ORIGINAL ARTICLE
Participatory research, people with intellectual disabilities and ethical approval: making reasonable adjustments to enable participation Ruth Northway, Joyce Howarth and Lynne Evans
Aims and objectives. The aim of this paper is to explore how making reasonable adjustments to the process of securing ethical approval for research can facilitate the meaningful involvement of people with intellectual disabilities as members of a research team. This is achieved through critical reflection upon the approach taken within one participatory research study whose objective was to explore how people with intellectual disabilities understand abuse. Background. Internationally participatory research studies (in which active involvement of community members in all stages of the research process is sought) are becoming increasingly common in the context of health care and, more specifically, within research involving people with intellectual disabilities. However, whilst it is acknowledged that participatory research gives rise to specific ethical challenges, how (or if) involvement in securing ethical approval is facilitated, is not discussed in most research reports. The significance of this paper is that it seeks to address this gap by exploring how meaningful participation can be promoted by making reasonable adjustments. Methods. Within the study, the research team worked in collaboration with the ethics committee to identify potential barriers that could prevent the participation of members of the research team who had intellectual disabilities. Reasonable adjustments (such as redesigning forms) were made to the processes involved in securing ethical approval. Conclusions. This study demonstrated that it is possible to ensure that ethical standards are upheld and the requirements of ethics committees met whilst also facilitating the meaningful involvement of people with intellectual disabilities. Relevance to clinical practice. The reasonable adjustments approach explored within this paper can be translated into the context of clinical practice: making changes to the way that services are delivered can promote greater involvement of people with intellectual disabilities in their own health care.
What does this paper add to the wider global clinical community?
• An understanding of practical
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measures that can be taken to promote the meaningful involvement of people with intellectual disabilities as members of research teams in the process of securing ethical approval for research. The potential to transfer this learning to the wider clinical context whereby critical examination of policies and procedures that potentially exclude people with intellectual disabilities from active involvement in their health care are identified and reasonable adjustments are made to promote participation.
Key words: ethical approval, intellectual disabilities, participatory research, reasonable adjustments, participation Accepted for publication: 23 August 2014 Authors: Ruth Northway, MSc (Econ), PhD, RNLD, Cert Ed (FE), FRCN, Professor of Learning Disability Nursing, Faculty of Life Sciences and Education, University of South Wales; Joyce Howarth, BEd, Research assistant, Faculty of Life Sciences and Education, University of South Wales, Wales; Lynne Evans, Chair of the Research Advisory Group, Bank Chambers, Rhondda Cynon Taff People First, RCT, Porth, UK
© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581, doi: 10.1111/jocn.12702
Correspondence: Ruth Northway, Professor of Learning Disability Nursing, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, Wales CF37 1DL, UK. Telephone: +44 (0)1443 483177. E-mail: [email protected]
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Introduction Aims This paper aims to explore both the context to, and the process of, involving people with intellectual disabilities as active participants in securing ethical approval for a participatory research project. It thus responds to calls for open and transparent discussion of such processes (Boser 2006, Brydon-Miller et al. 2006). Whilst the focus here is on involvement in the research process, the approach used was one of identifying barriers to participation and making adjustments to enable meaningful participation: this approach can also be applied to other aspects of healthcare provision enabling people with intellectual disabilities to have more active involvement in their health care.
Background The study The three-year participatory study discussed in this paper originated from the desire of a group of people with intellectual disabilities to undertake research concerning abuse. A partnership between the University of South Wales, New Pathways (an organisation providing postsexual abuse counselling) and RCT People First (self-advocacy organisation) thus developed a collaborative application and secured project funding from the Big Lottery Fund. Three coresearchers with intellectual disabilities were employed to work part time (01 WTE) alongside a fulltime universitybased research assistant. The research questions were: • What do people with intellectual disabilities understand by abuse? • What are their views about abuse? • What help and support do they need to keep safe? • When someone has been abused what are the best ways to help? Data were gathered via focus groups, individual interviews and questionnaires. All three methods were used during a residential event attended by 47 people with intellectual disabilities in November 2011. Further questionnaires were distributed to organisations of people with intellectual disabilities across Wales in January 2012 and in total 107 people with intellectual disabilities participated (see Looking into Abuse Team 2013). Throughout the research, people with intellectual disabilities [including volunteer members of the Research Advisory Group (RAG)] supported the project and made many of the key decisions concerning the study to
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ensure that participation was meaningful at all stages of the project, including securing ethical approval. There were four key issues that we needed to consider – the ethical challenges of participatory research, concerns relating to people with intellectual disabilities as ‘vulnerable’ research participants, the ‘sensitive’ nature of the research topic, and the challenges of how to facilitate meaningful involvement in securing ethical approval. Whilst other papers have discussed one or two of these issues together, the originality and significance of this paper lies in how all four were simultaneously addressed.
The ethics of participatory research The appropriateness of a biomedical model approach to ethical review of social science research has been questioned (Dingwall 2006) and this model can be particularly challenged in participatory research which involves a different set of social relations (Boser 2006) and a ‘unique’ set of ethical values (Brydon-Miller et al. 2006). Rather than emphasising detached objectivity participatory research is based on equality within relationships and involvement. Whilst participatory research (generally) has been viewed as an ethical approach to research it also gives rise to additional ethical challenges (Khanlou & Peter 2005, Perez & Treadwell 2009). For example, ethics committees usually require full details of the research to be undertaken before approval is granted due to such committees being increasingly expected to protect institutions from litigation (Brydon-Miller et al. 2006). However, within participatory research, the research design evolves as the research team start to work together, the roles of researcher and researched can become blurred (Khanlou & Peter 2005), and ethics committees may have difficulty in viewing co-researchers as members of the research team rather than as study participants (Malone et al. 2006). Such studies may need to return to ethics committees a number of times to accommodate the different study cycles and the development of specific guidelines to expedite reviews has been proposed (Khanlou & Peter 2005). Cornwall and Jewkes (1995) highlight the potential for ‘unintended negative consequences’ whereby members of previously disempowered groups, empowered though participation in the research, encounter further oppression when challenging existing power structures. They also suggest that involvement can make disempowered groups more aware of their oppression and increase unhappiness. Furthermore, participatory research includes a commitment to action but research may not always lead to the desired
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changes (Titterton & Smart 2006) and the impact upon participants needs to be carefully considered. Participatory research can thus present specific ethical challenges that require institutions (such as research funders, academics and ethics committees) to adjust their ways of working [International Collaboration for Participatory Health research (ICPHR) 2013]. Research teams therefore need to work with ethics committees to combine areas of expertise to support the development of ethical participatory action research (Boser 2006).
