Behavioral Health Study
Informed Consent Waiver Request
1. Study Information
Study Title
Principal Investigator
Institution/Department
Contact Information
Protocol Number (if applicable)
2. Description of the Study
Provide a brief summary of the research project:
3. Request for Waiver of Informed Consent
Describe the reason for requesting an informed consent waiver:
4. Justification for Waiver (45 CFR 46.116 Criteria)
Explain how the research involves no more than minimal risk to participants:
Explain why the waiver will not adversely affect the rights and welfare of participants:
Explain why the research could not practicably be carried out without the waiver:
Explain, if appropriate, how pertinent information will be provided to participants after participation:
5. Additional Information
Include any additional information relevant to the waiver request:
6. Certification
Name of Principal Investigator
Date