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Intention/aims of the meeting
Effective and appropriate processes for seeking consent and community engagement (CE) in health research contexts require the balancing of internationally recognised standards of good practice with responsiveness to local context. Relatively few sites have systematically documented the interventions that they have developed, the issues they have faced, and the implications of these experiences for research ethics policy and practice. Whilst sites that have begun to share practice have highlighted both significant benefits and problems in their initiatives, there is still a general lack of easily accessible advice regarding introducing and sustaining CE initiatives, and strengthening consent practices in developing countries. The importance of carefully designed empirical social science research on CE and consent is increasingly recognised and there is a small but growing body of such research which is of value to review and learn from.
The Wellcome Trust (WT) funded a four-day international collaborative workshop in Kilifi, Kenya, from the 28th of February to the 3rd of March, 2011, bringing together leading groups engaged in research and practice on CE and consent in collaborative global health research, with the following aims:
1. Share ideas, experiences and needs regarding CE and consent interventions, including monitoring and evaluation, and related social science methodologies;
2. Review ethical theories and approaches, and recent CE and consent guidelines, and consider how these frameworks can be incorporated into implementation activities and social science studies;
3. Develop proposals for future research, including comparative studies, and consider transferability of findings of studies conducted to date;
4. Discuss the possibility and practicalities of establishing an international network of groups working on CE and consent which might, for example, agree to develop on-line collaborative resources for the sharing of experiences and of training materials.
Participants
30 invited individuals with an interest in CE and consent from institutions all over the world attended the meeting, including universities and research centres in South Africa, Malawi, Kenya, Botswana, Brazil, Uganda, Burma, Cambodia, Thailand, Peru, Bangladesh, Canada, and UK. Workshop presentations and discussions were enriched not only by the diversity of contexts in which participants live and work, but also by the breath of disciplinary backgrounds and perspectives that were represented, including bioethics, philosophy, law, anthropology, human geography, psychology, tropical/clinical medicine and clinical trials, science communication, education, gender and development, theology, and health policy.
In addition to the above 30 participants, five individuals linked to a film project were separately funded by the WT to attend the meeting. This group drew on the workshop discussions to film ‘talking heads’ and to plan a participatory film project; both of which will feed into a WT funded workshop on CE that will be held in Thailand in June 2011. Members of the film project also contributed to the meeting through discussing the potential of participatory media production as a tool to support strengthening consent and CE activities.
Content and emerging issues
The workshop programme ensured that the diversity of experience across contexts and theoretical backgrounds was shared and drawn upon. A relatively packed programme of presentations about experiences with seeking consent and CE on days 1 and 2 informed more open discussion and debate on days 3 and 4. In addition to highlighting some key issues and ideas for both CE and consent separately, discussions identified a range of cross cutting themes and needs, including the need for but complexity in evaluating interventions.
Community Engagement: goals, values and practical experience
A rich range of experiences in designing and implementing CE strategies were presented, including the experiences of designing such strategies for institutions, for specific studies, for certain types of research (notably HIV), and the overlaps and coordination of strategies across these forms of engagement. Many reasons that CE is considered valuable were presented, including:
o Improving health and health care provision
o Improving understanding and consent
o Building partnership and trust between researchers and communities
o Improving the quality and success of research
o Building social capital – putting communities in a better position to understand and engage with research and service providers
o Obtaining community assent or permission for research
o The intrinsic value of engagement: respect, signal of regard, right thing to do, accountability
o Identifying, addressing and agreeing on how to address issues with an ethical component, such as appropriate levels of benefits in a study
o Providing a forum for the making of demands, asking of questions and clarification of roles
o Countering exploitation
o Improving the capacity of researchers to understand the concerns and values of community members
o Gaining evidence about community views to solve a research ethics committee problem
o Because it is a requirement of ethics approval or funding
The above goals or values can be broadly divided into those that are instrumental (e.g. engaging communities to improve the quality of research) and those that are intrinsic (e.g. engaging communities because this is a mark of respect), with many groups including a mix of both within specific initiatives or strategies. Notable however was that the aims of strategies were not always clearly articulated, and that there can be tensions between differing aims. The importance of greater clarity was highlighted because of the potential for negative impact in CE (as with all social endeavours), and the impossibility of CE solving all problems in research (e.g. background injustices, unfair distribution of benefits in research).
