Chapter 10 - Exempt Determinations

Reviewer Designation

Research specified by the investigator as qualifying for “exempt” status is reviewed by the IRB Exempt/Expedited Research Review 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.

Investigator Responsibilities

Requests for exemption must be submitted through the OSIRIS system, which includes specific questions 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 informed consent process and documentation are not required to be reviewed as part of this screening, the application reminds 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):

  • OSIRIS protocol 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.

IRB reviewers are expected to conduct an in-depth review of all materials and are provided access to Reviewer Checklists found in OSIRIS 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 IRB 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 46.101 (b)?"
  • The criteria for exemption as specified under 45 CFR 46.101 (b)(1), (b)(2) and (b)(4) and 21 CFR 56.104(c) and (d). If an investigator wishes to request an exemption under 45 CFR 46.101(b)(3), (b)(5) or (b)(6), s/he is instructed to contact the IRB Office for guidance.
  • If subjects are under the age of 18 years, the exemption criteria described in 45 CFR 46.101(b)(2), 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 46.101(b)(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.
    • NOTE: The exemption criteria in 45 CFR 46.101 (b) do not apply to studies involving prisoners.
    • The exemption criteria [with the exception of 45 CFR 46.101(b)(6) / 21 CFR 56.104(d)]do not apply to FDA-regulated research studies.

Review of Grant Application

For Federally-supported research, the IRB reviewer will ensure that the research application is essentially consistent with the grant application. This determination is documented as a note in OSIRIS.

Investigator Communications

Comments or concerns of the IRB reviewer with regard to the exempt status of the research activity are documented and communicated in OSIRIS to the principal investigator, as described in Chapter 8.

Responses of the principal investigator are returned for review by the IRB reviewer who conducted the initial review (or to another IRB 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 OSIRIS. The chair or vice chair reviews the protocol submission along with the IRB reviewer's determination and then makes the final determination surrounding the protocol submission.

Exempt Determination Notification

The principal investigator of the research activity is notified of IRB concurrence of exempt status through OSIRIS. 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 46.101 (b) (1-6) and/or 21 CFR 56.104(d));
  • That the IRB should be notified in advance of any proposed substantive modifications of the exempt research activity through “send comments to IRB staff” in OSIRIS. The Expedited/Exempt Reviewer will review the request to determine whether the change affects the exempt determination. In the event that a change of Principal Investigator is required for any reason, a new exempt request has to be submitted.

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 resubmit the research for expedited or full-board IRB review.

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, without identifiers, 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.

To grant this waiver, the IRB reviewer utilizes the Exempt with HIPAA Waiver checklist.

Frequency of Review

Protocols designated for exempt are not required to be submitted for annual renewal.

Archive Process

In order to properly manage projects designated as exempt in OSIRIS, an archive process has been established. Exempt projects will be archived three years after the initial determination has been made. Investigators will receive an email notification six weeks before the archiving process will take place and be given the opportunity to extend the study another three years if still conducting the project. The notification will provide instructions on extending the archive date, including saving a copy of the OSIRIS application for their records. After the date of archival, investigators may still continue to conduct the exempt project. However, if any changes to the study team are required or other changes need to be requested, a new request for exempt determination must be submitted.

version 12.8.2015