Exemptions under the Revised Common Rule
Research that is exempt is no greater than minimal risk and all research activities fall into one of the categories for exemption specified in the federal regulations. Exempt does not always mean exempt from all of the requirements of the Common Rule; the activity must fit the description of the exempt category and not include nonexempt research activities. Exempt research must be determined to satisfy specific criteria within each category for the research to be eligible for exemption.
Ongoing IRB oversight is not required of research qualifying for exemption; however, an exempt determination does not lessen an investigator’s ethical obligation to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct.
The revised regulations expanded the categories for exemption from 6 to 8. This included merging one previous category and adding three new categories. Each category has specific conditions for eligibility. See the published final rule or preview the RCS Exempt Determination Application and Worksheets for the full description of all exempt categories and their criteria. In summary, the three new categories include:
- Benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording of the subject with prospective agreement.
- Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use (broad consent required).
- Secondary research involving the use of identifiable private information or identifiable biospecimens (broad consent required).
Limited IRB Review
The revised regulations also incorporate an additional review requirement for studies otherwise qualifying for exemption but working with identifiable information or identifiable biospecimens. In these circumstances, an IRB member must conduct a limited IRB review to determine that the research design includes adequate provisions to protect participant privacy and maintain confidentiality of data.
New Exempt Review Process at UO
As the Federal Office of Human Research Protections (OHRP) guidance recommends that the investigator should not be the one making the exemption determination, exempt determinations will continue to be issued by RCS at this time.
RCS has developed a revised, streamlined process for exempt determinations at UO. RCS has created new forms that are designed to solicit only the information necessary to assess the criteria for exemption, including the information needed to conduct a limited IRB review. The process incorporates an investigator self-assessment followed by verification of exempt eligibility by RCS and an IRB member when limited review is required.
Investigators begin by conducting a self-assessment using the new exempt application materials to preliminarily determine whether their study may qualify for exemption. If the study appears to qualify for exemption, the investigator submits completed materials 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. When required, RCS will route applicable studies for limited IRB review. Once RCS issues a formal letter of exempt determination, human subject research activities may commence.
Investigators will indicate an anticipated end date for human subject research activities within the application materials. Protocol expiration will be based on the stated anticipated end date. Investigators will need to either close the protocol or request an extended approval period prior to the protocol expiration.
Amendments and events will still need to be submitted. The same application form is used for initial review as well as amendment reviews to verify a study continues to qualify for exemption.
New Exempt Application Materials at UO
The new Exempt Determination Application includes an initial screening section to immediately identify studies that do not otherwise qualify for exemption. The investigators are prompted to identify an applicable category(ies) for exemption related to their research and are then routed to the complementary Exempt Category Worksheets to assess the specific criteria within the category for exemption.
Preview the new exempt application and worksheets here.
To either extend a project period or close a protocol, investigators need to submit the Progress Report/Study Closure Form available here.