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Exclusion criteria explained - Federal regulations series part 4 of 5

Part 4 of MESM’s series on proposed federal research regulation amendments and the impacts on commericial sponsors and research organisations.

In this article we review what research may be excluded or exempted from the Common Rule, and consider the impacts of changes to independent review board (IRB) requirements, and amendments to requirements for continual review of clinical trials.

Under the NPRM proposals, a new section has been created for regulation of research that would be excluded from the Common Rule. Unlike exempt research, ‘excluded’ activities would not be required to undergo any institutional, administrative or IRB review to determine whether the activity is excluded; instead investigators would self-determine whether their research is excluded.

Read the full article to find out exactly what kinds of research may be excluded or exempt from the regulation changes, as well as to find out about changes to requirements around independent review boards and continuing review of studies. 

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