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

OBJECTIVES: Participant-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. METHODS: A 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. RESULTS: Data 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. CONCLUSIONS: Projects 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.