Abuse as a ‘sensitive’ topic Abuse is often considered to be a ‘sensitive’ research topic even where participants do not have intellectual disabilities. However, what constitutes a sensitive topic is open to individual interpretation: what one person finds sensitive another may be comfortable with (Alexander 2010). Furthermore, it may not be possible to anticipate all sensitivities before the research begins since they can emerge as a project develops (Davison 2004). Researchers therefore need to maintain ethical sensitivity (Abrahams 2007), to identify and highlight potential areas of concern, and put strategies in place to minimise any harm and to provide support should it occur. Nonetheless, whilst researching abuse can be challenging, a failure to investigate it also gives rise to ethical concerns since this can leave abuse unexposed and unchallenged. Furthermore, seeking the views of those vulnerable to abuse (or who may have been abused) is essential if interventions are not to run the risk of being ineffective at best or (at worst) being experienced as further abuse.
People with intellectual disabilities as ‘vulnerable’ People with intellectual disabilities are often viewed as a ‘vulnerable’ participant group within research. History reveals that such fears are not unfounded (Juritzen et al. 2011) but whilst they may be vulnerable to harm they are also vulnerable to exclusion from research (McDonald & Kidney 2012). Such exclusion may bring additional harm since (for example) the care that ‘vulnerable’ groups receive may escape research scrutiny thus increasing vulnerability (Juritzen et al. 2011). Iacono (2006) queries whether such exclusion is a form of protectionism or discrimination and Smith (2008) argues that exclusion from research due to ethical guidelines may be a form of marginalisation and discrimination. Indeed only people with intellectual disabilities can answer some questions regarding their lives (McCarthy 1998) and the exclusion of their voices from research raises © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
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not only ethical issues but also concerns regarding the validity of some research. The challenge is to find ways that support their inclusion in research (both as researchers and as participants) within a context of ethical review that often emphasises over-protection (McDonald & Kidney 2012). Given that research funders and government bodies are increasingly requiring evidence of participation of those who use services (including people with intellectual disabilities) in the process of developing and undertaking research, it is essential that this challenge is responded to in a positive manner. Failing to do so would lead to tokenism rather than true participation.
Facilitating meaningful participation Discussion concerning ethical approval is usually limited in published research to a brief mention as to whether such approval was granted, and by whom. This is evident in many of the papers reporting participatory research involving people with intellectual disabilities. For example, Chapman et al. (2011) note that ethical approval was obtained for their study, that particular attention had to be paid to issues of consent, and that accessible materials were required. However, they do not mention whether members of the research team with intellectual disabilities were involved in this process. Similarly, Kramer et al. (2011) and Inglis and Swain (2012) comment regarding their participatory studies that ethical approval was secured, and that informed consent was obtained, but there is no reference to how/if people with intellectual disabilities were involved in securing ethical approval. McDonald et al. (2013) examined the views of people with intellectual disabilities regarding research and hired advisors with intellectual disabilities to assist with the development and piloting of research materials. Once again whether the advisors were actively involved in securing ethical approval for the study is not reported. An exception to this omission is the work of Ham et al. (2004) who detail how active participation was achieved at this stage in the research process. Within the study discussed in this paper, the approach taken was to identify potential barriers to participation and then to make adjustments such that the required level of ethical scrutiny could be achieved (albeit it by using different strategies). Instead of assuming that people with intellectual disabilities are ‘unable’ to participate in what can be a complex stage in undertaking research the focus shifted to what might ‘prevent’ or limit their participation and the removal/reduction of any barriers. McDonald and Kidney (2012) and McDonald et al. (2013) also advocate such an approach stressing the need for ‘reasonable
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accommodations’ (‘adjustments’ in UK terminology) within the research process. They argue that this concept is used more broadly to enable the inclusion of disabled people within society and needs to be applied within the context of research as an ‘ethical imperative’ (McDonald & Kidney 2012) hence the focus of this paper.
Design A participatory research approach was used throughout the study and ethical approval was obtained from the Faculty of Life Sciences and Education Ethics Committee at the University of South Wales. Since the intention was to approach potential participants via autonomous self-advocacy organisations (rather than via health and social care services) approval from external ethics committee(s) was not required. The process of review mirrored that required by external ethics committees, and the required level of scrutiny and rigour was maintained. Nonetheless, day to day liaison with the Chair and administrator of the Committee was possibly easier which enabled us to work with the Committee over a period of time (as advocated by Boser 2006) to ensure that both ethical and scientific standards were upheld whilst facilitating maximum participation.
Accessing the funding Having secured project funding, we were immediately presented with our first potential barrier: the offer letter indicated that the funding would only be released once ethical approval had been obtained. Whilst this is common practice in terms of research grants, participatory research means that funding is required to recruit and employ the research team to develop the materials (such as research tools, consent forms etc.) required by ethics committees. To exclude people with intellectual disabilities from these processes would have gone against the whole ethos of what we were seeking to achieve and hence a satisfactory compromise needed to be secured. People with intellectual disabilities had been fully involved in developing the detailed study outline required for our grant application and we were confident that there had been meaningful participation in decision-making. An approach was therefore made to the Faculty Ethics Committee to determine whether, if the required ethics application form was completed and submitted along with a protocol based on the grant application form, they would be willing to consider a ‘Stage One’ application. It was stressed that we would only be seeking approval in principle for the study and that no data would be collected with-
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out further approval (conditional on the submission of all required documentation such as the participant information sheets). We also approached the funders and asked if they would be willing to accept such approval to release funding and hence enable the research team to work towards full ethical approval. Both parties agreed, the Stage One protocol and ethics application form were completed and submitted by the first author (RN), and approval in principle was given. This was accepted by the funders, funding was released, and we appointed staff to work on the project so that development of the study materials could commence.
Looking after people ‘Ethics’ is not a word commonly used in everyday language and so throughout the project we referred to ‘looking after people’. This was understood as making sure that: • People knew what they were being asked to do. • They knew they did not have to take part in the research. • They knew they could stop taking part at any stage. • They knew we would not use their name in any report so that other people would not know what they said. • They knew we would keep what they tell us confidential unless they tell us that they or someone else is being hurt. • Support was available should they become upset. Training events were held to increase our understanding of things such as how we could get information from other people, how we could analyse the information we gathered, and how we could tell other people what we had found out. These sessions were supported by opportunities to practice the necessary skills to increase confidence and competence. To ensure that support was available for participants, we agreed that during the residential event, counsellors would be available at all times, and that participants would regularly be made aware of this facility. We also ensured that there were people at the residential event who were experienced in dealing with disclosures of abuse and who had a working knowledge of the relevant policies and procedures. In relation to those receiving the questionnaire by post, however, we could not ensure that such support would be available. For this reason, we decided to focus the questionnaire on keeping safe and the provision of support rather than the other research questions where participants would be more likely to consider personal experience of abuse. In addition, we agreed that the questionnaires would be distributed via self-advocacy organisations where some existing support would be in place and that we would include © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
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details of helplines that might be useful should additional support be required. All of this information was written into the application for ethical approval. The issue of compensating people for the time they spend participating is research is a difficult ethical dilemma as whilst it is important (McDonald et al. 2013) it can also give rise to problems for those in receipt of welfare benefits (leading to loss of benefits). Whilst researchers wish to recognise participants’ contribution they do not want to disadvantage them in other ways. In this study, participants were not paid for their time but those attending the residential event had their travel expenses, and all accommodation and entertainment costs met during their stay at the hotel. The co-researchers were employed on a part-time basis but it is recognised that this led to a power imbalance in terms of both time and salary when compared with the full time research assistant. Members of the RAG acted in a voluntary capacity. When researching a subject such as abuse, it has to be remembered that distress may be caused not only to participants but also to members of the research team whether they have intellectual disabilities or not. Sessions were, therefore, held focusing on looking after ourselves, during the residential event we held regular debriefing sessions and had access to the counsellors if desired. In addition, a regular part of our weekly team meetings involved checking out how everyone was.
