PLoS Medicine
(Accessed 16 March 2013)
http://www.plosmedicine.org/

Policy Forum
Adapting Standards: Ethical Oversight of Participant-Led Health Research
Effy Vayenal, John Tasioulas

Summary Points
– Online social media and digital technologies have facilitated formation of communities of individuals engaged in establishing and conducting health research projects. The results of such participant-led research (PLR) have already appeared in leading biomedical journals.

– These projects involve research with human participants. Hence, what are the requirements for ethical oversight? To what extent is standard ethics review also suitable for PLR?

– A comparison of PLR with standard research reveals six areas that are of potential relevance to ethical oversight: institutionalization, state recognition and support, incentive structures, openness, bottom-up approach, and self-experimentation.

– The distinctive nature of PLR requires adaptation of ethical oversight standards to the character of such research. These should strike a balance between protecting interests of research participants and achieving promised benefits of PLR.

– The appropriate form of ethical oversight for PLR projects depends on which of three categories they fall into. If they meet the “institution-plus” criterion, standard ethics review applies. If not, then the appropriate form of oversight depends on the application of a minimal risk criterion.