Participation of childbearing international migrant women in research

Abstract

Fear of burdening or harming childbearing, migrant women, particularly refugees or others who have experienced war, torture, abuse, or rape, can result in their exclusion from research. This exclusion prohibits health issues and related solutions to be identified for this population. For this reason, while it may be challenging to include these women in studies, it is ethically problematic not to do so. Using ethical guidelines for research involving humans as a framework, and drawing on our research experiences. This discussion article proposes a number of strategies to improve the conditions for childbearing migrant women to participate in health research. What emerged as key for studying this diverse population and ensuring an ethically responsible approach are the use of methods that are adapted to the circumstances of childbearing migrant women and the involvement and support from “migrant-friendly” organizations. Ensuring migrant women are involved in the research process and knowledge produced is also critical. The more researchers working in this field communicate their experiences, the more will be learnt about how best to approach research with migrants. More migration and health research will enable a greater contribution to the knowledge base upon which the needs of this population can be met and their strengths maximized.

Keywords

Ethics international migration methods postpartum women pregnant women research

Introduction

There are over 135 million international migrants (individuals who moved permanently or temporarily from one country to another) in higher income nations/regions, including Australia, Europe, Japan, New Zealand, and North America.¹ Migration experiences vary widely and migrants include “immigrants,” individuals who moved through regular legal channels by choice, for economic, educational, or family reasons; “refugees,” those who are “unable or unwilling to return to their country of origin owing to a well-founded fear of being persecuted for reasons of race, religion, nationality, membership of a particular social group, or political opinion”;² “asylum-seekers,” persons who arrive in a country and apply for refugee status and are awaiting decision on their application; temporary migrants (students and migrant workers); and “undocumented persons,” those in a country without an official legal status.³ In 2008, the World Health Assembly called on member states to improve the health of migrants and a global consultation was subsequently held to identify priorities.⁴ Among key areas identified were monitoring migrant health and promoting the right of all migrants to health and equitable access to health services.⁵ Valid research with migrants is imperative to address these priorities.

Half of the migrant population are women, mostly of reproductive age.¹ Migrants also contribute substantially to the total number of births, exceeding, in some high-income countries, one-fifth of all births.^6,7 Populations such as childbearing (pregnant or recently gave birth) women face numerous barriers in a new country, such as poverty, isolation, discrimination, and marginalization, which may impede their access to health services.⁸ The migration experience, particularly a traumatic one (experiences of war, torture, abuse, or rape), further exposes these women to risk factors that can affect their health, especially during pregnancy.⁹ Evidence also suggests that some migrant women are at greater risk for harmful perinatal outcomes (i.e. preterm birth, perinatal mortality), have reduced access to prenatal care, and greater dissatisfaction overall with maternity services compared to nonmigrant women.^10
–12 Childbearing migrant women, however, remain under-studied. Limitations include: exclusion of more difficult to reach groups (i.e. refugees, asylum-seekers, undocumented, smaller ethnic/cultural communities, and those with low host-country language/literacy proficiency); homogenization of the migrant population (i.e. defined merely as “foreign-born”); little attention to their diversity (i.e. cultural/ethnic, linguistic, migration status, and length of time in receiving country) in analyses and interpretation of results; a lack of standardization and comparability of data across studies; and an inadequate examination of a range of outcomes and interventions.^10,13
–15

Research with international migrants poses many challenges, including defining the migrant population,¹⁶ ensuring the use of culturally adapted methods, and addressing communication barriers.^17

–20 The complexities of studying refugees have also been considered.²¹ For these reasons, researchers and ethics boards may grapple with balancing the safety of childbearing migrant women with the necessity of including them in research. As a result, access to participation in research may be inadvertently hindered in an attempt to safeguard against coercion and exploitation, or because of feasibility issues.

The underrepresentation of women in research, especially pregnant women in clinical trials for reasons of safety (woman and fetus), is a longstanding issue in research.^22,23 The exclusion of minority groups, for example African Americans in the United States,²⁴ on the grounds of feasibility or concerns of mistreatment, or being taken advantage of, has also been highlighted as a major concern in the research literature. Migrant populations present unique challenges, including their linguistic and cultural diversity and implications related to their migration status, for example, the precarity of their situation and lack of knowledge of their rights. While it may be challenging to include migrant women in research, it is ethically problematic to exclude them as their participation may ultimately reduce health inequities for them and their children. Drawing on our own research experience, this brief report details a number of challenges that may contribute to inequities of childbearing migrant women participating in research, including qualitative and quantitative studies, and provides strategies on how these challenges may be addressed. Our experiences speak primarily to research conducted in high-income receiving countries (Canada in particular) but are also in some instances relevant to settings in migration-source countries.

Ethical guidelines and principles

Guidelines concerning the ethical treatment of human subjects in research were reviewed for common principles and applications. Guidelines included the Declaration of Helsinki,²⁵ the Belmont Report,²⁶ The International Ethical Guidelines for Biomedical Research Involving Human Subjects,²⁷ and The Canadian Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (The Canadian policy document for research involving humans).²⁸ These principles require researchers to respect the autonomy of individuals or protect those with developing, impaired, or diminished autonomy; to safeguard the welfare of research participants and minimize the likelihood of harm; and to treat all people with equal respect and concern. Application of these principles translates to researchers being obliged to (a) be inclusive in selecting participants and provide special attention to those in vulnerable circumstances (i.e. those with insufficient power, intelligence, education, resources, strength, or other attributes to protect their own interests) in order to ensure just treatment regarding the benefits and burden of research participation; (b) obtain voluntary and informed consent; (c) respect privacy and safeguard information; and (d) balance benefits with harms. Challenges and strategies were compiled based on the authors’ research experience with childbearing migrant women and subsequently grouped according to these four overarching ethical principles/applications. All of the authors are nurses; AG and FC have been investigators on studies with childbearing migrant women, mostly in Canada; FC also has expertise in bioethics. LM worked as a research coordinator of AG’s program of research on Migration and Reproductive Health and AL was a student research assistant within this research program and conducted research in Tanzania for her Masters project. An iterative process with input from all authors was used to generate a complete and refined list of all strategies and challenges.

