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  1. Policies & Procedures

Chapter 10 - Exempt Determinations

Reviewer Designation

Research specified by the investigator as qualifying for “exempt” status is reviewed by a Designated Reviewer.  An individual may not serve as a Designated Reviewer if they have a conflict of interest as outlined in Chapter 20.

Investigator Responsibilities

Requests for exemption must be submitted through the PittPRO system. 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. 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 Designated Reviewer has access to the complete IRB submission including the following (as applicable):

  • PittPRO application;
  • 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.

HRP Staff are expected to conduct an in-depth review of all materials and are provided access to Reviewer Worksheets and 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 Designated Reviewer also has access to HRP-312 – Worksheet – Exemptions as a guide.

  • 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), they are instructed to contact the HRP 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 the University of Pittsburgh 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), may only apply when the research is 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.

  • 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

The purpose of a limited IRB review is to ensure that certain categories of exempt human subjects research include adequate protections for participants’ privacy interests and confidentiality of data as required by 45 CFR 46.111 (a)(7).  During the review, the Designated Reviewer will document the exempt determination category (Criteria 2 (iii) or Criteria 3(i)(C)), and that the provisions of 45 CFR 46.111(a)(7) were met. In cases where it is determined that the research does not meet the criteria for exemption or does not protect human subjects adequately, the study will be reviewed under an applicable expedited category or by full board review. This will be documented and the study team notified. A Designated Reviewer conducting a limited review may not disapprove research

Investigator Communications

Comments or concerns 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 reviewer if the initial reviewer is unavailable for an extended time).

Documentation of Determination

After reviewing the protocol submission, the Designated Reviewer documents the 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, if it was not previously completed.

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.

Archive Process

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. 

4/27/2026