Table 1. Areas of consensus and lack of consensus.

	Participant and community welfare	Scientific viability	Efficiency	Usefulness
Basic consensus standards	Participants and community no worse off (than baseline); no foreseeable, preventable increase in risk should be allowed	Trial meets statistical and scientific standards for answering primary research question		Trial addresses a research question which has some value for decision-making in one or more areas (for future research; regulatory; or policy)
Areas where there is no consensus	Including some or all best prevention methods when not locally available, which leads to issues surrounding sustainability in background package or in active trial arms		How to use non-scientific criteria, such as cost, ease of enrollment, in trial design decisions especially when these issues affect participant welfare or usefulness of the trial	Whether there should be a requirement for responsiveness to host country priorities and/or reasonable availability of study products; and how immediate these benefits would need to be