Preparing the documents The ethics committee application form and the study protocol required for the purposes of securing ethical approval presented potential barriers to inclusion. The form was modelled on standard health research ethics committee forms and whilst the information requested is needed by committees to make an informed judgement, the design of the form and the language used were not easily accessible to people with intellectual disabilities. Furthermore, the level of detail required within a study protocol makes it a lengthy document of little help to people with intellectual disabilities employed as researchers, and who therefore need to use the document as a guide for their work. Faced with these challenges, we asked for approval to develop an ‘easy read’ application form that would provide the committee with the same information as the standard form but in language that was easier for the team to understand (see Table 1 for an example of an adjustment made). Also we requested permission to submit an easy read study protocol alongside the full protocol to produce a document that could be used by all members of our research team. © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
Intellectual disabilities and ethical approval Table 1 Examples of how the ethical review application form was modified Standard form
Easy read form
What will the subject be told about: The project and what it is intended to show The frequency of procedures and what they entail Possible risks and side effects Exclusion criteria with reference to medical history etc. Entitlement to leave study
What will people be told about: The project and what it is finding out? What exactly will happen in the research? How many times they will be asked questions? If there is any risk of any harm happening to them? If they cannot take part because of their health? That it’s OK to change their minds about taking part in the research at any time? People taking part How many people will take part? Are you going to have certain groups involved? (older people, women, children)
Participants Discuss the number of participants required, from where the participants will be recruited, and the exclusion and inclusion criteria
Both requests were approved and easy read versions of the form and the protocol were developed and submitted to the ethics committee. These were only two of the many documents needed: data collection tools, participant information sheets, a DVD providing information for participants, invitations to the residential event and consent forms to name just a few. All of these needed to be developed in formats that were more readily accessible and acceptable to people with intellectual disabilities. To develop the questionnaire, interview and focus group schedules, we needed to work as a team, to test them with each other, to ask other people to try them out and to change them as necessary. We enlisted the help of our RAG to critique the documents we had developed. The RAG comprised on average 20 people and over half of the members were people with intellectual disabilities. Critical feedback was received both regarding the use of language and pictures where group members had strong views as to whether they were clear, ambiguous or misleading. Further changes were made to the documentation before submission to the ethics committee. This review process was viewed positively by the committee who felt it important that people with intellectual disabilities had critiqued these documents since they were best placed to judge their accessibility and acceptability to other people with intellectual disabilities.
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Preparing for the ethics committee meeting The ethics committee operates a system whereby two lead reviewers are identified for each project; they review all the documentation in depth and lead the discussion. All committee members, however, have access to the application form and the study protocol and have the opportunity to question and seek clarification. Usual procedure would then be for two people from a research team to attend the committee meeting (if they so wish) to address any queries committee members might have. We, however, felt that the three of us needed to attend as we were each able to address different aspects of the study. As Principal Investigator, it was important that R attended as she had overall responsibility for obtaining ethical approval. J also needed to be involved since she had worked with the research team to develop and test all of the materials. In addition, it was important that L, as Chair of the RAG and someone who had been involved in the project since its inception should be included. We therefore negotiated that all of us could attend. We also felt that to ensure we were all adequately prepared it would be helpful to know the nature of any queries two days before the committee meeting so that we could prepare our response. To facilitate this, we agreed with the Chair of the committee to submit our documentation earlier than usual to allow reviewers sufficient time. Adjustments by both parties thus removed potential barriers and facilitated participation. The queries received were only minor but we agreed our responses and who would address which issues with the committee.
Attending the meeting The meeting itself was quite daunting. We had to wait outside the room for our turn, when we entered the room there were about 15 people present, and even though we were aware of the queries raised by the lead reviewers, we knew that other committee members could raise different concerns. We were all treated respectfully and there was genuine interest in our research. In fact some committee members, who undertake research with young people and research in countries where literacy levels are low, asked if they could adapt our consent forms and participant information leaflets as they felt they would enhance their research. L felt that it was particularly important that as a woman with intellectual disabilities, she had been respected by the committee and that they had talked directly to her. We were given approval for our study and were told that even though our research involved a ‘vulnerable’ group and that the topic could be ‘sensitive’ we had recognised the
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potential risks and had strategies in place to address them. It is perhaps telling that in providing this overview of our ethics journey, the section regarding the meeting is brief: careful planning prior to this stage had led to a positive outcome.
Carrying out the study Obtaining ethical approval was, of course, only part of ensuring that the research project was conducted in an ethical manner. We had to make sure that all the information we collected was kept safely, that we did not reveal any personal information about the people who took part, and that support was available for anyone involved in the study that needed it. Having counsellors available during the research residential event proved to be important as all of their appointments were taken and, in some instances, participants have been able to access ongoing support. Whilst some people did become distressed at times they also indicated that this was the first time that they had been able to speak about abuse and someone had listened. Without the research and the support provided this may not have been possible reinforcing the importance of including ‘vulnerable’ people in research (Juritzen et al. 2011). Ethical issues also extend to ensuring that the findings of the research are disseminated to a range of audiences. Some papers have therefore already been written and published concerning aspects of the research process and presentations have been given at different conferences. Launch events have been held engaging a wide range of stakeholders including people with intellectual disabilities, policy makers and politicians, professionals from health and social care, the police and family members. It is planned that the findings will link directly to service development since one of the partner organisations (NP) wishes to use the information gathered to inform the development of service provision for people with intellectual disabilities who have been abused.