Challenges and strategies related to research participation of childbearing migrant women

Table 1 presents the relevant guidelines/principles and the associated challenges and strategies related to the research participation of childbearing migrant women. A brief discussion of these and reference to key reports from our work is provided below.

Table 1.

The ethical guidelines/principles and associated challenges and strategies related to the research participation of childbearing migrant women.

Ethical guidelines/principles^a	Challenges	Strategies
Justice and inclusiveness No group of persons (defined by culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age or other attributes) should bear more than its fair share of the burdens of participation in research or be deprived of its fair share of the benefits of research. Participants of research should be selected in such a way that burdens and benefits will be equitably distributed. The exclusion of groups must be justified. (CIOMS guideline 12, Belmont section C.3, Helsinki item A.5, TCPS2 Articles 4.1, 4.2, and 4.7) Research with vulnerable participants is justified if it will lead to knowledge/benefits specific to the vulnerable group. (CIOMS guideline 13, Belmont section C.3, Helsinki item B.17, TCPS2 Articles 4.1, 4.1, and 4.7)	A diverse group that is continually changing. Speak multiple languages and represent many cultures. Beneficiaries of research are not always evident. Asylum-seekers, temporary migrants, and those with an undocumented status may not benefit since often not eligible for formalized services and programs.	Select study participants without bias. Use a broad recruitment strategy to access women who are usually isolated in the community (e.g. recruit at the time of birth across several hospitals); culturally validate research methods with a diverse group of migrant women from the community and translate, back-translate, and test study tools with monolingual and bilingual speakers across several languages simultaneously; use cultural brokers and interpreters to recruit and collect data. Include migrants with different statuses and origins (use available statistics on migrant populations) to distribute the burden of participation among the migrant population. Work closely with organizations providing care and services to migrants to ensure relevancy of research and to access more isolated women. Include benefits for community as a whole in the description of the study. Use results to advocate for policy and practice changes. Request funding to support recruitment across many sites, to translate and culturally validate study tools, and to work with organizations that advocate/provide services to migrants.
Women (including women of reproductive age/pregnant) should not be excluded from research. (CIOMS guidelines 16 & 17, TCPS2 Article 4.2)	Multiple barriers preventing participation (need for childcare/tending to new baby, lack of transportation, unfamiliarity with new surroundings, presence of husbands and/or other family members, fatigue and stress, limited time).	Visit women in their homes or offer child-care services and bus tickets, and/or conduct research at a community center to facilitate participation. Invite husbands to accompany wives and have flexible schedules for recruitment and data collection. Allow sufficient time for recruitment and data collection.
It must be acknowledged that in some parts of the world women are vulnerable to neglect or harm in research because of their social conditioning to submit to authority, to ask no questions and to tolerate pain and suffering. (CIOMS guidelines 16 and 17)		Inform women of their rights regarding research participation.
Ethical review committees should be independent of the research team and composed to be able to provide complete and adequate review (should include men and women and lay persons to represent the cultural and moral values of the community and to ensure the rights and perspectives of participants will be respected). (CIOMS guideline 2, Helsinki item B.15, TCPS2 Articles 6.2, 6.4 and 6.5) Institutions should provide training opportunities to lay persons sitting on ethical review committees. (TCPS2 Article 6.4)	Ethics committees may not be equipped to evaluate and monitor research with a diverse population.	Include details of measures taken to translate and ensure cultural appropriateness of consent forms, protocols, and questionnaires in applications submitted to ethics committees.
Research across different institutions, regions, countries must be responsive to the research context and include ethical review from all responsible bodies. Researchers should be aware of relevant cultural practices for seeking entry into communities and be respectful of them. (TCPS2 Article 8.3) When multiple research ethics committees are involved, efforts should be made to formulate strategies to address disagreements/inconsistencies between the committees. (TCPS2 Articles 8.1, 8.2 and 8.4)	Research ethics committees in other countries (e.g. refugee camps) might not be available or have the capacity to review the research.	A form of local approval (from community or organization) should still be obtained even if informally given.
Studies in low-resource countries must contribute to national or local capacity-building (e.g., training/education of community, researchers, and healthcare professionals). (CIOMS guideline 20)	Funds for capacity-building in another country might not be an eligible expense for a granting agency.	Include justification for capacity-building in grant application.
Research that is likely to affect the welfare of an [Aboriginal] community, researchers shall seek engagement with the relevant community including sub-groups or vulnerable individuals within the group who may not have a voice. Engagement may take varied forms and should be documented in an agreement and detail the rights and benefits (including building research capacity within the community) for both the researcher and community. Communities lacking the infrastructure to support research should not be deprived of opportunities to participate in research. Participants shall be informed about collaborations with organizations/community leaders. (TCPS2 Articles 9.1, 9.2, 9.4, 9.5 & 9.11–9.18)	‘Migrant community’ consists of several multi-ethnic communities and changes over time. NGOs that could provide some representation of migrants often lack knowledge, time, and resources for research. How to effectively involve representatives from different sectors (government, community, and professional) is not evident and power differentials between researchers and community groups make it difficult to have a true collaboration. Hiring/involving community members can be difficult due to lack of knowledge of research process, or knowing participants if the community is small.	When developing research, work closely with organizations that advocate/provide services to migrants. Offer to meet with representatives individually at their location. Invite representatives from each sector to meetings and develop simple methods for obtaining feedback (e.g. provide study summaries and ask specific questions on what feedback is needed). Use written agreements with community organizations and provide ongoing updates on progress of research in format suited to their needs (pamphlet, handout, presentation, publication). Involve migrant women from various communities in the validation of research and study tools and interpretation of results. Request funding to support participation and training of community organizations/community members (compensation for time).
