qualitative research ethical boundaries

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• Perspect Med Educ
• v.7(2); 2018 Apr

Ethical dilemmas and reflexivity in qualitative research

Anne-marie reid.

1 Leeds Institute of Medical Education, University of Leeds, Leeds, UK

Jeremy M. Brown

2 Postgraduate Medical Institute, Faculty of Health and Social Care, Edge Hill University, Ormskirk, Lancashire, UK

Julie M. Smith

3 Nuffield Orthopaedic Centre, Oxford, UK

Alexandra C. Cope

4 Frimley Health NHS Foundation Trust, Surrey, UK

Susan Jamieson

5 School of Medicine, Dentistry & Nursing, Glasgow University, Glasgow, UK

For medical education researchers, a key concern may be the practicalities of gaining ethical approval where this is a national or local requirement. However, in qualitative studies, where the dynamics of human interaction pervade, ethical considerations are an ongoing process which continues long after approval has been granted. Responding to ethical dilemmas arising ‘in the moment’ requires a reflexive approach whereby the researcher questions his/her own motivations, assumptions and interests. Drawing on empirical studies and their experiences in academic and clinical research practice, the authors share their reflections on adhering to ethical principles throughout the research process to illustrate the complexities and nuances involved.

Objectives and findings

These reflections offer critical insights into dilemmas arising in view of the ethical principles driving good conduct, and through domains which distinguish between procedural ethics, situational ethics, ethical relationships and ethical issues in exiting the study. The accounts consider integrity and altruism in research, gatekeeping and negotiating access, consent and confidentiality, power dynamics and role conflict, and challenges in dissemination of findings. The experiences are based on a range of examples of research in a UK context from managing difficult conversations in the classroom to video-ethnography in the operating theatre.

Discussion and conclusions

These critical reflections make visible the challenges encountered and decisions that must be taken in the moment and on reflection after the event. Through sharing our experiences and debating the decisions we made, we offer insights into reflexivity in qualitative research which will be of value to others.

A Qualitative Space highlights research approaches that push readers and scholars deeper into qualitative methods and methodologies. Contributors to A Qualitative Space may: advance new ideas about qualitative methodologies, methods, and/or techniques; debate current and historical trends in qualitative research; craft and share nuanced reflections on how data collection methods should be revised or modified; reflect on the epistemological bases of qualitative research; or argue that some qualitative practices should end. Share your thoughts on Twitter using the hashtag: #aqualspace

Introduction and context

The importance of procedural ethics, gaining initial approvals for research studies, is well-established and guided by the principles enshrined in the Declaration of Helsinki and the Nuremberg code [ 1 ]. Ethical approval procedures are often viewed as a ‘hurdle’ to be surmounted, and arguably overshadow full consideration of the challenges of process ethics, the ethical tensions and dilemmas which arise throughout the practice of research. This paper aims to bring insights into ethical dilemmas which permeate research at all stages, from initial approval through data collection, dissemination of the findings and exiting the study [ 2 ]. These insights, developed from the authors’ personal accounts of their own practices, are derived from a range of experiences of medical education research in different settings.

Procedural ethics in medical education is guided by the codes of practice devised by education research bodies such as the British Educational Research Association (BERA) and the American Educational Research Association (AERA). These codes are applied by ethics committees who provide scrutiny at a national or local level depending on the context and nature of the research. For example, in the Netherlands, a national framework to review medical education research has been developed by the Ethical Review Board of the Dutch Association for Medical Education (NVMO) [ 3 ]. In the UK, ethical scrutiny is conducted under the auspices of university ethics committees, except where there is patient involvement, in which case clinical ethics committees are involved.

Until relatively recently, medical education research has been given something of a rough ride by ethics committees more used to considering clinical interventional research [ 4 ], although such committees are now becoming more familiar with educational research and the ethical issues arising. Guidelines for ethical behaviour are based on the philosophical principles of beneficence , do good; non-maleficence, do no harm; respect for autonomy, self-determination; and equity, treat fairly [ 5 ]. These principles are intended to guide thinking in applying for ethical approval by encouraging researchers to anticipate the ethical tensions and dilemmas which might arise during the study.

Guiding principles

The formulation of ethical research principles is based on the deontological approach proposed by Kant [ 6 ], whereby moral duty should be guided by principles which transcend circumstances. The utility of these principles in guiding practice is subject to critique on the basis that they may encourage following the ‘letter’ rather than the ‘spirit’ of the principle, or may in fact be too restrictive, limiting the scope and value of the research [ 7 ]. In addition, the consequences of research outputs are not entirely within the control of the researcher, and so the principle of non-maleficence, do no harm, may be difficult to achieve in all cases [ 8 ].

Guillemin and Gillam [ 9 ] distinguish between the domains of procedural ethics (gaining approval) and that of process ethics (ethics in the course of practice). In doing so they recognize that ethics are essentially situational, and that ethically sensitive issues occur ‘in the moment’ as research unfolds [ 7 , 9 ]. Tracy [ 2 ] elaborates further in proposing four domains to guide thinking; procedural ethics (approval processes), situational ethics (the research context), ethical relationships (dynamics between the researcher and participants) and ethical issues in exiting the study (completion and disseminating findings). This approach recognizes the ongoing, unanticipated challenges which might arise beyond gaining approval for the study and which require a high degree of researcher ‘reflexivity’ in responding ethically.

Shacklock and Smyth [ 10 ] describe reflexivity as the conscious revelation of the underlying beliefs and values held by the researcher in selecting and justifying their methodological approach. From an epistemological perspective, a reflexive approach recognizes knowledge as constructivist, developed throughout the research process and contingent upon existing understandings and beliefs [ 11 ]. Transparency about the researcher’s position and potential biases and assumptions is vital in judging accounts of qualitative research and the authenticity of the findings. This paper seeks to illustrate reflexivity in managing ethical tensions and dilemmas through accounts of ‘practitioner-researchers’, that is, those with a role in academic or clinical practice who also conduct research.