Critical discussion of methods used Park (2001) argues that within research there tends to be a focus on the acquisition of representational knowledge: the knowledge that helps us to predict and control the consequences of our actions. However, he further states that within participatory research, two other forms of knowledge acquisition are evident. The first is relational knowledge whereby we learn how to relate to each other and to work together based on trust, respect and authenticity. The second is reflective knowledge which is based on critical theory and which enables us to reflect critically upon how things are and what we need to do to bring about change where change © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
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is required. The account provided of how ethical approval was obtained in this study illustrates both how we needed to learn to work together as a team but also to work together with the ethics committee. Furthermore, rather than just accepting policies and practices as given, we needed to consider alternative ways of working and to effect change where this was required. Our account reflects the lack of fit between the standard process of ethical review and that required within participatory research (Khanlou & Peter 2005) and the key lessons we learnt are set out in Table 2. An additional challenge was also evident namely the requirement of funders for ethical approval to be secured before funding is released. We were fortunate that we had been working as a group for a long period of time and there had been participation of people with intellectual disabilities from the outset. We were also fortunate to secure a small amount of funding to assist with proposal writing which allowed for greater discussion and the opportunity for all partners to get to know each other better. In addition, we were able to work with the ethics committee and the funder to agree a staged approach to ethical approval. Nonetheless, the co-researchers were appointed to their posts once funding had been secured and therefore they had not been involved in the original application. Whilst this might be viewed as a limitation, it perhaps reflects the situation many researchers find themselves in when they apply for posts working on funded research projects. For others seeking to develop participatory research projects, however, this disconnect between participatory research, release of funding and ethical approval may present additional challenges and this reinforces the need to (where possible) develop research partnerships from existing relationships rather than seeking to bring together a group of people to collaborate for the first time when a research funding deadline is looming. It has been suggested that research funders should recognise that they are funding not only the research but also development of the partnerTable 2 Key lessons learnt Involve people with intellectual disabilities in the process of developing research proposals and bids rather than waiting until funding has been secured Be proactive in identifying potential barriers to participation and inclusion Offer solutions to the ethics committee rather than just presenting problems Test any materials to be used with people with intellectual disabilities and take account of their feedback See ethical approval as a process rather than an event. Make early contact with the ethics committee and try to work with them throughout the period of seeking ethical approval
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ship that is undertaking the research (Plumb et al. 2004) and perhaps small grants for the development of participatory proposals would be a helpful way forward. The limited inclusion of the views of people with intellectual disabilities in papers discussing research ethics has been noted (McDonald & Kidney 2012) and with the exception of Ham et al. (2004) little has been written about their involvement in this important stage in the participatory research process. However, this is an area that also seems to be neglected in the wider participatory research literature: there is acknowledgement of specific ethical issues that arise but not of how members of the ‘community’ have worked with academic researchers to secure approval. If people with intellectual disabilities are to be researchers, it is important that they, along with all other members of the research team, recognise and understand ethical issues and how they will be addressed: active participation in securing ethical approval can assist in achieving this understanding (Brydon-Miller & Greenwood 2006). Involving people with intellectual disabilities in reviewing the materials to be used within the study also proved very useful since their incisive feedback as to the strengths and weaknesses of the documents we had prepared made a significant difference to the quality of the final product as recognised by the ethics committee. Proactive identification of potential barriers to participation and focusing on ways of overcoming such barriers encouraged creativity both within the research team and on the part of the ethics committee. Offering potential solutions to the committee rather than just highlighting problems was also well received. In addition, using the language of ‘reasonable adjustments’ helped present the case as to why the process needed to be modified to ensure equality of opportunity. The ‘bureaucratised procedural approaches’ that can be evident within research ethics processes (Boxall & Palph 2009) were thus successfully challenged. We were fortunate to be able to work with the ethics committee over a period of time to ensure that adjustments to the process could be made and we would advocate making contact with ethics committees early in the research process wherever possible to facilitate a collaborative approach rather than presenting a fait accompli with a full application at a later stage. Brydon-Miller and Greenwood (2006) suggest that dialogue amongst stakeholders is required to enable appropriate ethical review of participatory studies and working with ethics committees is an important part of this process (Brydon-Miller et al. 2006). This study has provided an example of this in action: working with the ethics committee throughout the process ensured that the needs of all parties were recognised and
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met with adjustments being made where required. Whilst this may take additional time, it does facilitate discussion thus minimising the potential for later misunderstanding. As Boxall and Palph (2009) observe, it is important for researchers to educate ethics committees regarding participatory research and including people with intellectual disabilities as educators in this process is important. Some may feel that a limitation of this study is that ethical approval was ‘only’ obtained from the Faculty Ethics Committee rather than from a body such as NHS Research Ethics. However, as already noted the information required and the scrutiny applied was modelled on that required by such committees and challenges have also been noted in securing approval from University committees (BrydonMiller & Greenwood 2006). Opportunities to engage in dialogue with NHS ethics committees may be more limited but, since few discussions regarding engagement regarding studies such as this have been published, this is an assumption that perhaps needs to be tested. Hopefully papers such as this will assist with this process.
Conclusions Participatory research approaches are gaining increasing prominence within intellectual disability research and more widely within healthcare research. However, whilst this approach may bring additional ethical challenges little has been written concerning how the active participation of people with intellectual disabilities may best be facilitated in the process of securing ethical approval. This paper has sought to address this gap by providing an account of how such participation was facilitated in one study. Rather than viewing the process as fixed, and systems as precluding the participation of people with intellectual disabilities, potential barriers to participation and to ethical approval were anticipated and strategies put in place to reduce or overcome them. This required adjustments by the research team and the ethics committee in terms of processes, presentation
of information and timing. It also involved working proactively with the ethics committee to explain the rationale for adjustments and to demonstrate that appropriate ethical standards would be upheld. It is hoped that the strategies outlined in this paper may assist other research teams seeking to develop participatory research.
Relevance to clinical practice Whilst this paper focuses on facilitating the participation of people with intellectual disabilities in a participatory research project, the lessons learnt are transferable to other activities involving people with learning disabilities and to other participatory research projects. Moreover, the principle of identifying barriers to participation and developing strategies to reduce or eliminate them has implications for all nurses, given the overwhelming evidence that suggests people with intellectual disabilities do not always have their health needs met in an effective manner. Working in partnership with people with intellectual disabilities, and making adjustments to information, policies and practices to meet individual needs can enhance participation and enhance nursing care.
Disclosure The authors have confirmed that all authors meet the ICMJE criteria for authorship credit (www.icmje.org/ethical_1author.html), as follows: (1) substantial contributions to conception and design of, or acquisition of data or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, and (3) final approval of the version to be published.
Funding The project reported in this paper was funded by the Big Lottery Fund.
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McDonald KE & Kidney CA (2012) What is right? Ethics in intellectual disabilities research. Journal of Policy and Practice in Intellectual Disabilities 9, 27–39. McDonald KE, Kidney CA & Patka M (2013) ‘You need your voice to be heard’: research participants’ views on research. Journal of Intellectual Disabilities 57, 216–225. Park P (2001) Knowledge and participatory research. In Handbook of Action Research, Participative Inquiry and Practice (Reason P & Bradbury H eds). Sage, London, pp. 81–90. Perez LM & Treadwell HM (2009) Determining what we stand for will guide what we do: community priorities, ethical research paradigms and research with vulnerable people. American Journal of Public Health 99, 201–204. Plumb M, Price W & Kavanaugh–Lynch MHE (2004) Funding community based participatory research: lessons learned. Journal of Interprofessional Care, 18, 428–439. Smith LJ (2008) How ethical is ethical research? Recruiting marginalised, vulnerable groups into health services research. Journal of Advanced Nursing 62, 248–257. Titterton M & Smart H (2006) Can participatory research be a route to empowerment? A case study of a disadvantaged Scottish community. Community Development Journal 43, 52–64.
