Exempt Review

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

The following must be included in an exempt protocol submission:

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

1 original and 2 copies of the application for exemption,

3 copies of all study personnel training certificates,

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.

IRB protocols approved for exemption are not subject to continuing review; however any proposed modification to the protocol will necessitate re-evaluation of the protocol's exempt status.