Required for studies involving participants – the checklist should be used when creating the informed consent. Note OHRP last reviewed the content in 2014 but made no revisions.
Required for studies involving children ages 8-18 years of age.
Required for studies using HIPAA information
Required for all study modifications
Required when a new conflict of interest is identified
Required when an adverse, unanticipated event or violation occurs
Required for all continuing reviews
Required for the study closure of all minimal risk and full review studies
This form may be included with the any Application form when requesting a Waiver of Written Documentation of the Consent Process or a Waiver or Alteration of the Consent Process.