This researcher position is one with a working knowledge of the field of study, a shared identity with participants, sensitivity to competing priorities and as one known to participants outside of the researcher role. This practitioner-researcher position is valuable in developing practice insights. However, it may equally bring assumptions and biases which have ethical implications but which are not commonly made explicit in medical education research. The authors seek to address this by offering critical insights into their personal ethical dilemmas drawing on the ethical principles proposed by Beauchamp and Childress [ 5 ], and with reference to the framework proposed by Tracy [ 2 ]. As stated, the latter concerns procedural ethics (formal approval procedures), situational ethics (issues arising specific to context), relational ethics (awareness of researcher actions on others) and exiting ethics (considerations arising beyond data collection). The authors’ accounts (indicated by their initials) include gatekeeping and negotiating access in procedural ethics, debated by JB and SJ; questions of consent and confidentiality in situational ethics experienced by AC; power dynamics and role conflict in ethical relationships debated by AMR and JS and issues of confidentiality and anonymity which challenged AC in dissemination of her findings.

Procedural ethics

Procedural ethics, the formal approvals required for a study to commence, are dependent on the justification for the study and a stated commitment to adherence to ethical principles. Even before embarking on the formal application, the good intentions of the research need to be carefully weighed up against the vested interests of the researcher involved. Tracy [ 2 ] advocates that researchers practise (self-) reflexivity ‘even before stepping into the field … [to assess] … their own biases and motivations’ (P. 842). An illustration of this is provided by JB, an experienced academic and researcher in postgraduate medical education. He reflects on his role conflict as gatekeeper in pursuit of integrity and altruism in research practice. Gatekeepers are those who give access to a research field, or, ‘are able to control or limit researchers’ access to the participants’ [ 12 , P. 452]. Another aspect of the gatekeeper’s dilemma is described by SJ in relation to her role in managing the research of others. This follows JB’s story.

Integrity and altruism

JB: The Universities UK ‘Concordat to Support Research Integrity’ [ 13 ] calls for integrity and research excellence throughout the duration of a project. However, one, often hidden complexity, concerns the personal motivation of the researcher, a troubling question for me in leading a research program funded by a postgraduate medical department. Despite beneficent intentions and careful adherence to research governance processes, I retain lingering doubts as to the extent to which hidden coercive influences impact on participant recruitment.

Medical education research is relatively poorly funded and time pressured as many researchers are practitioners with substantial academic and/or clinical roles and responsibilities. As such, these researchers need to reflect upon, and be transparent about, their competing interests [ 14 , 15 ]. Although this issue has been highlighted for some time in the field, change has been slow, as evidenced by the relatively low number of competing interests disclosed in a survey of medical education related journals [ 16 ]. Walsh [ 17 ] suggests that medical education researchers may not deliberately fail to disclose, but rather fail to recognize their own competing interests due to the ‘bias blind spot’.

Bearing this in mind, I am conscious of relying heavily on the goodwill of participants with whom I may have relationships before, during and after the study. I believe that the participant should be exercising judgement based on the validity of the study in which they are consenting to participate, rather than on that relationship. Despite the best intentions to contribute to new knowledge, there must be an open and honest realization that research outputs are key benchmarks to measure how effectively researchers are performing. This dilemma was brought home to me while teaching postgraduate students, one of whom posed the question, ‘Can research ever be truly altruistic?’

Initially I was unsure of how to respond, but on reflection, admitted that in my experience, despite endeavouring to be honest and truthful to our participants, there may be a conflict between our personal motivations as researchers and reliance on the goodwill of participants. These reflections are unlikely to lead to any dramatic changes in practice; however, recognizing this potential conflict can at least remind us never to take for granted the commitment of willing participants.

Protection versus paternalism

SJ: Balancing the aims of beneficence, the value of research to the medical education community, with the principle of non-maleficence, avoiding harm, is an ethical conundrum which I have frequently encountered in managing an undergraduate medical education program. As a member of the medical education research community I am keen to support research, but am conflicted when faced with frequent requests to include our students as study participants. This particularly arises with survey research which is often the subject of such requests. The issue of survey fatigue is well-recognized [ 18 ], so much so, that my institution instigated a policy to restrict this [ 19 ]. The policy aims to prevent survey fatigue and ensure that students remain well-disposed to completing important internal and external surveys including the National Student Survey [ 20 ], the results of which are important key performance indicators for the institution.

On becoming director of a masters’ program in health professions education, tensions arising from my role as gatekeeper were exacerbated. The needs of the postgraduate students to recruit study participants potentially conflicted with the interests of the undergraduates. The availability of undergraduates as study material for postgraduate students and career academics is not new, and two decades ago undergraduate psychology students were described as ‘a captive population with little power’ [ 21 P. 74]. In a similar vein, Keune et al. [ 22 ] noted ethical issues arising in a scenario whereby a surgical resident introduced a mandatory team/trauma simulation training session. There was no indication that this session was also the basis of a research study until the trainees were presented with consent forms on arrival, clearly suggesting possible coercion. Another study explored the motivation of Indian medical students to participate in research conducted in their university and hospital learning environments [ 23 ]. Of the 300 participants, 61% admitted to participating against their genuine wishes, of which 26% agreed because a faculty member had asked them and 4% because they had not appreciated the right to refuse.

These examples demonstrate a tension between protecting potential participants and respecting their autonomy to choose whether or not to participate in research. One solution as gatekeeper may be to give agreement for participants to be recruited via a general email to a whole cohort, but prohibit purposive sampling of a specific group who may feel more pressurized. Managing access to students as participants highlights for me the ‘grey area’ between protecting the vulnerable and behaving paternalistically in upholding ethical principles.

Situational ethics

After formal approval and access has been granted, unanticipated ethical questions may arise due to the specific nature of the research setting [ 1 ]. In clinical settings data collection occurs within the course of clinical practice which brings specific challenges. AC, a colorectal surgeon whose doctoral research investigated teaching and learning in the operating theatre grappled with issues of consent in the context of patient autonomy.

Issues of consent in the operating theatre

AC: My research followed principles of naturalistic inquiry [ 24 ], capturing the phenomenon of teaching and learning in the operating theatre, as it happened, through ethnographic observation, video and audio-recordings [ 25 ]. One challenge of capturing naturalistic data is gaining prior consent of participants, as it can be difficult to predict who may be co-present within an operating theatre. In my study there was potential for inadvertent participants to be captured during data collection, defiling the research principle of autonomy—the right to determine participation or non-participation [ 5 ].

One approach to uphold autonomy was in the choice of microphone for audio capture: the ‘XTag RevoMic’ which has a short capture range. This meant that talk at the operating table of consenting participants was recorded but that others entering the operating theatre were not inadvertently recorded. The recording was taken from a camera placed within the operating lamp for open surgery, and from a laparoscopic (internal body) camera so that the site of the operation was captured but not the faces of those present. Assurance of this was key to maintaining trust between myself as researcher and the clinical teams involved.

