Overall ethical considerations in research with refugees and asylum seekers are not currently addressed in national and international guidelines. Most guidelines defined vulnerability in terms of limitations in people’s capacity to provide informed consent. The lack of guidance on other aspects of refugees and asylum seekers needs might affect ethics committees and researcher’s ability to adequately address the ethical complexities inherent in research with these participants.

Strengths and Limitations of the Systematic Review

A comprehensive and systematic search was conducted using a published strategy developed by Godin et al. (2015) for searching and retrieving grey literature (Godin et al. 2015). It was supplemented by a hand-search of the International Compilation of Human Research Standards (Office for Human Research Protections 2020) and targeted website searches using Google, an efficient tool for locating organizations’ publications on specific topics (Godin et al. 2015). Selection bias was minimized by having pre-set inclusion criteria.

One limitation was that only English language publications were included and it is possible that relevant papers in languages other than English were missed. The review focused on research with refugees and asylum seekers resettling in high income countries. However, most of the world’s displaced people in 2020 were located in low-and middle-income countries in Africa, Asia, and the Middle East (UNHCR 2020). Additional research ethics considerations are likely to be needed in politically unstable contexts, cross country research settings, and ongoing conflict settings where refugees, asylum seekers and displaced people are particularly vulnerable and volatile and these were not captured.

Limitations of GuidelinesConceptualization of Vulnerability

As has been highlighted in previous research, we found that ethics guidelines often describe vulnerability in ways that reinforce preconceptions about whole groups of people (Bracken-Roche et al. 2017; Schrems 2014; DuBois et al. 2012; Levine et al. 2004). While categorizing people by group when addressing vulnerability is efficient, it can create harm through stereotyping, creation or perpetuation of prejudice, stigmatization, discrimination, or creating an affront resulting from insensitivity (Thapliyal and Baker 2018). Furthermore, the group-based approach is limiting in situations where a person has multiple vulnerabilities and considerations of individual agency, circumstances or the context of the vulnerability are needed (Gordon 2020).

Furthermore, it has been argued that vulnerability is not a substantive ethical concept in itself, serving only as a marker of other research ethics concerns already captured by existing concepts such as risk of harm or voluntary consent (Wrigley 2015). If these concepts are otherwise missed, categorizing people as vulnerable may prove to be a valuable proxy and serve a practical function by indicating individual circumstances requiring special ethical consideration (Bracken-Roche et al. 2017). Categorization may lead researchers to take particular account of potentially vulnerable people thus signposting individual circumstances, in the context of the study, that place them at increased risk of harm.

As can be seen from our findings, few guidelines identified individual and circumstantial reasons for potential vulnerability (Interagency Advisory Panel on Research Ethics 2014; Council for International Organizations of Medical Sciences 2016). The widely recognized contextual approach (Gordon 2020; Cascio and Racine 2018; Block et al. 2013) allows for a more nuanced understanding of the nature of vulnerability which, in turn helps researchers formulate targeted protections (Childress and Thomas 2018). Circumstances may be personal, specific to a group, or structural in origin and may overlap. For instance, the pre-arrival experiences of refugees or asylum seekers who have mental illness or are incarcerated are generally at risk of harm in more than two ways and have particular needs related to their complex circumstances.

An additional concern is that most guidelines focus on individual, rather than broader social factors and structural coercion that may shape research participation in their advice about how to prevent coercion and ensure participation is voluntary. Since the social, cultural, economic and political contexts influence individual’s decision-making capacity (Fisher 2013), advice about how to address structural factors and avoid coercion needs to acknowledge that people have different adaptive capabilities, agency, needs, priorities and capacities which are not static (Mackenzie et al. 2007; Childress and Thomas 2018). Refugees and asylum seekers may misinterpret the risks and benefits of research participation. Refugees and more specifically those seeking asylum may agree to participate because they incorrectly perceive that it may be beneficial for them. Likely benefits might include granting of refugee status, release from detention or immigration assistance for family members (Gillam 2013). A broader conceptualization of coercion also highlights how power differences between the researcher and participants can intersect to increase the pressure to participate and might help researchers be aware of these and act on them (Childress and Thomas 2018).

