Ethical challenges of conducting health research in

Ethical challenges of conducting health research in UK school setting Linda Milnes and Sarah Kendal

Abstract

This paper offers guidance for novice nurse researchers on the ethical and methodological challenges of conducting health research in high school settings. Over the course of two studies in UK high schools with students aged 11–16 years, the authors encountered common ethical and methodological challenges. This article draws on these studies to build a critique of approaches to health research in school settings. Issues of consent and assent, confidentiality and participation can highlight tensions between the expectations of schools and health researchers. In this context, feasible research designs raise complex ethical and methodological questions. Ethical and methodological norms for health research may not be suitable for high school settings. Successful school-based health research designs may need to be flexible and responsive to the social environment of schools. Key words: Research n Health n Schools n Ethics n Methodology n Rigour n Consent n Confidentiality

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hildren and young people have the right to participate in research (United Nations (UN), 1989). Challenges relating to access, recruitment, and data collection in research with children and young people have been widely reported (Farrington et al, 2000; Rowling and Jeffreys, 2006; Kirk, 2007; Humphrey et al, 2010). However, there has been little exploration of the specific ethical considerations of school-based research. High schools are often identified as appropriate settings for research, facilitating opportunities to collect data efficiently with a large, representative group of young people (Testa and Coleman, 2006). This paper discusses tensions between school cultural norms and the ethical issues of consent, confidentiality and voluntary participation that face health services researchers in schools. These tensions highlight the interplay of methodology and ethics in school-based health research. The discussion draws upon two qualitative health studies conducted by the authors (Kendal, 2009; Milnes, 2010) in urban, state-funded, non-selective high schools in the UK.

Linda Milnes is Lecturer, Children and Young People’s Nursing and Sarah Kendal is Lecturer, Mental Health Nursing, School of Nursing, Midwifery and Social Work, University of Manchester, Manchester. Accepted for publication: January 2012

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The studies were conceived and managed independently of each other. Milnes (2010) conducted three nominal groups to gain the consensus of students (aged 13–18 years) on an intervention for improving communication in consultations with health professionals. Kendal (2009; Kendal et al, 2011a; b) explored the mental-health needs of students through individual interviews with students (aged 11–16 years) and focus groups with students and staff. In sharing experiences of conducting this work, the authors found that the ethical and methodological challenges were strikingly similar across the two studies. This paper intends to inform health research methods that are suitable for the real-world setting of schools, and capable of supporting the ethical and methodological standards appropriate for contemporary health research (Popay et al, 1998). Children and young people involved in health research are often in a position of particular vulnerability regarding persuasion, adverse influence and harm (Hill, 2005). In healthcare settings, this vulnerability and, indeed, the rights of this population are protected by guidance for ethical research with children and young people (McIntosh et al, 2000). The Royal College of Nursing (RCN) (2009) offers further ethical guidance for nurses conducting research. The common principles of consent, confidentiality and voluntary participation are also expressed in guidelines supporting educational and social research (British Educational Research Association (BERA), 2004; Economic and Social Research Council (ESRC), 2011). It is well known that applying these principles in the real world can be difficult (Inchley et al, 2000). The authors’ experiences of conducting small health research studies in high schools showed that in this setting, particularly if operating without the support of a research team, health researchers can feel like intruders, facing unexpected ethical and practical problems that arise from the unfamiliar environment (Kendal, 2009; Milnes, 2010).

Consent Milnes’ study (2010) was conducted in one school and Kendal’s study (2009), across three schools. In these research projects, the consent process relied on the student bringing home a study information letter from school, which invited the parent or carer to contact the school if they did not wish their child to participate. In a school environment, it is common practice to use an opt-out system in order to gain non-written carer consent for research (Ward et al, 2004; Junghans et al, 2005; Campbell et al, 2007; Boddy and Oliver, 2010). This is the process that was advised by managers in each school. However,

