HRPP policies & procedures manual

401: Expedited review

1. Purpose

The purpose of this policy is to describe and outlines the process to determine if the research meets criteria for expedited review.

2. Policy

During the pre-review, the IRB coordinator will determine if an application meets the criteria for expedited review under 45 CFR 46.110(b) and the FDA 21 CFR Parts 50 and 56, Washington State regulations and University policy.  If an initial application qualifies for expedited review, the chair (or designee) will select two members of the IRB to review the application.  Each reviewer will have ten working days to review the application and render a decision or comments for clarification.  If any changes are requested, the reviewers will notify the IRB Coordinator who will contact the researcher.  In most cases, the IRB coordinator will act as a liaison between the reviewer and the researcher.  This policy pertains to both initial, continuing review, and modifications to previously-approved research.

The categories of research that may be reviewed by the IRB through an expedited review procedure include research activities that:

  1. present no more than minimal risk to human subjects
  2. do not involve identification of subjects and/or responses that would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentially are no greater than minimal
  3. are not classified, and
  4. involve only procedures listed in one or more the specific categories on Addendum 1: Expedited Categories and Determination.

Expedited categories

The expedited categories are listed on Addendum 1 of the non-exempt application.

3. Specific policies

3.1 Initial review

In reviewing the research, the reviewers may exercise all of the authorities of the full IRB except that the reviewers may not disapprove the research. In the case of a split decision by the reviewers, the chair will act as a third reviewer, or the application will be brought before the full board IRB meeting.

  • The reviewer(s) will have access to the entire study file including the following documents (if applicable):
    • IRB application with any required addendums
    • Research protocol, if applicable
    • Investigator brochure or device specifications
    • Questionnaires and assessment instruments
    • Proposed informed consent documents (including assent)
    • Proposed subject instructions, recruitment materials, and advertisements
    • Letters of permission
    • Recruitment materials (flyers, posters, etc.)
    • Translations of materials
    • Documentation of completion of required training
    • FDA Form 1572 (drug study) or signed investigator agreement (device study)
    • HIPAA documentation
    • If additional IRB review is sought at another institution: name, address and telephone number of the IRB
    • If additional review is being sought at another WSU committee, the approval, if it is completed (included on application)

3.2 Continuing review

Studies which have been approved as expedited may be reviewed via expedited review.

A study that received full-board review may be determined by the full board to be minimal risk and thus, if the board so determines, can be annually reviewed by the expedited procedure. This determination will be documented in the minutes.

The reviewers at continuation will have access to the entire study file including the following documents:

  • Completed continuing review form
  • Copy of the current approved protocol and all intermediate amendments
  • Copy of the current consent document(s)
  • A copy of the current HIPAA authorization document, if separated from the informed consent
  • Background information

3.3 Minor modifications to previously approved research

Unless they will change the level of the review, expedited amendments are reviewed in the IRB office. The IRB coordinator may approve minor modifications of previously approved research during the period for which approval is authorized.

Minor modification is defined as a change and is considered minor when it does not materially affect an assessment of the risk and benefits of the study, does not change the aims of the study design, and is not directly relevant to the determination required for approval.

Examples of minor modifications include, but are not limited to:

  • Protocol revisions that entail no more than minimal risk
  • Changes to the informed consent documents that do not affect the rights and welfare of study subjects, or do not involve increased risk, or significant changes in the study procedures
  • Changes in research personnel or contact information

3.4 Additional items that may be reviewed by the expedited review process

IRB meeting determination: minor modifications
  • The IRB will stipulate specific revisions that require simple concurrence or agreement by the investigator. These stipulations must be clear so that the IRB coordinator can determine whether the protocol, consent, advertisement, or other document was modified as requested by the IRB.
  • New or revised recruitment advertisements or scripts

3.5 Documentation of expedited review

The IRB coordinator will document the expedited review (initial, continuing review, amendments) by use of the reviewer’s comment sheet, which will become part of the study file.

3.6 Expedited approval notifications

Once both designated reviewers have approved the application, the IRB coordinator will notify the researcher of approval, on behalf of the committee. The IRB attempts to complete expedited reviews within ten working days from receipt of the application.

When the expedited review procedure is used (initial, continuing review, modifications) all regular members shall be informed of actions taken by the IRB staff at the next convened meeting. The expedited actions will be listed in the IRB agenda.

4. Applicable regulations and guidelines

45 CFR 46.102, 46.110

21 CFR 56.102, 56.110

Office for Human Research Protections (OHRP) IRB Guidebook

5. Forms

Addendum 1: Expedited Categories and Determination

6. Procedures employed to implement this policy & assignment of responsibility

ORA director, chairperson, IRB coordinatorMake initial determination regarding qualification for expedited review.

Refer to checklists as needed.
ReviewersReview study using appropriate expedited reviewer’s comment sheet and any other appropriate checklist.

Ask the IRB office to make the contact for clarifications or revision.
IRB coordinatorIf the study qualifies for expedited review, assemble reviewers' materials and assign to reviewers.

Enter study into the database.

Report all expedited reviews on IRB meeting agenda.

Ensure reviewer(s) turn in checklists and add to study file.

Send out correspondence of action or approval to investigator.