In terms of discussing both the experiences and sets of values inherent in CE, it was clear that there is considerable complexity around the core components. Definitions of community can be based on geography, special interests or goals, or similar situations and experiences. For individuals themselves, community membership may be choice based, or linked to innate personal characteristics, with membership typically being in multiple communities and shifting over time. In health research, definitions can be internally or externally defined, but in much non-participatory research, relevant communities, at least initially, are often defined by those involved in the research (i.e. external), and therefore are related to the nature of the research activity and institution. The distinction between ‘community’ and ‘public’ engagement, including for example where the media and national level interest groups fit into engagement plans, has implications for the scope and type of engagement activities considered.
Engagement with communities can be formal and informal, with potential formal interactions including communities coming into research activities (e.g. visits, exhibitions, student placements), and research staff and representatives going out to be with communities (e.g. participatory training, science cafes, drama, school visits). Activities can be continuous or once off initiatives, and may be led or coordinated by members of a research team, or by a relatively separate group of community liaison officers or social scientists attached to the research centre. Other players taking on a key role formally or informally at the ‘interface’ between research institutions and communities include fieldworkers, Demographic Surveillance Systems (DSS) data collectors, and various forms of community representative groups including KEMRI Community Representatives (KCRs – a network developed at the KEMRI-Wellcome Trust in Kenya), Community Advisory Boards (CABs), or Community Advisory Groups (CAGs).
Cross-cutting the complexity of definitions of community and engagement were the different uses of the word ‘representation’ in community representative groups. In some cases representatives were selected to be able to ‘speak on behalf’ of a particular community; in other cases individuals were considered representatives in terms of having similar characteristics and views to others in the community of interest. Also noted was the importance of carefully considering how to deal with differences in view points and recommendations within and across ‘representative’ groups.
Consent: beyond minimalist legal notions
Some aspects of consent can be considered a part of CE, and strengthened consent processes were highlighted as an intended outcome of some CE activities. However several presenters focussed on the design and conduct of consent processes as a distinct activity, including considering mechanisms for improving such processes.
Although consent is a focus of international and national requirements, guidelines and activity, it remains a problematic and contested area in terms of who should be involved in the designing and giving of consent, and what requirements need to be satisfied for a consent process to be locally appropriate and ethically acceptable. Specific issues that presenters raised about seeking consent included determining what information about a study it is most important to provide to participants, and the best means of determining if that information has been understood. CE activities could potentially provide insights into populations’ understandings of research institutions and activities, the forms of information most needed, and the ways in which potential participants may interpret information about a study. Issues were also raised about the extent of researchers’ responsibilities to ensure that consent is voluntary, and how to respond to internal and external constraints on free decision-making. A presentation on ‘silent refusals’ – where participants do not want to participate but feel unable to or choose not to verbally express this – illustrated the complexity of seeking consent in practice, and the importance of incorporating an understanding of this complexity into conceptualisations of consent.
In terms of strengthening processes, there was some discussion on improving consent forms, although it was recognised that consent forms are only a small part of a far broader process. Overall, there was agreement that it is important to move beyond minimalist legal notions when conducting and researching consent, and to recognise that consent is rarely a one-off activity; more often it is part of relationships that begin before a specific study is introduced, and that change over the course of and after the completion of studies.
