Childbearing migrant women and equal access to research participation Amy Low BSc MSc (c), Anita Gagnon RN MPH PhD, Lisa Merry RN MSc( A ), Franco Carnevale RN PhD McGill University and McGill University Health Centre Canadian Public Health Association June

Introduction Health is a human right (WHO & UN High Commissioner for Human Rights) “governments must generate conditions in which everyone can be healthy as possible” Availability, Accessibility, Acceptability, Quality Respect, Protect, Fulfill Research needs to address means of fulfilling this right Especially for vulnerable populations Childbearing migrant women face reduced access to research participation Marginalized position seems to limit their participation

Introduction Childbearing migrant women are more vulnerable to harmful health outcomes Migration history Infections, nutritional deficiencies, PTSD, depression Reduced access to care, language barriers, low SES There are challenges that limit their research participation It is unethical to deny them research that could improve their health status Existing ethical guidelines have limitations None specifically addressing childbearing migrant women Little guidance on the procedures for upholding these ethics

Scenario 1 Researcher wants to conduct a study addressing the health concerns in the early post- partum period of childbearing refugees and asylum seekers in Canada Methods proposed: Consultations with NGO’s for the development of questionnaires Recruitment from post-partum unit Submitted to hospital and universities Research Ethics Boards (REBs)

Scenario 2 Asylum-seeking woman from Afghanistan only speaks Dari, the husband is present and speaks English and Dari Recruiter asks mother if she would like to participate in a study and hands her a consent form, which she directly hands to her husband Her husband reads it and asks if this will help with their asylum seeking application

Research Question What are the challenges that contribute to inequities of childbearing migrant women participating in research? How may these challenges be addressed in an ethical manner?

Methods Step 1 Ethics’ guidelines reviewed: The Declaration of Helsinki The Belmont Report Tri-Council Policy Statement: Ethical conduct for research involving humans CIHR Guidelines for Health Research Involving Aboriginal People Guidelines for the conduct of research involving human subjects at the NIH Common ethical principles Respect for justice and inclusiveness Respect for free and informed consent Respect for privacy and confidentiality Respect for vulnerable persons Balance of harm and benefit Minimizing harm Maximizing benefits

Methods Step 2 Review of the literature Identified challenges Strategies to overcome challenges Step 3 Consultation with researchers and ethicists Indentified challenges and strategies

Results Challenges and strategies to overcome challenges

Challenges and strategies to overcome challenges (Scenario 1) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for justice and inclusiveness: Benefit from research REB conduct Unfair burden of research Identifying beneficiaries REBs may not be equipped to evaluate protocols Burden of research REBs used external resources to evaluate Scientific support for recruitment Respect for vulnerable population: Community input Involvement of NGO necessitate time Paid NGO’s for their time

Challenges and strategies to overcome challenges (Scenario 1) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for justice and inclusiveness: Benefit from research REB conduct Unfair burden of research Identifying beneficiaries REBs may not be equipped to evaluate protocols Burden of research REBs used external resources to evaluate Scientific support for recruitment Respect for vulnerable population: Community input Involvement of NGO necessitate time Paid NGO’s for their time

Challenges and strategies to overcome challenges (Scenario 1) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for justice and inclusiveness: Benefit from research REB conduct Unfair burden of research Identifying beneficiaries REBs may not be equipped to evaluate protocols Burden of research REBs used external resources to evaluate Scientific support for recruitment Respect for vulnerable population: Community input Involvement of NGO necessitate time Paid NGO’s for their time

Challenges and strategies to overcome challenges (Scenario 1) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for justice and inclusiveness: Benefit from research REB conduct Unfair burden of research Identifying beneficiaries REBs may not be equipped to evaluate protocols Burden of research REBs used external resources to evaluate Scientific support for recruitment Respect for vulnerable population: Community input Involvement of NGO necessitate time Paid NGO’s for their time

Challenges and strategies to overcome challenges (Scenario 1) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for justice and inclusiveness: Benefit from research REB conduct Unfair burden of research Identifying beneficiaries REBs may not be equipped to evaluate protocols Burden of research REBs used external resources to evaluate Scientific support for recruitment Respect for vulnerable population: Community input Involvement of NGO necessitate time Paid NGO’s for their time