Researchers should be familiar with the cultural, social and economic circumstances of participants and anticipate the needs that participants might have during the research. (TCPS2 Article 4.7) Research with populations or in communities with limited resources must be responsive (as much possible) to the health needs and priorities of the population/community and make every effort to have the knowledge/intervention/product developed reasonably available for the benefit of that population/community. (CIOMS guideline 10, TCPS2 Article 4.7) Researchers should consider ways to ensure the equitable distribution of any benefits of participation in research and should consider the expectations of participants regarding potential benefits. (TCPS2 Article 4.7)	Health (including mental health) and social concerns may be identified but addressing them could create a dependency on the research team, particularly for migrants who are not eligible for government services. Asylum-seekers, workers, and those without status may not benefit from research.	Identify existing services that can best address the issues and develop a referral protocol. Assist migrant women in making the link to the health and social system if there are language barriers. Work closely with migrant agencies that provide services, especially for migrants without status/eligibility for services. Provide direct care only in emergency situations (provide trauma training to research staff and have psychologist/psychiatrist on research team who can provide care/support).
Research results must be made available and researchers are accountable for the completeness and accuracy of the reports. Ensure individuals, groups and communities are informed of how to access research results. (Helsinki item B.30 and C.34, TCPS2 Article 4.7) Research results should be made available to participants in a culturally appropriate and meaningful format. (TCPS Article 4.7)	The diversity and the precarious status make it challenging to disseminate results to all migrant groups.	Offer participants to contact research team if they would like a summary of results. Distribute results to community organizations, service providers, and policy-makers to maximize dissemination. Request funding for development (and translation) of different forms of dissemination.
Research may present risks to the interests of communities, societies or racially or ethnically defined groups and therefore publishing of data must be sensitive and respectful to these interests. To minimize harm, researchers should seek advice from communities on use of data. (CIOMS guideline 8, TCPS2 Articles 9.2 and9.17)	Results from studies with migrants may be used to fuel anti-immigration rhetoric (e.g. terrorism, causing crime, spreading disease, draining resources).	Involve community members/organizations in the interpretation and dissemination of results.
Voluntary and informed consent
Inform individual that they are free to participate and will be free to withdraw at any time without penalty or loss of benefits to which he/she would otherwise be entitled. (CIOMS guideline 5, Belmont section C.1., Helsinki items B.22, B.24 and C.34, TCPS2 Article 3.1) Inform individual of all risks that a reasonable person would consider material to making a decision about whether to participate. (CIOMS guideline 6, Helsinki item B.24, TCPS2 Article 3.2) Renew informed consent if there are significant changes and/or in long-term studies. (CIOMS guideline 6, TCPS2 Article 3.3) Refrain from unjustified deception, undue influence, or intimidation. Informed consent should be sought by an appropriately qualified individual who does not have a relationship to the participant. (CIOMS guideline 6, Belmont section C.1, Helsinki item B.26, TCPS2 Articles 3.1 and 3.2)	Language barriers and literacy levels may hinder information dissemination and comprehension. Excessive information may overburden anxious participants. Those with precarious status (asylum-seekers, migrant workers) may feel obliged to participate. Migrant women may be unfamiliar with their rights regarding research. Ensuring true voluntariness is complicated when husbands/family members respond on behalf of women; some cultures are collective oriented so women may feel an obligation to participate on behalf of their family/community. Participants may be reluctant to withdraw participation for fear of reprisals or diminution of services.	Culturally adapt and translate consent forms. Minimize text and use simple language on consent forms (conduct readability tests) and offer to read consent forms to potential participants. Use multi-lingual staff to obtain consent. Allot time to explain study objectives and participation and to respond to questions. Repeat and summarize important points of consent form to maximize understanding. Highlight (with highlighter) on the form the name and contact information of who participants may contact to ask questions or express concerns. Ensure that the person obtaining consent is not a direct care-provider. Use female recruiters as they may be less intimidating and more culturally appropriate especially in a childbearing context. Train research staff on issues for recruiting childbearing migrant women. Educate research team of ethical guidelines and basic rights of participants. Provide explanation to husbands/family members on why it is important for the women to respond to questions themselves. Inform participants more than once that immigration status and care provisions will not be affected irrespective of whether or not they participate.
Informed consent is given through repetition and explanation, and by answering questions as they arise. Ensure information was understood. Adequate time and resources should be set aside for informed-consent procedures. Each individual must be given as much time as is needed to reach a decision. (CIOMS guideline 4, Belmont section C.1, Helsinki item B.24, TCPS2 Article 3.2) Develop culturally appropriate ways to communicate information. Investigator must convey the information in language that suits the individual’s level of understanding. Include the provision of resources to ensure that informed consent can be obtained with different linguistic and cultural settings. (CIOMS guideline 4, Belmont section C.1, TCPS2 Article 3.2)	Assessment of participants’ understanding may be difficult due to language constraints and unfamiliarity with research process. Working with multiple languages and cultures requires significant resources (time and money) to develop and translate consents and to hire and train appropriate staff.	Use multi-lingual staff to obtain consent. Request adequate funding to support translation and validation process of study tools and to hire and train research staff.
Special care should be made for women in vulnerable circumstances to ensure they have adequate time and a proper environment in which to take decisions. Only the informed consent of the woman herself is required for her participation. In no case should the permission of a spouse or partner replace individual informed consent. Women consulting their spouses/partners is ethically permissible and in some contexts highly desirable. (CIOMS guideline 16)		Provide explanation to husbands/family members on why it is important for the women to respond to questions themselves. Accept husband/family member’s/staff consent but only after the woman has given her own informed consent.
Consent may be indicated in a number of ways … voluntary actions, handshake, orally, or sign a consent form. (CIOMS guideline 4, Helsinki item B.24, TCPS2 Article 3.12)	Issues of mistrust (e.g. refugees, nonstatus migrants) or low literacy may require nonwritten consent.	Accept other forms of consent.
