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Research ethics
Obtaining informed consent: observations from community research with refugee and impoverished youth
  1. R Nakkash,
  2. J Makhoul,
  3. R Afifi
  1. Department of Health Behaviour and Education, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
  1. Correspondence to Dr J Makhoul, Department of Health Behaviour and Education, American University of Beirut, Beirut 1107 2020, Lebanon; jm04{at}aub.edu.lb

Abstract

This paper presents challenges facing researchers in applying basic ethical principles while conducting research with youth in a developing country context. A discussion of the cultural and social challenges to adherence to the elements of informed consent: disclosure, comprehension, capacity, voluntariness and consent is presented. The authors argue that the current institutional review board requirements that guide research reflect values and stem from western contexts that may not be fully applicable to non-western contexts. More dialogue is needed among researchers in developing world contexts on challenges of and possible revisions to requirements that maintain respect for persons, beneficence, autonomy and justice, particularly when working with youth.

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Basic ethical principles of research highlighted by the Belmont report,1 dictate that beneficence, justice and respect for individual autonomy need to be considered when dealing with research participants. These same principles are ingrained in the World Medical Assembly’s Declaration of Helsinki, last updated in 2008,2 as well as in the Council for International Organizations of Medical Sciences guidelines for research involving human subjects.3 Beneficence requires that the research does more good than harm. Respect ensures that participants’ rights are preserved, and their autonomy in decision making is guaranteed. Justice provides that all participants have an equal opportunity to be involved in and benefit from the research. Institutional review boards (IRB) are required by ethical protocols of the Declaration of Helsinki and the Council for International Organizations of Medical Sciences and are set up to protect human subjects in research projects, following the basic principles highlighted in the Belmont report.1 However, despite the existence of guidelines and the emphasis these have been given through widespread IRB, adherence may be difficult when research is conducted in a non-western setting, especially involving youth.

The principle of autonomy is embodied in the concept of informed consent, the focus of this paper. When applied as intended, informed consent involves five elements: disclosure; comprehension; capacity; voluntariness and consent.1 This means that researchers should seek participants’ consent to participate in the research study. When signed consent is not possible, IRB allow oral consent taking, in which case the person seeking oral consent signs the consent form, gives it to the participant and keeps a copy. A literature review of published articles that address ethical issues in research particularly with children or youth identified studies in industrialised world settings.4 5 6 7 8 9 10 11 Issues highlighted include barriers to obtaining parental consent to their children’s participation.5 Information sent to parents with their children is not always delivered, which could influence proper “informed consent”.6 Suggestions to ensure that parents and children have been given enough time to grasp information and decide on participation include using multiple wave procedures for collecting consent.8 Whereas younger children are found to be able to understand what they are being asked to participate in and older children, 7–12 years of age, were able to describe the purpose; however, all were less clear about risks and benefits. In all cases, children’s free assent is difficult to determine because they have been socialised to fear declining adult requests.9

Despite some discussion of the process of consent taking in developing countries,12 13 14 15 16 debates about the influence of community level contexts within which this process takes place and the communal determinants, such as the power relations governing social issues pertaining to youth, are scarce. This article contributes to the evolving body of empirical work reflecting on cultural and social challenges to adherence to the five elements of informed consent in research projects involving youth in underprivileged communities in a developing country context.