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research ethics it would not normally be acceptable practice in UK NHS settings (McIntosh et al, 2000; RCN, 2009). Assent is the agreement to participate in research obtained from a minor and, unlike consent, has no legal status (Gibson and Twycross, 2007). Guidelines for the participation of children and young people in health research require informed written consent from parents or carers and informed written assent from young people under the age of 16 years. The informed consent process aims to ensure that young people and their parents or carer/s receive clear and explicit information about the research study, facilitating their ability to make an informed decision about participation. It should include written and verbal explanations on potential benefits and harm, the purpose and detail of the intervention, the researcher’s name and details on how to withdraw (McIntosh et al, 2000). In some circumstances, it is acceptable that minors participating in health research can consent for themselves as long as it is clear that they understand what is being proposed (RCN, 2009). This judgement may be made by the researcher, often in conjunction with parents or carers (RCN, 2011). However, young people might struggle to make sense of study information and could misunderstand their right to decide whether or not to participate (Robinson, 2004). Written information may not be accessible (Bhutta, 2004; Lema et al, 2009). Good practice would also include additional practical ways of ensuring informed consent, such as providing potential participants with a detailed explanation, followed by an opportunity to talk through the study information. The researcher can check for signs of discomfort (e.g. indicated by body language) which may indicate withdrawal of consent or assent. Non-engagement should be respected as withdrawal, and consent and assent should be treated as ongoing processes (Hoagwood et al, 1996; Greene and Hogan, 2005; Hill, 2005; Blakemore and Choudhury, 2006; Boddy and Oliver, 2010). For the authors’ studies, these issues were especially pertinent because the students were diverse in terms of ethnicity, literacy and social background. Therefore, the authors attempted to be particularly responsive to nonverbal cues indicating they had doubts about participating. For instance, in Milnes’ study (2010), there was a policy of not following students up if they did not attend a meeting. In Kendal’s study (2009), however, students who had agreed to participate but then seemed unwilling to talk were invited to reconsider their decision, and some responded by terminating the interview. The validity of the opt-out system depends on two main assumptions: that no response from the carer indicates passive consent; and that passive consent is adequate. The strength of the opt-out system is that it may increase response rates in healthcare research, with low risk to participants (Junghans et al, 2005); yet, it is not always clear whether parents and carers actually receive sufficient information to make an informed choice (David et al, 2001). Both the Kendal (2009) and Milnes (2010) studies gained approval from a university ethics committee. Nevertheless, using opt-outs caused the authors some anxiety owing to uncertainty around whether parents and carers had agreed to students’ participation.


Teachers can be in a position of facilitating opportunities for researchers to approach and ask students to assent to take part in health research. In health settings, this would be the role of clinicians and parents or carers. Compared with parents or carers and health professionals, teachers may not have depth of knowledge about a student’s health history. This raises questions about their capacity to make a decision on the appropriateness of their students’ participation in health research. It also suggests that students could be in a position of vulnerability. It is, therefore, important that the health researcher has the skills for assessing a student’s competence to make an informed decision to assent, or can access suitable guidance from a skilled person. There are ethical and conceptual problems with taking assent from children and young people (Ward et al, 2004) in the context of health care or health research. In addition, there is a lack of legal guidance in assessing children’s competence to assent (Lambert and Glacken, 2011). An argument has been made that parents and carers should consent for their child except where the child is deemed competent, because taking assent can cause confusion and, potentially, friction, between the parent or carer and child (Baines, 2011). Asking young people to consent for themselves might be an alternative ethical research model that could work in educational, health and other settings (Santelli et al, 2003; Hester, 2004). These are issues that perhaps need to be supported by discussions between ethics committees, families and researchers. Appropriate guidance could promote consistency, reducing the potential for neglecting children and young people’s rights.

