https://orcid.org/0000-0002-1879-553X
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Abstract
Current research ethics frameworks were developed on the footprint of biomedical, experimental research and present several pitfalls when applied to non-experimental social sciences. This work explores how the normative principles underpinning policy and regulatory frameworks of research ethics and the related operational processes work in practice in the context of collaborative health and social care research. The work was organised in three phases. First, UK research ethics policy documents were analysed thematically, with themes further organised under the categories of ‘Principles’ and ‘Processes’. Next, we conducted a scoping review of articles about research ethics in the context of collaborative health and social care research, published in English between 2010 and 2022. We then held an exploratory focus group with ten academic researchers with relevant experience to gather their views on how the research ethics system works in practice in England (UK). The thematic framework developed in the first phase supported the analysis of the articles included in the scoping review and of focus group data. The analysis of policy documents identified twelve themes. All were associated to both a principle and a related operational process. The scoping review identified 31 articles. Across these, some themes were barely acknowledged (e.g., Compliance with legislation). Other themes were extensively covered (e.g., The working of Research Ethics Committees), often to discuss issues and limitations in how, in practice, the research ethics system and its processes deal with collaborative research and to suggest options for improvement. Focus group data were largely consistent with the findings of the scoping review. This work provides evidence of the poor alignment between how the research ethics system is normatively expected to work and how it works in practice and offers options that could make research ethics more fit for purpose when addressing collaborative research in health and social care.
Citation: De Poli C, Oyebode J (2023) Research ethics and collaborative research in health and social care: Analysis of UK research ethics policies, scoping review of the literature, and focus group study. PLoS ONE 18(12): e0296223. https://doi.org/10.1371/journal.pone.0296223
Editor: Alberto Molina Pérez, Spanish National Research Council: Consejo Superior de Investigaciones Cientificas, SPAIN
Received: August 7, 2023; Accepted: December 7, 2023; Published: December 22, 2023
Copyright: © 2023 De Poli, Oyebode. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting Information files.
Funding: The Authors were funded by The Health Foundation, grant number 1274233. The funding source had no involvement in the study design; in the collection, analysis and interpretation of data; in the writing of the articles; and in the decision to submit it for publication.
Competing interests: Chiara De Poli had research grant funding from the National Institute for Health and Care Research, School of Social Care Research, grant number 106152/CBF/LSECDP-IF14. She currently has, as co-applicant, research grant funding by the National Institute of Health and Care Research - Three Schools Dementia Programme, grant number 102645/3SDRP/LSEACH-DP05. Jan Oyebode currently has research grant funding from the National Institute for Health Research, grant number 204266, Social Care for People with Young Onset Dementia.
Introduction
Research ethics and governance represent the regulatory and institutional cornerstones for the conduct of research involving human participants, aiming to oversee its ethical quality and protect research participants from harmful research practices. Since the Nuremberg code (1947) [1], respect for autonomy, justice, beneficence (i.e., to do good), and non-maleficence (i.e., to do no harm) have been recognised as core ethical principles of biomedical, experimental research involving human participants. These principles were embedded in international guidance and regulation (e.g., the Declaration of Helsinki by the World Medical Association (1964) [2,3], the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences (CIOMS, 2016) [4] and in national research ethics frameworks (e.g., the US Belmont Report (1978) [5], the Canadian Tri-Council Policy Statement [6], and the UK Policy Framework for Health and Social Care Research [7]). Over time the application of this research ethics framework has been expanded from regulation of traditional biomedical research to also regulate social sciences, including health and social care research.
Extant research on research ethics has underscored the intrinsic complexity of establishing whether ethics oversight results in ethical research and participant protection. The use of processes and structures as surrogate measures for effectiveness of research ethics has been found particularly unsatisfactory [8–10]. Although there are several reasons to believe that research ethics processes and structures contribute to ensuring ethical research and the protection of research participants, little empirical evidence is available on whether and how research ethics institutions actually achieve these ends [9,11,12]. Alongside assumed benefits, negative or unwanted consequences of the research ethics system have been documented. At the procedural level, the apparent arbitrary nature of decision-making, long delays in obtaining research approvals, and the bureaucratic restrictions imposed on the conduct of studies are a frequent source of problems [8,13]. At the organisational level, the establishment of a research ethics industry [14], with a perceived emphasis on box ticking [15,16] and rule fetishization [17], ultimately concerned with issues around risk, litigation, and institutional reputation, seems to have contributed to an ‘ethics creep’ [17]. At an epistemological level, the problems of using a framework rooted in experimental, biomedical research to assess social sciences and research using non-experimental methods (e.g., big data research [18], social media research [19], research using machine learning [20], ethnography [21] and digital ethnography [22]) are well documented [23–26].