While vulnerability is rarely defined, most guidelines implicitly suggest that it is fundamentally an inability to provide free and informed consent. The focus on potential participants’ capacity to provide informed consent is a limitation of existing guidelines. This may limit researchers’ awareness of and ability to address other threats, for example the risk of exploitation (Macklin 2003), or to embrace notions of being harmed and being wronged (Hurst 2008). Furthermore, the COVID-19 pandemic added new complexities to conducting research with populations which have layered vulnerabilities such as people with refugee-like backgrounds. As Salam and colleagues (2022) suggest, with restrictions focusing on maintaining physical distancing set in place to curb the spread of the virus, conducting in-person research and obtaining truly informed consent was further complicated for these communities (Salam, Nouvet, and Schwartz 2022).

One guideline (TCPS2) considers the principle of justice in relation to ethnic minorities (Interagency Advisory Panel on Research Ethics 2014). The TCPS2 states that ethno-cultural minorities are an example of a group who have sometimes been treated unfairly and inequitably in research or have been excluded from research participation opportunities. TCPS2 does recognize that people or groups whose situations make them vulnerable or marginalized may need special attention in order to be treated justly in research. McLaughlin and Alfaro-Velcamp (2015) supports this assertion by suggesting that often, the choices about research participation made by one individual, whose interests may or may not be consistent with those of their community, can influence other people’s decision to take part in a research project (McLaughlin and Alfaro-Velcamp 2015). More recently COVID-19 restrictions have impacted on individuals being recruited into research. For instance, local community organizations may have closed and communication about research with community may be limited and difficult to establish (Salam et al. 2022). An individual’s decision to participate may contribute to unfair distribution of risks such as retaliation from the community and few benefits for people in some refugee communities (Dingoyan, Schulz, and Mosko 2012; Gabriel et al. 2017; Council for International Organizations of Medical Sciences 2016).

TCPS2 also provides some consideration of the principle of beneficence with respect to concern for welfare for First Nations people but does not extend this to immigrant or refugee people. This is a gap in the existing guidelines, as the importance of showing benefits of research has been widely acknowledged (Block et al. 2013; Mackenzie et al. 2007; Brear and Gordon 2021). MacKenzie and colleagues (2007) argue that researchers might move beyond harm minimization and recognize the obligation for researchers to prioritize research projects that promote benefits for refugee participants and their communities (Mackenzie, McDowell, and Pittaway 2007).

Linking Ethical Considerations to Participants’ Circumstances or Situation

A key finding was the limited guidance available on ethical considerations specifically aimed at refugees and asylum seekers (National Health and Medical Research Council 2007; Interagency Advisory Panel on Research Ethics 2014; Council for International Organizations of Medical Sciences 2016). This is an important gap as it is widely acknowledged that detailed descriptions of the contexts of vulnerabilities and how they relate to specific ethics principles need to be addressed in research protocols and taken into consideration by ethics committees (National Health and Medical Research Council 2007; Pieper and Thomson 2016; Bracken-Roche et al. 2017). The role of guidelines is to introduce the broad principles of responsible and accountable research practice and provide ethical norms for research conduct (National Health and Medical Research Council 2007). However, this review highlights the need for supplementary frameworks that provide practical advice about how to operationalize and apply ethical principles in research with refugees and asylum seekers who may face particular challenges.

Suggested Refinements to Research Ethics Guidelines

First, we believe that ethical guidelines should refine and expand their concept of vulnerability. A more inclusive and nuanced conception of vulnerability is needed to advance understanding of the meaning of vulnerability in the context of research participation (Rogers et al. 2012). Further, revising and expanding current definitions of vulnerability to acknowledge the circumstances that can expose research individual participants to coercion, harm, or risk has been suggested by Fisher (Fisher 2013). Also, Luna’s (2009) guidance on circumstances related to increased risk of harm uses a conceptual tool to examine a research participant’s environment (Luna 2009). The tool identifies potential risks such as those relating to capacity or social pressure in the consent process and suggests targeted strategies for their remediation. It allows for identifying layers of vulnerability and shows how they are expressed and can interact with the research context.