Community backgrounds

This paper describes the preparatory phases for a research intervention aimed at improving the mental health of Palestinian refugee youth 10–14 years of age. The preparatory phases took place in two communities in the southern suburbs of Beirut: the Lebanese community of Borj el Barajneh and the Palestinian refugee camp of Shatila. Borj el Barajneh, where the validation of the mental health instrument for the study was conducted, houses impoverished rural migrants from the countryside and war-displaced families. Family structures range from nuclear families to traditional extended structures in which family members reside in the same households. With the influx of families and illegal development over the war years, the streets are crowded and households have no proper addresses. A shy number of health and social services are provided by a small number of agencies, both governmental and others but are inadequate to meet the needs of the population.17 Residents of the Palestinian camp are refugees who originally came from Palestinian villages in waves since 1948 and settled in neighborhoods, which carry their villages’ names. According to a report by N Sarieddine and S Knox (May 2008), Shatila is crowded with an estimated population of 8000–12 000 living in breeze-block buildings lining extremely narrow alleys, where water almost always runs underfoot and the sky is crisscrossed by electricity wires. During the war of the camps in the 1980s, the majority of the camp was destroyed and reconstruction was unofficial and haphazard until the 1990s. Inhabitants of the camp have high unemployment and face economic hardships as a result of state-imposed legal and political restrictions. As is the case in all refugee camps, the physical infrastructure, health care and education are inadequate, despite the presence of many non-governmental organisations (NGO).

Research study

At the American University of Beirut (AUB) where this research is undertaken, the IRB reviews all research proposals that involve human subjects to ensure adherence to international standards of ethical conduct. Approval by the IRB is a precondition for conducting any study undertaken at the university.1 The authors applied to and received approval from this board to conduct the two phases of the research study in question. Both phases of the study were preparatory to a randomised controlled trial to test the impact of a social skill-building intervention to improve the mental health of 600 refugee youth through working with the youth, teachers and parents.

The first phase involved clinical validation of a culturally sensitive mental health instrument (the Arab Youth Mental Health (AYMH) scale) to measure mental health of Arab youth and took place in Borj Barajneh. The instrument was an outcome of an extensive search of validated instruments used in regional and international settings, adapted to meet the needs of Palestinian youth, 10–14 years of age. The AYMH is a 21-item scale focused on screening for common mental disorder, and thus includes items relevant to anxiety and depression. It is not meant to be diagnostic, rather epidemiological. The 21 items are each rated on a three-point scale from always, sometimes, to rarely. The clinical validation was the final phase of psychometric testing of the AYMH scale, and had been preceded by content validation, construct validation and internal consistency reliability testing. Informed consent was required as part of this study to validate the scale. Approximately 150 youth were identified with the help of three social workers from a local Ministry of Social Affairs centre, who were hired and trained on ethical principles and procedures including seeking consent and assent. The social workers were familiar with the community and accessed the homes in the neighborhood to recruit the youth. After their parents’ consent and their own assent, the youth were administered the mental health instrument and then underwent a clinical mental health assessment conducted by a psychiatrist.

The second phase took place in Shatila to pilot test all aspects of the actual intervention trial on a smaller scale. One hundred Palestinian refugee youth attending a United Nations Relief and Works Agency (UNRWA) school were involved in the pilot process and participated in a small number of mental health promotion activity sessions. The objectives of the pilot programme included to test the logistics of the recruitment process and the acceptability and appropriateness of the selected informed consent-seeking process. The researchers themselves conducted the pilot recruitment and obtained consent and assent from parents and youth, respectively, at their homes, accompanied by representatives of local Palestinian NGO.

The research experience reflected on in this paper stems from the researchers’ observations. The research team of health promotion and health education backgrounds and experienced in community-based participatory research led the study in the Lebanese community of Borj el Barajneh and the pilot project in Shatila camp also in Beirut. The researchers reside in Lebanon and are knowledgeable of the social context and speak Arabic fluently. The fieldwork process was enhanced by their collective social and theoretical capacities, familiarity with the community contexts and their awareness and commitment to social justice issues and ethics. The researchers’ commitment to a participatory approach and ethical behaviour contributed to developing an eye for detail from the fieldwork.

A community coalition composed of the research team together with youth, representatives of local Palestinian NGO and UNRWA staff prepared the consent procedures and forms. The research team prepared and conducted an intensive training for the social workers who helped recruit Lebanese youth for the validation of the mental health scale. Through a division of labour assisted by the coalition, the research team conducted the recruitment process in the Palestinian camps. During these home visits to seek consent from the parents, the research team took both mental and written notes about the process and issues that they felt needed to be raised for discussion among the team, such as the place and timing of visits, the number of researchers seeking consent and their gender, length and style of conversation, as well as the flow of information in the consent forms. The recurring themes from these observations are discussed below.