In some cultures consent should also be obtained from community leaders or other authorities (but not as a substitute for individual informed consent). (CIOMS guideline 4, Helsinki item B.22, TCPS2 Article 9.3)	The ‘migrant community’ consists of several multi-ethnic communities and changes over time.	When developing research, work closely with organizations that advocate/provide services to migrants. Involve migrant women from various communities in the validation of research and study tools and interpretation of results.
Obtain consent for anticipated secondary uses of data. Use of secondary data without consent may be acceptable in some instances (e.g. group is large and difficult to track). (CIOMS guideline 4, TCPS2 Article 5.5)	Migrants may not be available to give consent for secondary use of data as migrants tend to be mobile and those with a precarious status may be deported or go underground.	Obtain other contact information (friends or family members) to be able to contact them for further information if required. As much possible request consent for secondary use of data.
Compensation for participation (payments, medical services) must not be so extensive that prospective participants consent against their better judgement (‘undue inducement’). (CIOMS guideline 7, Belmont section C.1, TCPS2 Article 3.1)	Migrants with low social-economic status and/or precarious status might be more vulnerable to undue inducement.	Reiterate to participants that participation is voluntary.
Privacy and confidentiality
The investigator must protect the privacy of participants and establish secure safeguards of the confidentiality of research data within the extent permitted by the law. (CIOMS guideline 18, Helsinki item B.23, TCPS2 Articles 5.1, 5.2, & 5.3) Researchers shall avoid being put in a position of becoming informants for authorities or organizations. (TCPS2 Article 5.2) Enhanced security measures should be used when working with large linked databases that permit re-identification of individuals (e.g., restrict number who can perform merge of datasets, remove identifiers from merged file, password protect/encrypt files). (TCPS2 Article 5.7)	Participants may fear information will get back to family or community members especially if research staff/interpreters are from their community. Participants may fear that participation will compromise their application for status. Participants with an undocumented status may fear information will go to immigration authorities. Women in abusive situations (husband or family) may worry about being reported to authorities. Women may be concerned about having children taken away (in abusive situation or simply out of fear of authorities).	Develop/use a code of confidentiality form and have all research staff sign it. Hire professional staff who, by professional oaths and codes of conduct, are obliged to maintain confidentiality (e.g. nurses and interpreters). Offer the option of having an interpreter who is not from their community (to further reassure women that information will not get back to their community). Require research staff to notify research team when they know a participant and have different staff recruit/collect data from the participant (there should be no penalty in remuneration for these instances). Physically separate forms with personal identifiers from data collected in front of participants. Inform participants more than once that information will not be shared with immigration authorities and that immigration status will not be affected irrespective of whether or not they participate. For women in abusive situations, offer a referral to appropriate services and inform them of the laws protecting against violence and abuse. Train research staff to be sensitive to migrant women/families’ fear of children being taken away. Inform women/families of laws regarding child abuse.
Balancing harms and benefits
Because scientifically invalid research is unethical in that it exposes research participants to risks without possible benefits, studies must conform to generally accepted scientific principles and be based on scientific literature. (CIOMS guideline 1, Belmont section C.2, Helsinki item B.12)		All research must undergo scholarly and ethical review. Work closely with organizations providing care and services to migrants to ensure relevancy of research.
Ensure that potential benefits and risks (physical, psychological, legal, social, or economic) for the participants are reasonably balanced and risks are minimized. The importance of the research must outweigh risks and burdens. (CIOMS guideline 8, Belmont section C.2, Helsinki items B.20, B.21, C.31, & C.34, TCPS2 Article 4.7) The well-being of the participant should take precedence over the interests of science and society. (CIOMS guideline 8, Helsinki items A.4 & A.6)	Questions on migration experiences, trauma, or abuse may cause distress. Potential of a participant having an interpreter/research staff from a group from who they suffered persecution.	Work closely with organizations providing care and services to migrants to ensure relevancy of research. Train research staff on issues for recruiting/collecting data from childbearing migrant women. Offer opportunity to have staff/interpreter not from their community. Culturally adapt study tools (validate with migrant women). Offer interview-style or self-administration of questionnaires. Do not begin questionnaires or interviews with sensitive questions. Explain why sensitive questions are being asked. Broach more sensitive topics once trust has been established (have more than one contact with same research staff to develop trust). Develop a referral protocol.
Interests other than those of the participant may be sufficient to justify risks as long as the participant’s rights have been protected. Loss of substantial benefits that might be gained from research is also of concern. (Belmont section C.2) Every study must be preceded by a careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the participant or to others. Risks and burdens must be minimized and satisfactorily managed. (CIOMS guideline 8, Belmont section C.2, Helsinki items B.18 & B.20) Research should only be performed with women/pregnant women if it is relevant. A thorough discussion of risks is a prerequisite for a woman to make a rational decision to participate. (CIOMS guidelines 16& 17) Well-informed volunteers are not precluded for participating in research for altruistic reasons or for modest remuneration. (CIOMS guideline 8, Belmont section C.2)	Determining the direct beneficiaries of research is not always evident.	Include benefits for community as a whole in the description of the study. Work closely with organizations providing care and services to migrants to ensure relevancy of research.
Health services that are essential to the safe conduct of the research must be provided. Participants who suffer injury as a result of their participation are entitled to free treatment and compensation for resultant impairment, disability or handicap. (CIOMS guidelines 19 and 21)	Addressing concerns could create a dependency on the research team.	Identify existing services that can best address the issues and develop a referral protocol. Assist migrant women in making the link to the system if there are language barriers. Work closely with migrant agencies that provide services, especially for migrants without status/eligibility for services. Provide direct care only in emergency situations. Hire and train staff (e.g. nurses, social workers) that can provide assistance to participants as needed. Have psychologist/psychiatrist on research team who can provide care/support.