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Participatory research, people with intellectual disabilities and ethical approval: making reasonable adjustments to enable participation Ruth Northway, Joyce Howarth and Lynne Evans
Aims and objectives. The aim of this paper is to explore how making reasonable adjustments to the process of securing ethical approval for research can facilitate the meaningful involvement of people with intellectual disabilities as members of a research team. This is achieved through critical reflection upon the approach taken within one participatory research study whose objective was to explore how people with intellectual disabilities understand abuse. Background. Internationally participatory research studies (in which active involvement of community members in all stages of the research process is sought) are becoming increasingly common in the context of health care and, more specifically, within research involving people with intellectual disabilities. However, whilst it is acknowledged that participatory research gives rise to specific ethical challenges, how (or if) involvement in securing ethical approval is facilitated, is not discussed in most research reports. The significance of this paper is that it seeks to address this gap by exploring how meaningful participation can be promoted by making reasonable adjustments. Methods. Within the study, the research team worked in collaboration with the ethics committee to identify potential barriers that could prevent the participation of members of the research team who had intellectual disabilities. Reasonable adjustments (such as redesigning forms) were made to the processes involved in securing ethical approval. Conclusions. This study demonstrated that it is possible to ensure that ethical standards are upheld and the requirements of ethics committees met whilst also facilitating the meaningful involvement of people with intellectual disabilities. Relevance to clinical practice. The reasonable adjustments approach explored within this paper can be translated into the context of clinical practice: making changes to the way that services are delivered can promote greater involvement of people with intellectual disabilities in their own health care.
What does this paper add to the wider global clinical community?
• An understanding of practical
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measures that can be taken to promote the meaningful involvement of people with intellectual disabilities as members of research teams in the process of securing ethical approval for research. The potential to transfer this learning to the wider clinical context whereby critical examination of policies and procedures that potentially exclude people with intellectual disabilities from active involvement in their health care are identified and reasonable adjustments are made to promote participation.
Key words: ethical approval, intellectual disabilities, participatory research, reasonable adjustments, participation Accepted for publication: 23 August 2014 Authors: Ruth Northway, MSc (Econ), PhD, RNLD, Cert Ed (FE), FRCN, Professor of Learning Disability Nursing, Faculty of Life Sciences and Education, University of South Wales; Joyce Howarth, BEd, Research assistant, Faculty of Life Sciences and Education, University of South Wales, Wales; Lynne Evans, Chair of the Research Advisory Group, Bank Chambers, Rhondda Cynon Taff People First, RCT, Porth, UK
© 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581, doi: 10.1111/jocn.12702
Correspondence: Ruth Northway, Professor of Learning Disability Nursing, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, Wales CF37 1DL, UK. Telephone: +44 (0)1443 483177. E-mail: [email protected]
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Introduction Aims This paper aims to explore both the context to, and the process of, involving people with intellectual disabilities as active participants in securing ethical approval for a participatory research project. It thus responds to calls for open and transparent discussion of such processes (Boser 2006, Brydon-Miller et al. 2006). Whilst the focus here is on involvement in the research process, the approach used was one of identifying barriers to participation and making adjustments to enable meaningful participation: this approach can also be applied to other aspects of healthcare provision enabling people with intellectual disabilities to have more active involvement in their health care.
Background The study The three-year participatory study discussed in this paper originated from the desire of a group of people with intellectual disabilities to undertake research concerning abuse. A partnership between the University of South Wales, New Pathways (an organisation providing postsexual abuse counselling) and RCT People First (self-advocacy organisation) thus developed a collaborative application and secured project funding from the Big Lottery Fund. Three coresearchers with intellectual disabilities were employed to work part time (01 WTE) alongside a fulltime universitybased research assistant. The research questions were: • What do people with intellectual disabilities understand by abuse? • What are their views about abuse? • What help and support do they need to keep safe? • When someone has been abused what are the best ways to help? Data were gathered via focus groups, individual interviews and questionnaires. All three methods were used during a residential event attended by 47 people with intellectual disabilities in November 2011. Further questionnaires were distributed to organisations of people with intellectual disabilities across Wales in January 2012 and in total 107 people with intellectual disabilities participated (see Looking into Abuse Team 2013). Throughout the research, people with intellectual disabilities [including volunteer members of the Research Advisory Group (RAG)] supported the project and made many of the key decisions concerning the study to
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ensure that participation was meaningful at all stages of the project, including securing ethical approval. There were four key issues that we needed to consider – the ethical challenges of participatory research, concerns relating to people with intellectual disabilities as ‘vulnerable’ research participants, the ‘sensitive’ nature of the research topic, and the challenges of how to facilitate meaningful involvement in securing ethical approval. Whilst other papers have discussed one or two of these issues together, the originality and significance of this paper lies in how all four were simultaneously addressed.
The ethics of participatory research The appropriateness of a biomedical model approach to ethical review of social science research has been questioned (Dingwall 2006) and this model can be particularly challenged in participatory research which involves a different set of social relations (Boser 2006) and a ‘unique’ set of ethical values (Brydon-Miller et al. 2006). Rather than emphasising detached objectivity participatory research is based on equality within relationships and involvement. Whilst participatory research (generally) has been viewed as an ethical approach to research it also gives rise to additional ethical challenges (Khanlou & Peter 2005, Perez & Treadwell 2009). For example, ethics committees usually require full details of the research to be undertaken before approval is granted due to such committees being increasingly expected to protect institutions from litigation (Brydon-Miller et al. 2006). However, within participatory research, the research design evolves as the research team start to work together, the roles of researcher and researched can become blurred (Khanlou & Peter 2005), and ethics committees may have difficulty in viewing co-researchers as members of the research team rather than as study participants (Malone et al. 2006). Such studies may need to return to ethics committees a number of times to accommodate the different study cycles and the development of specific guidelines to expedite reviews has been proposed (Khanlou & Peter 2005). Cornwall and Jewkes (1995) highlight the potential for ‘unintended negative consequences’ whereby members of previously disempowered groups, empowered though participation in the research, encounter further oppression when challenging existing power structures. They also suggest that involvement can make disempowered groups more aware of their oppression and increase unhappiness. Furthermore, participatory research includes a commitment to action but research may not always lead to the desired
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changes (Titterton & Smart 2006) and the impact upon participants needs to be carefully considered. Participatory research can thus present specific ethical challenges that require institutions (such as research funders, academics and ethics committees) to adjust their ways of working [International Collaboration for Participatory Health research (ICPHR) 2013]. Research teams therefore need to work with ethics committees to combine areas of expertise to support the development of ethical participatory action research (Boser 2006).