Challenges to seeking informed consent

In both research study phases, the researchers noted a number of challenges to obtaining adult consent and youth assent. These challenges will be reviewed as they pertain to the five elements of informed consent: disclosure; comprehension; capacity; voluntariness and consent. This issue of information provision and who gives consent in a patriarchal society is related to power and, as will be described below, affects all aspects of the informed consent process.

Disclosure

Relevant guidelines stipulate that before commencement, researchers should review with the potential research participants all the objectives of the study, explain the potential risks and benefits associated with the study and answer their questions. In some aspects of this research, disclosure was poorly practised and research participants were provided with incomplete information. In phase 1, despite training of social workers on the importance of being thorough and accurate in the description of the research while recruiting youth, the researchers at the centre following up on recruitment discovered that a large number of the young recruits who were coming to take part in the validation of the mental health scale were not able to describe clearly the purpose of their visit. When the children arrived at the centre, they were asked why they thought they were there. Their answers revealed that they did not have all the necessary information to assent; for example they stated: “I was told to answer that I am coming for a check-up”. This could be due to the fact that the topic, mental health, is a social stigma, and the social workers felt uncomfortable discussing it with people because of its sensitive nature. Also, it seems that the informed consent was not valued by the social workers despite training and discussions with the researchers. In a discussion with one of the social workers about the progress of the fieldwork, she stated, “In our societies, people don’t know about this [consent and assent] and don’t really care. I am telling you from our previous experience.”

There were also challenges to satisfying the comprehension requirement of an informed consent process. Comprehension requires that the researchers ensure that the information received has been understood. Despite efforts to reach full disclosure with youth and their parents by the researchers, it was often difficult to simplify the terms and make them comprehensible in lay terms to both parents and children, as noticed in the pilot phase. The complexity of the intervention research design, a randomised controlled trial, and the necessity to explain the reasons for control and intervention groups and randomness of selection increased the challenge to comprehension. This was often exacerbated by parents’ low educational levels.

Capacity suggests that identification be made of the cognitive ability of the participant to comprehend and provide consent. There were two main issues here. The first was related to who can provide consent for the child. This decision was complicated by: patriarchal rule in which only fathers can give final consent; extended families, or complex families, such as fathers having remarried with the child living with him and the step-mother; cases in which the parents were deceased. The second was due to the social conceptions that youth are not capable of deciding what is best for them. This perception was held both by the social workers as well as the parents, and resulted in less information being provided to the child than needed to make an informed decision.

The lack of voluntariness mostly threatened the informed consent process. In phase 2, one of the researchers accompanied by an employee of a local Palestinian social service agency was greeted by the mother who hastened to give her consent to allow her daughter to participate before the researchers completed their explanation: “Miss Zaynab knows, whatever she asks, we will do.” In addition, the crowded setting of the households meant that assent was taken with the youth most often in the presence of their parents, which also affected voluntariness. In fact, this was obvious in some cases when parents sensed hesitation from their children and started to negotiate with them in a manner that nullified any possible voluntariness.

After disclosure, comprehension, ensuring capacity and voluntariness, obtaining actual consent from the parent was complicated at times by the presence of more than one “guardian”, especially in extended family structures, as mentioned above. Also, in more than one instance the messages that the researchers received from the parents about consenting to their child’s participation in the intervention were inconsistent. For example, at times, the mother’s consent would not be met with her husband’s consent, thus invalidating it.

Obtaining actual consent or assent may very well be unrelated to the quality of the information provided and intention to participate, but more an outcome of the chance for a young person to practise making a choice in a context in which children are not given choices or consulted for their opinion. In fact, according to the researchers seeking consent, a number of youth refused participation when they were offered the opportunity to decline for the first time.