Potential patient participation in the study also raised issues of autonomy. The study explored interactions between surgeon and trainee, but the patient’s body cavity formed the backdrop for video recordings of hand movements and the interactions involved. This meant that the patient would be co-present during the data collection episode although under anaesthetic. Murphy and Dingwall [ 26 ] state that ‘one must distinguish between those for whom the research is likely to be consequential and those who are tangential to it’. The ethics committee deemed that patient participants were peripheral, and that for this non-interventional research, patient consent was not required. General Medical Council (GMC) guidance specifies that doctors may use recordings such as laparoscopic video streaming or images of internal organs for secondary purposes (such as research), without seeking consent from patients, provided that the recordings are captured as part of patient care and are anonymized [ 27 ]. In this study recordings were captured by the research team and therefore were not a routine part of patient care.

The clinician participants, in particular the nursing staff, expressed very strong feelings that the patient should also be recognized as having the right to consent in making an informed judgement in whether or not to participate. Despite this presenting an extra hurdle for me as researcher, in my surgeon role I was used to gaining patient consent for operations and agreed that patients should be given the right for their procedure to be part of the study or otherwise. I discussed the study with patients, providing a bespoke ‘plain language’ Participant Information Sheet and consent form. Inevitably this raised separate ethical difficulties as patients were anxious that by consenting, they were agreeing to be operated on by a learner surgeon (given that the study was investigating clinical teaching and learning). I had to deal with patient vulnerability sensitively, explaining that participation in the study or otherwise would have no bearing upon their clinical treatment, or the person performing the operation, emphasizing that this was a non-interventional study. In this way the autonomy of patients to choose to participate was respected. No patient declined to be part of the study on this basis.

Ethical relationships

The issues arising described by AC highlight the complex nature of ethical relationships in research. The researcher-participant dyad is dependent upon any existing relationship with potential participants and a reassessment of the status of this in the context of the study aims and demands [ 28 ]. Managing power dynamics, role conflict and role boundaries in relationships are explored here firstly by AMR and then by JS, each of whom experienced such issues in their respective doctoral studies.

Power dynamics and role conflict

AMR: Power asymmetry is a feature of research with the balance generally considered to be in favour of the researcher who directs the process while the participant responds [ 28 , 29 ]. Ben-Ari and Enosh [ 30 ] argue that this power is actually co-constructed through the process, as participants exert power in shaping knowledge through choosing what to reveal. An illustration of such power dynamics occurred during my study on partnership working in the development and design of a new healthcare degree, commissioned by the Health Authority [ 31 ]. As program leader, I led the development and delivery of the curriculum and managed the team involved. This brought me the benefit of access to the university team and senior healthcare managers as participants, but also role conflict in managing relationships as the study progressed.

I was acutely aware of my potential biases and power dynamics as both researcher and manager; when interviewing members of my own team I was sensitive to the ‘ethics of care’ [ 1 ]. A specific dilemma arose during an interview with a lecturer when I asked a question from the schedule. Rather than respond to this, the interviewee took the opportunity to air personal grievances. The interview may be viewed as a dialogic process, and my sense of control of the dialogue was challenged by the participant taking ‘counter-control’ [ 11 ] in deviating from the schedule. I was unsure of how to react, feeling it inappropriate as researcher to challenge or make a direct response. In order to avoid distractions and regain control, I steered the conversation back to the interview schedule.

Although in the moment I felt that I was acting ethically in prioritizing the quality of the research [ 32 ], the issue troubled me later. It seemed inappropriate to raise the grievance with the interviewee in my management role after the event as I had assured participants of the confidentiality of the proceedings. With hindsight, given the power asymmetry in the manager-employee relationship, I now believe that seeking a later opportunity to discuss the grievances would have respected the autonomy of the staff member and provided duty of care. On reflection, a different interviewer may have avoided such circumstances occurring, but in this instance I was expected to conduct my own interview as part of the doctoral training.

Managing multiple identities in an acute setting

JS: My doctoral study involved conducting a multi-site, observational, longitudinal research study, focusing on clinical reasoning development in final year medical students as they transitioned to junior doctors 1 . This required managing a number of boundary issues through my overlapping roles of clinician, researcher, teacher and mentor. As I observed participants in both simulated and clinical workplaces, the ethical challenges of these roles developed. I had to ensure that participants could opt in or out of various clinical scenarios as well as at different data collection points. I also had to be mindful of my own potential biases and the need to treat them equitably, neither advantaging nor disadvantaging them as participants in the study. Furthermore, I had to consider the secondary participants who were the patients and ward staff in each workplace. Given the opportunistic and serendipitous nature of the workplace, audio-recorded consent was initially sought in the moment from secondary participants, followed by full written consent.

My ontological position, in particular my predominantly insider role, required a high degree of self-reflexivity [ 2 ]. Despite extensive prior approvals and permissions, I anticipated and faced ethical dilemmas arising from my relationships as both an ‘insider’ (a middle grade clinician), and an ‘outsider’ (clinical settings beyond my own workplace and field of expertise). The potential for role conflict also arose between my clinical and researcher role. It was agreed that should an emergency occur within the workplace, I would intervene if necessary in my clinical role in accordance with the GMC’s Good Medical Practice [ 33 ]. Furthermore, I would identify a senior member of staff in advance for each shift to whom I could report any instances of unsafe medical practice. Participants were made aware of my role and ethical position as this may have influenced their decision to be involved.

Ethical dilemmas arising during the study included critical incidents ranging from observing unsafe medical practice to observing primary participants being expected to deal with situations beyond their capabilities. One example occurred in observing a junior doctor who was covering obstetrics, an area in which they had little expertise. The junior doctor had been ‘emergency-paged’ to review an obstetric patient following a significant bleed, where no obstetrician was available. Walking to the emergency, as I unpicked the participant’s clinical reasoning, it became clear that this individual lacked the experiential knowledge and practical skills required. I felt very concerned by this and decided in the moment, that in the interests of non-maleficence (avoiding harm), I would switch role and take an active part in the patient management. Fortunately, shortly after our arrival at the emergency, an appropriate senior doctor appeared and no intervention on my part was required. Had there been unsafe practice, I would have reported the incident following the protocols in place to protect patient safety. Although in this case the situation was resolved, recognising the vulnerability of the junior doctor, I alerted the clinical supervisor to the incident to provide support and ensure that the clinical team debriefed after the event.

