Expedited Review

Research studies that may be considered for expedited review are minimal risk and conform with one or more of the categories of research defined in 45 CFR 46.

There are two applications available for initial review of research which falls into expedited categories: the Full Board and Expedited Application and the IRB Application for Retrospective/Record Review.

The following must be included in an initial expedited protocol submission:

1 original and 2 copies of the Initial IRB Submission Reminder List,

1 original and 2 copies of appropriate IRB application,

3 copies of the protocol,

3 copies of all study personnel training certificates,

3 copies of Investigator Financial and Other Interests Disclosure Forms,

1 original and 2 copies of consent and assent forms or letters,

1 original and 2 copies of advertisements, data collection sheets, and any other study related materials,

3 copies of grants and/or contracts.

For studies conducted at Kennedy Memorial Hospitals, attach the required GAFA Form along with the signature of the Vice President Graduate Medical Education.

Following review, your protocol will receive one of the following status determinations: Approved, Approvable pending re-review by the chair or his/her designee, Approvable pending re-review by the subcommittee, or Approvable pending re-review by the full board.