The IRB Chair or the IRB Chair’s designee will determine whether a submitted research project meets the requirements for exemption from IRB review. The IRB Chair, or the IRB Chair’s designee, can require Expedited or Full Review of any research at his/her discretion, even if the research would otherwise qualify for Exempt review status.
The decision to actually grant Exempt review status is initially made by the IRB Chair, or the IRB Chair’s designee, who must review the full set of documents submitted by the investigator in reaching a decision during an Exempt review.
Please see Steps for Submitting a New IRB Application to determine which documents and forms must be submitted to the IRB for consideration of exempt review.
If it is determined that Exempt review is appropriate for a study, and the IRB Chair or the IRB Chair’s designee wishes to utilize this procedure, the IRB Chair or the IRB Chair’s designee will document his/her determination of risk. The review is then performed by the IRB Chair or the IRB Chair’s designee.
The IRB Chair or the IRB Chair’s designee will evaluate research determined to be Exempt to ensure that it meets Rocky Vista University’s ethical standards. Such an evaluation might include the following:
- The research holds out no more than minimal risks to subjects.
- Selection of subjects is equitable.
- If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.
- If there are interactions with subjects, there will be a consent process that will disclose such information including:
a) that the activity involves research;
b) a description of the procedures;
c) that participation is voluntary;
d) name and contact information for the investigator; and
e) there are adequate provisions to maintain the privacy interests of the subjects.
When a study has been certified as Exempt from IRB review, continuing review and approval is not required. Certification of Exemption is effective for the life of the study. However, all modifications to a study that has been certified Exempt must be submitted to the IRB for prospective review and certification of exemption prior to implementation.
In some circumstances, changes to the protocol may disqualify the project from Exempt status. If it is determined that the proposed study is exempt, the PI will be provided with a Certificate of Exemption that will include under what category of exemption the study was granted.
If it is determined that the proposed study is not exempt or additional information is needed to determine Exempt status or certification is granted pending acceptance of requested modifications/clarifications, the PI will be notified of this information in written form.