NGO: nongovernmental organization; CIOMS: Council for International Organizations of Medical Sciences.

^aCommon principles/guidelines are summarized and the relevant sections from the Declaration of Helsinki (Helsinki), the Belmont Report (Belmont), The Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS2), and the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS) cited.

Justice and inclusiveness

Migrant populations pose a unique challenge in that they represent a diverse population that is continually changing in composition as migration patterns shift. They speak multiple languages, represent a range of cultures, and have varied migration experiences including trauma and forced migration. To adequately study this population, it requires valid and properly translated tools to multiple languages,²⁹ multi-lingual, trained personnel, and flexible methods.³⁰ It also necessitates creativity and accommodation to address certain cultural traditions and barriers related to the childbearing context.³⁰

Training for personnel should include how to address sensitive topics (e.g. refugee history), adapt to different cultures to be inclusive and maintain privacy and confidentiality. Understanding of the immigration system and migration terminology is also essential (e.g. knowing the difference between an asylum-seeker and a refugee). Demonstrating empathy, timing sensitive questions towards the middle of an interview to allow women to ease into the discussion and so that questions end on a more neutral tone, allowing women to choose a convenient time and location to meet, ensuring adequate time for responses and breaks, and reminding women that information they share is confidential and will not be shared with anyone outside the research team, creates conditions more conducive for participation.^30,31 Flexible methods also ensure comfort, for example, questions may be asked interview-style to allow for a more human exchange or a questionnaire may be given to be completed by oneself so that they feel anonymous. Similarly, women might be offered participation via focus group or a one-on-one interview. Offering interviews at home may also facilitate participation of new mothers and offer more privacy.³⁰ Cultural adaptations might include, for example, asking husbands to respond to certain questions or to participate in a separate interview so that they are involved and feel comfortable with their wives’ participation.³²

Achieving cross-language/culturally equivalent tools is a lengthy and intensive process. As stated by Hunt and Bhopal,²⁹ “Collecting self- reported data by ethnic group in multi-ethnic settings is necessary and difficult” (p. 619). Recommendations for developing valid, translated tools across several languages include interdisciplinary collaboration in the development process, translation and back-translation, comparison of translations and negotiation of “best items” within and across languages, consultation and testing tools with migrant women/monolinguals, and testing reliability (when appropriate) between translated and original language versions.^16,29,33,34 This endeavor is costly but can be accomplished by providing a detailed justification in a grant application and appending publications supporting cross-language/culture research, drawing on the support of study collaborators that might be able to provide translation services through in-kind support and using oral back-translation (i.e. a variation of back-translation where the translator orally translates the translated questionnaire back to the original language version rather than written translation)¹⁶ to make the procedure more cost-efficient. Hiring and training lay translators from the community is another strategy to reduce cost and has an added benefit of capacity-building by enhancing skills, knowledge, and competencies in research. A lack of professional translation experience may affect the quality of translation however, this may be offset by having multiple steps and people to review the translation in the process.

The changing demographics make it difficult to determine who will benefit from the research. Asylum-seekers, temporary migrants, and those with undocumented status are often not eligible for formalized services and programs and thus may not benefit at all.³⁵ A concern that research could potentially fuel anti-migration rhetoric (e.g. terrorism, spreading disease, draining resources, criminals) further raises the debate as to whether certain migrant groups should be studied. Despite these concerns, there are a number of benefits (see below under Balancing harm and benefits) of migrant women’s participation in studies, even for the most vulnerable. Collaboration with experts in the area of migration and health, from the government (immigration, public health), nongovernmental organization (NGO), and health professional sectors, however, is vital to ensure research is relevant and carefully conducted, and in order to “safely” access women who are more isolated and/or have a precarious status (undocumented).³⁶ Advocacy, at the policy and practice levels, must also be incorporated into knowledge translation activities so that research results are not misused. In Canada, the definition of knowledge translation includes an “ethically-sound application of knowledge.”³⁷ To this end, knowledge creation, dissemination, and recommendations for practice and policy must be consistent with ethical norms and principles, social values, and legal and other regulatory frameworks.³⁷ In an international context, knowledge translation activities must respect and align with international human rights. Advocacy raises awareness to the issues faced by migrants from the perspective of migrants and has greater potential of research results being used for the purpose to advance the conditions and improve health of migrants. For example, study results might be used to promote the rights of all migrants, including those without status, to have access to healthcare.