Research using qualitative or mixed methods [27] and less codified and predictable designs, such as participatory research (e.g., participatory action research, community-based participatory research) [28] and research using collaborative approaches (e.g., co-creation, co-design, co-production) [29], have been particularly affected. As a consequence of the fundamental poor alignment between the biomedical framework of research ethics and qualitative, participatory, and collaborative research, researchers have described their experience of navigating the research ethics system as “jumping through hoops” or “walking a tightrope”, or “something to get through” [30,31]. The requirement to submit a detailed research protocol to prospectively outline research activities clashes with the emergent nature of qualitative, participatory, and collaborative research [29,30]. The bureaucratic practices around consent that are used to operationalise the principle of autonomy are often unworkable for research with a strong relational component [17,32–34]. Additionally, research participants and co-researchers may disagree with the way the principle of participant protection is interpreted and risks and benefits are assessed by research ethics institutions [29,35,36]. These may be perceived as leaning towards paternalism, in particular in the case of populations with characteristics that are perceived as making them vulnerable [37–39].
If some of these features of qualitative, participatory, and collaborative research result in great scrutiny by research ethics institutions, other features with equally relevant ethical implications are not given due attention. For example, current research ethics frameworks designed to address the principle of justice (which requires the equitable distribution of both the burdens and the benefits of participation in research [40]) fail to consider how power relations between individuals or groups shape research and do not offer any mechanisms to help address the power differentials intrinsic to research [41]. Research ethics processes also have a blind spot in relation to gatekeepers, who have a substantial influence on who gets to participate and, conversely, who is excluded from research. There is no mechanism in place to oversee how they perform their role and whether they impact upon free choice of potential participants to take part in studies [34].
Alongside these issues reported for qualitative, participatory, and collaborative research that reaches the stage of seeking ethics approval, the academic debate has also aired concerns that research which is anticipated to be met with resistance by research ethics institutions is not actually pursued [17,42,43]. The perceived or expected barriers might deter researchers from conducting research on sensitive topics, involving vulnerable groups, or using more innovative methods. At best, this could contribute to homogenisation of the research landscape. At worst, it could undermine the role of qualitative, participatory, and collaborative research in promoting research inclusivity and social justice, and in answering research questions that no other research methods could address.
In order to move these debates forward, we conducted a study on research ethics aimed at generating a set of practical recommendations for improving how the research ethics system deals with participatory and collaborative research approaches (collaborative only, hereon). In this context, we used collaborative research as an umbrella term for various research approaches (e.g., participatory action research, community-based participatory research, co-creation, co-design, co-production) where participants are actively involved in shaping the research, beyond simply providing data, and where the primacy of academic knowledge is challenged by other types of knowledge (e.g., based on lived experience).
The study was organised in five consecutive phases. In the first phase, we carried out an analysis of UK research ethics policies, which informed a scoping review of the literature (phase 2). We then held an exploratory focus group with academic researchers in this field to understand their perspectives on the topic (phase 3). Results of these three phases informed a two-round Delphi study, involving academic researchers with experience of conducting participatory and collaborative research involving vulnerable groups in England (UK). The Delphi study aimed to generate consensus on what changes to the research ethics system should be considered to improve the ethics oversight of collaborative research (phase 4). A final focus group with experts was organised to inform the practical recommendations and explore their expected benefit (phase 5). This article reports the results of the first three phases of the work, whilst the remaining phases are reported elsewhere [44].
Through the analysis of policies (phase 1), we aimed to (i) understand what the UK research ethics system is intended to achieve and how it is designed to work, (ii) identify its underpinning principles, and (iii) map the operational processes and procedures which are designed and implemented to achieve the principles.
Since our work was carried out in the context of a UK-based study, the focus of the analysis was limited to UK research ethics policies, which reflect relevant domestic legislation (as set out in Appendix 2 of the UK Policy Framework for Health and Social Care Research [7],), but also draw on international standards, governance mechanisms, and good research practice (as per [7], para 3.4). By design, such policies have a deliberate wide scope: they do not, and possibly cannot, exhaustively compile principles, requirements, and standards that may be relevant for specific types of research, which are left to organisations with responsibilities under the national policy framework. In this sense, the UK system largely shares the bedrock of research ethics principles with other countries [45–48] and can be considered an example of a modern research ethics system. The analysis of policies was also instrumental to the development of the analytical framework of ‘Principles’ and ‘Processes’ that supported the scoping review of the literature that followed (phase 2).
The aim of the review was two-fold. Firstly, we aimed to understand how the normative principles and operational processes of research ethics play out in actual research that adopts participatory or collaborative approaches, often using qualitative methods, in the health and social care field. Secondly, we set out to map the recommendations that the literature had suggested to improve how the research ethics system deals with this type of research. The scoping review approach was deemed fit for the purpose of efficiently gathering and examining the extent, range, and nature of the literature available on this topic.
In phase 3, the exploratory focus group aimed to bring to light actual experiences of navigating the research ethics system from the perspective of active academic researchers with experience of conducting collaborative research in England (UK). By gathering their experiences, we were able to identify current patterns in the English context and to read them against the background of the literature review.