Abuse as a ‘sensitive’ topic Abuse is often considered to be a ‘sensitive’ research topic even where participants do not have intellectual disabilities. However, what constitutes a sensitive topic is open to individual interpretation: what one person finds sensitive another may be comfortable with (Alexander 2010). Furthermore, it may not be possible to anticipate all sensitivities before the research begins since they can emerge as a project develops (Davison 2004). Researchers therefore need to maintain ethical sensitivity (Abrahams 2007), to identify and highlight potential areas of concern, and put strategies in place to minimise any harm and to provide support should it occur. Nonetheless, whilst researching abuse can be challenging, a failure to investigate it also gives rise to ethical concerns since this can leave abuse unexposed and unchallenged. Furthermore, seeking the views of those vulnerable to abuse (or who may have been abused) is essential if interventions are not to run the risk of being ineffective at best or (at worst) being experienced as further abuse.
People with intellectual disabilities as ‘vulnerable’ People with intellectual disabilities are often viewed as a ‘vulnerable’ participant group within research. History reveals that such fears are not unfounded (Juritzen et al. 2011) but whilst they may be vulnerable to harm they are also vulnerable to exclusion from research (McDonald & Kidney 2012). Such exclusion may bring additional harm since (for example) the care that ‘vulnerable’ groups receive may escape research scrutiny thus increasing vulnerability (Juritzen et al. 2011). Iacono (2006) queries whether such exclusion is a form of protectionism or discrimination and Smith (2008) argues that exclusion from research due to ethical guidelines may be a form of marginalisation and discrimination. Indeed only people with intellectual disabilities can answer some questions regarding their lives (McCarthy 1998) and the exclusion of their voices from research raises © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
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not only ethical issues but also concerns regarding the validity of some research. The challenge is to find ways that support their inclusion in research (both as researchers and as participants) within a context of ethical review that often emphasises over-protection (McDonald & Kidney 2012). Given that research funders and government bodies are increasingly requiring evidence of participation of those who use services (including people with intellectual disabilities) in the process of developing and undertaking research, it is essential that this challenge is responded to in a positive manner. Failing to do so would lead to tokenism rather than true participation.
Facilitating meaningful participation Discussion concerning ethical approval is usually limited in published research to a brief mention as to whether such approval was granted, and by whom. This is evident in many of the papers reporting participatory research involving people with intellectual disabilities. For example, Chapman et al. (2011) note that ethical approval was obtained for their study, that particular attention had to be paid to issues of consent, and that accessible materials were required. However, they do not mention whether members of the research team with intellectual disabilities were involved in this process. Similarly, Kramer et al. (2011) and Inglis and Swain (2012) comment regarding their participatory studies that ethical approval was secured, and that informed consent was obtained, but there is no reference to how/if people with intellectual disabilities were involved in securing ethical approval. McDonald et al. (2013) examined the views of people with intellectual disabilities regarding research and hired advisors with intellectual disabilities to assist with the development and piloting of research materials. Once again whether the advisors were actively involved in securing ethical approval for the study is not reported. An exception to this omission is the work of Ham et al. (2004) who detail how active participation was achieved at this stage in the research process. Within the study discussed in this paper, the approach taken was to identify potential barriers to participation and then to make adjustments such that the required level of ethical scrutiny could be achieved (albeit it by using different strategies). Instead of assuming that people with intellectual disabilities are ‘unable’ to participate in what can be a complex stage in undertaking research the focus shifted to what might ‘prevent’ or limit their participation and the removal/reduction of any barriers. McDonald and Kidney (2012) and McDonald et al. (2013) also advocate such an approach stressing the need for ‘reasonable
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accommodations’ (‘adjustments’ in UK terminology) within the research process. They argue that this concept is used more broadly to enable the inclusion of disabled people within society and needs to be applied within the context of research as an ‘ethical imperative’ (McDonald & Kidney 2012) hence the focus of this paper.
Design A participatory research approach was used throughout the study and ethical approval was obtained from the Faculty of Life Sciences and Education Ethics Committee at the University of South Wales. Since the intention was to approach potential participants via autonomous self-advocacy organisations (rather than via health and social care services) approval from external ethics committee(s) was not required. The process of review mirrored that required by external ethics committees, and the required level of scrutiny and rigour was maintained. Nonetheless, day to day liaison with the Chair and administrator of the Committee was possibly easier which enabled us to work with the Committee over a period of time (as advocated by Boser 2006) to ensure that both ethical and scientific standards were upheld whilst facilitating maximum participation.
Accessing the funding Having secured project funding, we were immediately presented with our first potential barrier: the offer letter indicated that the funding would only be released once ethical approval had been obtained. Whilst this is common practice in terms of research grants, participatory research means that funding is required to recruit and employ the research team to develop the materials (such as research tools, consent forms etc.) required by ethics committees. To exclude people with intellectual disabilities from these processes would have gone against the whole ethos of what we were seeking to achieve and hence a satisfactory compromise needed to be secured. People with intellectual disabilities had been fully involved in developing the detailed study outline required for our grant application and we were confident that there had been meaningful participation in decision-making. An approach was therefore made to the Faculty Ethics Committee to determine whether, if the required ethics application form was completed and submitted along with a protocol based on the grant application form, they would be willing to consider a ‘Stage One’ application. It was stressed that we would only be seeking approval in principle for the study and that no data would be collected with-
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out further approval (conditional on the submission of all required documentation such as the participant information sheets). We also approached the funders and asked if they would be willing to accept such approval to release funding and hence enable the research team to work towards full ethical approval. Both parties agreed, the Stage One protocol and ethics application form were completed and submitted by the first author (RN), and approval in principle was given. This was accepted by the funders, funding was released, and we appointed staff to work on the project so that development of the study materials could commence.