Exiting the study

Ethical dilemmas may continue beyond the study as exemplified by AC, who faced challenging issues in maintaining confidentiality and anonymity in dissemination of her findings which included video and audio data.

Challenges in dissemination of findings

AC: Observational field notes and interview transcripts from my study could be presented at academic meetings in anonymized format. However, data from synchronized video and audio, although names were removed, could not be fully anonymized as voices, gestures and body language rendered individuals identifiable. As a clinical researcher, I was able to select clips and the appropriate mode of presentation for particular audiences. For example, at surgical academic meetings where there was a high chance of identification of participants, which might make them vulnerable, I used subtitled video clips to illustrate research findings. This meant that intonation, pitch and rise and fall of delivery within speech were lost; however, the identity of participants was concealed.

For presentation at medical education meetings there was a lower chance of participant identification. The audience was particularly interested in analysis of exact timing of ‘teaching talk’, the guidance given and subsequent responses of the trainee surgeon including pauses, hesitations and hand movement. To enable this, with support I digitally altered audio data so that the pitch of speakers’ voices was modified to conceal identity. On occasion, specific clips with names removed but not completely anonymized format were presented using speakers’ own voices. Express written permission was received from participants for use of that particular clip, recognizing my ability as practitioner-researcher to gauge the likely sensitivity of the data and the audience. For publication purposes, Jeffersonian [ 34 ] transcription notation was used. This technique records pauses, intonation, pace and stresses in the delivery of speech so that the transcript indicates not only what is said, but also how it is said. These different methods of presenting the data were selected in the spirit of non-maleficence, avoiding potential harm to participants, acknowledging that complete anonymity could not be entirely guaranteed. This was made clear to participants at the outset.

Discussion and conclusion

Qualitative research, by its nature, involves immersion in situations and relationships which are complex and unpredictable. These personal accounts have explored the nuanced nature of ethical tensions and personal dilemmas which have emerged for us, as practitioner-researchers beyond the approval process and arising throughout the research. Although some issues are particular to specific situations, there are common features in the challenge of thinking and acting ethically as a qualitative researcher. These include striving to maintain integrity and altruism, upholding autonomy in gaining consent and access, balancing protection of vulnerable participants with paternalism, managing multiple roles and power relations and avoiding harm in dissemination of findings.

The common thread running through our experiences is the sometimes troubling questions raised which may be difficult to foresee, and even when anticipated, require a response ‘in the moment’ [ 9 ], which has ethical consequences. Although the risks involved in JS’s experience of managing an obstetric situation as a clinician-researcher on the wards seem high, and the consequences are immediate, JB’s classroom conversations regarding integrity and altruism in research may have far reaching consequences. Training those learning the craft of research carries significant responsibility as it is key to how future researchers understand ethical principles and manage their own conduct in applying them.

The principles of beneficence, non-maleficence, justice and equity should guide action, but the balancing of these principles effectively from the initial approval through to completion of the study and beyond requires a truly reflexive approach. Through sharing our reflections and insights we hope to raise awareness, not only of the challenges of conducting qualitative research ethically, but also of its value when conducted in a rigorous, ethically informed, thoughtful and reflexive manner. This has implications for those undertaking qualitative enquiry as well the gatekeepers who manage access and for those who prepare and train the researcher of the future.

Biographies

BDS, MEd, PGCert, EdD PFHEA, is Associate Professor of Medical Education, University of Leeds. Her clinical background is in General Dental Practice. She has a Professional Doctorate in Education, is a Principal Fellow of the Higher Education Academy and is a member of the Association for the Study of Medical Education (ASME) Research Committee.

BA (Hons), PGCE, PhD, is Professor of Clinical Education at Edge Hill University. He leads a medical and dental education research program funded by Health Education England North West.

BMSc (Hons), MBChB, MRCS, PGCert, MFST (Ed), PhD, is a Specialty Registrar in Trauma and Orthopaedic Surgery at The Nuffield Orthopaedic Centre, Oxford. She has a PhD in medical education for which she received ASME’s New Researcher Award.

MBBS, MEd, PhD, FRCS, is a Consultant General and Colorectal Surgeon at Frimley Health. She has a PhD in medical education and is a module lead on a Masters in Surgical Science and Practice at the University of Oxford.

BSc (Hons), PGCert, EdD, PhD, is Professor of Health Professions Education at Glasgow University. She has a Professional Doctorate in Education and is Chair of the Education Research Committee of the Association for the Study of Medical Education (ASME).

Conflict of interest

A.-M. Reid, J.M. Brown, J.M. Smith, A.C. Cope and S. Jamieson declare that they have no competing interests.

1 Smith, JM. The Transition from Final Year Medical Student to Foundation Doctor: The Clinical Reasoning Journey. Dundee; 2015 (unpublished thesis)

Editor’s Note: Commentary by: E. Paradise, 10.1007/s40037-018-0414-0.

• key messages
• Introduction
• Qualitative research to inform biomedical research design and PPIE – one contested boundary
• User-testing and co-production: another contested boundary
• Co-designing research interventions as a way forward?
• Working at the boundaries, or the margins?
• Funding details
• Acknowledgements
• Conflict of interest

Subjects and Keywords

Related content.

• Previous Article
• Next Article

Drawing straight lines along blurred boundaries: qualitative research, patient and public involvement in medical research, co-production and co-design

Biomedical research policy in many countries has adopted the principle of active involvement in research. However, how different approaches to involvement such as patient and public involvement/engagement (PPIE), qualitative research, participatory research, co-design and co-production sit alongside each other, is contentious and unclear. There has also been a subtle shift in the discourse, with the language of co-design and co-production used more widely in debates about involvement. This shift has surfaced once again debates about what counts as meaningful involvement. In this paper we seek to contribute to this debate by exploring boundaries and overlaps between them. We suggest that they share some underpinning philosophies and all are prone to be challenged on the grounds of tokenism despite avowed good intentions. We argue that these different approaches are not necessarily as distinct as is often advocated and question whether there is merit in this family of marginalised approaches working more collaboratively to give patient voices greater traction. At the same time, we recognise that this creates challenges and tensions.

User perspectives are argued to increase relevance and use of research evidence.

Activities to effect this include:

patient and public involvement/engagement (PPIE)

qualitative research

participatory research, co-design

co-production

Considerable effort is invested in drawing clear lines along blurred boundaries between them.

