Approaches to governance of participant-led research: a qualitative case study

Abstract

ObjectivesParticipant-led research (PLR) is a rapidly developing form of citizen science in which individuals can create personal and generalisable knowledge. Although PLR lacks a formal framework for ethical review, participants should not be excused from considering the ethical implications of their work. Therefore, a PLR cohort consisting of 24 self-trackers aimed to: (1) substitute research ethics board procedures with engagement in ethical reflection before and throughout the study and (2) draft principles to encourage further development of the governance and ethical review of PLR.MethodsA qualitative case study method was used to analyse the ethical reflection process. Participants discussed study risks, risk management strategies and benefits pre-project, during a series of weekly webinars, via individual meetings with the participant-organisers, and during semi-structured interviews at project completion. Themes arising from discussions and interviews were used to draft prospective principles to guide PLR.ResultsData control, aggregation and identifiability were the most common risks identified. These were addressed by a commitment to transparency among all participants and by establishing participant control via self-collection and self-management of data. Group discussions and resources (eg, assistance with experimental design and data analysis) were the most commonly referenced benefits of participation. Additional benefits included greater understanding of one’s physiology and greater ability to structure an experiment. Nine principles were constructed to encourage further development of ethical PLR practices. All participants expressed interest in participating in future PLR.ConclusionsProjects involving a small number of participants can sustain engagement in ethical reflection among participants and participant-organisers. PLR that prioritises transparency, participant control of data and ongoing risk-to-benefit evaluation is compatible with the principles that underlie traditional ethical review of health research, while being appropriate for a context in which citizen scientists play the central role.

Open Humans: A platform for participant-centered research and personal data exploration

“…Furthermore, members of Open Humans are invited to participate on the approval of new projects that want to be shared on the platform via a community review process, as illustrated by the Google Search History project use case described above. This community review process parallels e orts made elsewhere to pursue participant-centred alternatives to institutional review boards [99], which at present include extremely limited input from community members. Indeed, traditional policies for project approval from an ethical standpoint have been repeatedly questioned [100], and even more so for the case of participant-centric research [101], due to inconsistent levels of engagement from non-academic members [102] and lack of participant protection and autonomy [101].…”

mHealth Research Applied to Regulated and Unregulated Behavioral Health Sciences

“…Unregulated health research carried out by citizen scientists continues to rapidly expand. While there are various terms to describe this category of researcher such as lead innovators, 40 quantified self, 41 bio-citizens, 42 do it yourself, 43 and participant-led researchers 44 -one thing they all have in common is taking health matters into their own hands. Another commonly used term is N-of-1, which can be attributed to the labels introduced above, as well as systematic cross-over studies that are carried out by the individual or, in partnership with their physician/clinician.…”

Ten simple rules for open human health research

“…Health research is no longer exclusive to scholars or medical professionals. Technology developers are increasingly engaging in and leading biomedical research, participants are taking on a more active role as partners in research, and nonscientists are even designing and deploying their own health research projects [11]. While this greater involvement of nontraditional parties in health research has the potential to advance the research in novel ways, it is critical for these parties to abide by ethical and responsible practices, to ensure privacy and safety.…”