Methods
Analysis of UK research ethics policies
The analysis focused on the UK Policy Framework for Health and Social Care Research [7] and on UK Health Research Authority (HRA) policies publicly available online [49,50]. Policy documents were analysed thematically. The analysis proceeded deductively at first, with themes identified from the research ethics principles stated in the UK Policy Framework for Health and Social Care Research. The initial codebook was then expanded inductively, to include additional themes that were not codified as principles in the UK Policy Framework, but that appeared relevant. To help systematise the data collected, we divided the material under each theme into two categories: ‘Principles’ for data that referred to underpinning principles of the UK research ethics system, and ‘Processes’ for data describing the operational processes and procedures supporting the implementation of the principle (Table 1). The Authors worked collaboratively: CDP started the data extraction and discussed the emerging results with JO as the analysis progressed. Instances of uncertainty or ambiguity were resolved through ongoing discussion.
Scoping review of the literature
The scoping review was conducted following the Arksey and O’Malley framework [51] and is reported based on the PRISMA extension for scoping reviews (PRISMA-ScR) [52]. The review was guided by the following questions: How does the current research ethics system work for collaborative research in health and social care? What are the challenges that the current research ethics framework poses to collaborative research in health and social care? What options have been discussed in the literature to overcome these challenges?
Eligibility criteria.
Articles examining the research ethics and governance systems in the context of collaborative research in the field of health and social care were included. They had to be written in English and published in peer-reviewed journals in the period January 2010-May 2020. The original search was updated in December 2022, to identify articles published between June 2020-December 2022. Three online databases (Web of Science, PubMed/Medline, PsycInfo) were searched in June 2020, using search strings available in S1 File. In December 2022, we re-ran the original search using the same online databases and the same search criteria. Retrieved studies were imported into a reference management software. After removing duplicates, titles, and abstracts of the retrieved results were screened by CDP for eligibility against the inclusion criteria. Full text of all possible eligible articles was retrieved and screened by CDP, with JO screening the articles for which eligibility was uncertain.
Data extraction and analysis.
Data extraction and analysis was conducted by CDP and iteratively discussed and reviewed by JO. The analysis was supported by an analytic framework organised around the themes identified in the analysis of policy documents. At the level of each theme, the analytical framework was organised as a 2X2 matrix. On the first dimension we placed the categories of ‘Principles’ and ‘Processes’, consistently with the way we had analysed the policy documents. On the second dimension, we used the categories of ‘Current system’ and ‘Options for improvement’ (Table 2), to map the debate in relation to how the current research systems deal with collaborative research and to collect suggestions put forward to ensure a better fit of research ethics in the context of collaborative research. The resulting analytic framework was applied to each article. Each article was also charted in relation to its typology, country in which the research was conducted, research approach, and research population(s).
As recommended by methodological guidance on scoping reviews [51,53], this analytical process allowed us to describe the literature available in this field. It also allowed us to systematically document how the set of a priori themes, derived from the policy documents, had been discussed in the literature. Lastly, it enabled us to identify, in relation to each theme, how the system currently works and opportunities for improvement.
Exploratory focus group.
Following approval by the London School of Economics and Political Science, as per the School’s research ethics policy, the exploratory focus group was conducted online, via Zoom, in May 2020 to discuss actual experiences of navigating the English research ethics system in the context collaborative research in the health and social care field. The emphasis in recruitment of participants was on identifying active researchers with relevant experience of undertaking collaborative research in health and social care, and therefore of having applied for ethical review in England (UK).
Twelve participants were identified or snowballed via the professional networks of the research team and invited by e-mail to take part. Ten academic researchers with different levels of relevant experience, some undertaking research involving populations deemed vulnerable, expressed interest and were sent background information about the study and what their participation would entail. All gave written consent to take part in the study (Table 3).
The group was facilitated by JO with assistance from CDP, both with similar research interests and experience. The discussion was audio-recorded with consent from participants.
The discussion lasted about two hours and was guided by two broad questions. We started off by asking participants about issues they had encountered in obtaining research governance and ethics approval for studies using collaborative approaches and involving groups deemed vulnerable. The second question invited participants to consider what changes could ensure that research governance and ethics approval processes were better suited for collaborative research with vulnerable groups.
The focus group was transcribed verbatim. Data were imported to Nvivo12 and analysed thematically using a deductive approach supported by the analytical framework developed for the study [54] (Table 2).
Results
Analysis of UK research ethics policies
The analysis of the UK Policy Framework [7] and HRA documents [49,50] resulted in 12 themes (Table 4).
Theme 1—General ethical principles is a general theme which reflected Principle 3 (Scientific and Ethical Conduct Research) of the UK Policy Framework, by which research projects are expected to be scientifically sound and guided by ethical principles in all their aspects [7].
We identified both principles and processes for three of the 11 remaining themes: Theme 3—Protection of research participants corresponds to Principle 8 (Benefits and risks) of the UK Policy Framework. The corresponding operational process revolves around the role of Research Ethics Committees (RECs, known as Institutional Review Boards (IRBs) in the US and Canada) to ensure that the rights, safety, dignity, and wellbeing of research participants are adequately protected [49]. Theme 6—The working of RECs reflects Principle 9 (Approval) of the UK Policy Framework. Operationally, this principle relies on Research Ethics Committees (RECs) providing ethical review of new applications and keeping approved applications under review [49]. The HRA Standard Operating Procedures for RECs make specific provision regarding the review process (e.g., ‘flagged’ RECs, Proportionate Review Service, expedited review) for different types of research [50]. Theme 7—The research protocol is equivalent to the Principle 6 (Protocol) of the UK Policy Framework. From an operational perspective, this translates into a requirement to submit the standard protocol for any new research study and a standard Notice of Substantial Amendment when significant changes to the original study are proposed [50].