There may be scope for approaches to work together and peacefully co-exist.

This paper examines different approaches to involving patients and family members in biomedical research, particularly in designing interventions to be tested in randomised controlled trials. Unlike drug trials, intervention trials commonly rely on changes in behaviour. Understanding what matters to patients is therefore crucial in designing interventions that are acceptable and rooted in the reality of patients’ daily lives. Examples of interventions include: weight loss and exercise programmes for people with diabetes; online cognitive behavioural therapy; or self-monitoring of long-term conditions.

Much has been written – in different disciplinary fields – about how health research and healthcare can be better designed around patient and family needs and preferences. This is a crowded landscape, fraught with contested definitions and normative positioning, in which others’ approaches are often dismissed as less empowering, authentic and patient-centred than one’s own. Terms such as co-creation, co-production, co-design, participatory action research, involvement and engagement mean different things in different disciplinary and international contexts. As Ocloo and Matthews ( 2016 , 627) point out ‘language does not always reflect the underlying ethos of these involvement activities’.

‘Engagement’ is one example. In the UK INVOLVE, a national body promoting patient and public involvement in health research, defines it as simply telling people about research, ‘where information and knowledge about research is provided and disseminated’ ( INVOLVE, 2018a ). This is in contrast to ‘involvement’ – carrying out research with patients as active partners. In other contexts, however, ‘engagement’ is used to mean something similar to ‘involvement’; both the American Patient-Centered Outcomes Research Institute and Canada’s Strategy for Patient-Oriented Research use ‘engagement’ in this way. In this paper, therefore, we use the term PPIE (patient and public involvement/engagement) to reflect the international interest in patients as partners in research.

The ‘co’ terms (including co-production and co-creation) have increasing traction in academic and policy debates about working with stakeholders, but the extent to which this shift signals a fundamental change in attitudes and practices is unclear. Hahn et al (2017) suggest these activities may remain tokenistic, despite the change in language. Equally there is a risk of assuming that any activity described using less fashionable terms must by defnition be lacking in good intention.

Much of the debate around these many terms is found within the literatures on community development, health systems and improvement ( Goodyear-Smith et al, 2015 ). The idea of co-production and codesign is already well-embedded within healthcare quality improvement research and practice. However, it is relatively new in biomedical research, and this is therefore our focus. Making intervention trials more user-centred is promoted both to ensure that evidence generated is as relevant as possible to patients and to challenge traditional notions of what counts as evidence. However, medical research is also a site of complex intersection between biomedical and social science traditions, and one where patient risk and a discourse of patient rights are added to the mix. As Goodyear-Smith et al (2015, 1) have pointed out, the adaptive nature of participatory co-design work ‘sits oddly with ethics committee protocols that require precise pre-definition of interventions’. The world of biomedical research is less flexible, more tightly structured and regulated, and more hierarchical than the fields in which co-production has flourished, raising questions over its transferability.

In this paper we seek to:

Examine the boundaries and commonalities between approaches to incorporating user perspectives in the context of designing biomedical research interventions, particularly:

• ◦ Qualitative research
• ◦ Patient and public involvement
• ◦ User testing
• ◦ Co-production and codesign

Consider the potential of codesign as a way forward

Explore the ethical assumptions underpinning different approaches

In doing so, we do not seek to offer simple answers or impose spurious clarity, but rather to unpack overlaps, confusion and competing philosophical standpoints for reflection. Boundaries between approaches, we argue, may in part be more imagined than real, reflecting differing origins and traditions, and the language ‘work’ each may undertake to differentiate their own contribution. While genuine differences in both method and intention exist, we suggest there may also be areas where boundary work can seem like an unhelpful guarding of territory. This resonates with Gieryn’s (1983) analysis of ‘boundary work’ as an ideological exercise engaged in by scientists to demarcate their work from other ‘non-scientific’ activities. By definining the characteristics of what is or is not science they work to create intellectual authority, preserve career opportunities and protect their autonomy; those on the other side of this boundary are denied access to these resources. Yet, as Gieryn argues, the selection of demarcation characteristics is not static or universally agreed; rather boundaries are continually drawn and redrawn to suit a particular claim.

From conversations with many colleagues we know this is a debate which causes much division and disagreement, but one which is increasingly aired in journals and conferences in health research. We offer this paper as a contribution to the debate.

While these reflections are largely based on developments and debates in the UK, we hope they have wider international resonance given the growing international debate about participation and involvement.

Qualitative research has a long independent tradition in medical sociology, health psychology and anthropological studies of healthcare. Of course not all qualitative research is about patient perspectives, nor is much of it intended to inform medical intervention studies (the ‘enhancement’ model, as Popay and Williams (1998) call it). Much qualitative health research is about building social theory (Popay and Williams’ ‘difference’ model). However, the value of qualitative methods in informing intervention research is increasingly recognised, and in this context it often takes a particular pragmatic and applied form. An in-depth elicitation of people’s perspectives to understand their experiences and needs can help surface trial programme theory and inform the development of interventions. Qualitative research can also help to evaluate how an intervention is received and why it does or does not work in particular contexts.

On the face of it, PPIE in medical research seems to have a role which is distinct from qualitative research. PPIE involves patients as lay advisers to make sure that the research is acceptable to people like them, checking that the information and consent materials are understandable and advising on the dissemination of findings (including the production of lay summaries). People involved in PPIE are not participants in research, but partners in the research process. Unlike qualitative research into patients’ perspectives, PPIE in research has not emerged from an academic hinterland; rather its origins lie in a combination of the consumerist movement and an efficiency discourse ( Evans, 2014 ), (though evidence that it will make research more efficient is still incomplete).

However, in the context of biomedical intervention studies, arguably both approaches have coalesced towards a common purpose: to make interventions more likely to reflect the needs of patients and fit with their daily lives. We suggest that the boundaries between PPIE and applied qualitative research in this context may be less clear than we sometimes suppose. Partly this is because PPIE itself has grown and changed to be more ambitious in scope; and partly because as qualitative methods have been brought into intervention design, they take on a specific character. These two strategies for bringing patient perspectives into medical research design have expanded side by side, but have been keen to demarcate a sharp boundary. We do not seek to argue they are identical or completely interchangeable. However, we suggest they tend to set up ‘straw man’ versions of each other as part of boundary maintenance work, to defend their own territory. Qualitative researchers may feel PPIE is a threat to their sense of professional identity, and to the distinct role of qualitative research expertise.

