The unit of analysis for my study is an entire community (or village, culture, ethnic group, etc.). Do I still need to obtain the consent of each individual?
In general, yes. But it might depend upon the circumstances of your study. For example, in some cultures one or more individuals customarily make decisions for the group (e.g., the village elders) and less emphasis is placed on individual autonomy than we are accustomed to in American culture. In such a situation it might be more appropriate for the leader(s) to consent on behalf of the group. If appropriate, this might be followed up with a more informal consent from individuals. Situations of this type would need to be evaluated by the IRB on a case-by-case basis. It should also be noted that in many circumstances involving research on cultures, groups, villages, communities, etc., the investigator should consider both individual and social group confidentiality protections with appropriate descriptions of the confidentiality protections provided in the consent process and in the IRB application. 15. If there is reason to believe individual identity may be deduced from the study loca
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