The remaining eight themes substantially mirrored principles of the UK Policy Framework, but no corresponding operational process could be identified.
Scoping review of the literature
The search conducted in June 2020 yielded 230 references, of which 166 were unique records. After screening titles and abstracts, 109 articles were excluded. The full texts of the remaining 57 papers were retrieved and reviewed. A total of 30 articles were deemed relevant for inclusion. The December 2022 update search identified 23 further references, of which 10 were unique records. After screening titles and abstracts, eight articles were excluded. The full texts of the two remaining papers were retrieved and assessed, and one was included. Combining the two searches, a total of 31 articles were deemed relevant for inclusion in the review (Table 5). The screening process is illustrated in Fig 1.
Seven articles reported research based in Canada [28,30,56,61–63,75], seven reported research based in the USA [38,57,60,67,68,73,77], four in England or the UK [35,55,76,78], two in Scandinavian countries [32,71], one in Malta [69], and one in Australia [64]. Four referred to multiple countries (e.g., low and middle income countries [72], Ireland and the UK [59]). Of these, two did not specify the geographical setting in full [34,58]. Five articles did not provide any reference to the geographical setting of their work [29,65,66,70,74].
In terms of research design, 15 articles adopted a single or multiple case study design [32,34,71,75–78,35,55,56,58,61,64,67,69]. The majority of these presented recommendations for policy and research practice derived from the authors’ experiences of research ethics-related issues they had faced and navigated in their own studies. Six articles were commentaries offering critical reflections on research ethics, without reference to a specific empirical study [29,30,60,66,68,72]. Four articles reported on empirical studies that generated primary data: Guta et al’s work discussed the results of a content analysis of ethics review documentation submitted to Research Ethics Boards (REBs) [62], complemented by a qualitative study based on interviews with REC members, staff, and other key informants [28,63], whereas Shore et al’s article reported the results of a survey of community-engaged research studies reviewed by RECs [73].
Of the remaining articles, two were methodological and discussed research ethics implications of Community-based participatory research [57] and Participatory Action Research [67]. A further two were theoretical in nature: Ross et al presented a research ethics framework to support Community Engaged Research [38]; Lange et al [65] discussed the concept of vulnerability and its implications for research ethics. The remaining two were literature reviews. Doyle et al provided a synthesis of the literature that supported the design of a framework to aid the research ethics approval process by RECs [59]. Tamariz and colleagues’ systematic review identified the most common perceived barriers and facilitators to evaluating research ethics oversight for Community based participatory research [74].
Research methodologies underpinning the reviewed articles were wide-ranging. Some articles referred to participatory or collaborative research [32,35,72] or community engaged research [38,66,73] as loosely defined umbrella terms, or emphasised the use of qualitative research methods [30,34,59,64,68–70,75,76]. Other articles were grounded in specific definitions and epistemological traditions, such as Community-based participatory research [28,57,62,63,67,71,74,77] or Participatory Action Research [56,61,78]. One article positioned co-design as a collaborative approach to implementation research [29], one focused on collaborative approaches in quality improvement [60], and one referred to co-production in the context of participatory organisational research [55].
Study populations could be classified into two broad groups. About a third of the articles did not describe or provide a definition of their study population [28,29,74,30,34,38,57,60,62,63,73]. Such articles typically focused on a specific methodological approach and discussed its implications for research ethics, regardless of the study population or research setting. Of the remaining studies, three focused on vulnerable individuals broadly defined [34,65,68] and the others focused on specific populations deemed vulnerable. In these articles, vulnerability was defined according to demographic characteristics such as age (e.g., young [56,78] or older people [55]), illness (e.g., mental health problems [35,70,72], palliative care patients [76], people living with HIV/AIDS [66]) or disability [61], socio-economic deprivation [77], geography [71]. In other cases, vulnerability was framed as situational, being defined by individual circumstances at a specific point in time. These included grandparent caregivers [67], Lesbian, Gay, Bisexual, Transgender, Queer (LGBTQ) former foster youth [67], participants from small connected communities, which may pose challenges to the anonymity and confidentiality of research participants [58,69], or people diagnosed with a long-term condition who may move through vulnerable moments in their illness trajectory (such as rheumatoid arthritis [75]), and clinical staff and patients who had been involved in clinical incidents which made them temporarily vulnerable [64].
