” says Aultman.
Researchers can mitigate harms in these ways, says Aultman:
• by stopping a study or withdrawing a participant when harms significantly outweigh benefits;
• by being familiar with the refugee community, and carefully examining potential risks;
• by giving study participants transparent and understandable details of the proposed study;
• by using translation and interpretation services for study participants who speak different languages and dialects;
• by addressing literacy barriers. “It is important to determine what types of barriers are present, whether they can be addressed, and, if so, what financial, social, clinical, or spiritual resources may be needed,” says Aultman.
Ethical considerations vary depending on the type of research and the nature of the particular refugee population, according to Kelly FitzGerald, PhD, CIP, executive institutional review board (IRB) chair and vice president of Institutional Biosafety Committee affairs at WCG. For example, survey research that might be minimal risk for a non-refugee population could be greater than minimal risk because of a risk of criminal or civil liability if participants’ immigration status is unclear. “Those risks can often be managed with appropriate protection for the research data,” says FitzGerald. For example, researchers can ask for a waiver of documentation of consent. IRBs might approve the waiver if the only record linking a participant to the research is a signed consent form, and the principal risk of the research is a loss of confidentiality. By breaking the link between the individual and their research data, the individual is protected from any negative outcomes of the research.
For research involving children, parental permission is required in most cases. However, waivers can be granted in limited situations when parental permission is deemed not to be a reasonable requirement. “This could allow for unaccompanied minors to give consent for themselves to enroll in research in some cases where risks are low,” says FitzGerald. One example of research that might be approved with this type of waiver is minimal risk survey or interview research studying refugees who are unaccompanied adolescent minors. It would be impracticable to obtain permission from the parent because they are not present, so a waiver of parental permission could be approved by the IRB.
It is crucial to respect refugees’ rights and dignity and minimize harm when enrolling this vulnerable population in research studies, stresses Eva Regel, DBe, MS, an assistant professor in the Department of Medical Humanities and Bioethics at UAMS College of Medicine. Factors such as language barriers, limited literacy, cultural differences, and exposure to traumatic events complicate the process of obtaining informed consent. “We must also be mindful of the power dynamics between researchers and refugees, which can raise significant concerns about undue influence or coercion,” says Regel. It often is not enough to merely state that participation is voluntary. Refugees may feel implicitly pressured, particularly if they worry that their decision to participate will affect access to services or support from humanitarian aid agencies. “Researchers should adopt a more comprehensive approach that may include using an independent consent facilitator or a neutral third party,” says Regel. Researchers also could engage a trusted community leader to communicate the voluntary nature of the participation, and provide participants with a safe space to ask questions.
One of the most significant ethical challenges in researching the refugee population is the participation of minors, especially those who are unaccompanied by caregivers. “This situation demands utmost caution and sensitivity,” says Regel. Researchers must navigate the complex issues of obtaining valid consent while safeguarding a minor’s well-being and ability to assent to participation.
Researchers must take additional precautions to protect participants’ confidentiality by anonymizing data and creating robust security protocols. “It is also essential to ensure that participants understand how their data will be used and stored, and what will be done to protect their privacy,” says Regel. Regal adds that particular attention should be given to minors, women, and the elderly. “While designing their study, researchers should consider the ethical issues of assent and guardian consent, as they are much more complex and multifactorial than in the general population of participants,” says Regel. A consent of a minor refugee participant should include an age-appropriate explanation of a study, a clear statement that a minor can dissent, and an explanation why researchers also should consent the minor’s guardian. Study protocols should include ethical principles of minimizing harms, prioritizing minors’ well-being and confidentiality, and respecting their expressed wishes.
It also is important to ensure the involvement of refugee communities, and to be knowledgeable of this population’s vulnerabilities. “This will ensure that IRBs have a trauma-informed approach when conducting risk-benefit reviews,” says Regel. Researchers can accomplish this by including detailed information about the vulnerabilities of the refugee population in study protocols. “This information is critical for IRB to do their work effectively and to ensure that the review process is thorough,” says Regel.
Researchers conducting studies on refugee and undocumented immigrant populations should consider the risk of exposure of undocumented status that could result in deportation or other legal action, and make provisions to ensure anonymity of participants, according to Edward Kuczynski, director of the Human Research Protection Program at University of California, San Francisco.
For undocumented minors, there is the additional risk of legal requirements to report the individual to a state’s version of child protective services.
“In these instances, protecting against such an outcome must be weighed carefully against the potential that harm may come to the minor participant,” says Kuczynski.
Many refugees have lived experiences that are very traumatic. Asking them questions related to their experiences can trigger negative emotions and feelings. “Some individuals may not be emotionally fit to participate in the study and if they are, they may become emotionally distressed,” says Barbara DeCausey, MPH, MBA, director of Virginia Tech’s Human Research Protection Program. To be prepared for this possibility, someone on the IRB should have expertise with conducting refugee-focused research, adds DeCausey. If no one has the expertise, the IRB can work with a consultant to help work through the ethical issues and considerations. “The risks for this type of research may be more emotional and related to trauma. The IRB should ensure that the researcher has a plan to address these types of risks and be prepared to provide additional guidance,” says DeCausey.
Researchers should have a plan for excluding individuals who may not be emotionally fit to participate and for providing support for participants who become emotionally distressed. “It is important to understand the potential risks and develop a plan for minimizing them to the extent possible,” urges DeCausey.
REFERENCE
- Aultman JM, Zaaeed N, Payton C, et al. Research with refugee populations in North America: Applying the NIH guiding principles for ethical research. Ethics Hum Res 2024;46:2-16.
The federal government recognizes vulnerable and marginalized populations, such as prisoners and children, in research and has created special protection guidelines for investigators to follow when working with these populations. However, refugee populations do not have specific special protections.
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