Looking after people ‘Ethics’ is not a word commonly used in everyday language and so throughout the project we referred to ‘looking after people’. This was understood as making sure that: • People knew what they were being asked to do. • They knew they did not have to take part in the research. • They knew they could stop taking part at any stage. • They knew we would not use their name in any report so that other people would not know what they said. • They knew we would keep what they tell us confidential unless they tell us that they or someone else is being hurt. • Support was available should they become upset. Training events were held to increase our understanding of things such as how we could get information from other people, how we could analyse the information we gathered, and how we could tell other people what we had found out. These sessions were supported by opportunities to practice the necessary skills to increase confidence and competence. To ensure that support was available for participants, we agreed that during the residential event, counsellors would be available at all times, and that participants would regularly be made aware of this facility. We also ensured that there were people at the residential event who were experienced in dealing with disclosures of abuse and who had a working knowledge of the relevant policies and procedures. In relation to those receiving the questionnaire by post, however, we could not ensure that such support would be available. For this reason, we decided to focus the questionnaire on keeping safe and the provision of support rather than the other research questions where participants would be more likely to consider personal experience of abuse. In addition, we agreed that the questionnaires would be distributed via self-advocacy organisations where some existing support would be in place and that we would include © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
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details of helplines that might be useful should additional support be required. All of this information was written into the application for ethical approval. The issue of compensating people for the time they spend participating is research is a difficult ethical dilemma as whilst it is important (McDonald et al. 2013) it can also give rise to problems for those in receipt of welfare benefits (leading to loss of benefits). Whilst researchers wish to recognise participants’ contribution they do not want to disadvantage them in other ways. In this study, participants were not paid for their time but those attending the residential event had their travel expenses, and all accommodation and entertainment costs met during their stay at the hotel. The co-researchers were employed on a part-time basis but it is recognised that this led to a power imbalance in terms of both time and salary when compared with the full time research assistant. Members of the RAG acted in a voluntary capacity. When researching a subject such as abuse, it has to be remembered that distress may be caused not only to participants but also to members of the research team whether they have intellectual disabilities or not. Sessions were, therefore, held focusing on looking after ourselves, during the residential event we held regular debriefing sessions and had access to the counsellors if desired. In addition, a regular part of our weekly team meetings involved checking out how everyone was.
Preparing the documents The ethics committee application form and the study protocol required for the purposes of securing ethical approval presented potential barriers to inclusion. The form was modelled on standard health research ethics committee forms and whilst the information requested is needed by committees to make an informed judgement, the design of the form and the language used were not easily accessible to people with intellectual disabilities. Furthermore, the level of detail required within a study protocol makes it a lengthy document of little help to people with intellectual disabilities employed as researchers, and who therefore need to use the document as a guide for their work. Faced with these challenges, we asked for approval to develop an ‘easy read’ application form that would provide the committee with the same information as the standard form but in language that was easier for the team to understand (see Table 1 for an example of an adjustment made). Also we requested permission to submit an easy read study protocol alongside the full protocol to produce a document that could be used by all members of our research team. © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
Intellectual disabilities and ethical approval Table 1 Examples of how the ethical review application form was modified Standard form
Easy read form
What will the subject be told about: The project and what it is intended to show The frequency of procedures and what they entail Possible risks and side effects Exclusion criteria with reference to medical history etc. Entitlement to leave study
What will people be told about: The project and what it is finding out? What exactly will happen in the research? How many times they will be asked questions? If there is any risk of any harm happening to them? If they cannot take part because of their health? That it’s OK to change their minds about taking part in the research at any time? People taking part How many people will take part? Are you going to have certain groups involved? (older people, women, children)
Participants Discuss the number of participants required, from where the participants will be recruited, and the exclusion and inclusion criteria
Both requests were approved and easy read versions of the form and the protocol were developed and submitted to the ethics committee. These were only two of the many documents needed: data collection tools, participant information sheets, a DVD providing information for participants, invitations to the residential event and consent forms to name just a few. All of these needed to be developed in formats that were more readily accessible and acceptable to people with intellectual disabilities. To develop the questionnaire, interview and focus group schedules, we needed to work as a team, to test them with each other, to ask other people to try them out and to change them as necessary. We enlisted the help of our RAG to critique the documents we had developed. The RAG comprised on average 20 people and over half of the members were people with intellectual disabilities. Critical feedback was received both regarding the use of language and pictures where group members had strong views as to whether they were clear, ambiguous or misleading. Further changes were made to the documentation before submission to the ethics committee. This review process was viewed positively by the committee who felt it important that people with intellectual disabilities had critiqued these documents since they were best placed to judge their accessibility and acceptability to other people with intellectual disabilities.
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Preparing for the ethics committee meeting The ethics committee operates a system whereby two lead reviewers are identified for each project; they review all the documentation in depth and lead the discussion. All committee members, however, have access to the application form and the study protocol and have the opportunity to question and seek clarification. Usual procedure would then be for two people from a research team to attend the committee meeting (if they so wish) to address any queries committee members might have. We, however, felt that the three of us needed to attend as we were each able to address different aspects of the study. As Principal Investigator, it was important that R attended as she had overall responsibility for obtaining ethical approval. J also needed to be involved since she had worked with the research team to develop and test all of the materials. In addition, it was important that L, as Chair of the RAG and someone who had been involved in the project since its inception should be included. We therefore negotiated that all of us could attend. We also felt that to ensure we were all adequately prepared it would be helpful to know the nature of any queries two days before the committee meeting so that we could prepare our response. To facilitate this, we agreed with the Chair of the committee to submit our documentation earlier than usual to allow reviewers sufficient time. Adjustments by both parties thus removed potential barriers and facilitated participation. The queries received were only minor but we agreed our responses and who would address which issues with the committee.
Attending the meeting The meeting itself was quite daunting. We had to wait outside the room for our turn, when we entered the room there were about 15 people present, and even though we were aware of the queries raised by the lead reviewers, we knew that other committee members could raise different concerns. We were all treated respectfully and there was genuine interest in our research. In fact some committee members, who undertake research with young people and research in countries where literacy levels are low, asked if they could adapt our consent forms and participant information leaflets as they felt they would enhance their research. L felt that it was particularly important that as a woman with intellectual disabilities, she had been respected by the committee and that they had talked directly to her. We were given approval for our study and were told that even though our research involved a ‘vulnerable’ group and that the topic could be ‘sensitive’ we had recognised the
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potential risks and had strategies in place to address them. It is perhaps telling that in providing this overview of our ethics journey, the section regarding the meeting is brief: careful planning prior to this stage had led to a positive outcome.
Carrying out the study Obtaining ethical approval was, of course, only part of ensuring that the research project was conducted in an ethical manner. We had to make sure that all the information we collected was kept safely, that we did not reveal any personal information about the people who took part, and that support was available for anyone involved in the study that needed it. Having counsellors available during the research residential event proved to be important as all of their appointments were taken and, in some instances, participants have been able to access ongoing support. Whilst some people did become distressed at times they also indicated that this was the first time that they had been able to speak about abuse and someone had listened. Without the research and the support provided this may not have been possible reinforcing the importance of including ‘vulnerable’ people in research (Juritzen et al. 2011). Ethical issues also extend to ensuring that the findings of the research are disseminated to a range of audiences. Some papers have therefore already been written and published concerning aspects of the research process and presentations have been given at different conferences. Launch events have been held engaging a wide range of stakeholders including people with intellectual disabilities, policy makers and politicians, professionals from health and social care, the police and family members. It is planned that the findings will link directly to service development since one of the partner organisations (NP) wishes to use the information gathered to inform the development of service provision for people with intellectual disabilities who have been abused.
