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Research Led by Participants: a New Social Contract for a New Kind of Research

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Research Led by Participants: a New Social Contract for a New Kind of Research Downloaded from http://jme.bmj.com/ on November 8, 2016 - Published by group.bmj.com Current controversy Research led by participants: a new social contract for a new kind of research Effy Vayena,1 Roger Brownsword,2 Sarah Jane Edwards,3 Bastian Greshake,4 Jeffrey P Kahn,5 Navjoyt Ladher,6 Jonathan Montgomery,7 Daniel O’Connor,8 Onora O’Neill,9 Martin P Richards,10 Annette Rid,11 Mark Sheehan,12 Paul Wicks,13 John Tasioulas14 For numbered affiliations see ABSTRACT Several examples illustrate the diversity of activ- end of article. In recent years, there have been prominent calls for a ity in the growing field of PLR. Perhaps the most Correspondence to Dr Effy new social contract that accords a more central role to well known case is the amyotrophic lateral sclerosis Vayena, Institute of Biomedical citizens in health research. Typically, this has been (ALS) lithium study carried out on the online plat- Ethics, University of Zurich, understood as citizens and patients having a greater form PatientsLikeMe. It was initiated by two Pestalozzistrasse 24, Zurich voice and role within the standard research enterprise. patients with advanced-stage ALS from Brazil and 8032, Switzerland; Beyond this, however, it is important that the the USA, both of whom died prior to the comple- [email protected] renegotiated contract specifically addresses the oversight tion of the study.5 One hundred and forty-nine Received 2 January 2015 of a new, path-breaking approach to health research: patients with ALS on the platform took lithium in Accepted 18 February 2015 participant-led research. In light of the momentum order to test the findings of a small earlier study Published Online First behind participant-led research and its potential to into its effects on disease progression and symptom 30 March 2015 advance health knowledge by challenging and alleviation. The PatientsLikeMe ALS study, which complementing traditional research, it is vital for all was completed over 8 months, was eventually pub- stakeholders to work together in securing the conditions lished in Nature Biotechnology. Its finding that that will enable it to flourish. lithium had no effect was subsequently confirmed by standard clinical trials. 6 A rather different example, profiled recently in the It is increasingly commonplace to hear calls for Wall Street Journal, is the research experiment con- patients to have a greater voice in medicine and to ducted by parents of children suffering from the work in partnership with clinicians and researchers in extremely rare lipid storage disease, Niemann-Pick 1–3 improving healthcare. In health research, funding Ty p e C . 7 In their quest for a cure, the parents engaged bodies and academic institutions actively undertake in extensive negotiations with the Food and Drug patient and public involvement programmes to Administration for permission to administer cyclodex- ensure that studies adequately reflect the perspectives trin to their children, first intravenously, and then and input of patients and citizens. Despite measures eventually directly into the spinal fluid. These activities to engage patients, however, their role still remains led to a phase 1 clinical trial of cyclodextrin.8 Other limited within standard research. These limitations examples of PLR activity include online platforms on have motivated a new approach to research in which which individuals can upload their genetic data, patients and citizens take matters into their own usually acquired via direct-to-consumer genomic com- hands in designing and conducting research activities. panies, for the purpose of initiating research.910 Open Access Scan to access more We have termed this new phenomenon PLR activity is likely to become increasingly free content participant-led research (PLR) and we contend that it common and diverse. Along with the call for greater needs to be governed by a new social contract. patient engagement in healthcare and participant- centric initiatives for managing self-collected data, WHAT IS PLR? various forms of PLR will aspire to become a recog- As in standard research, PLR is an activity that nised part of the process of health knowledge produc- characteristically aims at the socially valued goal of tion. However, given the distinctive nature of these producing generalisable health knowledge. activities, including their differences from standard ▸ http://dx.doi.org/10.1136/ However, it is distinctive in being initiated and con- research, it is not obvious that they should be governed medethics-2015-102704 by the existing social contract for health research. This ▸ http://dx.doi.org/10.1136/ ducted by the participants themselves, often using medethics-2015-102731 the tools of online social media. Many of the parti- contract, which sets out norms and mechanisms for ▸ http://dx.doi.org/10.1136/ cipants in PLR are patients suffering from the con- conducting and recognising research, including over- medethics-2015-103003 dition that is the subject of their research. sight