The IRB Chair or designee shall make the final determination whether an initial study qualifies for exempt status by virtue of the fact that it provides no more than minimal risk and that it falls within the criteria required to be exempted from federal regulations. This decision shall be made according to regulations included in 45 CFR 46.101(b)(1)-(6), 21 CFR 56.104(d) and according to the UM policy defining these criteria (c.f. Policy 8.1). The IRB may grant exempt status only if all research activities within the study involve procedures listed under 45 CFR 46.101(b) and 21 CFR 56.104(d). The IRB shall not grant exempt status to research involving prisoners, human in vitro fertilization and to FDA-regulated research under categories 1-5 of 45 CFR 46.101(b). Research involving minors will be exempt on a limited basis under 45 CFR 46.101(b)(2).
IRB Chairs or designees may use their discretion as to whether a study should be exempt or requires IRB review even if the study fulfills the criteria for exemption according to the regulations. The Chair or designee shall conduct a substantive and meaningful review of all materials related to the assigned study, conduct informal queries of the Principal Investigator and/or other experts as necessary to provide a thorough review and present clear and concise requirements/recommendations for changes and/or questions in written form (via ePROST, by email or otherwise) for communication to the Principal Investigator. The Chair or designee may request minor revisions and/or clarifications before approval for exemption is granted. The Chair or designee may request a second reviewer and/or may seek recommendations from an expert consultant(s) for issues which require expertise beyond, or in addition to, that available on the IRB.
If approved, the IRB Chair or designee shall document the exempt category that applies to the study. Policy 8.1 lists the exempt categories that are defined in federal regulations. 45 CFR 46 Part D and 21 CFR 50 Part D must be satisfied if the research involves minors and 45 CFR 46 Part B must be satisfied if the research involves pregnant women, fetuses, neonates of uncertain viability, placenta, dead fetuses or fetal material. This documentation shall be provided to the HSRO which is responsible for record-keeping and for creating correspondence to the Principal Investigator.
Approval of a study as exempt does not automatically include exemption from the informed consent or HIPAA authorization requirements. If exemptions from these requirements are requested by the Principal Investigator, these requests must be reviewed and decided upon by the IRB Chair or designee. If informed consent is required, the documents should contain all required elements unless an alteration is justified in writing by the Principal Investigator and approved by the IRB Chair or designee.
Regulations do not require continuing review of exempt research. However, the IRB chair or designee may require such reviews at his/her discretion.
The convened IRB shall be notified of exempt approvals in a timely manner. If the IRB Chair or designee does not approve a study as exempt, the chair or designee shall defer the study to expedited or convened IRB review by notifying the HSRO of this decision. The Principal Investigator shall be informed of this decision and its reasons. If the study is deferred for expedited review, the Principal Investigator may appeal this decision to the IRB chair. If the study is deferred for review by the convened IRB, the Principal Investigator may appeal this decision to the convened IRB.
All changes in exempt studies must be reported to the IRB for review and approval prior to implementation. The IRB and Principal Investigators shall understand that the criteria to exempt a study from federal regulations must remain applicable during the entire time that an exempt study remains active and that certain changes may disqualify the research from exempt status.