||Use to request an amendment to an approved IRB protocol
||Use to apply for a waiver of documentation of consent, waiver of a consent element, and/or waiver of letter of cooperation.
|Extensions and Terminations
||See Continuing Review requirements based on approval type.
|Adverse and Unexpected Events Reporting Form
||Use to report adverse events or unexpected events during the course of a research project. Unrelated events do not need to be reported. (e.g., subject injury in a car accident on the way to the intervention)
|PHI Authorization Language
||Additional information required in an informed consent for use of PHI
|PHI Authorization Waiver Form
|| Use for PHI collection where patient authorization (consent) can not be accessed without compromising the research
|HIPAA De-Identification Certification Form
||Use to certify receipt of data in a de-identified format for HIPAA purposes
|Informed Consent Waiver Request
||Use this form to request any alteration to the informed consent process or letter of cooperation.
|Human Subjects Financial Conflict of Interest Disclosure
||Use this form to disclose a potential conflict of interest where the researcher has a financial interest in the outcome of the human subjects research.