Recruitment should aim to include a diverse population, a representative sample if research is quantitative, in order to distribute the participation burden, and so that results can speak to a broad group (not just one language or cultural group). Data collection, however, should include key migration indicators (country of origin, status, language(s) proficiency (including languages in receiving-country), ethnicity, length of time in receiving country)³⁸ so that results may be more clearly interpreted. To accurately gather migration data, a migration questionnaire and a discussion with women are useful since terminology can be unfamiliar to participants, women might not exactly know their status if they came as a dependent on their husband’s or another family member’s immigration application, and some migration trajectories are more complex.¹⁶

To further promote the inclusion of migrant women in research, funding must be requested in grant applications and time allocated to create collaborations and foster their involvement in the research process (e.g. compensation for NGO workers time), and for capacity-building in research (including in low-resource settings). Including organizations that work closely with migrants throughout the research process can also offer some reassurance to ethics committees, particularly for committees that are less prepared to review and monitor studies with migrant women, and maximize the dissemination of study results back to participants. All details of the rationale and ethical safeguards taken should also be included in grant applications to facilitate the task of review for ethics committees and to enhance their understanding and appreciation for the challenges inherent in working with this population.

Voluntary and informed consent

Issues related to obtaining voluntary and informed consent include language, cultural, and literacy barriers, mistrust of those in authoritative positions, or conversely a sense of obligation to care providers, and an unawareness of rights regarding research, particularly for refugees, asylum-seekers, or those with a temporary status.^36,39 Previous experiences with corrupt governments or other officials, uncertainty regarding their future in the new country, or feeling indebted to the new country for accepting them (in the case of refugees) could unduly influence one’s decision to participate. Translating the consent form, reading the form to potential participants via interpreters or bilingual personnel, and highlighting and repeating key points can aid in understanding. Hiring female personnel, who are not care- or service-providers, and explicitly informing women that their immigration status or care/services will not be affected by their participation or nonparticipation can reduce intimidation and coercion. Accepting verbal consent can also address issues of mistrust and low literacy.³⁰

Participation in research is an opportunity for migrant women and their families to learn more about equality and legal rights, including the rights of women and minorities and the right to refuse to participate in research without repercussions. Providing explanations regarding the requirement that participants give their own consent, and leaving the form and allowing time for a woman to discuss with her family/husband, demonstrates respect for cultural traditions while maintaining adherence to ethical guidelines.

Privacy and confidentiality

Migrants, especially those with no status or those applying for asylum, may fear information getting back to immigration authorities.¹⁹ They may also worry that information will get back to their community or family/husbands, particularly if it is a small community and research staff are from their community. For women, they may feel uncomfortable responding to questions openly with family members present.³⁰ Informing participants that information, including their migration status, will not be communicated to anyone outside the research team, and hiring professionals (e.g. nurses, interpreters), who, by professional oaths and codes of conduct, are obliged to maintain confidentiality, and providing appropriate training can build trust and give reassurance to participants.³¹ Research personnel/interpreters should also report when they know a participant (without penalty in their remuneration) and family members/husbands can be included in the study, but must be informed of rights to confidentiality.

Situations of abuse need special attention. Women, who were sponsored or came on the same immigration application as the abuser, may not want to divulge their abusive situation.⁴⁰ Women may also be concerned about having children taken away despite there being no abuse.⁴¹ Women should be informed of laws protecting against abuse, including child abuse. Referrals should be safely (i.e. without knowledge to the abuser) offered to women^42,43 and research personnel should be sensitive to migrants’ fears of having children removed from the family.

Balancing harm and benefits

A major concern in conducting research with childbearing migrant women is that participation may result in distress or some other harm depending on the type of research, or further trauma for those with a refugee history. Migrants themselves may fear that they are being targeted for research for malevolent reasons. While causing harm is a concern for research with any population, the issue is magnified if services are not available, accessible (i.e. not eligible for services), or inappropriate for migrants. A referral protocol for addressing concerns must be developed and include services for the uninsured, and the research team should be equipped to provide care for acute health issues identified.³¹ Offering the option of not having an interpreter from a specific ethnic community can also prevent further trauma to refugees who suffered persecution from specific ethnic groups.

Additional strategies to reduce distress include staggering data collection over more than one point of contact, providing ongoing opportunity for the participants to ask questions about the research, discussing sensitive topics (e.g. abuse) once some trust has been established with the participant, and providing explanations about the purpose of questions and/or procedures before they are asked/done.³¹

There are many potential benefits to migrant women participating in research. Overall, migrant women might appreciate being included in research and having their voices heard. They may feel empowered in knowing that they are potentially contributing to the improved living and working conditions, delivery of care, and health outcomes for other migrants in the future. They may also enjoy taking an active role in their health and may benefit from additional services or care that are offered as part of the study. Participants and their families may learn more about the healthcare system and services as well as the new country in general, including their rights as described above. Women may also connect with other migrant women and create/expand their support networks.