Confidentiality and privacy Confidentiality in research is a right of young people (Roache, 2008) and it is possible to protect their identities and contributions by collecting data in conditions of privacy. However, in the authors’ studies, there was a general lack of suitable interviewing space in the school buildings. On occasions when the school boardroom was offered up for research interviews, occupying semi-public spaces or rooms that were normally out of bounds appeared to unnerve students, as observed by their anxious body language and comments (Milnes, 2010). In contrast, some interviews were conducted in the corner of a communal area, compromising privacy (Kendal et al, 2011a; b). There is potential here for anxiety caused by an uncomfortable environment or lack of privacy. This can inhibit discussions and potentially expose participants to their peer group – a particular concern, given young people’s known sensitivity to peer group opinion (Heaven et al, 2005; Milnes, 2010; Kendal et al, 2011b). Data collected in such circumstances may then reflect a range of views that participants feel are socially desirable, rather than their genuine personal perspectives (Klesges et al, 2004). In a complex setting, such as a school, the removal of bias from research studies may be unrealistic. Instead, qualitative methodologies require that bias is acknowledged and explored in research reports (Popay et al, 1998). The lack of private spaces in schools may reflect a culture that values transparency. It can be characteristic of schools to be quite open with information. For example, students

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have reported that staff may attempt to conduct ad hoc personal conversations with them in public spaces such as school corridors (Kendal, 2009). In the authors’ research, it was found that some school staff felt that it was in the best interests of the school community, to restrict opportunities for private meetings between students and researchers. Health researchers can be perceived as strangers, which in fact they are, with little relevance to the social culture of the school (Inchley et al, 2000). There is a possibility that if they defend data confidentiality they will be perceived as uncooperative. A good rapport with school staff can create opportunities for discussions and shared decision making, increasing the acceptability of the study research methods. Transparency and openness within school environments may reflect a commitment to following policy guidelines. In the UK, information sharing is proposed as a key safeguarding strategy (Department for Education and Skills, 2004; Department for Education, 2011). Arguably, therefore, methodological challenges facing health researchers in high schools stem from an organizational value system that is consistent with policy frameworks. From the perspective of school staff, limiting researchers’ access to students, especially if they are asking for privacy, is good practice because it protects students’ welfare. However, from the perspective of a researcher used to collecting data confidentially, lack of privacy is a problem that can compromise the feasibility and acceptability of the study, and potentially challenge methodological rigour. The reality of data collection in the authors’ studies was very different from what was anticipated but in order for the research to take place at all, the authors were aware of the need to adapt to the setting. This is not unusual, but novice researchers may feel under pressure to adhere to proscribed research methods. Time spent learning about the culture and values within a proposed research setting can help a field worker make sense of how privacy is understood and prepare them for the impact of the real world on the research design.

Participation in research There is a power imbalance between researcher and participant, particularly in the case of young participants (Alderson, 1995; Boddy and Oliver, 2010), which can be improved through the choice of research methods. For instance, group data collection methods might reduce the power differentials in research with young people (Morgan and Krueger, 1993). In schools, group discussion is a routine activity and, therefore, a familiar setting for students that could put them at ease. However, peer values appear to be a powerful driver of young people’s attitudes and actions (MacLean et al, 2010). Therefore, social pressures are likely to influence the data collected from a peer group discussion of young people, even in confidential settings. This is another contextual influence that should be explored during data analysis (Popay et al, 1998). The authors’ research projects illustrated that individual teachers were quietly acting as gatekeepers by promoting the research to certain individuals—such as articulate, older students—and by definition, steering other students away from them. In effect, school staff had considerable control