Cross-cutting issues in consent and CE consent activities
Given the overlaps between consent and CE, in terms of aims, activities and the players involved, many issues raised at the workshop were relevant across both topics. These included the important influence of gender, power and trust relations, all of which might work in complex and unexpected ways, and in ways that are constantly shifting over time. Also highlighted was the centrality of context – socio-cultural, political, institutional and study-related (age and gender of participants, how many sites, and what stage of the study) – in terms of who the key communities might be, and how consent and CE activities might be defined, implemented or perceived. It was clear that all of these influences have to be considered, and goals and planning of activities clearly articulated, in an effort to ensure that both CE and consent activities do not fall into the trap of becoming simplistic ‘tick-box’ activities, or ritualistic initiatives that add relatively little value. Activities have to be responsive to continuous change in contextual influences, and therefore require monitoring and reflection over time. Also of cross-cutting interest was the potential to share more about, and learn from, the different ‘position’ of community liaison groups within programmes: groups are embedded or incorporated into studies and institutions in different ways, with implications – in both positive and more challenging ways – for those roles.
Exploring and evaluating community engagement and consent
Across the presentations, it was clear that researchers were drawing upon and working with a whole range of social science methods, often several in combination. This included combinations of both qualitative and quantitative methods; and drawing upon more standard qualitative interviews (individual and group interviews and observations), as well as more participatory and deliberative approaches. There was a clear interest and need for more social science research, including formative research to inform potential future initiatives, and more research evaluating how well these initiatives are working.
With regards to designing and evaluating CE activities, it was recognised that social science to date has suffered from the activities themselves being relatively complex and unclear; often in the absence of clearly articulated aims. The need to move towards developing clearer conceptual frameworks to help unpack what is expected to be impacted upon and to consider appropriate methodologies was highlighted. Two very different frameworks were presented at the meeting that might be of value in future evaluations. One framework presented a range of ethical dimensions to community engagement, to facilitate considering the quality or effectiveness of CE in relation to each dimension. The other outlined the various implementation activities expected to interact to impact on the key outcomes of interest, which included nature of relationships between research institutions and populations, and improved mutual understanding. Regardless of the framework developed, it was recognised that interventions rarely have a linear relationship between implementation and impact, and that it is typically impossible to know what would have happened in the absence of an intervention. Understanding of some elements of interest in CE evaluations, and how all of the different elements come together to form a whole, therefore requires methodological creativity and innovation.
With regard to consent, it was noted that although this has been the subject of more published empirical research than CE, there is still relatively little information about issues arising when seeking consent and how best to tailor consent processes to specific contexts. The role of rapid assessments incorporating a range of qualitative data collection methods were discussed at the meeting as a valuable approach for identifying issues arising when seeking to design contextually-appropriate consent processes. Such methods have considerable potential for adaptation in a wide range of research settings. More specifically, regarding what needs to be understood and on adequate understanding, suggestions included having a workshop involving trial team members and ethicists to identify key informational requirements for a given study, and including as an indicator of an adequate consent process that a participant does not regret his or her participation. The latter implies that the information giving process facilitated adequate consideration of the personal implications of involvement.
Across all types of research in CE and consent, the importance of considering dynamic trust and power relations, and research group positionality, was emphasised. It was agreed that recruitment rates, particularly in the absence of good quality information on participants’ or non-participants’ understanding and voluntariness, are in themselves inadequate indicators of CE and consent ‘success’. Also noted was that some key areas of interest – for example respect and dignity – require careful conceptualisation and may be particularly difficult to measure. Theoretical frameworks of interest included cooperative conflicts models, consideration of patient-provider power relations, and trust literature building ideas around aiming for ‘a healthy mistrust’ between research institutions and communities. Regarding positionality, there was no best set up identified (insider/outsider). Instead, it was recognised that these positions change over time and in relation to different individuals or groups, and that there is a need for reflexivity and for enabling a range of positions where feasible.
New approaches in empirical ethics?
Much of the work presented at the workshop could be defined as ‘empirical ethics’; i.e. a research strategy that combines the collection and analysis of empirical data with ethical analysis ‘in order to make normative claims’. There was valuable debate as to how normative much of the social science presented was, and regarding how different empirical ethics really is to other strands of social science with an advocacy goal. Nevertheless, an overview of different forms of empirical ethics, and – given the limitations of current approaches – a suggestion for building up new approaches where normative argument and justification are imported directly into the process of collecting and analysing data, was informative. Examples of such approaches were presented in the workshop and included:
o Grounded moral analysis (where data analysis and normative work are undertaken alongside data collection to ensure that ethical analysis is actively incorporated into the empirical process);
o Moral conversation (developing a deliberative forum for stakeholders to enter into an evaluative conversation about relevant ethical issues); and
o Moral participation (the researcher experiences the practical context, personally reflecting on, and seeking to resolve, in situ, ethical issues as they arise).