We found wide variation in the level of coverage of the twelve analytical themes (Table 6). A few themes have been sparsely discussed. The theme on compliance with legislation was touched on only by one article. This highlighted the possible tension in decision-making processes about research ethics when pieces of relevant legislation or regulation are broad in scope and require (or allow) some degree of interpretation [77]. The theme on integrity, quality and transparency of research was discussed only by Øye and colleagues in two different but related articles. In the first, they discussed how gatekeepers may influence the way in which the recruitment of participants is carried out and reported [34]. In the second, they questioned the principle of scientific integrity and research independence in the context of collaborative research, when stakeholder groups with different interests and agendas, necessarily negotiate research plans and the reporting of research results [32]. The theme of accessible findings was discussed in two articles, suggesting ways in which RECs could support wider dissemination of research, beyond academic circles [57,62].
Other themes have been explored more widely, often using the experiences, positive or negative, of their authors as a starting point to discuss how the ethics system currently handles collaborative research, to highlight good practices and identify recommendations for improvement. Several articles highlighted that the biomedical and technocratic approach of research ethics processes and the way in which RECs work are poorly aligned to collaborative research, its relational nature, emergent designs, inclusive approach, and do not allow the flexibility and ongoing adaptations that such research requires [28,29].
The literature has discussed the tension between the involvement of patients, service users, and the public in research–a key feature of collaborative research–and the protection of research participants–a primary concern of research ethics. Although the need for appropriate participant protection was consistently recognised [34,75,76], some authors highlighted that, at times, RECs showed an over-protective attitude towards participants, which ultimately could affect agency of individuals and their participation and inclusion in research [38,61,65,68,72]. Therefore, they argued for an overhaul of the way risks and benefits associated with qualitative and collaborative research are framed and assessed, considering that risks are often low (and lower than for biomedical research), whilst benefits from participation are apparent and should not be dismissed [38,57,59,60,73,76,78]. Moreover, they highlighted that, given the nature of collaborative research, benefits and risks can unfold both at the individual and at the community level and should be assessed accordingly [29].
Consent-seeking practices can be seen as an example of how research ethics principles are operationalised in the context of collaborative research [35]. The suitability and appropriateness of traditional consent-seeking procedures, by which participants are requested to give one-off consent in writing, were questioned with specific reference to collaborative research [55,57]. Similarly, traditional research ethics systems were perceived as being uneasy about co-researchers identified from groups labelled or potentially perceived as vulnerable [32,67,78].
The role of the researcher and the nature of the research protocol were also recurring themes. Some authors contended that the role of the researcher is relational and constructed continuously on the spot [34]. They argued that researcher’s skills and experience in attending to ethical relationships with participants and in self-reflection should be integrated into research ethics frameworks [72,75] and considered when defining acceptable levels of risk tolerance [59].
Several authors commented on the constraints of the biomedical framework that underpins the research protocols required by RECs [62,74]. Standard protocols do not fully allow articulation of the relational nature of collaborative research (e.g., to define the nature of the relationships across participants, co-researchers, and researchers, and establish how their power differentials will be addressed [61]). They also fail to accommodate its emergent and iterative nature, e.g., when initial research results inform subsequent data gathering and methodological choices [64], and those layers of everyday ethics which are intrinsic to collaborative research [35].
Privacy and confidentiality are further themes which have been covered in the literature. The blanket approach to anonymity as the bedrock of confidentiality and privacy was disputed: whilst for some research participants this may be appropriate (e.g., in small connected communities [58,69]), for others, protection of anonymity should be flexed to reflect participants’ preferences (e.g., in the case of young participants, who may perceive the requirement of anonymity as unjust and discriminatory when based on age [78]). Researchers argued that concepts of privacy and confidentiality are context-specific and culturally-constructed, and research ethics practices should be tailored accordingly.
The literature review highlighted two themes not included in the initial thematic framework. The first was the membership of RECs [28,29,32,56,57,60,62,74]: a recurrent perception was that experience and expertise of qualitative and collaborative research among REC members is minimal, affecting how applications are reviewed and approved. To overcome this, some authors recommend establishing special RECs for collaborative research.
Training was a further additional theme. The literature highlighted the need for REC members to receive training in the full range of research methods and study designs and also recommended that researchers, co-researchers, and gatekeepers engaged in collaborative research should be offered an opportunity to gain a deeper understanding of research ethics, REC culture, and processes [29,32,56,57,60,62,74].
Exploratory focus group
The analysis of the focus group data identified 9 of the twelve themes of the analytical framework (Table 7).