Conceiving vulnerability in this layered way leads to multiple approaches, each addressing different layers. It suggests that multiple answers should be sought and that these should be in accordance with more subtle evaluations of what constitutes risk in research. This may help researchers consider different kinds of protection regarding the kind of layer involved. For example, the illiteracy layer can be addressed by offering two or three short sessions informed consent and working with illustrations. This suggestion was highlighted in only one guideline which recommended the use of consent materials appropriate for the level of literacy and comprehension of potential participants (Interagency Advisory Panel on Research Ethics 2014).

Second, refugees and asylum seekers were only mentioned as populations needing enhanced protections in four of the fourteen guidelines (National Health and Medical Research Council 2007; Council for International Organizations of Medical Sciences 2016; World Health Organization 2011; European Commission Directorate-General for Research and Innovation 2020). Ethics committees and researchers working with refugees and asylum seekers need guidance on how to best protect these participants considering their complex circumstances and the specific challenges of structural coercion. Lange et al. (2013) suggests that identifying different sources of vulnerability generates distinct obligations on the part of the researcher (Lange et al. 2013). For instance, it is important for researchers not to generate or exacerbate a person’s dependency on others, especially dependency on those who are in a position to withhold support. To do so would increase a person’s risk of exploitation or domination by others and might increase their sense of powerlessness. In another example, outlined by Palmer and colleagues (2011), research that seeks to identify and reduce the risk of harm for people who are prone to depression or at threat of domestic violence is often justified by the potential benefits compared with the risks of individual harm.

However, researchers have an obligation to be aware of and limit potential adverse effects of participation including exacerbating feelings of embarrassment, shame, isolation, and an inability to care for one’s family (Palmer et al. 2011). Luna goes further by suggesting researchers and ethics committees can only identify participants who are at risk of harm by carefully examining the characteristics of the potential participants in conjunction with the nature of the proposed research (Luna 2009). Refugees and asylum seekers may be vulnerable to real or perceived threats when participating in research particularly in the early resettlement period in a host country. For example, as Gillam (2013) suggests immigration detention centres remove autonomy of those seeking asylum who are detained and suggests researchers consider whether it is possible to conduct research in a setting where autonomy is not respected (Gillam 2013). Cascio and Racine (2018) also support an individualized person-oriented research ethics approach that considers needs, preferences, or priorities that might impact a person’s risk of harm when participating in research (Cascio and Racine 2018). In order to facilitate this, for example, The National Statement provides advice by suggesting an advocate or support person when potential participants are considering taking part in research (National Health and Medical Research Council 2007).

Furthermore, there are many assumptions about the potential risk of harm for refugees and asylum seekers participating in research. Gillam (2013) suggests that the role of researcher includes investigating the experiences participants have in the research process and the impacts it has on them (Gillam 2013). To date minimal research has been undertaken exploring the effect on refugees and asylum seekers of participating in research (Dyregrov, Dyregrov, and Raundalen 2000; Gabriel et al. 2017). A small number of studies indicate there are therapeutic benefits for refugees and asylum seekers (McMichael and Gifford 2009; Puvimanasinghe et al. 2019). However, there is scarce published evidence on the harmful effects of participation for these groups. As Gillam (2013) suggests, collecting information from studies involving refugees and asylum seekers provides the opportunity to gather data on the effects of research participation and enhance evidence on participation (Gillam 2013). Further research in this field might be used to develop evidence-based guidelines and practice.

