Chapter 10 - Exempt Determinations
Research specified by the investigator as qualifying for “exempt” status is reviewed by the IRB Coordinators, who are designated as IRB members. No one may serve as a reviewer if they have a conflict of interest as outlined in Chapter 20.
Requests for exemption must be submitted through the PittPRO system. Each exemption has a separate form that is completed and uploaded under the Basic Information section which provides the Designated Reviewer information relevant to that exemption. to determine eligibility under each exempt category permitted by federal regulation. Investigators are required to answer questions about the proposed project which allows the IRB to evaluate the protection of human subjects participating in the exempt project, including information about risk to subjects, subject selection, and provisions for protecting the privacy interests of subjects and the confidentiality of subject data. While the exemptions do not require an informed consent process or documentation, , the applicable exempt forms remind researchers of their ethical obligations to ensure that participants are fully informed about the nature of the research project so they can make an informed decision to participate. When appropriate, investigators are required to develop an introductory script that describes the study requirements, indicates that it is research, and indicates that participation is voluntary.
Provision of Review Materials
The IRB reviewer has access to the complete IRB submission including the following (as applicable):
- PittPRO application;
- Applicable exempt form;
- Recruitment materials (e.g., advertisements, flyers, phone screening procedures, scripts, and/or screening questions, etc.);
- Measures that will be utilized in the study (e.g. survey instruments, questionnaires, interview scripts, recruitment material, etc.
- Grant application;
- Verification of approval from site(s) outside of the University of Pittsburgh or UPMC;
- Other materials specific to the proposed study.
Designated Reviewers are expected to conduct an in-depth review of all materials and are provided access to Reviewer Checklists found in PittPRO as a guide to ensure inclusion of the regulatory criteria including whether the research holds out no more than minimal risk to subjects, the selection of subjects is equitable, and if there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.
Criteria for Exemption
The Designated Reviewer determines if the proposed research is exempt from federal policies governing human subject protections. This determination is made in accordance with:
- The OHRP Decision Chart #2- “Is the Research Involving Human Subjects Eligible for Exemption under 45 CFR 46.104(d)?”
- The criteria for exemption as specified under 45 CFR 46.104 (d)(1), (d)(2), (d)(3), and (d)(4) and 21 CFR 56.104(c) and (d). If an investigator wishes to request an exemption under 45 CFR 46.104(d)(5) or (d)(6), s/he is instructed to contact the HRPO for guidance. The criteria for exemption under 45 CFR 46.104(d)(7) and (d)(8) will not be utilized as the concept of broad consent is not be implemented at this time.
- If subjects are under the age of 18 years, the exemption criteria described in 45 CFR 46.104(d)(2)(i) and (ii), are not applicable with the exception of research limited to (a) the use of educational tests or (b) to observations of public behavior when the investigator does not participate in the activities being observed. For studies subject to the DoD regulations, no exemptions may be applied when children are involved as participants.
- For protocols that meet the criteria for an exemption under 45 CFR 46.104(d)(2), investigators are required to provide an introductory script that includes key elements of consent and is consistent with the principles of the Belmont Report.
- The exemption criteria in 45 CFR 46.104(d) do not apply to studies involving prisoners except for research aimed at involving a broader subject population that only incidentally includes prisoners.
- The exemption criteria [with the exception of 45 CFR 46.104(d)(6) / 21 CFR 56.104(d)]do not apply to FDA-regulated research studies.
Limited IRB Review
For exemptions under Criteria 2 (iii) and Criteria 3(i)(C), the Designated Reviewer will conduct a limited IRB review to determine that the study is no more than minimal risk and to ensure there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data as required by 45 CFR 46.111 (a)(7).A Designated Reviewer conducting a limited review may not disapprove research.
Comments or concerns of the Designated Reviewer with regard to the exempt status of the research activity are documented and communicated in PittPRO to the principal investigator, as described in Chapter 8.
Responses of the principal investigator are returned for review by the Designated Reviewer who conducted the initial review (or to another Designated Reviewer if the initial reviewer is unavailable for an extended time).
Documentation of Determination
After reviewing the protocol submission, the IRB reviewer documents his/her determination in PittPRO by executing the “Submit Designated Review” activity.
Exempt Determination Notification
The principal investigator of the research activity is notified of IRB concurrence of exempt status through PittPRO. This notification letter specifies, at a minimum:
- The IRB number assigned to the submission;
- The regulatory basis for granting exempt status (i.e., 45 CFR 46.104 (d) (1-6) and/or 21 CFR 56.104(d));
- That changes that might affect the exempt determination should be submitted for consideration by the IRB.
Determination that Activity Does NOT Meet the Exempt Criteria
For research activities that involve human subjects but are determined to not qualify for exempt status, the principal investigator is advised to withdraw the submission, revise as appropriate and resubmit for expedited or full board IRB review in order to ensure that scientific review is conducted.
Waiver of HIPAA Authorization and Exempt Review
The IRB may grant a waiver of HIPAA Authorization for an exempt project if the recording of medical information will be conducted by or under the oversight of an investigator who would normally have access to this information by virtue of his/her patient care responsibilities.
Frequency of Review
Protocols designated as exempt are not required to be submitted for continuing review.
Exempt projects that were approved in the OSIRIS system may have been archived rather than requiring transition into PittPRO. Study teams were notified that after the date of archival, the project could continue. However, if any changes were required, a new request for exempt determination would be required in PittPRO.