Abstract
Participant-led or -driven research is research that is typically bottom up in nature as opposed to top down researcher-driven, designed and led. It is related to participatory research, where the research participants become researchers as part of the project, but is (in principle, at least) more radical, since participatory research is still typically researcher driven. In the context of health care this may be driven by a shared set of mutual health concerns or simply interest in resolving particular questions. This small but growing practice is significantly facilitated by new online tools, both for making contact with fellow citizen-researchers but also for conducting the research itself. While some raise concerns about the scientific validity of participant-led research, others view it as emancipatory, developing the ideal of the citizen-scientist. In this issue of Research Ethics we have a special section on participatory research, with an editorial and two articles arising from a conference on patientcentricity in Rome.
In this editorial I discuss how we might regulate such research ethically, responding to a recent article by Vayena and Tasioulas published in PLOS Medicine (Vayena and Tasioulas, 2013). There is much which is good about their article − in particular, it highlights a significant gap in ethical oversight with regard to participant-led health research. However, I want to challenge the conclusions reached by the authors in two ways. I firstly want to suggest that at least some research ethics systems have means of capturing much of this research, and secondly that where this is not the case there are good reasons to be sceptical of their proposed solution – that of having participant/researchers assess the level of risk and determine whether external review is required.
The first issue I have with Vayena and Tasioulas’ article is that they treat existing ethical oversight systems as homogeneous, whereas they are really heterogeneous, with significant differences existing between different countries’ regulatory systems. They are right that, in certain jurisdictions where research is regulated at an institutional level, participatory research, particularly that which has no institutional connections, will escape current ethical review systems. Not all countries operate on an institutional level, however: the UK, for example, regulates all (roughly) medical research, and Australia regulates all research. Therefore, in these jurisdictions there is not such a significant issue with the regulation of participatory research. Indeed, one might take it as an advantage of these systems that they do capture such research. Nonetheless there are a number of jurisdictions where this is not the case, so it is the suggestion of Vayena and Tasioulas that researcher/participants ought to assess the risk themselves and decide whether external scrutiny would be helpful.
It certainly is in keeping with the spirit of participatory research, but I am not convinced that this is a reliable or sensible approach with regard to regulation. I have two main concerns, as follows. Firstly, naturally people are likely to underestimate the risk in their own research (Weinstein, 1989). Given this, they are likely to think mistakenly that research that does require scrutiny does not. Secondly, I have an epistemic concern about whether ethical issues will be identified. Research and research ethics is complex and controversial, and I am not sure that a researcher/participant or indeed a small group of researcher/participants are well placed to determine what ethical issues may arise (Elliott and Hunter, 2008).
I think instead we should try to capture such research within existing regulatory frameworks. I think the Social Care REC in the UK could be an instructive model to follow – this REC was set up to assuage the concern that a number of projects by, for example, charities did not have appropriate support of ethical review because they did not involve health and were not affiliated institutionally. While we do not want to multiply RECs indefinitely for every special topic, nonetheless we could have one REC devoted to dealing with all of these special cases.