Under what circumstances should an institution inform the Agencies about changes to its policy for research involving humans?
Institutions should inform the Agencies about significant changes to their institutional policy for research involving humans and may be required to submit their revised institutional policy for review. Examples of significant changes include the following cases: • changes to the status of the institution: e.g., from college to university status • changes to the ethics governance structure of the institution: e.g., merging of two or more institutions and adoption of a single ethics governance structure and policy; an affiliated institution acquires an independent status and develops its own institutional policy for research involving humans • changes to the institutions research ethics policy: e.g., changes to the research ethics board (REB) reporting structure or REB membership categories which might influence the independent decision-making of the REB; changes to the appeal mechanism, for example where an institution seeks to rely on an external REB as its appeal board. Institutions
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