Operational Guidelines for Ethics Committees That Review ...

6.2.5.5 the provisions made for receiving and responding to queries
and complaints from research participants or their representatives
during the course of a research project;
6.2.6 Community Considerations
6.2.6.1 the impact and relevance of the research on the local community
and on the concerned communities from which
the research participants are drawn;
6.2.6.2 the steps taken to consult with the concerned communities
during the course of designing the research;
6.2.6.3 the influence of the community on the consent of individuals;
6.2.6.4 proposed community consultation during the course of the
research;
6.2.6.5 the extent to which the research contributes to capacity
building, such as the enhancement of local healthcare, research,
and the ability to respond to public health needs;
6.2.6.6 a description of the availability and affordability of any
successful study product to the concerned communities
following the research;
6.2.6.7 the manner in which the results of the research will be
made available to the research participants and the concerned
communities.
6.3 Expedited Review
ECs should establish procedures for the expedited review of research
proposals. These procedures should specify the following:
6.3.1 the nature of the applications, amendments, and other considerations
that will be eligible for expedited review;
6.3.2 the quorum requirement(s) for expedited review;
13