Limited IRB Review
The Revised Common Rule, which goes into effect on January 21, 2019, includes new Exempt Categories that may be reviewed under a Limited IRB Review. Limited IRB review is a new category of review meant to reduce regulatory burden for faculty conducting research that does not involve greater than minimal risk to participants. The UConn IRB will complete a limited IRB review for new Exempt Categories 2 (iii) and 3 (C). UConn is not adopting Exempt Categories 7 and 8.
Limited IRB review is an expedited review process where the protocol submission is reviewed by the IRB Chair or an experienced IRB member designated by the Chair. Similar to the expedited review process, there is no deadline for IRB submission. If the research does not meet the criteria for limited IRB review, an IRB member may determine the research be reviewed under an expedited category, as long as the approval criteria are met under 45 CFR 46.111. Under this new review category, researchers can collect sensitive information. Data collection may include verbal and written responses, and may include audio or video recordings.
The limited IRB review process ensures the protocol submission meets regulatory criteria under the Revised Common Rule and that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. The IRB maintains the authority to approve, require modifications, or disapprove research under this category. The components of submission to the IRB include the IRB-5 InfoEd electronic application form, the new Limited IRB Review Study Protocol, the Data Security Assessment Form, an information sheet/consent form, any recruitment material, the electronic InfoEd Appendix A Form, and study questionnaires.
This category of review does not apply to Subpart D; research on children.
UConn will conduct a limited IRB review under the following two exempt categories:
(2)(iii)
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) and (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB member conducts a limited IRB review to make the determination required by §46.111(a)(7) (if identifiable private information will be obtained and recorded in such a way that the identity of human subjects can readily be ascertained, either directly or through identifiers linked to the subject).
(3)(i)(C)
Research involving 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 if the subject prospectively agrees to the intervention and information collection and (C ) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB member conducts a limited IRB review to make the determination required by §46.111(a)(7).
For more information regarding limited IRB review, please read the Revised Common Rule.
For more information, contact: Karen Moré at 860-486-2459/ karen.more@uconn.edu