Chapter 11 - Expedited Reviews
This section applies to initial IRB review, modifications, renewals, renewals with modifications, and approval of research that qualifies for expedited review.
Research studies submitted for “expedited” review status are reviewed by Exempt/Expedited Research Review Coordinators, who are appointed as Designated Reviewers.
For research that purposefully requires the inclusion of children with disabilities or individuals with mental disabilities and is funded by the National Institute on Disability, Independent Living and Rehabilitation Research, the protocol will be reviewed by at least one individual who is primarily concerned with the welfare of these research subjects and who has the appropriate scientific or scholarly expertise to serve in this capacity. In the absence of an appropriate reviewer, the IRB will identify a consultant to serve in this role. This will be included on the Documentation Form generated by the Exempt/Expedited Research Review Coordinator.
No one may serve as a reviewer if they have a conflict of interest as outlined in Chapter 20.
Provision of Review Materials
The Designated Reviewer has access to the complete IRB submission including the following (as applicable):
- PittPRO application;
- Continuing Review Form;
- Modification Cover Sheet;
- Investigator- or sponsor-provided protocol informed consent documents;
- 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.)
- Confirmation of scientific review;
- Grant application;
- Other materials specific to the proposed study (e.g. Investigator’s Brochure or relevant investigator correspondence with regulatory agencies. etc.)
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 and informed consent requirements that must be met as per 45 CFR 46.111 and/or 21 CFR 56.111. In addition, assigned reviewers are expected to evaluate informed consent documents from the perspective of addressing the required and additional elements of informed consent addressed under 45 CFR 46.116, 21 CFR 50.20 (if applicable) and any other relevant ethical or compliance considerations (if applicable).
The Designated Reviewer complete applicable documentation forms to ensure that all regulatory issues are addressed as part of the review.
Categories of Expedited Review
The IRB reviewer determines whether the proposed research qualifies for expedited review in accordance with the “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure” as published by the OHRP, 45 CFR 46.110 and FDA 21 CFR 56.110.
Minor modifications of studies previously approved by the Full Board that would not materially affect an assessment of the risks and benefits of the study or do not substantially change the specific aims of the study are eligible for expedited review. Modifications that do not meet this definition will be reviewed at a convened meeting. Examples of minor changes may include:
- The addition of research activities that meet expedited criteria under 45 CFR 46.110 or 21 CFR 56.110;
- An increase or decrease in proposed human research subject enrollment supported by a statistical justification;
- Narrowing the range of inclusion criteria;
- Broadening the range of exclusion criteria;
- Alterations in the dosage form (e.g., tablet to capsule or oral liquid) of an administered drug, provided the dose and route of administration remain constant;
- Decreasing the number or volume of biological sample collections, provided that such a change does not affect the collection of information related to safety evaluations;
- An increase in the length of confinement or number of study visits for the purpose of increased safety monitoring;
- A decrease in the length of confinement or number of study visits, provided that such a decrease does not affect the collection of information related to safety evaluations;
- Alterations in human research subject payment or liberalization of the payment schedule with proper justification;
- Changes to improve the clarity of statements or to correct typographical errors, provided that such a change does not alter the content or intent of the statement;
- The addition or deletion of study sites;
- Minor changes specifically requested by the IRB, Human Use Subcommittee, Radiation Safety Committee, Radioactive Drug Research Committee
Initial expedited review is not applicable to research studies where the subjects are known to be prisoners (see Chapter 14 for additional information). However, modifications that do not affect the prisoner population, can be expedited. In addition, minor modifications affecting prisoners may be expedited with review by the prisoner representative.
Comments or concerns of the Designated Reviewer are documented and provided to the investigator through PittPRO. Procedures for investigator communications are outlined in Chapter 8.
Responses of the principal investigator are reviewed by the Designated Reviewer who conducted the expedited review (or to another non-conflicted IRB reviewer if the initial reviewer is unavailable for an extended time).
In the event of a failure to resolve problems or concerns related to the investigator’s response(s), the IRB submission (including prior correspondence between the Designated Reviewerand investigator) will be reviewed at a convened meeting of an IRB committee.
Designated Reviewers cannot disapprove an IRB submission or modification through an expedited mechanism. In the event that a Designated Reviewer cannot resolve an issue related to an expedited submission, the study will be referred to a convened meeting for discussion by a committee.
Documentation of Determination
After reviewing the protocol submission, the Designated Reviewer documents his/her determination in PittPRO by executing the “Submit Designated Review” activity. Once all of the issues are appropriately addressed. final expedited approval of the research study and corresponding informed consent document(s) (as applicable) is granted. Designated Reviewers maintain the option of sending the final version of the application to a Vice Chair for review. If an IRB submission is determined to involve more than minimal risk, this will be documented, and the principal investigator will be advised that the submission has been referred for full-board IRB review.
Basis for Approval
The minimal risk status of the research and the applicable category or categories of research activities listed in “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure” will be documented, within the IRB Research Protocol and/or review materials.
Expedited Approval Notification
The principal investigator is notified of IRB approval for initial or continuing review (if required) via an electronic letter sent from PittPRO. This letter specifies, at a minimum:
- The IRB number assigned to the submission
- The basis for granting expedited review and approval, including identification of the applicable category or categories
- The date of IRB approval
- The date IRB approval expires (if a determination is made that this is required)
Studies originally reviewed via full board meeting
For continuing review or modification, the Designated Reviewer determines if research that was initially approved by the full-board IRB may now qualify for expedited review. This determination is made based on the risk level or status of the research and in accordance with the “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure.”
Studies originally approved via expedited review
For IRB protocols originally approved by the expedited process are re-evaluated to ensure that the submission continues to qualify for expedited review as specified in “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure.” If the research no longer meets these requirements, it will be forwarded for review by a convened IRB Committee and the principal investigator so informed.
New Information and Significant New Findings
For studies requiring continuing review, the IRB reviewer evaluates whether any new information/significant new findings should be provided to subjects when this information might relate to the subjects’ willingness to continue to take part in the research.