and accountability procedures, was devised However, PLR also includes participants who are exclusivelywithstandardresearchinmind.Wethere- not patients, but rather individuals interested in fore need to agree on a new social contract that will acquiring health information, whether about them- enable us to harness the great potential of PLR while selves or more generally. The PLR label applies to a avoiding the major pitfalls that lie in its path. very heterogeneous range of research activities. To cite: Vayena E, Often, they cannot be sharply distinguished from WHAT ARE THE POTENTIAL BENEFITS AND Brownsword R, Edwards SJ, standard research, partly because of the tendency PITFALLS? et al. J Med Ethics of some PLR projects to evolve over time and PLR is potentially valuable as a source of generalis- – 2016;42:216 219. become entangled with standard research activity.4 able health knowledge that benefits participants 216 Vayena E, et al. J Med Ethics 2016;42:216–219. doi:10.1136/medethics-2015-102663 Downloaded from http://jme.bmj.com/ on November 8, 2016 - Published by group.bmj.com Current controversy and the wider society. Moreover, through PLR, this knowledge In light of this situation, we propose that the new social con- can be generated in ways that realise the important value of par- tract on health research should set out relevant standards that ticipation in scientific research, something to which there is a those involved in PLR must satisfy if their activities are to be human right under the broader rubric of participation in science socially recognised as research. In turn, the wider society, and culture.11 12 It promises to be a vital supplement to stand- including scientific journals, funding bodies and healthcare pro- ard research: it can focus on conditions that are neglected by fessionals, would have corresponding responsibilities to recog- standard research, such as rare diseases or side effects, and can nise and facilitate PLR that meets these standards. draw on a broader range of data and deliver outcomes more rapidly.13 It can also be a way of realising valuable forms of SOCIAL RECOGNITION OF PLR AS RESEARCH: A MATTER social interaction and support in cases where members of a com- OF MUTUAL RESPONSIBILITY munity conduct PLR together, for example, patients suffering The rationale for subjecting health research to oversight, scien- from the same illness. tific and ethical, is to facilitate its ability to produce generalis- Like any mode of scientific research with human partici- able health knowledge that can be properly recognised and used pants, however, PLR may involve the risk of harm to partici- by the participants and society. Such oversight provides assur- pants or others, including relatives. Beyond the issue of harm, ance of the scientific quality of research outcomes, and the research activity may imperil societal values such as dignity and ethical acceptability of the ways in which they were achieved. justice. Certain characteristic features of PLR can exacerbate The same quality assurance requirements apply in no less these concerns: for example, self-experimentation may lead measure to PLR if it is to be recognised as genuine research. participants to run excessive risks, and the existence of a com- In standard research the means of securing these requirements munity may provide a setting that facilitates undue peer pres- involve formal scientific and ethical review. In relation to PLR, sure and exploitation. In addition to these concerns, PLR may by contrast, such mechanisms tend to be neither in operation, face special obstacles in meeting epistemic standards required nor easily accessible. A crucial question is whether PLR should of scientific research, including problems of bias and distortion also be subjected to identical formal oversight mechanisms. The arising from the use of self-reported and self-collected worry is that these mechanisms may needlessly deter or burden data.14 15 those engaged in valuable forms of PLR due to the cost, delay and difficulty of undergoing formal review. WHY IS A NEW SOCIAL CONTRACT NECESSARY? To strengthen the ability of PLR to meet the conditions for It is important to negotiate the terms on which PLR is socially social recognition, we should be prepared to accept alternative recognised and enabled to flourish, keeping the potential bene- mechanisms of oversight that are adapted to the distinctive char- fits and pitfalls in mind. Of course, society has a legitimate acter of PLR.17 Appropriate mechanisms should be identified in general interest in regulating the permissibility of actions that a new social contract on PLR that outlines the reciprocal respon- may harm those engaged in them or impact negatively on third sibilities of those engaged in PLR activities and of others in the parties and publicly funded health services. However, our spe- societies hosting these activities. The social contract would cific focus here is not on the permissibility of PLR. We assume facilitate PLR activity by providing a publicly accessible set of that PLR activity would be generally permissible within a just standards for its oversight, operating as a focal point that coor- legal framework.
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