Discussion

Guidelines for ensuring the protection of human subject participants promote the inclusion of vulnerable participants and provide many recommendations for improving research participation. Feasibility issues and fear of burdening or harming participants because they are migrants, childbearing, and victims of trauma, however, remain a concern for researchers and ethics committees, and may result in limiting research participation. Researchers are therefore faced with balancing (a) inclusion of a broad mix of participants that more accurately represents the migrant population, with feasibility, including the cost and time resources to study a multi-lingual and cultural population; (b) flexibility, with methodological rigor; and (c) safeguarding against ethical risks (harm, confidentiality breach, nonvoluntary participation) versus altogether excluding these women from research.

What emerged as key for studying this diverse population and ensuring an ethically responsible approach are the use of methods that are adapted to the circumstances of childbearing migrant women and the involvement and support from “migrant-friendly” organizations. Participation from community-based agencies can be particularly beneficial as they often have established credibility and trust and thus have a greater understanding of a community’s needs and a capacity to act as liaisons.²¹ It must be recognized, however, that they may also pose barriers by blocking access to participants and conflicting perspectives/agendas can induce complexities to the research process.⁴⁴ An investment of time, negotiation, and respect are essential for building true and trusting partnerships.⁴⁴ Ensuring migrant women are involved in the research process and knowledge produced is also critical. Researcher engagement with under-served/marginalized communities before and after projects fosters a collaborative relationship with community members and can bring them closer to health and social services systems.^45,46

The cost of implementing many of the suggested strategies is a practical issue for researchers. Governments and granting agencies therefore have an important role to play in promoting research with migrants and in ensuring that adequate funding is made available so that researchers can build and maintain partnerships, develop appropriate research methods, and conduct culturally and ethically sound studies. The implementation of standard collection of migrant indicators in health administrative databases would also be useful for ongoing monitoring of migrants’ health.

Power imbalances between the research team and community-based agencies, and limited resources and understanding of research pose barriers to developing true collaborations.^45,46 Further research is required to know how best to address these issues and to work with community organizations in a research context, especially when one or more ethno-cultural groups are small and thus render maintenance of confidentiality more difficult. More knowledge is also needed to know how to involve representatives from different sectors (professional, government, and community-based) in an effective way and to incorporate capacity-building into research activities.

This report has limitations in that it is based on the experiences of a few Canadian researchers. Researchers working in a non-Canadian context may offer insight on challenges and methods for addressing issues that have not been described here. An exhaustive review of the literature including articles not written in English and examination of grey literature may also yield additional information. However, this article has put forth a number of mechanisms to practically address some of the challenges to including childbearing migrant women in health research.

Constraints that may limit childbearing migrant women from participating in research include researchers and/or review committees’ limited knowledge of and experience with conducting research with migrants and a poor understanding of the benefits that the “migrant community” may gain. In drawing attention to the ethical guidelines that promote inclusion of vulnerable participants and by suggesting a number of practical strategies, it is hoped that this brief report will further improve the conditions and raise awareness to the importance of conducting research with migrant women. While some challenges and strategies discussed are particular to the childbearing context, many are relevant to other migrant groups as well. The more the researchers working in this field communicate their experiences, the more will be learnt about how best to approach research with migrants, and more knowledge will be generated so that health inequalities faced by this population may be addressed.

Footnotes

Conflict of interest

The authors declare that there is no conflict of interest.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

References

Trends in international migrant stock: the 2013 revision (United Nations database, POP/DB/MIG/Stock/Rev.2013). New York, 2013, http://esa.un.org/unmigration/documents/WallChart2013.pdf (accessed 20 May 2014).

United Nations High Commissioner for Refugees (UNHCR). Refugee status determination, identifying who is a refugee. Geneva: UNHCR, 2005.

International Organization for Migration (IOM). International migration law—glossary on migration. 2nd ed. Geneva: IOM, 2011.

Sixty-first World Health Assembly , 19–24 May 2008, Geneva, http://www.who.int/mediacentre/events/2008/wha61/en/index.html (accessed 20 May 2014).

World Health Organization. Health of migrants—the way forward: report of a global consultation, Madrid, 3–5 March 2010. Geneva: World Health Organization Press.

Sobotka

. Overview chapter 7: the rising importance of migrants for childbearing in Europe. Demogr Res 2008; 19: 225–248.

Statistics Canada. Canada’s demographic situation: fertility of immigrant women. The Daily Monday, 22 December 2003, http://www.statcan.gc.ca/daily-quotidien/031222/dq031222c-eng.htm (accessed 20 May 2014).

Carballo

Nerukar

. Migration, refugees, and health risks. Emerg Infect Dis 2001; 7: 556–560.

Ioannidi-Kapolou

. Health barriers and inequities for migrants. In: Apostolopoulos

Sonmez

(eds) Population mobility and infectious disease. New York: Springer, 2007, pp. 41–54.

10.

Gagnon

Zimbeck

Zeitlin

. Migration to western industrialised countries and perinatal health: a systematic review. Soc Sci Med 2009; 69: 934–946.

11.

Heaman

Bayrampour

Kingston

. Migrant women’s utilization of prenatal care: a systematic review. Matern Child Health J 2013; 17: 816–836.

12.

Small

Yelland

Lumley

. Immigrant women’s views about care during labor and birth: an Australian study of Vietnamese, Turkish, and Filipino women. Birth 2002; 29: 266–277.

13.

Almeida

Caldas

Ayres-de-Campos

. Maternal healthcare in migrants: a systematic review. Matern Child Health J 2013; 17: 1346–1354.

14.

Higginbottom

Reime

Bharj

. Migration and maternity: insights of context, health policy, and research evidence on experiences and outcomes from a three country preliminary study across Germany, Canada, and the United Kingdom. Health Care Women Int 2013; 34: 936–965.

15.

