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IRB Member as Expedited Reviewer

IRB Member as Expedited Reviewer

This page describes the process for conducting non-exempt reviews. Only voting IRB members can conduct a review of non-exempt research (i.e., an expedited review). In conducting an expedited review, an IRB member may ask the IRB Chair to appoint, as needed, a consultant with specialized expertise.

IRB members refrain from participating in reviews where they may have a conflict of interest.

     » Declaration of Commitment to Avoid Conflict of Interest

 

EXPEDITED REVIEW of NON-EXEMPT RESEARCH

Alverno researchers initially proposing non-exempt research generally complete both the New Study Application (old) for IRB Review formand the Research Protocol (old). However, student researchers who have completed a sufficiently equivalent description of their proposed research in the context of faculty supervised program requirements may substitute that proposal for the requirement of completing the Research Protocol.

New Studies

Standard Submission (Outside RRC Context): The principal investigator submits all application materials to the IRB Administrator. After determining the submission is complete, the IRB Administrator forwards a copy to the IRB Chair. The IRB Chair may make a determination that the new study application is eligible for an expedited review or requires a full IRB review. If the chair, determines the submission appears eligible for expedited review, he or she may:

  • Conduct an expedited review him/herself, or
  • Assign one or more IRB members to conduct an expedited review.  (In some cases, the IRB Chair may make formal standing appointments for expedited reviewers for particular kinds of research.)

RRC Supported Submission (If IRB member has RRC Standing Appointment to do Expedited Reviews): Although submission may sometimes proceed directly through an RRC, a principal investigator, at the same time, routes a copy of all application materials to the IRB Administrator. This begins a process of IRB documentation parallel to the standard submission.

Note that a researcher may directly submit an application for a new study to an RRC for an expedited review if and only if:

  • the RRC supports expedited reviews,
  • the RRC uses, as a reviewer, a voting IRB member authorized by a standing appointment from the IRB Chair to review proposals in that field,
  • an authorized IRB member agrees to conduct the expedited review (based on expertise and lack of conflict of interest), and
  • the researcher also submits at that same time a copy of all application materials both to the reviewer and to the IRB Administrator.

Conducting the Review

When conducting an expedited review, the IRB reviewer(s) completes a Reviewer Checklist and Action Determination in support of that review. The IRB reviewer may request from the researcher additional materials and changes. We encourage a collaborative process.

Review Determination

In all expedited review contexts, an expedited reviewer must determine whether a research proposal meets criteria for an expedited review. See Section VIII of the New Study Application for IRB Review entitled New Study Application (old) for IRB Review form. If it is not eligible for expedited review, the reviewer recommends full IRB review (see #4 below). The full array of possible determinations are noted on the bottom of the New Study Expedited: Reviewer Checklist and Action Determination form. These are:

  1. approve the research in expedited review,
  2. stipulate changes required for approval in expedited review,
  3. request a consultant or another reviewer with additional expertise prior to making a determination, or
  4. recommend that the study go forward to a full IRB review (Note, a study may be disapproved in a full IRB review, but not in an expedited review.

Completing the Review

The expedited reviewer completes and signs the New Study Expedited: Reviewer Checklist and Action Determination. Completion of the form includes recommending a determination to the IRB Chair, The reviewer may or may not also communicate what his or her recommendation is to the investigator. However, in all cases, the reviewer makes clear to the principal investigator that the research may not begin until a written approval letter is received from the IRB Chair. After making his or her recommended determination, the reviewer forwards to the IRB Administrator the following:

  • The signed checklist,
  • Documentation of any required changes, and
  • A clean copy of the final consent form(s).

Note, the IRB Administrator then routes all application materials to the IRB Chair. The IRB Chair then makes a determination and writes a letter to the investigator (copied to the IRB Administrator), which indicates whether the research is approved and any required revisions.  

Continuing Review

The IRB Administrator supports the researcher’s continuing review submission. The IRB Chair determines approval in the context of continuing review.

IRB Member as Expedited Reviewer >