Clarifying the roles of patients in research
BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1463 (Published 10 April 2018) Cite this as: BMJ 2018;361:k1463
All rapid responses
Clarifying the roles in any partnership is very important, whether it be in a multi-disciplinary research team or patient, public or practitioner engagement. I commend the authors for bringing this important issue forward. The article, however, seems to set ethical research up as something that is difficult to do in partnership situations. When patients’ contributions as partners are taken seriously, ethical research must be partnership research. Partnerships should make research more ethical, not less so.
The article suggests that when patients contribute as partners their contributions cannot also be analysed as data: “To do so would circumvent ethical approval and result in poorly conducted, unethical research”. There are, however, strong qualitative research traditions in other areas that engage both practitioners and public (e.g., nursing, education, social work) that have well-developed frameworks for conducting participatory research. This can include a) research co-design where partners design studies and collect data and analyse with researchers and b) action research where partners are simultaneously researchers and part of the data. There are of course careful negotiations of roles, boundaries and consent but to say that this is impossible is to ignore that it is already being done in valuable, ethical and rigorous ways in other fields.
The article seems to also over-emphasize only one element of ethical research. In describing the possibility that partners might contribute to pilot data and the analysis of that data, they argue “There are ethical challenges to these practices, however, such as how to maintain anonymity of participants in the research report once they become active partners.” It is important for everyone to be aware of ethical implications of their participation in any aspect of research but there are ethical principles beyond protection of anonymity that must be considered. For example, the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans [1] is explicitly guided by three principles: Respect for Persons (including autonomy of research participants and partners), Concern for Welfare, and Justice. It explicitly outlines that in some kinds of research, especially where contributions are made beyond providing data, respect for the participants’ contribution should be shown by identifying them for those contributions or offering them the choice to be identified. Respecting autonomy and providing justice for communities that have been historically been harmed by unethical research, as the authors rightly argue that patients have been, can mean respecting their ability to choose whether their contributions are anonymous or named and recognized.
I thank the authors for bringing attention to the importance of thinking carefully about patients’ roles in research but suggest that this must go further to recognize that including patients as partners is not a challenge to ethical research but an essential element of it.
1. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2014.
Competing interests: No competing interests
> “Common misunderstandings are a barrier to real progress”
Well said. In human discourse, meaning depends on context, and when social roles are evolving, such misunderstandings can have the full force of a head-on collision. How many times have we seen Party A state something (perhaps with the best intentions) and Party B respond, “That’s madness!” The exchange can lead to anger: “Don’t tell me you didn’t mean it that way – I know what you said!”
And that’s not to mention the clashes as perspectives shift from passive to active. Even within the patient movement anger can erupt if one party says s/he wants to shift from “passive patient” to “empowered consumer” while another activist considers “consumer” to be a pawn of the industrial economy.
> an unhelpful diversity of terms [engagement, participation, involvement]
Our “paradigm of patient” is at a breaking point. In his landmark 1962 book Structure of Scientific Revolutions (the book that brought “paradigm” into popular usage) Thomas Kuhn wrote that scientific fields have predictable stages, and that the pre-paradigm stage is characterised by the lack of agreement about fundamental principles – a stage in which practitioners literally cannot talk to each other.
Aside from those words for engagement (whose meanings overlap but are not identical), we have multiple conceptions of how to understand observations of a patient’s role or how to intervene: Hibbard’s Patient Activation Model [“PAM”], Prochaska’s TTM (trans-theoretical model), Miller & Rollnick’s motivational interviewing, etc. And that’s not to mention Angela Coulter’s The Autonomous Patient, a concept unimaginable to the benighted, though she wrote it sixteen years ago.
The most egregious example I’ve seen of this “model blindness” was the February 2013 issue of the US policy journal Health Affairs, titled “New Era of Patient Engagement.” Its articles contained at least three different implied definitions of engagement, yet not a soul noticed. No wonder we haven’t made much progress and people talk at cross purposes.
And lacking an agreed (and evidence-based) model, it’s no wonder that people keep creating policies and practices that treat patients as passive recipients. Besides, it gets so messy when policies have to respond to diversity of patient wants and aptitudes.
But Kuhn also wrote, “Discovery commences with the awareness of anomaly, i.e., with the recognition that nature has somehow violated the paradigm-induced expectations that govern normal science.” Indeed, today we constantly see examples of engaged, empowered, informed, thinking patients altering the outcomes of their cases, which makes it patently obvious that Liabo is right in saying the term “patient” no longer denotes a passive recipient of healthcare.
It can be no clearer: every time a clinician, researcher, administrator or government policy agent imagines patients as passive recipients, s/he is not only out of touch with evolved reality but is thus actively holding back progress. We the patients object.
Competing interests: No competing interests
I am afraid I could not disagree more with this. It reflects a UK-centric view of patient and public involvement which takes as given the NIHR definitions as well as current ethics committee approaches. It is perfectly possible for patients/the public to be both active collaborators and providers of data, and this approach has deep roots in the action research and community-based participatory research traditions. That our current UK ethical procedures struggle with these approaches is true, but the solution lies not in making artificial distinctions, buying reforming our approaches to ethics. We need to move beyond an approach that equates ethical behaviour with consent, and return to a deeper consideration of potential benefits and harms, and consider carefully how society as a whole might benefit from research in which engaged community members are both researchers and researched.
Competing interests: No competing interests
Our paradigm of patient must evolve (citation)
Some may be interested in my longer articles on the paradigm of patient. Apologies, I should have included these in my first RR.
"The paradigm of patient must evolve: Why a false sense of limited capacity can subvert all attempts at patient involvement," Patient Experience Journal: Vol. 4 : Iss. 2 , Article 2. Available at: http://pxjournal.org/journal/vol4/iss2/2
"The engaged patient is an anomaly. Let’s fix the paradigm." Engaging Patients blog, April 2017. http://www.engagingpatients.org/shifting-the-paradigm/engaged-patient-an...
"Beyond Empowerment: Patients, Paradigms, and Social Movements" - Patient Safety & Quality Healthcare, April 2016 (cover story) https://www.psqh.com/analysis/beyond-empowerment-patients-paradigms-and-...
Competing interests: No competing interests