What do PPIE advocates say about qualitative research? Perhaps that it is too passive and exploitative – simply extracting data from people and not giving them a say in the way the intervention is refined. But is this really the case if people are asked for their thoughts iteratively and in detail on every aspect of the intervention (as is the case, for example, in Yardley et al’s (2015) ‘Person-Based Approach’)? Can qualitative research not also be emancipatory and take the form of a co-conversation?

What do the advocates of qualitative research say about PPIE in intervention design? Perhaps that it is based on small numbers of atypical people, who cannot reliably extrapolate from their personal experience to speak for others, and that it tends towards a mandated, bureaucratised, managerialist approach. However, PPIE is only a tick-box exercise limited to a handful of middle-class people on a committee, if we researchers choose to make it so. PPIE methods can also involve focus groups with multiple participants ( Doria et al, 2018 ) and one-on-one discussions on sensitive topics, or creative workshop activities. In any case, as the field of PPIE has matured, arguably patients collectively have started to challenge researcher and funder control over how they ‘should’ be involved ( Locock et al, 2017 ; O’Shea et al, 2017 ).

Ironically many of these criticisms of PPIE – that it is based on small numbers; unrepresentative; subjective; and privileges particular groups of people who are willing to take part – have also been levelled at qualitative research. Purposive sampling in qualitative research is not designed to be ‘representative’ of a whole population but may rather be aimed at capturing a broad range of perspectives, or an in-depth exploration of a subset of relevant experiences. Nonetheless, advocates of qualitative research would emphasise its richness, scale and depth of insight compared to PPIE, as well as its ability to inform other future studies through theory development.

Some authors have suggested the two approaches can be complementary. Morgan et al (2016) describe using a combined PPIE and qualitative research approach, in which women from mother-and-baby groups in deprived areas were involved using PPIE methods as study co-investigators, and subsequently took part in one-to-one research interviews. They argue that this led them to a wider range of perspectives than if they had asked women from these communities only to take part in a research interview, an invitation they might have declined without the rapport-building during the PPIE phase. This is an interesting form of bridging across boundaries.

Meanwhile, in a parallel disciplinary space, engineers and app developers have designed interventions using iterative user testing and focus groups, drawing on design science. While sometimes making use of research methods, Yardley et al (2015) argue that usability testing is too narrowly focused on physical product design and neglects other, wider aspects of intervention design such as whether the intervention is motivating, convincing and even enjoyable. This may be a fair point – though design scientists might argue that in theory good designers will be designing a whole experience, not just a product.

And in another space altogether, researchers and their partners have developed co-production and participatory action research (PAR) approaches, where the lines between researcher and researched, between lay and expert, are deliberately blurred and challenged, underpinned by an egalitarian, emancipatory philosophy. Co-production has evolved far from biomedical research and intervention design, and would not by any means see this as a central concern. Its origins are in community-based service planning and quality improvement ( Ostrom et al, 1978 ), where paternalist ideas about consenting to someone else’s research have little traction. The ‘R’ in PAR is in theory a collective process of discovery, unlike the traditional view of research in medical contexts as a risky process ‘done to’ patients.

Despite co-production’s potential to address the democratic deficit and promote active citizenship, Osborne et al (2016) argue that it can remain tokenistic, if it is just an attempt to ‘add in’ public participation to bureaucratic processes, rather than fundamentally overturning them. (This sounds remarkably similar to common criticisms of PPIE). Osborne et al suggest co-production is ‘poorly formulated and has become one of a series of “woolly-words” in public policy’. Crucially they argue that co-production is inherent in all public service delivery; the very act of providing and receiving services shapes those services, whether people are consciously ‘co-producing’ or not. Thus it may lose its potential emancipatory qualities.

Alford (2014) argues for a clearer differentiation between ‘production’ – turning input into products – and the ‘co’ element, implying mutual relationships. Increasingly, the PPIE field is turning towards co-production to get beyond a tick-box procedural interpretation of PPIE. This is evident in the UK in the National Institute for Health Research’s new strategic plan ( NIHR, 2015 ), which actively promotes ‘co-production’ or the ‘participatory research paradigm’ as a way for academics, patients and public, and clinicians to work collaboratively across the research pipeline. A first attempt at developing principles for co-producing research in the NHS has since been produced ( INVOLVE, 2018b ).

Co-production of medical research is not well-documented in published literature, as Pinfold et al (2015) note. They argue that there is scope to develop co-production approaches as a way of challenging inequalities in power in research, but further conceptual and theoretical work is needed alongside empirical studies to understand what co-production means in practice. While co-production could be seen by advocates of PPIE as extending and improving its reach, advocates of co-production may object that it is difficult to do meaningful co-production within the confines of a mandated activity. As a result they might suggest this is an argument for keeping the two distinct, and focusing PPIE on a more limited range of activities.

Osborne et al (2016) propose a series of definitions for co-production, co-design, co-construction and co-innovation. Whereas co-production may be involuntary, they define co-design as an active, voluntary process of producers and users working together to redesign individual services (as opposed to whole system redesign).

While co-production across the whole medical research cycle is an ambitious and perhaps far-off goal, co-design of interventions may be more realistic in the short to medium term.

Does one approach provide a sufficiently wide umbrella to draw in all the approaches we have discussed? Following Osborne et al’s definition, co-design, using participatory action research methods, has potential to be applied to intervention development, cutting through the boundaries between PPIE and qualitative research. Done well, it can offer the best of both: genuine involvement; a focus on understanding many perspectives; an iterative and investigatory style; and a commitment to changing things in the interest of those who have to live and work with the results. The fact that intervention design generally does not use co-design, but is rather torn between other types of qualitative research and PPIE, is to some extent a disciplinary accident, and also reflects the initial consumerist rather than participatory origins of PPIE.

A clear distinguishing feature of co-design processes such as experience-based co-design is the way they can bring together multiple stakeholders, not just researchers and patients. Frontline health service staff, including cleaners, receptionists and managers, as well as clinical staff, have an understanding of healthcare context which is crucial to anticipating how an intervention might translate into the real world ( Marjanovic et al, 2019 ). Arguably, there is a moral imperative for frontline healthcare staff to also contribute to research decision making, because most intervention delivery will involve them. Clinical academics are represented on funding panels and research teams, but this is only one type of staff perspective. Staff stakeholders are notably absent from the PPIE discourse, and some advocates of PPIE would be hostile to their inclusion.