Discussion

The paper has presented several barriers to achieving informed consent in the full ethical sense. Suggestions for obtaining proper informed consent include involving senior researchers to ensure that the consent is taken appropriately,18 seeking consent with the help of locals,13 community consultation to facilitate particularly challenging situations and ensure trustworthiness,18 19 20 simplifying the technical jargon appearing in the form to reduce complicated language and to suit the context,5 6 7 16 21 and allowing sufficient time for the participants to review the information and to allow them to consider consent, especially when consent is sought for children’s participation.7 11 These suggestions pointed out in the relevant literature were applied to the best of the researchers’ knowledge and yet barriers to informed consent remained.

One may attribute these barriers to a number of factors in the sociocultural environment in both communities. First, these observations say a good deal about how society is organised, its values and how decisions are made. They suggest a possible mismatch between the well-intended IRB guidelines, originating in the west and the local community context. In many Arab societies, autonomous choices are absent. Arab societies are collectivist in nature,22 in which individuals are bound to others in a web of social relations. Individuals’ choices are affected and even diluted by this collectivism in which groups become significant for the transfer of information, laying out social norms, usually across family units.23 This means that despite efforts to create the opportunities for autonomous choices, a prerequisite for informed consent, researchers come across resistance because such opportunities rarely exist,24 especially for youth.

Second, in extended families such as these, a number of adults contribute to child rearing and become decision makers about issues related to youth.25 A grandparent, a step-mother or an older brother’s wife can contribute to the role of guardian. This complicates matters by presenting the researcher with more adults to ask consent from and whose opinions may be influential in one way or another in the decision. Also, the family, widely accepted as the basic building block of Arab societies,26 is a site in which attitudes and behaviours are socially reproduced. Guardians’ reactions about their children’s autonomy indicate that they believe that they are the only ones whose opinions should be solicited for decisions regarding their children.

Third, also from a western viewpoint, comprehension is enhanced through the extensive information given to the participant to make informed choices. The information the researchers were providing was overtly and on purpose very thorough, which ironically, although being ethical practice, in some instances led to complicating the informed consent process and made it more time consuming and painstakingly detailed for lay persons with varying levels of literacy. The information sheet, which showed details of the project in more than one place to ensure comprehension through repetition of key points, seemed tedious for the participants. In addition, as Del Pozo and Fins23 rightly point out, in disadvantaged communities in which much research has taken place without benefit to the populace and without informed consent, detailed information in the process of obtaining consent may be counterproductive as it may raise suspicion as to the motives of the researcher in providing too much information when only a little (or none) is required.

Fourth, the hierarchical power relations inherent in the social dynamics are complex. Power relations deeply rooted in the local social structure together with those created by the presence of researchers from an American institution play out within the family, and between the family and the agencies providing services. An interaction between the two parties, in which consent is sought, may result in non-voluntary consent. At other rare instances, refusal to participate may be driven by the unfavourable perception that the camp residents have of the researchers because of the university’s affiliation to America, which has a history of political interventions in the region and is not trusted for supporting Israel. A small number of parents actually voiced their suspicion of the AUB’s motives in this research. Also, social workers and NGO are perceived to be more knowledgeable and in general regarded in the society as protective of the participants’ rights and interests. For this purpose any suggestion or activity supported by NGO or AUB could be immediately regarded as beneficial and did not require questioning or clarification.

Fifth, exacerbating the social obstacles to obtaining voluntary assent and consent is the physical environment of the households. The crowded living conditions within the homes prevented retreating to a secluded room to request assent privately from the youth. In all cases, private discussions with the child were nearly always impossible. As an indicator of the crowding in the camp, a number of families were reported to have heard of the project from their neighbours who live right next door. Some parents actually wanted their children to join any programme because they believed that if anything, it would be better than staying at home and playing in the streets, a situation in which voluntary consent would be coloured by the difficult living conditions of a refugee camp.