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over access, recruitment and sampling. The authors were aware, however, of their status as outsiders and the fact that being sensitive to the way things ran in the schools was an unspoken condition of access to school communities. Therefore, it was concluded that this gatekeeping must be accepted despite the implications for the data, in order to ensure progress of the research was not impeded. Practitioner gate keeping is recognized as an important influence on health services research with vulnerable populations (Moore and Miller, 1999). A similar dynamic can be seen in school-based research. A school’s approach to caring for students is reflected in its organizational and social culture (Maguire et al, 2010). Teachers and school managers assume responsibility for the welfare of students while they are at school and can influence the decisions about whether to introduce a study into the school, what access to students will be provided, and where and how data will be collected. Adults involved in recruitment of young people to health research studies may consider gatekeeping as a means of protecting them from potentially harmful effects of research participation. Therefore, the gatekeeping practices the authors observed in schools seemed to perform contradictory functions of protecting young people from potential harm, while reducing opportunities to participate in research. This suggests a difficulty in balancing a young person’s right to be protected with their right to be involved in decision-making processes (UN, 1989). Equally, coercive influences within a school setting can diminish the extent to which young people make informed and independent choices about taking part in health research. Just as in health settings, institutional norms of compliance may act as coercive factors, together with explicit and implicit expectations of school staff. Power dynamics within schools are likely to influence the decisions and actions of students who are considering participation and engagement in research.Young people’s experiences of, or anxieties about, their own health or health care could be a contributing factor. There is potential for coercion if a young person does not want to take part but their carer has already agreed (Brody et al, 2005). The prospect of a reward, or the desire to please adults (health practitioners, researchers, teachers or carers), could also affect decisions about participating. There are many factors that could affect a student’s decision to participate in school-based research and students may not articulate these clearly. By working together, researchers and school staff can help students to understand their rights with regard to participating in research.

Conclusion The authors have presented the reflections in this article in order to support nurse researchers embarking on projects in school settings in the UK. Consent, confidentiality and participation in high-school-based research are complex issues with methodological and ethical implications. However, solutions are necessary as young people have the right to express their views and participate in societal decision making (UN, 1989). Research context is an important and influential process on the development and delivery of interventions (Popay et al,


research ethics 1998; Campbell et al, 2007). The ethical and methodological issues are interdependent because by definition, ethical research is methodologically rigorous (Popay et al, 1998); and methodological problems require ethical solutions (Hill, 2005). Health services research in the UK complies with stringent ethical processes for obtaining parental consent and children and young people’s assent, as well as recruitment, data collection and protecting confidentiality. This is an extra layer of protection, which does not necessarily apply to research in schools. Differences between ethical procedures within and outside health contexts mean that a young research participant might encounter bewilderingly inconsistent approaches to the protection of their welfare, depending on the study context. Tensions between the cultures of health services research and high schools can threaten to destabilize health research in schools. The values and expectations of both cultures could be brought together to inform new guidelines that encourage young people to participate in health research in schools, leading to better decision making in matters that concern them.

Recommendations for conducting health research in high schools Ethically and methodologically sound research studies in schools can be facilitated at theoretical and practical levels. At the planning stage, a pragmatic perspective on research design could embrace, rather than fight, the tension between school norms and the expectations of health researchers. This might enable practical strategies that are sensitive to the needs of both cultures. Developing an understanding of the culture and processes unique to a school setting is a key task that has potential to underpin the other research processes. Prior to the start of the research, time spent building effective working relationships with pupils and teachers in the schools may help integrate researchers into the school community and enhance the feasibility and acceptability of the study. A valuable development might be finding a way to harness the efficiency of the opt-out system, without compromising the rights of students or parents, carers and guardians. Incorporating some flexibility into applications for ethical approval could accommodate idiosyncratic conditions for recruiting students and collecting data. Information sheets could describe how data will be collected, so that participants have prior warning. Ultimately, collaborative research planning and design could inform mutually acceptable guidelines for research governance BJN regarding health research in high schools. Acknowledgements: Linda Milnes’ PhD was supervised by Professor Peter Callery and Dr Linda McGowan and Sarah Kendal’s PhD was supervised by Professor Peter Callery and Dr Philip Keeley (University of Manchester, UK). Conflict of interest: none. Alderson P (1995) Listening to Children: Children, ethics and social research. Barnardo’s, London Baines P (2011) Assent for children’s participation in research is incoherent and wrong. Arch Dis Child 96(10): 960–2 Bhutta ZA (2004) Beyond informed consent. Bulletin of the World Health Organization 82(10):771-7


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Key points n Children and young people have the right to participate in research n School personnel and health researchers are likely to have contrasting perspectives on issues of consent and assent, confidentiality and student participation n By working closely with schools, health researchers can gain a genuine understanding of customs, practices and values to inform mutually acceptable, practical, research designs

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