It is important to note that this process is different from co-design with members of the target population. Sometimes developers seek the opinions of users concerning what elements and characteristics they believe the intervention should include. A potential problem with this approach is that it encourages users to try to anticipate the needs of others, which they are unlikely to do well, rather than simply reporting their own experiences and views, which they do very well. We find that users are naturally expert at telling us what they like or dislike about our intervention, but most users are understandably less able to generate effective behaviour change techniques or good design solutions.

While researchers will obviously bring theoretical and wider empirical insights to the table, one could query how far they are really better positioned to ‘anticipate the needs of others’ than well-informed users. On the other hand, approaches which describe themselves as co-design or co-production may be more superficial and less genuinely empowering than the idealist narrative which surrounds them. Again, language and practice may be at odds.

We would not wish to dismiss approaches that do not meet the test of ‘co-design’ or ‘co-production’. In some cases, simple PPIE feedback on an idea may be the most effective input. We should also not let the best be the enemy of the good, given inevitable funding and timing constraints.

Ethics, power and agency

Why does it matter whether involving patients (or staff) in designing interventions is positioned as qualitative research, PPIE, user-testing or co-design? One reason (at least in the UK) is the implications for ethics review. This is not just a practical process issue, but also a philosophical issue of power and agency, and how we construct stakeholders. How these different activities engage with ethics reveals some of the real and perceived differences between them.

The UK Health Research Authority’s (HRA) policy framework for health and social care research states that ‘the involvement of patients, service users or the public in the design, management or conduct of research… is not subject to approval (eg from a research ethics committee)’ [our emphasis].

Ethical review and approval processes start from an assumption of vulnerability, risk and the need for protection. In health research, this is driven by the Declaration of Helsinki, designed with biomedical human experimentation in mind. Qualitative research conducted in healthcare settings has largely been subject to the same ethics processes and requirements as biomedical research. However, as Hoeyer (2006) has argued, social sciences and medical research have ‘conflicting notions’ of ethics. It is over 10 years since Dingwall (2006) described the ethical governance of health services research as a mess and ‘an exercise in fatuity’, characterised by ‘excessive and inappropriate bureaucratic requirements’. His argument that health services research should only be subject to external regulation in the few cases where participants are exceptionally vulnerable has fallen on deaf ears. By contrast, Goldstein et al (2018) argue more conservatively that quality and service improvement research in healthcare should remain governed by existing medical research ethics committees. Even though these were not designed with quality improvement research in mind and are not a perfect fit, they have the advantage of being based on internationally accepted ethical principles. A proportionate approach is recommended, including seeking ethics committee advice on whether a particular piece of work meets the definition of research.

However, a traditional ethics approach is even more at odds with the philosophy of partnership underpinning community-based participatory action research, where paternalist ideas about consent and ethics have little traction. In the context of implementation research, Goodyear-Smith et al (2015, 3) argue that ‘with co-creation design, there is a move from protection of individual participants to the development of a relationship between researchers and community partners which is mutually advantageous’.

However, this still constructs the issue as a question of forms of research (which may be more or less participatory). It does not address the boundary with the non-research activity of PPIE. It is not our intention to drag PPIE within the research framework – though we have seen examples of people applying for ethics approval ‘just in case’, or ‘so we can publish it’. The fact that PPIE can be more informal and lighter of foot is something to cherish, not to suffocate.

How, then, can we liberate from a disproportionate ethics regime this family of approaches to intervention design which have many goals and methods in common? How can we avoid constructing people as vulnerable participants rather than partners, with agency?

The following should not be reported: Questionnaire surveys and interview studies that do not include human biological material. (Section 14, paragraph 2, Danish National Committee on Health Research Ethics, 2017 )

At one level, this creates problems for our colleagues in those countries when they seek to publish qualitative studies in English-speaking journals, but it also frees them to work in participatory spaces in an eclectic way, without having to draw boundaries.

Arguably all this work can be seen as what Gibbons et al (1994) described as Mode 2 activities, and therefore to a large extent remains at the boundaries of the academic disciplines/fields to which researchers belong. Gibbons distinguishes between traditional research activity (Mode 1) and the development of a new mode (Mode 2), in which knowledge production is more socially situated, transdisciplinary and socially accountable. Nowotny et al (2001) developed these ideas further, considering the different epistemology that underpins Mode 1 and Mode 2. The authors argue that encouraging non-scientific actors to participate in the knowledge production process can have a transformative impact on knowledge, enhancing its relevance, reliability and scope for impact. However, empirical studies of researchers engaged in Mode 2 knowledge production have suggested it can be an uncomfortable place to operate ( Ferlie and Wood, 2003 ). More traditional Mode 1 academic activity retains what Ferlie and Wood describe as ‘considerable defensive power’, limiting the extent to which Mode 2 research may develop. This may be especially true in the structured and process-driven world of clinical trials.

This paper has identified similarities as well as differences between the different groups working to promote involvement/engagement in biomedical research. Despite the policy discourse, these are all largely marginal activities. As Watermeyer (2012) notes in his study of public engagement, engaging in marginal activities can have negative effects on academic identity, research practice and career progression. As such these marginal activities carry potential career risks for the individuals who engage in them.

All these approaches – PPIE, qualitative research, user testing and co-design – may share similar values but represent competing understandings and beliefs of how to get there. At times, this competition encourages different groups to retreat to and fortify their own power base. Becher (1989) described academic tribes as warlike and hostile in defending their disciplinary territories. To what extent do we see such conflict and tribal work also in this debate, as those aligned with the different perspectives seek to distance themselves from each other? To what extent does professional identity (for example the pressure to publish and demonstrate ‘ethics’) constrain people to reinforce rather than overcome disciplinary demarcations? Has the mandatory quality of PPIE led to burdensome and disproportionate encroachment territory previously occupied by research? This defence of territories adds to the confusion of the very stakeholders we seek to work with as we attempt to draw clear boundaries along blurred lines.

Is an alternative vision to encourage more boundary spanning? In her work on the boundary between anthropology and demography, Greenhalgh (1997, 822) argues for ‘peaceful coexistence’, greater sensitivity to the potential for learning across boundaries and respect for disciplinary difference. She does not argue that fields need to merge (indeed fields are embedded in and shaped by the cultures and histories of their fields). However, in terms of learning she argues that methods can fruitfully travel, albeit gaining new purposes and meanings.

