Protocols are submitted either for full IRB review or for expedited review.  Expedited review is authorized by 45 CFR 46.110 and 21 CFR 56.110 and is applicable for research activities that:

-          New protocols that present no more than minimal risk to human subjects

                                                      and

-          Involve procedures listed in one or more of the expedited review categories (see Appendix 5),

or

-          Minor changes in previously approved research during the current approval period.

If expedited review is being requested, the investigator must complete the Expedited Review Form (Appendix 5) and the investigator must identify which of the categories qualifies the protocol for expedited review.   This form must accompany the documents identified in Section E, IRB Review.   The criteria for informed consent still apply to protocols that meet expedited review criteria. (See section F, Informed Consent)

Expedited review may also be used for continuing review of certain protocols and advertisements or recruitment material, if easily comparable to the consent and protocol.  Minor changes in previously approved research may be approved through expedited review if done during the period of IRB approval.

Procedure

1.     The investigator must request expedited review and indicate on the request form which category of human subject involvement best describes the procedures in the protocol. (see Appendix 5)

2.     Two members of the IRB will review the protocol.  These two members will be identified by the chairperson.  At the chairperson’s discretion, additional members or consultants may be requested to review a protocol if specific clinical expertise is indicated.

3.      The protocol will be sent to the reviewers with an expected turn around time of no more than 15 business days.

4.     The reviewers will indicate the following:

-          Approved as written

-          Approved with recommended changes

-          Full IRB review needed

5.     Both reviewers must approve the protocol for the research to be approved.  If the reviewers do not approve the protocol, the protocol is automatically sent to the full IRB for review.

6.      If the reviewers deem that the protocol requires "Full IRB Review", this will be communicated to the Chairman and to the principal investigator.  The protocol will be scheduled for review at the next monthly meeting and the requirements for full IRB committee review must be fulfilled.

7.      The protocols receiving Expedited Review and the results of that review will be presented to the full IRB for informational purposes at the next scheduled meeting and noted in the minutes of the meeting.

8.      The investigator will receive written documentation of the reviewers’ decision.  If clarifications and/or changes are required to the protocol or consent form document, these changes must be incorporated into that appropriate document and submitted to the IRB for review.   Two copies of the final document must be submitted: one copy with the changes clearly identified (either in bold or underlined) and one “clean” revised copy.

9.      Initiation of a protocol may not begin until the investigator is in receipt of the approval letter from the IRB chairman, the stamped informed consent document, if applicable, and the signed application form.