- -Tuesday, 26 January 2010 19:00
Please make note of changes in Sterling IRB’s policy pertaining to the review of studies that may involve cognitively impaired persons:
- See Chapter 9-D of the Investigator Handbook, noting Sterling IRB’s policy pertaining to obtaining assent (when possible) from persons unable to provide legally effective informed consent, including documentation of their assent to participate, and the added details regarding the continued verification of capacity to consent throughout the study.
- New Study Submission Application updated: revised question 22 (re ICD(s) submitted with protocol).
- Submission Application for the Investigator/Site updated: added questions 33 (re plan for determining capacity to consent/assent) and 38 (re process for continued verification of a subject’s capacity to consent).
- Registry Study Submission Application for the Investigator/Site updated: added questions 21 (re process for continued verification of a subject’s capacity to consent) and 28 (re plan fordetermining capacity to consent/assent.
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