This reinforces the need for a comprehensive supplementary refugee-specific research ethics framework as identified by Seagle and colleagues (Seagle et al. 2020). We agree that a practical framework addressing characteristics or circumstances that may contribute to refugees and asylum seekers’ need for special protections is warranted. The National Health and Medical Research Council’s Ethical Conduct in research with Aboriginal and Torres Strait Islander peoples (2018) is an example of what is being proposed for research with refugees and asylum seekers (National Health and Medical Research Council 2018). These ethics guidelines provide a set of specific principles to ensure research is safe, respectful, responsible, high quality, of benefit to Aboriginal and Torres Strait Islander people and communities. By applying the concepts of spirit and integrity, cultural continuity, equity, reciprocity, respect, and responsibility, these guidelines provide greater recognition of the ethical considerations and additional protections required for this group (National Health and Medical Research Council 2018).

A supplementary refugee and asylum seeker specific framework might include advice about how to assess and manage the special protections needed relating to their experiences, cultural and linguistic differences, and participants’ potential limited English language proficiency and lack of familiarity with research processes. Advice about how these challenges might increase the risk of research-related harms, affect capacity to give informed consent, and participants’ understanding of the planned research activities is also needed. Such a framework might also address the individual contexts of agency, resilience, and skills of people with refugee and asylum seeker backgrounds and how these can be acknowledged, reaffirmed, and strengthened.

A supplementary ethics framework could emphasize the need for researchers to ensure the research question and methods can be made appropriate for people from refugee-like backgrounds contributing data to research. It should also offer guidance on appropriate forms engagement with refugee communities and individuals who participate in research. Guidelines for research with Indigenous Australian people (National and Medical Research 2003) provide guidance on ethical research conduct with this population and may be equally applicable to or provide a model for research with refugee participants. Examples of culturally and linguistically sensitive recommendations for research with refugee participants could include: 1) negotiating the practicalities of participation such as the steps that will be taken to discuss informed consent within the community; 2) the sharing of information about the research process in community languages beyond research participants to the community as a whole; 3) establishing processes that incorporate the needs and rights of both communities and individuals; 4) establishing a community advisory group and respecting the community’s decisions regarding the way the research is to be conducted from project conception to conclusion; and 5) being guided by communities’ cultural norms and suggested methodologies when developing research proposals, where appropriate. These examples advocate refugee centred ethics practices by empowering individuals and communities so they may harness their own agency and decision-making (Bose 2022).

Further recommendations could endorse active and equal participation for refugee communities and individuals in codesigning the research process, facilitating trust-building, and enabling inclusive and respectful conduct of research (Filler et al. 2021). For instance, participants may prefer same gender researchers, particularly for research involving sensitive topics. The researcher’s nationality may be a matter of concern for others in certain political contexts (Gabriel et al. 2017). Establishing participants history of trauma and background experiences is also recommended so that their participation in research is meaningful and beneficial for trauma-exposed participants (Jefferson et al. 2021). Ascertaining previous research experience, fear of consequences of refusing to participate, and fear of loss of confidentiality (Gabriel et al. 2017) particularly for asylum seekers are key recommendations for inclusion in guidelines.

Strengths and Limitations of the Systematic Review

A comprehensive and systematic search was conducted using a published strategy developed by Godin et al. (2015) for searching and retrieving grey literature (Godin et al. 2015). It was supplemented by a hand-search of the International Compilation of Human Research Standards (Office for Human Research Protections 2020) and targeted website searches using Google, an efficient tool for locating organizations’ publications on specific topics (Godin et al. 2015). Selection bias was minimized by having pre-set inclusion criteria.

One limitation was that only English language publications were included and it is possible that relevant papers in languages other than English were missed. The review focused on research with refugees and asylum seekers resettling in high income countries. However, most of the world’s displaced people in 2020 were located in low-and middle-income countries in Africa, Asia and the Middle East (UNHCR 2020). Additional research ethics considerations are likely to be needed in politically unstable contexts, cross country research settings, and ongoing conflict settings where refugees, asylum seekers, and displaced people are particularly vulnerable and volatile and these were not captured.