Request for Project Exemption forms are available in Microsoft Word Format. To download a form, click on the link provided in the form title.
Guidelines/Request for Exempt Status
All research involving human subjects conducted at MHRI Institutions MUST go through the MHRI IRB. However, some minimal risk research may be eligible for Exemption from IRB review. This is referred to as granting "Exempt Status" to a protocol/research activity.
The IRB, not the investigator, has the authority to determine and confirm "Exempt Status." Therefore, a "Request for Exempt Status" form MUST be submitted to the IRB to allow confirmation of "Exempt Status" of the research activity.
Please read the Guidelines for Requesting "Exempt Status for a Protocol in their entirety. If, subsequent to reading the Guidelines, the research activity is determined to be eligible for "Exempt Status," please complete the "Request for Exempt Status" review form below.
|Type of Review|
|Request for Exempt Status: IRB Form #3||Exempt|
- The above form is an application for Exemption from IRB Review only. Granting of "Exempt Status" for a protocol in no way negates the requirement for informed consent or HIPAA authorization, where applicable.
- The form should be utilized for minimal risk research activities eligible for exemption from IRB review as indicated in the Exempt Categories listed on the "Request for Protocol Exemption" form and Guidelines above.
- The IRB, not the investigator, has the authority to determine and confirm exempt status. Therefore, a "Request for Protocol Exemption" form MUST be submitted to the IRB to allow confirmation of "Exempt Status" of the research activity.
- Research activities may NOT begin until a letter granting "Exempt Status" to the protocol is received.
- If "Exempt Status" is granted, amendments or modifications to the protocol may NOT be implemented until submitted to the IRB for confirmation that the amendment or modification does not in any way alter the existing Exempt Status of the protocol. Implementation of the amendment or modification may NOT occur until a letter granting approval for continued Exempt Status of the protocol (with the inclusion of the amendment or modification) is received.
- HIPAA requirements still apply to the Use/Disclosure of Protected Health Information (PHI) specifically for research purposes. Please see the 18 identifiers that constitute PHI. Please carefully review the HIPAA Decision Matrix to determine whether or not HIPAA documentation is required for the research activity. When in doubt, please contact ORA staff for guidance."