At a general level, participants described obtaining ethics approval as a bureaucratic hurdle, particularly burdensome for research involving groups deemed vulnerable by research ethics committees
“I feel the burden of newly found bureaucracy. As we were going through the procedures to prepare for our project, that involved people with dementia, one of the questions that emerged was how much more paperwork will it entail to involve them. Maybe it’s a bit trite, but there was a consideration of how can we involve this group less, so the burden on getting ethics is smaller.” (FG1-4)
They also talked about the poor fit between their research and the underpinnings, practices, and language of the research ethics framework within which they were expected to operate. Participants highlighted how the research ethics approval process posed great emphasis on the approval phase of a study, when the study is appraised prospectively, with less relevance given to the actual conduct of research
“One of the things that I found problematic is the extent to which the whole process is front-loaded. Ethics committees will be very paternalistic in the initial stages of giving approval to a piece of research, but then don’t seem to particularly be interested in monitoring the conduct of the research.” (FG1-3)
In relation to Theme 2—Patient, service user, and public involvement, participants highlighted that there could be scope to engage the public and ask what ethical research means to them
“Some of those concepts [about research ethics] haven’t really been aired, in terms of public contribution and what the public would say are important concepts when we think about ethics. There’s something about unravelling some of those concepts and saying, are they the right ones actually now? Are they fit for purpose? (…) And as soon as you start talking about the public, their view of what is ethical conduct around involvement or around research can feel different.” (FG1-6)
In relation to Theme 3—Protection of research participants, the group highlighted the protectionist approach that RECs seem to take towards research participants. They underscored the lack of a proportionality in the way risks and benefits are assessed, at times catastrophising the worst scenarios and discounting (or ignoring) possible benefits of research participation
“What’s interesting about it is (…) the very high level of paternalism that is triggered when you’re trying to organize consent process in a research context (…) which sits rather awkwardly with the idea of empowering members of the public, patients, participants in research, to make their own judgments about their involvement. And here we’re really only talking about studies which involve interviews and questionnaires from highly experienced researchers.” (FG1-5)
In their view, this approach was inconsistent with the ongoing discourse around involvement in health and social care research. In particular, they unravelled the tension between the involvement of groups who are seldom heard in research and the perceptions that RECs may have of these groups (such as homeless people as discussed in the extract below)
“People around the [research ethics] system have a particular view of what homeless people are like, and they’re all horribly vulnerable and we should never approach them. And often they’re not. They have quite a high degree of agency.” (FG1-8)
Alongside highlighting the need to shift towards a more proportionate, risk-based approach to research ethics oversight, participants also underscored the need to design processes better suited to ensure participant protection
“Ethical processes are very important, to make sure that we’re protecting the participants, and they are necessary. It’s just how we implement them in a way that’s most appropriate and acceptable and feasible for the people who are completing them…” (FG1-9)
In relation to Theme 5—Role and competence of researchers, in the experience of participants, the research ethics system seemed to be concerned with protecting participants from possible unethical behaviour of researchers, whose ethos and competencies are undervalued
“I feel sometimes as if I’m a delinquent, who hasn’t yet been found out. The system is geared to treat me as if I’m fundamentally likely to be irresponsible in my dealings with people who are involved in research with me. My experience is that researchers, if anything, are very cautious and careful and thoughtful about the way they engage in this kind of activity.” (FG1-5)
Participants also discussed how the research ethics system is ambivalent in the way the idea of trust towards researchers is framed. On the one hand, the system seems to rely on a front-loaded process that aims to pre-empt ethical issues at the outset of a study and to foresee procedures to mitigate potential issues. On the other, when in the field, researchers operate with substantial degrees of freedom
“Once you get through, there is quite a lot of trust. All the day-to-day ethical decisions we make as researchers… we’re being trusted on those.” (FG1-10)
The group agreed that research ethics policies and institutions should move away from research ethics pivoted around the written word and accept the relational and situated dimension of research ethics
“(Any changes) should be on the basis of trying to introduce more trust into the system. The trustees seem to rely so much on the paperwork rather than on the people with the people, and the trust and responsibilities that people have.” (FG1-8)
Related to Theme 6—The working of RECs, participants described the interactions between research teams and RECs, at times perceived as confrontational and transactional
“It took three iterations of the REC meeting to be able to get approval in the end to involve people who lacked capacity in the research, and then it was at the expense of having to make other concessions.” (FG1-3)
They also highlighted how the review process of research aiming to involve groups deemed vulnerable was in their experience more burdensome than for other populations
“We did eventually get approval for that (i.e., a study that included people who lacked capacity). Although it took more times going back to the committee than other projects have.” (FG1-2)
Participants could envision the research ethics approval being handled in a more relational way and as a two-way process, by which RECs and researchers could identify, discuss, and address ethical matters together as the study unfolds. This shift could be beneficial in particular for research with an emergent design, given the expectation that amendments of the research protocol would be required as the research process progresses
“I wish that the whole process could be more collegiate in the way that it’s carried out. That it could be more like a process of mentoring throughout the whole research process, than having to pass an exam at the beginning of it.” (FG1-3)
Participants discussed options to mitigate the uneasiness of some RECs in dealing with collaborative research approaches, specific topics, and research groups that could be perceived as vulnerable
“I wonder if it’s possible to have RECs that are more topic-specific. Or since there are specific consideration for working with vulnerable populations, can there be one or two RECs that specialize on this particular concern? And they apply the principles in a consistent way across the country.” (FG1-1)
