Table 2 Potential indicators for evaluating the contribution of community engagement (CE) to ethical goals

Broadly protect communities in research

• Procedures developed through CE exist to investigate events that have been reported indirectly, such as through a third party, taking account of confidentiality issues [14]

 Weijer and Emanuel, 2000 [20]; Dickert and Sugarman, 2005 [21]; King et al., 2014 [24]

• Procedures developed through CE exist for reporting social harms, and whether these are to be reported to sponsors, ethics committees, and regulatory bodies if not specifically required by them [14]

• Documentation that stakeholders reflective of the potential reach of the research are identified and actively engaged, beyond individual research participants [24]

Minimize the possibility of exploitation

• Procedures developed through CE exist to ensure community members know where the research is being conducted and by whom [3]

 Emanuel et al., 2004 [9]; Tindana et al., 2007 [6]; Critical Path to TB Drug Regimens, 2012 [15]

• Documentation of use of appropriate mechanisms to ensure community members understand research concepts (e.g., the difference between research and clinical care) [3]

Increase the likelihood that the research will generate fair benefits locally

• Evidence that CE empowered stakeholders to develop systems that are useful to the community, build local capacity and gain control over their lives [54]

 Emanuel et al., 2004 [9]; Dickert and Sugarman, 2005 [21]; Nuffield Council of Bioethics, 2005 [53]; Ahmed and Palermo, 2010 (COPR) [1]; UNAIDS and AVAC, 2011 [14]

• Evidence that community members used the knowledge gained through CE to improve community members’ health and well-being [1]

• Research benefits identified during CE are demonstrated to accrue to research participants and participant communities [1]

Ensure awareness of and respect for cultural differences

• Evidence that researchers and research staff are aware of cultural differences relevant to the research and have established procedures that respect those differences and allow for them in research [24]

 Emanuel et al., 2004 [9]; Tindana et al., 2007 [6]; King et al., 2014 [24]

• Evidence that community members feel the research procedures and process was/is respectful to their culture [24]

• Evidence of on-going relationships and open-ended discussions with key stakeholders regarding the research and whether it is respectful of cultural differences [24]

Ensure respect for recruited participants and study populations

• Evidence that trust between communities and investigators increases following implementation of CE [1]

 Emanuel et al., 2004 [9]; Nuffield Council of Bioethics, 2005 [53]; Ahmed and Palermo, 2010 (COPR) [1]; King et al., 2014 [24]

• Evidence of listening to, acknowledging, and being responsive to stakeholders [24]

Legitimacy of the engagement process

• Documentation of who in a community is engaged in deliberation and discussion about the research and the extent to which they represent the views of the larger community and relevant minority groups within communities [24]

 Dickert and Sugarman, 2005 [21]; UNAIDS and AVAC, 2011 [14]; King et al., 2014 [24]

• Processes are in place to air disagreements and discuss the concerns and interests of the stakeholder community [24]

• Documentation of clearly articulated goals for CE and tools for tracking progress in achieving those goals [24]

Partners share responsibility for the conduct of the research

• CAB provides documented feedback on the protocol, consent materials and/or recruitment materials [3]

 Dickert and Sugarman, 2005 [21]; Ahmed and Palermo, 2010 (COPR) [1]

• Documentation that community members share suggestions for research with researchers or are comfortable with the proposed approach [3]

• Documentation that researchers and staff respond to community input [3]

• Documentation that communities participate in research throughout the entire process, including determining the importance of the problem, assessing the value of the research and conducting the study [54, 9]

• Documentation of substantive community contributions to the design and evaluation of the informed consent process [54]

• Documentation of substantive CAB member participation on protocol development teams and scientific committees [3]

• Procedures are in place to actively probe participants and encourage reporting of social harms [14]

• Documentation that CAB meeting(s) are held with community stakeholders to discuss study design, eligibility, and implementation [3]

• Documentation that CAB meetings are held with researchers and research staff to discuss research results and that the wider community is informed of research results [3, 9]

Minimize community disruption

• Evidence that conflicts, misunderstandings, and criticisms are minimized or prevented through CE [1]

 Tindana et al., 2007 [6]

Ensure that disparities, inequalities and stigma are not inadvertently replicated or reinforced

• Evidence of changed norms and behaviors around disease-related stigma in the community due to CE [54]

 Tindana et al., 2007 [6]; Critical Path to TB Drug Regimens, 2012 [15]

• Evidence that traditionally underserved communities increase their power as a result of CE [1]

• Evidence that financial and other rewards of research identified through CE are shared fairly [9]