Full Board Review

Any research study that is greater than minimal risk must be reviewed by the full board. Research protocols that present minimal risk to participants but which do not conform to any of the categories of expedited or exempt research must also be presented for review before the full board. Full board review requests must be completed using the Full Board and Expedited Application

The following must be included in a full board protocol submission:

1 original and 17 copies of the Initial IRB Submission Reminder List,

1 original and 17 copies of the IRB application,

1 original and 17 copies of the consent and assent forms or letters, advertisements, data collection sheets, and any other study related materials,

5 copies of the protocol,

5 copies of all study personnel training certificates,

5 copies of Investigator Financial and Other Interests Disclosure Forms,

5 copies of the full grant 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.

Protocols which require full board review are assigned to a full board meeting based upon date and time of submission to the IRB office.

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, Tabled, Disapproved.