Document Name


Application Submission

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.