Challenges and strategies to overcome challenges (Scenario 2) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for free and informed consent: Information understanding voluntariness Language barriers Husband answers for wife Familiarity with research and rights Translation, back-translation, cultural validation Use simple language Obtain consent from husband and wife Take time for explanations Respect for privacy and confidentiality Precarious immigration statusStrict code of confidentiality Information is not relayed to government immigration officials Respect for vulnerable population: Culturally appropriate Culturally appropriate method of data collection and subject matter Address both husband and wife Explain methods and why questions are being asked

Challenges and strategies to overcome challenges (Scenario 2) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for free and informed consent: Information understanding voluntariness Language barriers Husband answers for wife Familiarity with research and rights Translation, back-translation, cultural validation Use simple language Obtain consent from husband and wife Take time for explanations Respect for privacy and confidentiality Precarious immigration statusStrict code of confidentiality Information is not relayed to government immigration officials Respect for vulnerable population: Culturally appropriate Culturally appropriate method of data collection and subject matter Address both husband and wife Explain methods and why questions are being asked

Challenges and strategies to overcome challenges (Scenario 2) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for free and informed consent: Information understanding voluntariness Language barriers Husband answers for wife Familiarity with research and rights Translation, back-translation, cultural validation Use simple language Obtain consent from husband and wife Take time for explanations Respect for privacy and confidentiality Precarious immigration statusStrict code of confidentiality Information is not relayed to government immigration officials Respect for vulnerable population: Culturally appropriate Culturally appropriate method of data collection and subject matter Address both husband and wife Explain methods and why questions are being asked

Challenges and strategies to overcome challenges (Scenario 2) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for free and informed consent: Information understanding voluntariness Language barriers Husband answers for wife Familiarity with research and rights Translation, back-translation, cultural validation Use simple language Obtain consent from husband and wife Take time for explanations Respect for privacy and confidentiality Precarious immigration statusStrict code of confidentiality Information is not relayed to government immigration officials Respect for vulnerable population: Culturally appropriate Culturally appropriate method of data collection and subject matter Address both husband and wife Explain methods and why questions are being asked

Challenges and strategies to overcome challenges (Scenario 2) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for free and informed consent: Information understanding voluntariness Language barriers Husband answers for wife Familiarity with research and rights Translation, back-translation, cultural validation Use simple language Obtain consent from husband and wife Take time for explanations Respect for privacy and confidentiality Precarious immigration statusStrict code of confidentiality Information is not relayed to government immigration officials Respect for vulnerable population: Culturally appropriate Culturally appropriate method of data collection and subject matter Address both husband and wife Explain methods and why questions are being asked

Challenges and strategies to overcome challenges (Scenario 2) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for free and informed consent: Information understanding voluntariness Language barriers Husband answers for wife Familiarity with research and rights Translation, back-translation, cultural validation Use simple language Obtain consent from husband and wife Take time for explanations Respect for privacy and confidentiality Precarious immigration statusStrict code of confidentiality Information is not relayed to government immigration officials Respect for vulnerable population: Culturally appropriate Culturally appropriate method of data collection and subject matter Address both husband and wife Explain methods and why questions are being asked

Challenges and strategies to overcome challenges (Scenario 2) Ethical principles & Guidelines ChallengesOvercoming challenges Respect for free and informed consent: Information understanding voluntariness Language barriers Husband answers for wife Familiarity with research and rights Translation, back-translation, cultural validation Use simple language Obtain consent from husband and wife Take time for explanations Respect for privacy and confidentiality Precarious immigration statusStrict code of confidentiality Information is not relayed to government immigration officials Respect for vulnerable population: Culturally appropriate Culturally appropriate method of data collection and subject matter Address both husband and wife Explain methods and why questions are being asked

Discussion Challenges: Maintaining confidentiality Family members present Small ethnic/cultural community Costs burden of implementing strategies

Conclusion Recommendations Hiring and training of experienced staff researchers Cultural sensitivity Trauma training Strict code of confidentiality Further development of strategies Collaboration

Thank you Thanks to Jane Chambers-Evans and Dr. Carolyn Ells for their contributions to the strategies to overcome challenges, Zeinab Jeambey for the development of the scenarios & to Diane Habbouche, Marie-Pier Joly and Praem Mehta for their general support.