[We] need to be alert to the subtle and rarely discussed transformations that occur when methods cross disciplinary borders… My counsel is to respect disciplinary difference and to recognise that anthropological methods when transported to another field such as demography will be shorn of some of their meanings and endowed with new meanings that may be inconsistent or even antithetical [to original meanings]. ( Greenhalgh, 1997 , 823)

However, boundary-spanning work is not without risk. It requires a degree of confidence, skill and commitment which may be lacking. We also recognise that such boundary spanning can be troubling for those who feel something of the richness and rigour of their preferred approach is lost in translation as it is (mis)appropriated by another field. Far from emulation being interpreted as a sincere form of flattery, it may represent unwelcome encroachment and a dilution of the core mission. We have previously written about the different ‘worlds’ of research, policy and practice, and the risks faced by adventurous souls who choose to migrate between worlds ( Locock and Boaz, 2004 ). People working in these marginal, boundary-spanning spaces may find it invigorating and liberating – but they also face disapproval or lack of understanding from their ‘home’ community, career disadvantage and frustration at the need for unpalatable compromise. This is not easy terrain, and we cannot offer a simple, clear roadmap. Not everyone will want to occupy (or get lost in) this space, and there is good work to be done within one’s own separate territory of qualitative research or PPIE, for example. Not everything has to be co-designed, and PPIE may not always be needed. But for others the intersections will be more interesting than the demarcations.

This paper aims to stimulate discussion about the extent to which the approaches described here might peacefully coexist. Firstly we consider why this matters. For the research community, pursuing boundary maintenance wastes time, and makes it harder to talk to and involve one another. There is also an issue of scale: the activities we discuss here are often small-scale, poorly-funded and with limited incentives. As advocates of PPIE, co-production, co-design and qualitative research, would we be more powerful if we worked together more often, assumed we are all equally well-intentioned, and treated each other with mutual respect rather than suspicion? Can we learn from each other to overcome the challenges these approaches face? For example, co-design provides useful learning about how service providers can be involved alongside service users.

One challenge all these approaches share is to move beyond tokenism and overcome the gap between language and practice. Madden and Speed, for example, argue that PPIE is frequently subject to ‘narrow technocratic cooption’, ‘offering (but never providing) a solution to purported deficits in democratic engagement’ ( Madden and Speed, 2017 ). These are criticisms that might equally be levelled at co-production in some manifestations, or indeed at some qualitative research studies. For example, a review of experience-based co-design projects found a wide range of projects describing themselves as co-design, but only completing some elements of the process ( Donetto et al, 2015 ).

We would argue that these approaches are sometimes distinct but complementary, sometimes overlapping and sometimes interchangeable, and that overlaps are sometimes exacerbated by the diversity of practice in application. Choices about which approach to take should in future be driven not by preferences (of researchers or funders), but by methodological and practical considerations, and a concern for what Rycroft-Malone et al (2016, 223) describe as ‘authentic collaboration’, which emphasises ‘the importance of engaging and integrating the multiple perspectives of stakeholders that can shape the understanding and process of knowledge generation and use’.

Through the ‘Co-Creative Capacity’ pursuit, this work was supported by the National Socio-Environmental Synthesis Center (SESYNC) under funding received from the National Science Foundation DBI-1052875.

Louise Locock’s post at the University of Aberdeen is supported by the Chief Scientist Office, Scotland.

Thanks to many colleagues (too numerous to name) for discussions over the years which have prompted this paper, but particularly the late Rosamund Snow and Anne-Marie Boylan for initial ideas; Pat Hoddinott, Glenn Robert and Allison Metz for commenting on previous drafts and debating our thinking with us; and our anonymous reviewers. We alone remain responsible for content.

The authors declare that there is no conflict of interest.

Alford , J , 2014 , The multiple facets of co-production: building on the work of Elinor Ostrom , Public Management Review , 16 , 3 , 299 – 316 . doi: 10.1080/14719037.2013.806578

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Statistics for the Public Good

Ethical considerations associated with Qualitative Research methods

Introduction.

This high-level guidance has been developed by the UK Statistics Authority’s Centre for Applied Data Ethics (CADE), and the UK Government Data Quality Hub (DQHub), based at the Office for National Statistics (ONS). The guidance can be used as a practical resource to help researchers identify different ethical issues when conducting qualitative research.  

This guidance is not exhaustive but aims to support researchers navigating the ethical issues surrounding qualitative research projects (particularly in relation to primary data collection). It brings together existing literature on qualitative research methods and their ethical concerns. Links to further resources are provided if you would like to read about aspects in more detail.  

The guidance has been created for researchers using qualitative methods within the ONS . However, the ethical considerations discussed, and the mitigations for these, can be more widely applied to all types of qualitative research.  

The guidance is divided into several parts.    

• An introduction to qualitative research and why ethics matters in this space.   
• An overview of some of the ethical considerations associated with qualitative research methods, and some potential mitigations for these issues. This includes an overview of some of the qualitative methods used within the ONS.  
• An ethics checklist which summarises the main points covered in this guidance.    
• A list of helpful links to further resources.   

Uncloaking the Researcher: Boundaries in Qualitative Research

• Kalyani Thurairajah MacEwan University, Canada

Qualitative researchers are expected to engage in reflexivity, whereby they consider the impact of their own social locations and biases on the research process. Part of this practice involves the consideration of boundaries between the researcher and the participant, including the extent to which the researcher may be considered an insider or an outsider with respect to the area of study. This article explores the three different processes by which boundaries are made and deconstructed, and the ethical complexities of this boundary making/(un)making process. This paper examines the strengths and limitations of three specific scenarios: 1) when the researcher is fully cloaked and hiding their positionalities; 2) when there is strategic undressing to reveal some positionalities; 3) when there is no cloak, and all positionalities are shared or revealed. This paper argues that it is insufficient to be reflexive about boundaries through acknowledgement, and instead advocates reflexivity that directly examines the processes by which social locations are shared and hidden during the research process.

Author Biography

Kalyani thurairajah, macewan university, canada.

Kalyani Thurairajah is an Assistant Professor in the Department of Sociology at MacEwan University. Her research is focused on questions pertaining to national identities among immigrants, and the process through which they negotiate their loyalties between their countries of origin and countries of settlement. She is also interested in how narratives of multiculturalism and racism influence the development and maintenance of national identities.

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