Revisions to Section A.2 (Subjects)

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As part of the IRB’s continuous quality improvement efforts, and to ensure harmony with our revised SOPs (anticipated released date is 2/1/2017), Section A.2 (Subjects) of the IRB application has been revised to collect additional information about the inclusion of vulnerable subjects in research.

Historically, the IRB application provided a single list of “vulnerable or select populations”; regardless of the group(s) included, a single text box was provided for a description of “plans to provide additional protections” for the group(s) selected.  With this revision, population-specific questions have been added and researchers must now provide a justification for involving individuals in these groups.

Announcement-Changes to Section A.2., includes draft SOP 1201 (2017.01.17)