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
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.
For sponsored studies, a sponsor research attestation is now required. This is ONLY for sponsored (not grant-related) research.