Critical discussion of methods used Park (2001) argues that within research there tends to be a focus on the acquisition of representational knowledge: the knowledge that helps us to predict and control the consequences of our actions. However, he further states that within participatory research, two other forms of knowledge acquisition are evident. The first is relational knowledge whereby we learn how to relate to each other and to work together based on trust, respect and authenticity. The second is reflective knowledge which is based on critical theory and which enables us to reflect critically upon how things are and what we need to do to bring about change where change © 2014 John Wiley & Sons Ltd Journal of Clinical Nursing, 24, 573–581
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is required. The account provided of how ethical approval was obtained in this study illustrates both how we needed to learn to work together as a team but also to work together with the ethics committee. Furthermore, rather than just accepting policies and practices as given, we needed to consider alternative ways of working and to effect change where this was required. Our account reflects the lack of fit between the standard process of ethical review and that required within participatory research (Khanlou & Peter 2005) and the key lessons we learnt are set out in Table 2. An additional challenge was also evident namely the requirement of funders for ethical approval to be secured before funding is released. We were fortunate that we had been working as a group for a long period of time and there had been participation of people with intellectual disabilities from the outset. We were also fortunate to secure a small amount of funding to assist with proposal writing which allowed for greater discussion and the opportunity for all partners to get to know each other better. In addition, we were able to work with the ethics committee and the funder to agree a staged approach to ethical approval. Nonetheless, the co-researchers were appointed to their posts once funding had been secured and therefore they had not been involved in the original application. Whilst this might be viewed as a limitation, it perhaps reflects the situation many researchers find themselves in when they apply for posts working on funded research projects. For others seeking to develop participatory research projects, however, this disconnect between participatory research, release of funding and ethical approval may present additional challenges and this reinforces the need to (where possible) develop research partnerships from existing relationships rather than seeking to bring together a group of people to collaborate for the first time when a research funding deadline is looming. It has been suggested that research funders should recognise that they are funding not only the research but also development of the partnerTable 2 Key lessons learnt Involve people with intellectual disabilities in the process of developing research proposals and bids rather than waiting until funding has been secured Be proactive in identifying potential barriers to participation and inclusion Offer solutions to the ethics committee rather than just presenting problems Test any materials to be used with people with intellectual disabilities and take account of their feedback See ethical approval as a process rather than an event. Make early contact with the ethics committee and try to work with them throughout the period of seeking ethical approval
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ship that is undertaking the research (Plumb et al. 2004) and perhaps small grants for the development of participatory proposals would be a helpful way forward. The limited inclusion of the views of people with intellectual disabilities in papers discussing research ethics has been noted (McDonald & Kidney 2012) and with the exception of Ham et al. (2004) little has been written about their involvement in this important stage in the participatory research process. However, this is an area that also seems to be neglected in the wider participatory research literature: there is acknowledgement of specific ethical issues that arise but not of how members of the ‘community’ have worked with academic researchers to secure approval. If people with intellectual disabilities are to be researchers, it is important that they, along with all other members of the research team, recognise and understand ethical issues and how they will be addressed: active participation in securing ethical approval can assist in achieving this understanding (Brydon-Miller & Greenwood 2006). Involving people with intellectual disabilities in reviewing the materials to be used within the study also proved very useful since their incisive feedback as to the strengths and weaknesses of the documents we had prepared made a significant difference to the quality of the final product as recognised by the ethics committee. Proactive identification of potential barriers to participation and focusing on ways of overcoming such barriers encouraged creativity both within the research team and on the part of the ethics committee. Offering potential solutions to the committee rather than just highlighting problems was also well received. In addition, using the language of ‘reasonable adjustments’ helped present the case as to why the process needed to be modified to ensure equality of opportunity. The ‘bureaucratised procedural approaches’ that can be evident within research ethics processes (Boxall & Palph 2009) were thus successfully challenged. We were fortunate to be able to work with the ethics committee over a period of time to ensure that adjustments to the process could be made and we would advocate making contact with ethics committees early in the research process wherever possible to facilitate a collaborative approach rather than presenting a fait accompli with a full application at a later stage. Brydon-Miller and Greenwood (2006) suggest that dialogue amongst stakeholders is required to enable appropriate ethical review of participatory studies and working with ethics committees is an important part of this process (Brydon-Miller et al. 2006). This study has provided an example of this in action: working with the ethics committee throughout the process ensured that the needs of all parties were recognised and
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met with adjustments being made where required. Whilst this may take additional time, it does facilitate discussion thus minimising the potential for later misunderstanding. As Boxall and Palph (2009) observe, it is important for researchers to educate ethics committees regarding participatory research and including people with intellectual disabilities as educators in this process is important. Some may feel that a limitation of this study is that ethical approval was ‘only’ obtained from the Faculty Ethics Committee rather than from a body such as NHS Research Ethics. However, as already noted the information required and the scrutiny applied was modelled on that required by such committees and challenges have also been noted in securing approval from University committees (BrydonMiller & Greenwood 2006). Opportunities to engage in dialogue with NHS ethics committees may be more limited but, since few discussions regarding engagement regarding studies such as this have been published, this is an assumption that perhaps needs to be tested. Hopefully papers such as this will assist with this process.
Conclusions Participatory research approaches are gaining increasing prominence within intellectual disability research and more widely within healthcare research. However, whilst this approach may bring additional ethical challenges little has been written concerning how the active participation of people with intellectual disabilities may best be facilitated in the process of securing ethical approval. This paper has sought to address this gap by providing an account of how such participation was facilitated in one study. Rather than viewing the process as fixed, and systems as precluding the participation of people with intellectual disabilities, potential barriers to participation and to ethical approval were anticipated and strategies put in place to reduce or overcome them. This required adjustments by the research team and the ethics committee in terms of processes, presentation
of information and timing. It also involved working proactively with the ethics committee to explain the rationale for adjustments and to demonstrate that appropriate ethical standards would be upheld. It is hoped that the strategies outlined in this paper may assist other research teams seeking to develop participatory research.
Relevance to clinical practice Whilst this paper focuses on facilitating the participation of people with intellectual disabilities in a participatory research project, the lessons learnt are transferable to other activities involving people with learning disabilities and to other participatory research projects. Moreover, the principle of identifying barriers to participation and developing strategies to reduce or eliminate them has implications for all nurses, given the overwhelming evidence that suggests people with intellectual disabilities do not always have their health needs met in an effective manner. Working in partnership with people with intellectual disabilities, and making adjustments to information, policies and practices to meet individual needs can enhance participation and enhance nursing care.
Disclosure The authors have confirmed that all authors meet the ICMJE criteria for authorship credit (www.icmje.org/ethical_1author.html), as follows: (1) substantial contributions to conception and design of, or acquisition of data or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, and (3) final approval of the version to be published.
Funding The project reported in this paper was funded by the Big Lottery Fund.
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