Sixth, barriers to applying IRB procedures in seeking voluntary consent in underserved areas may be related to inadequate universal social and healthcare services. For instance, participants may confuse a research project that tests the impact of a certain health interventions with a health service. This tends to happen more in countries or communities where participants lack equitable and affordable healthcare services15 27 and where consenting to the participation in a study may be perceived as an opportunity to access a possible treatment without careful weighing of risk or benefit. In all the instances mentioned above, refusal seemed more difficult than consent. Refusing to participate may be perceived as influencing participants’ access to current social services or denial of possible benefits. The social programmes of health care, educational support, literacy programmes and home visits provided by the Ministry of Social Affairs centre are the only public services for the Borj area. It is also well known that the agencies serving the pilot study community and other Palestinian camps are the most active, despite their low financial capacities, in service provision in the absence of any state support and the diminishing UNRWA funds. People have shown their willingness to consent to participate in the anticipation of accessing such services through the study. Parents of many of the children involved in phase 2 asked if through the project, their children and one of their siblings’ needs would be met, such as remedial academic lessons, mental health counselling or other specialised medical care, not related to the objectives of the project. To other parents, the research study presented an opportunity to complain about current services and economic hardship.

Lessons learnt and implications

Our experience suggests that implementing informed consent procedures effectively is subject to a variety of contextual circumstances that need to be considered and dealt with if adherence to the autonomy is valued. We depict these specific circumstances in a flow chart (fig 1) that lists the issues to consider and possible solutions. The flow chart also allows for consideration of other issues that may arise in difference contexts than ours.

Figure 1

Contextual factors influencing informed consent.

As a result of observations made in our context, several measures were taken to enhance the informed consent procedures in the full trial. In order to enhance comprehension, the project was explained twice, once in a group meeting at the school using pictures and photo presentations rather than just words, and subsequently in individual households while seeking consent and assent. To decrease the power dynamics, consent seeking was conducted by Palestinian youth from the Borj camp where the trial was based. They were trained extensively in the process of informed consent. This facilitated entry into people’s homes, particularly important in cases in which parents doubted the agenda of the project being conducted by an academic institution in an era in which communities are increasingly tired of being “used” for research. Although there may be some intrusion on confidentiality given that the youth might know the family, the researchers felt that this was less dangerous than that of coercion resulting from power relations.

As we were committed to decreasing possible coercion in the assent process, and as it was culturally inappropriate to ask the youth to move to another room in the presence of the parent, the researchers decided to move the location of assent seeking to the school before the administration of the pretest. Neither the school administration nor the parents were present. Researchers used oral consent and documented this by signing the form themselves to document receiving consent from the adults and assent from the youth.

This was a result of the researchers’ awareness that requesting people’s signatures may be alarming for the participants, because in this social context signatures are binding and are only used for approving transactions of a formal nature. IRB’s approval of obtaining consent orally from parents and children was necessary and facilitated the informed consent process despite the many challenges discussed above.

Despite the challenges of achieving “true” informed consent in the field, the researchers argue for the necessity of upholding ethical principles in research in as much as they are appropriate to the local context within which consent is sought. The detailed guidelines developed in the west to guide research reflect values and contexts that may not be fully applicable to non-western contexts and may result in sensitive situations. More reflections and dialogue are needed among researchers in developing world contexts on challenges of abiding to IRB standards and possible adaptations of revisions that maintain respect for persons, autonomy (of whoever is most appropriate in the context) and justice. Such dialogue is even more necessary for research with young persons. The process of informed consent would without doubt be enriched by further reflections from research analysing environmental, social and cultural barriers.

Acknowledgments

The authors would like to thank Diana Jamal, Research Assistant at the Faculty of Health Sciences, for her support in developing the flowchart.

REFERENCES

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Footnotes

  • Competing interests None.

  • Provenance and Peer review Not commissioned; externally peer reviewed.

  • Ethics approval Ethics approval was received from the IRB of the American University of Beirut to conduct the two phases of this research study.

  • Patient consent Obtained.

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