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Table 4 Planned Ethical Safeguards Specific to the Vulnerable Nature of theStudy Population of CHARSNN

From: The childbearing health and related service needs of newcomers (CHARSNN) study protocol

Ethical Guidelines Planned Safeguards
Respect for justice & inclusiveness
Tri-Council Guidelines [95]Article 1.1a. All research that involves living human subjects requires review and approval by an REB in accordance with this Policy Statement, before the research is started... Justice connotes fairness and equity. Procedural justice requires that the ethics review process have fair methods, standards and procedures for reviewing research protocols, and that the process be effectively independent.  
Tri-Council Guidelines [95]Articles 5.1–5.3 – Inclusion in research. Principles of distributive justice reflects respect to human dignity and diversity. States that people should not bear unfair burden of research, nor be unfairly excluded (including exclusion on the basis of cultural, religion, race..., ethnicity..., unless there is a valid reason to do so). NAC, CAC and ECLG formed and 13 study languages chosen in such a way to ensure maximum representation of target population in the 3 study cities. Categories of recruitment are based on migration status (with scientific support), and participants are recruited into one of four groups, distributing the burden of participation to promote knowledge of health of vulnerable populations and prevent exploitation of any one group.
Recruiting uninsured populations Not only should investigators seek to enroll uninsured, but they should focus research on medical and socially vulnerable areas, including effects on health of decreased access to care [96]. See above.
Recruiting populations with precarious immigration status. Refugees and asylum seekers are a vulnerable population, and utmost care must be taken not to coerce participation. However, it is unethical not to deal with problems and inequities facing refugee populations [97]. See above.
Respect for free & informed consent
Tri-Council Guidelines [95]Articles 2.1–2.8. Free and Informed Consent. (e.g. potential subjects informed of study info, harms/benefits, voluntary, ongoing consent, etc). Article 2.1(b). Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, verbal agreement, or handshake can be used and should be documented. Provisions should be made that any language barriers should not disqualify any participant from informed consent. Information about the study is available in all rooms before women are for approached the study. Women can request unit staff that they not be approached by a researcher. Back-translation and validation of the consent forms and all questionnaires/protocols have been done. Readability tests were conducted on all documents. All documents were reviewed by ECLG and monolinguals for cultural appropriateness and recommended changes made. Increased time is allotted for explanation of study and consent process in case of language, cultural barriers and to prevent any undue coercion to participate.
  The consent is left with the woman if she does not want to make her decision right away. Interpreters are used when needed. Women who give informed consent but prefer not to sign their name (for cultural reasons, concerns of confidentiality during immigration process) may give verbal consent. Where requested for cultural reasons, a husband can be the one to sign the actual consent form for a woman but only after she has given her own informed consent. Women are reminded at all contacts that they may withdraw at any point in the study process.
Tri-Council Guidelines [95]Article 4 – Conflict of interest. ...consent must be voluntarily given, without manipulation, undue influence or coercion. Researchers, recruiters and study nurses do not provide direct patient care unless a nurse identifies an emergency situation during a home visit (i.e., they are independently hired for the research study).
Respect for privacy & confidentiality
Tri-Council Guidelines [95]Articles 3.1–3.6. Provisions must be made to ensure privacy and confidentiality. This includes special care with secondary use of data and creation of data linkages. All data are strictly confidential. All nurses and interpreters follow a strict code of confidentiality. Recruiters and data entry clerks sign confidentiality forms when hired. All data are coded and summarized to prevent identification of individuals in reports of results. No data linkages are being made. No personal info is communicated to CIC or other government agencies. No study results can have any impact on individual migration or welfare status as results are de-nominalized. All women are reassured about this, and this reassurance is restated in the consent form. Women who choose to have interpreters present have the option of choosing an interpreter who is not from their community (to further reassure women that information will not get back to their community).
Respect for vulnerable persons
Obtaining community input Mistrust is an ethical challenge to recruitment. Can be improved with feedback from community and advisory boards [98, 99]. NAC, CAC, and ECLG formed to assess cultural appropriateness and to find strategies to increase participation while decreasing potential harm or offence.
Recruiting vulnerable populations. Women having just given birth may be considered vulnerable. However, recruitment on postpartum units is an acceptable and valid approach [74]. Educating research team of ethical guidelines and basic rights of participants is necessary and will improve ethical quality [98]. There will be careful screening of recruiters and nurses who are hired. Two days of initial training will include sensitivity issues for recruiting on postpartum populations. Additional support will be offered by the research team to the women as deemed necessary. Reimbursement will be made to all women participating. Based on ECLG feedback, trained nurses are being used instead of non-nurse research assistants. Nurses at home visit will provide emergency care if needed, until referral to an Emergency Department is possible.
Culturally appropriate approach to gathering data Interview-style or self-administration of questionnaires are offered to each woman. Extra time is accorded for the woman to ask questions, consider, consult husband, etc.
Balancing harms & benefits
Recruiting populations that may have been victims of trauma or oppression It is misguided (even unguided) to argue that studies should not be done because of potential harm [100]. Research on refugee populations with traumatic experiences can have beneficial effects if carried out sensitively and appropriately. Research nurses will receive specific 1-day training by trauma professionals to provide response strategies for working with victims of psychological trauma. The team also includes expert trauma professionals, who are available for any individual referrals of women at risk and needing extra psychological support. NAC and CAC professionals in trauma offer additional support to the study procedures. Based on NAC, CAC and ECLG feedback, the burden of participation will be distributed over three encounters. Based on ECLG feedback, women will be explained reasons for asking sensitive questions. The most sensitive topics will be assessed at the final home visit with nurse, i.e. after more trust has developed between the women and the nurse.
Minimizing harm
Avoid, prevent or minimize harms [95] As described above several steps have been taken to ensure protocols and questionnaires are culturally appropriate. Sensitive questions are administered at the 2nd home visit so participants are "warmed-up" to the study and have developed a relationship with the nurse. Introductory statements always precede sensitive questions. To minimize "questionnaire burden", questionnaires are administered over 3 interviews. To minimize inconvenience, nurses visit women in their homes.
Maximizing benefit
Dissemination of research findings Partnerships with NAC and CAC include health, policy and advocacy stakeholders. The strong multidisciplinary research team coupled with ongoing meetings with NAC and CAC facilitate representation and moral responsibility to the vulnerable study population. Diversity of stakeholders also suggests that findings will be disseminated to the largest possible audience in a position to make appropriate recommendations to health, community and government policies after the study is completed.