Participants reported several issues in relation to Theme 7—The research protocol. The current protocol template was described as unfit for use in the context of collaborative research using emergent designs
“You find you have to fit your project into a particular kind of language and forms and structure in order to get through.” (FG1-10)
Researchers found the information sheets that they were required to use when recruiting study participants particularly problematic. They felt that these documents looked officious and were hard for the lay public to understand, seemingly protecting the institutions sponsoring the study rather than the participants themselves. Participants suggested that documents supporting participant recruitment could be simplified in many ways
“Information sheets that it’s in one to two pages maximum in decent size font, without all of the sort of legal clauses that are really complicated to understand. (…) I’d really like to see it literally in very easy, accessible everyday language.” (FG1-9)
Relatedly, participants also highlighted that in their experience consent-seeking was operationalised in standardised, one-off procedures heavily reliant on the written word (e.g., completing and signing a consent form) rather than as a relational, continuous process. They also raised issues about how the Mental Capacity Act (MCA) is interpreted by RECs. This resulted in limiting the opportunities for individuals with fluctuating capacity and declining cognitive function to take part in research, or in resorting to secondary consent, in contradiction with the discourse around empowerment, or in research lacking real-world relevance
“During the XX research study, I was put under pressure by a REC to only recruit people who had capacity, even though there would have been a small minority of the people living in that care environment, on the basis that Sections 30–33 of the Mental Capacity Act [which relate to research with people who may lack capacity in England and Wales] say that you can include people who lack capacity only if it’s not possible to answer your research question by including people who do have capacity. And I was told by the Chair of that REC that the representativeness of the research was not an issue, as far as they were concerned. It didn’t matter if the participants who were actually recruited represented the people living in that care environment or not, because they were going by the letter of the Mental Capacity Act.” (FG1-3)
Lastly, they underscored the burden posed to research by current legislation (or its interpretation by RECs, as illustrated by the extract above on the MCA) and how the legal requirements were embedded in the documentation used for research purposes (e.g., to comply with legislation on privacy and confidentiality) (Theme 9 –Compliance with legislation).
No data were collected in relation to themes 4, 11, and 12. One additional theme on local research governance arrangements when carrying out research involving statutory organisations (e.g., NHS hospital trusts) was identified
“The local R&D governance processes raise many of the same issues (…). The system, certainly at the local level, is still really organized as if everyone’s doing a clinical trial” (FG1-5)
Discussion
This article provides an overview of the literature on research ethics in the context of collaborative health and social care research and complements it with the perspectives of active academic researchers with experience of navigating the English research ethics system.
The thematic framework that supported the scoping review and the analysis of the focus group data was organised around the normative principles and operational processes identified with the analysis of UK research ethics policies.
In taking this approach, this work focuses on research ethics as a function of the apparatus of research governance (i.e., the broad range of regulations, principles, and standards of good practice in research) and moves away from previous work conflating the discussion of research ethics requirements and ethical practice in research [80–82].
Importantly, using an analytical framework that stems from a normative standpoint allowed comparison of how the research ethics system is expected to work vs how it works in practice, according to the literature and based on actual experiences of researchers in the field. We applied the framework to the literature identified with the scoping review and updated and improved on a previous review assessing the literature published between 1990 and 2002 against the ethical principles outlined in the Belmont Report (i.e., autonomy, beneficence, and justice) [83]. We then used the framework to analyse focus group data, generating original empirical evidence about how the research ethics system is currently experienced by active researchers undertaking collaborative research in England.
Our review shows that the literature on this topic is heterogenous (e.g., in terms of language used to identify research using collaborative approaches) and broad in scope. By mapping out how key ethical principles and processes have been dealt with in the literature, it shows that the coverage received by each theme varies substantially. Despite being among the stated principles underpinning research ethics policies, themes around compliance with legislation, integrity, quality and transparency of research, and accessibility of research findings were sparsely covered in the literature. Similarly, they were not discussed by focus group participants as extensively as other topics. Reasons for this are unclear, but it may be that these themes are perceived as peripheral to research ethics per se and are expected to be addressed at different points in the wider research systems (e.g., accessibility of research findings may be addressed prospectively at the point of research funding application and/or at the end of a study, and may be largely seen as a concern of research teams and research funders, not of RECs).
Other themes, such as the working of RECs, the research protocol, and the protection of research participants were found to have received substantial attention in the literature and resonated among focus group participants.
Through the review process, it also became apparent that two themes (‘Training on research ethics’ and ‘REC membership’) discussed in the literature were not captured by the analytical framework we developed from policy documents. The lack of consideration of these two themes seems to reflect the dominant epistemological framework underpinning research ethics policies, at least in the UK context, since international guidance addresses both [4]. In relation to training, the UK Policy Framework looks exclusively at competencies and qualifications of research teams (Principle 2 Competence [7]), echoing one of the recommendations of the Helsinki Declaration (“Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications” [3]), taking for granted that REC members are competent to review any type of study regardless of their actual research expertise. Policies do not address REC membership and their expertise either. Historically, this has led to co-option of members with quantitative expertise, well-aligned to the dominant epistemological framework of research ethics, with other types of expertise under-represented [30]. This issue was also pinpointed by focus group participants who aired the idea of establishing RECs with specialist interest in specific research approaches, topics, or populations.
