WPP #: VIII-2
Initial Review - Expedited
06-20-00; 09-20-01; 06-07-04; 12-06-04; 6-21-06; 02-05-07; 01-15-08; 04-22-14
All proposed projects that involve human subjects and that satisfy the definition of research must be reviewed prior to the activity beginning. This review is called “initial review.” The types of initial review are exempt, expedited and full. Expedited initial review is described within this WPP.
Identification of research projects that qualify for expedited review will be made by the IRB administrative staff. Expedited research projects will be reviewed by the Chairperson of a VCU IRB Panel or by an experienced member of the IRB designated by the Chairperson.
Description and Procedures
- Qualification for Expedited Initial Review:
Only projects involving no more than minimal risk are considered for expedited review. The reviewer makes the final decision as to whether or not the protocol meets the applicability criteria and qualifies for the category or categories noted (or another one or more of the 7 categories) and can make a decision to refer the review to the full board. Investigators must submit sufficient information to ensure that the IRB criteria for approval are met, including but not limited to the Smartform application, scientific rationale, research protocol, consent form and any other necessary information.
- Minimal Risk Determination:
At initial review, the expedited review type applies to research projects that:
- pose no more than minimal risk, AND
- involve one or more research activities (see 9 categories below) listed in the federal regulations as qualifying for expedited review.
NOTE: The activities listed should not be deemed to be of minimal risk simply because they are included in the federal regulations as qualifying for expedited review. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
Minimal risk is defined in 45 CFR 46.102(i) and 21 CFR 56.102(i): “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
The following conditions also apply:
- The expedited review procedure is not used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
- The expedited review procedure cannot be used for classified research.
- For FDA-regulated research: 21CFR56.110 (d) states "The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subjects." 21 CFR 46.110(d) states that "The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedures."
- Expedited Review Categories:
The following 9 categories include two categories (8 and 9) that specifically pertain to continuing review and NOT initial review. VCU IRB WPP#: VIII-4 addresses Continuing Review. However the 9 categories are quoted here in their entirety as published at 63 FR 60364-60367 and referenced in 45 CFR 46.110(a).
The following research activities are listed in the federal regulations as qualifying for expedited review:
- Reviewer, Approval, and Disapproval Guidelines:
A Panel Chairperson or experienced IRB member may conduct expedited reviews. The reviewer may (1) approve research submitted for Expedited review (as submitted) or may (2) require modifications prior to approval. An experienced reviewer is one who has served with the IRB for a duration that has allowed for an evaluation of the reviewer's understanding of the regulations and the VCU IRB written policies and procedures as they pertain to expedited review. Expedited research is assigned to a reviewer by the VCU ORSP staff, based upon area of expertise.
The reviewer may not disapprove projects that have been submitted for expedited review. In cases where the research cannot be approved via expedited review, the reviewer must recommend resubmission for full board approval or forward to the VCU IRB panel for review as full board, with their written comments.
- Document Distribution and Reviewer Actions:
- If there is any protocol-related information requiring clarification, the expedited reviewer should contact the principal investigator (or student/trainee conducting the activity) directly.
- Final review comments by the expedited reviewer must be documented in writing and forwarded to the IRB coordinator for processing. Expedited reviewers will document the following:
- Confirmation that the research meets the criteria for review found at 45 CFR 46.111 and 21 CFR 56.111.
- Confirmation that the research meets the requirements found at Subparts B, C and D, when applicable.
- Confirmation that the research meets the requirements for informed consent, including consent alterations or waivers.
- Confirmation that the research poses no more than minimal risk;
- Identification of the Expedited Research Category;
- Determination of the requirement for continuing review and any other additional requirements;
- Review of any recruitment procedures involving advertisements.
- Final documentation of approval will be generated by the ORSP staff and communicated in writing to the principal investigator.
- Research studies approved via expedited procedure are reported on a monthly basis to the relevant IRB Panel (as part of the meeting agenda).