Policies & Procedures - Emory IRB - Emory University

Emory University IRB P&Ps Revised 1/18/2013
The economic prosperity of the area in which the Research is to take place;
The influence of local officials on the population;
If the Research is in another country, whether the country or area allows foreign
visitors;
The nature of the procedures conducted;
The literacy rate of the area;
The local legal rights of the population (including relevant sub-populations such as
women in general, unmarried v. married women, children, etc.);
How complaints will be reported and to whom;
The relevance of the Research to the local population’s needs and interests;
The possibility of including officials from the area in the monitoring of the Research; and
The local standards of care for relevant medical conditions.
The Emory IRB must also assure that adequate provisions are made for data and safety
monitoring, and take into consideration that some foreign IRBs or Ethics Committees may not
require Continuing Review of approved Research.
Consideration of Issues Associated with Informed Consent: In reviewing Research to be
conducted at an international site or other non-Emory site, in addition to ensuring that the
elements of Informed Consent are met, (as established in Section 41, entitled: Informed Consent
Policy), the Emory IRB will consider the following issues:
Disclosure of information to individuals who may be unfamiliar with and distrustful of
the concepts:
Differences in societal and cultural norms;
Differences in the role of women in society;
Differences in the role of family and community in the consent process;
Multiple local languages; and
Literacy level.
The informed consent documents must be in language appropriate to the location of the
Research, and understandable to the proposed participants.
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