RCS has developed a revised, streamlined process for exempt determinations at UO. The process incorporates an investigator self-assessment followed by verification of exempt eligibility by RCS.
A new exempt self-assessment tool and exempt application form are now available. The new form is designed to solicit only the information necessary to assess the criteria for exemption. The same application form is used for initial review as well as amendment reviews to verify a study continues to qualify for exemption.
Investigators begin by conducting a self-assessment using the Self-Assessment Tool to preliminarily determine whether their study may qualify for exemption. If the study appears to qualify for exemption, the investigator completes the new Exempt Application Form and applicable Category Worksheet(s). The completed materials must be submitted to RCS for verification of the exempt determination. If additional information is needed to make an exempt determination or the study does not qualify for exemption, RCS will guide investigators to further submit.
Once RCS issues a formal letter of exempt determination, human subject research activities may commence. Amendments and events will still need to be submitted.
Protocol expiration will be based on the stated anticipated end date solicited in the application materials. Investigators will need to either close the protocol or request an extended approval period prior to the protocol expiration.