Agenda for action
Two of the workshop objectives were related to future activities, including developing proposals for future research, and development of an international network. On Day 4, discussions from days 1-3 were drawn upon to brainstorm a range of potentially interesting areas for future research. Ideas included research around:
o Clarifying the goals and value of CE, and how these might differ in different contexts. It was recognised that answering this question could draw on a range of approaches, including involving those involved in CE in bottom up deliberative processes in different contexts, and more philosophical analyses. Considering the appropriate mix of methods would in itself be a valuable output. Related work is already being conducted by several groups, and is likely to be taken forwards in planned proposals. Such work could help group CE goals/values, inform debates on if and when CE should happen, and in what form. Recommendations are expected to differ for different types of research (e.g. emergency research versus community based trials involving well children) and in different contexts (politically unstable or mobile populations versus relatively stable populations).
o Comparing community engagement activities and impacts across different types of research and in different contexts. Linked to the above research activity is the need to evaluate how well community engagement activities currently being conducted by research groups and studies are working. This would require clarifying and comparing the goals and underlying values of current activities, and therefore the intended or expected outcomes. This work would benefit from building up conceptual frameworks, including through drawing upon those presented at the workshop. These frameworks should include consideration of responsiveness to local populations/communities, and would facilitate cross-site comparisons. Several sites have begun to discuss the possibility of taking forwards this work.
o Incorporating relational aspects of consent more centrally into consent plans and evaluations. Clearly illustrated over the course of the workshop was the central but complex influence of trust and power relations on consent processes on the ground. Given their fundamental influence on the functioning of consent processes, these relational aspects of consent forms need careful attention in studies on informed consent, including asking: What are these relational influences? How do they work? What are the implications for the conceptualization and implementation of consent processes? Several workshop participants are involved in and working in this area, and expected to take this work forwards over the next year.
o Considering the deliberative spaces research institutions and studies work with. Research institutions and studies often work with groups of community representatives of various forms, to advise on research practice, including CE and consent processes. There needs to be clearer articulation of the similarities and differences between the different groups that are constituted (goals, forms of representation, forms of discussion), and the intended and actual use of these deliberations in research practice. Specific questions include: Who is representing whom in what way? How do we ensure that there are “authentic voices” in these discussions? What do we do with differences in opinion between community members? And between community member and research institution representatives? Reflection on experience with current practice would be a useful starting point, followed by carefully designed prospective studies.
o Engaging with communities across multi-centre studies. As the possibilities and gains from multi-centre studies continue to expand, there is an interest in considering how we can bring together and learn from the multiple communities involved in the same studies from very different contexts. Initial ideas include bringing together community liaison officers and community members/representatives from different sites to discuss on-the-ground realities, with inputs from ethicists and academics.
Agreed action points and workshop outputs
1. Draw on above discussion to develop a more detailed research agenda.
2. Revisit the research agenda at a future similar meeting, including a discussion of research progress and outputs.
3. Set up a group within the global ethics website linked to the global clinical trials initiative, and a list-serve to enable continued discussion and shared access to materials, including continued discussion on sources of funding for agreed research agenda.
4. Produce a newsletter or paper for publication that allows us to share the valuable learning and discussion from this meeting with a wider interested network.
5. Contribute to the planned Wellcome Trust meeting on CE in June 2011 through: a series of talking heads i.e. one minute videos of different workshop participants illustrating key issues and dilemmas emerging from the workshop; a presentation summarizing the key workshop themes and research ideas.
Overall, the workshop was considered to be an extremely valuable exercise in highlighting the wealth of experience across a diverse range of settings, and the need for what is expected to be an exciting body of social science work in future years.