We note that our review did not find effectiveness of research ethics as an emergent theme across the body of the literature we included. Therefore, this work does not contribute to the ongoing debate about the effectiveness of ethics processes [8,9,11,12].
Looking at the results across themes, principles, and processes, findings from the literature and from the focus group were highly concordant. The pattern that emerges from both the literature and the focus group converges around issues in how the research ethics system deals with collaborative research and how the research ethics system negatively affects what collaborative research is conducted, and how. On the one hand, this could represent compelling evidence that the positivist underpinnings of research ethics oversight make it unfit for the purpose of reviewing research which does not sit within a positivist paradigm. On the other hand, some of these issues have also been reported in relation to biomedical, experimental research, for example in relation to informed consent [84], risk-benefit assessments [85], and the emphasis on procedures and documents to the detriment of day-to-day conduct of research [86]. Altogether these findings provide empirical corroboration of the concept of ethics creep [63]: the regulatory structure of the ethics bureaucracy has been expanding outward (e.g., taking over research using collaborative, non-experimental approaches in the social sciences) while at the same time intensifying the regulation of practices deemed to fall within its original scope (i.e., biomedical, experimental research). Consistently with this finding, this work adds to the literature documenting burdens associated with research ethics processes [9,87].
Indeed, the overarching discourse that emerges from both the literature and the focus group points towards the need for an overhaul of the rule-based, procedural approach to ethics threaded throughout current regulatory policies and structures, and endorses processes of ‘micro ethics’ [42], ‘situated ethics’ [34,88,89], relational ethics [90,91], that place emphasis on ‘ethical mindfulness’ [92] and reflexivity [93] on the part of individual researchers.
In this vein, this work also offers a rich catalogue of options for improving how the research ethics system could deal with collaborative research. Improvements expressed at the level of principles (e.g., framing consent as an ongoing process or embedding some degree of tolerance around risk, both discussed in the literature and among focus group participants) could open a line of work for research ethics institutions interested in exploring how to translate these principles into institutional processes. Among those expressed at the level of processes, some could be considered for implementation by research ethics institutions (e.g., the creation of specialist RECs, as suggested by focus group participants), others could be used as practical recommendations and advice for researchers navigating the research ethics system.
It is important to recognise strengths and weaknesses of this work. Our analytical framework was based on the analysis of research ethics policies published by UK institutions. However, the themes themselves are consistent with international research ethics frameworks currently in use and the analytical categories of ‘Principles’ and ‘Processes’ are broad enough to ensure that the results of the review are relevant beyond the UK context.
To our knowledge, the scoping review is the first attempt to map the academic literature discussing how the research ethics system deals with collaborative research in the health and social care field. The review identified journal articles published between 2010 and 2022 and indexed in three online academic research databases. Most of the included article were published between 2010 and 2015, when collaborative research approaches became increasingly popular. The academic debate about research ethics flourished at this time [29], with researchers sharing their experience of navigating the research ethics approval process for collaborative studies and often offering guidance and advice to others with similar research interests. This may have contributed developing a community of practice comfortable with addressing the requirements of research ethics. Perhaps as a result, the scholarly interest in writing about this topic in academic outlets subsequently faded away, to be replaced by methodological and good practice guidance published in the grey literature. Although this was outside the scope of this work, we are aware that resources have been made available by organisations such as those under the WHO umbrella (e.g., [94]), national research infrastructure (e.g., [95,96]), University-based Research Ethics Committees, and organisations acting as research facilitators and gatekeepers (e.g., [97]).
The identification of focus group participants began from our professional networks, which may have led to a dominance of participants from certain fields (e.g., dementia care and social care research) and exclusion of others. This could have biased the nature of the discussion towards certain themes or experiences. Also, the focus group was conducted at the beginning of the COVID pandemic, which affected the recruitment of participants.
Conclusions
The need for regulation and ethics oversight of research using collaborative approaches is not questioned. It is clear, however, that the biomedical regulatory framework currently in use presents obstacles to this type of research. This work documents the wide range of issues that researchers may experience when navigating the research ethics system in relation to research adopting a collaborative approach but, more importantly, it also offers options that could help address those issues within the current framework of research ethics.
It would be unrealistic to expect that every option identified could be immediately taken up and seamlessly implemented, and will then deliver positive results. Some practical recommendations could be voluntarily adopted by research teams and RECs alike and could help streamline some elements or procedures of the research ethics system. However, other options would require formal and procedural changes in research ethics processes that should be initiated by relevant institutions. Some of these may need to be accompanied by fundamental changes in the culture that surrounds research ethics, from it being a bureaucratic, prospective, front-loaded process taking place in a confrontational environment to an opportunity to think through ethical issues throughout a study in the context of a formative and collaborative process.
We hope that this work will help move the debate onwards and contribute to an agenda for change of research ethics for collaborative research in the health and social care field, and beyond.
Supporting information
S1 File. Scoping review of the literature–search strings.
https://doi.org/10.1371/journal.pone.0296223.s001
(DOCX)
S2 File. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist.
https://doi.org/10.1371/journal.pone.0296223.s002
(DOCX)
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