Table 1.

Key features of engagement in ethics guidance

Broad and inclusive
CIOMS (2016)	“Stakeholders are individuals, groups, organizations, government bodies, or any others who can influence or are affected by the conduct or outcome of the research project. The process must be fully collaborative and transparent, involving a wide variety of participants, including patients and consumer organizations, community leaders and representatives, relevant NGOs and advocacy groups, regulatory authorities, government agencies and community advisory boards” (p. 25)
UNAIDS‐AVAC GPP (2011)	“any individual or collection of individuals who have a stake in a biomedical HIV prevention trial” (p. 14)
UNAIDS (2012)	“the concept [of community] needs to be broadened to civil society so as to include advocates, media, human rights organizations, national institutions and governments, as well as researchers and community representatives from the trial site” (p. 18)
Early and sustained
CIOMS (2016)	“Researchers, sponsors, health authorities and relevant institutions should engage potential participants and communities in a meaningful participatory process that involves them in an early and sustained manner in the design, development, implementation, design of the informed consent process and monitoring of research, and in the dissemination of its results” (p. 25)
WHO (2011)	“Researchers should actively engage with communities in decision‐making about the design and conduct of research” (p. 15)
UNAIDS‐AVAC GPP (2011)	“activities required for the development, planning, implementation, and conclusion of a trial, including dissemination of trial results” (p. 5), “a long‐term process that extends throughout and beyond the life‐cycle of any single clinical trial” (p. 66)
UNAIDS (2012)	“engage in consultations with communities who will participate in the trial from the beginning of the research concept, in an open, iterative, collaborative process” (p. 17)
Responsive and dynamic
CIOMS (2016)	“In the design and conduct of the research[…] the researchers and the sponsors must be responsive to the concerns of the community” (p. 63)
UNAIDS‐AVAC GPP (2011)	“The application of each practice or set of practices will vary by location, the type of trial being conducted, and trial site experience” (p. 26), “stakeholders interests, priorities, perspectives, and culture may change over time” (p.16), “Stakeholder identification and inclusion considers the dynamic stakeholder landscape” (p. 31)
UNAIDS (2012)	“engage in consultations with communities […] in an open, iterative, collaborative process” (p. 17), “find solutions to unexpected issues that may emerge once the trial is underway” (p. 17), “Defining the relevant community for consultation and partnership is a complex and evolving process” (p. 18)