IRB Authority: Observation of Consent and Conduct of the Research Guidance Documents and References Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: August 25, 2019 Guidance The IRB has authority to observe or have a third party observe the consent process, and the conduct of the research. See SOP […]
Read MoreVerification From Other Sources Guidance Documents and References Points to Consider ⏴back to Board Member Guidance Series Board Member Guidance Series Version: April 30, 2019 Guidance The IRB determines which clinical investigations need verification from sources other than the clinical investigator that no material changes in the research have occurred since the previous IRB review. […]
Read MoreExpedited Category 9 Decision Chart Guidance Documents and References ⏴back to Board Member Guidance Series Board Member Guidance Series Version: February 6, 2019 Guidance Decision Chart Use this chart to determine whether a study being discussed at a convened board meeting may be expedited under Category 9. After using the decision chart above to determine […]
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