Patil

Maripuu

Hadley

. Identifying gaps in health research among refugees resettled in Canada. Int Migr. Epub ahead of print 14 February 2014. DOI: 101111/j1468-2435.2011.00722.x.

16.

Merry

Gagnon

Hemlin

. Cross-border movement and women’s health: how to capture the data. Int J Equity Health 2011; 10: 1–15.

17.

Small

Yelland

Lumley

. Cross-cultural research: trying to do it better. 1. Issues in study design. Aust N Z J Public Health 1999; 23: 385–389.

18.

Birman

. Ethical issues in research with immigrants and refugees. In: Trimble

Fisher

(eds) The handbook of ethical research with ethnocultural populations and communities. Thousand Oaks, CA: Sage, 2005, pp. 155–178.

19.

Ogilvie

Burgess-Pinto

Caufield

. Challenges and approaches to newcomer health research. J Transcult Nurs 2008; 19: 64–73.

20.

Small

Yelland

Lumley

. Cross-cultural research: trying to do it better. 2. Enhancing data quality. Aust N Z J Public Health 1999; 23: 390–395.

21.

Goodkind

Deacon

. Methodological issues in conducting research with refugee women: principles for recognizing and re-centering the multiply marginalized. J Community Psychol 2004; 32: 721–739.

22.

Macklin

. Enrolling pregnant women in biomedical research. Lancet 2010; 375: 632–633.

23.

Kelty

Bates

Pinn

VW.

National Institutes of Health policy on the inclusion of women and minorities as subjects in clinical research. In: Gallin

Ognibene

(eds) Principles and practice of clinical research. 3rd ed. London: Elsevier, 2012, pp. 147–159.

24.

Shavers

Lynch

Burmeister

. Racial differences in factors that influence the willingness to participate in medical research studies. Ann Epidemiol 2002; 12: 248–256.

25.

WMA declaration of Helsinki—ethical principles for medical research involving human subjects, 2008, http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage]2008 (accessed 20 May 2014).

26.

Blemont Report. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research, 1979, http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html (accessed 20 May 2014).

27.

Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International ethical guidelines for biomedical research involving human subjects, 2002, http://www.cioms.ch/publications/layout_guide2002.pdf (accessed 20 May 2014).

28.

Canadian Institutes of Health Research NS, and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-council policy statement: ethical conduct for research involving humans, 2010, http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf (accessed 20 May 2014).

29.

Hunt

Bhopal

. Self report in clinical and epidemiological studies with non-English speakers: the challenge of language and culture. J Epidemiol Community Health 2004; 58: 618–622.

30.

Merry

Clausen

Gagnon

. Improving qualitative interviews with newly arrived migrant women. Qual Health Res 2011; 21: 976–986.

31.

Gagnon

Wahoush

Dougherty

. The childbearing health and related service needs of newcomers (CHARSNN) study protocol. BMC Pregnancy Childbirth 2006; 6: 31.

32.

Gagnon

Merry

Bocking

. South Asian migrant women and HIV/STIs: knowledge, attitudes and practices and the role of sexual power. Health Place 2010; 16: 10–15.

33.

Ruppenthal

Tuck

Gagnon

. Enhancing research with migrant women through focus groups. West J Nurs Res 2005; 27: 735–754.

34.

Strohschein

Merry

Thomas

. Strengthening data quality in studies of migrants not fluent in host languages: a Canadian example with reproductive health questionnaires. Res Nurs Health 2010; 33: 369–379.

35.

Gagnon

. The responsiveness of the Canadian health care system towards newcomers. In: Forest

P-G

Marchildon

McIntosh

(eds) Changing health care in Canada: the Romanow papers, vol. II. Toronto, ON, Canada: University of Toronto Press, 2004, pp. 349–388.

36.

Yancey

Ortega

Kumanyika

. Effective recruitment and retention of minority research participants. Annu Rev Public Health 2006; 27: 1–28.

37.

More about knowledge translation at CIHR, http://www.cihr-irsc.gc.ca/e/39033.html (updated 27 February 2014; accessed 20 May 2014).

38.

Gagnon

Zimbeck

Zeitlin

. Migration and perinatal health surveillance: an international Delphi survey. Eur J Obstet Gynecol Reprod Biol 2010; 149: 37–43.

39.

Frayne

Burns

Hardt

. The exclusion of non-English-speaking persons from research. J Gen Intern Med 1996; 11: 39–43.

40.

Martin

Mosher

. Unkept promises: experiences of immigrant women with the neo-criminalization of wife abuse. Can J Women Law 1995; 8: 3–44.

41.

Earner

. Immigrant families and public child welfare: barriers to services and approaches for change. Child Welfare 2007; 86: 63–91.

42.

Stewart

Gagnon

Merry

. Risk factors and health profiles of recent migrant women who experienced violence associated with pregnancy. J Womens Health 2012; 21: 1100–1106.

43.

Gagnon

Carnevale

Saucier

. Do referrals work? Responses of childbearing newcomers to referrals for care. J Immigr Minor Health 2010; 12: 559–568.

44.

Sixsmith

Boneham

Goldring

. Accessing the community: gaining insider perspectives from the outside. Qual Health Res 2003; 13: 578–589.

45.

Mackereth

Appleton

. Social networks and health inequalities: evidence for working with disadvantaged groups. Community Pract 2008; 81: 23–26.

46.

Rankin

Backett-Milburn

Platt

. Practitioner perspectives on tackling health inequalities: findings from an evaluation of healthy living centres in Scotland. Soc Sci Med 2009; 68: 925–932.