Instructions for Preparing the Packets

NOTE: Packets must be complete in order to be reviewed by the IRB.

Checklists:

Primary Reviewer Packet

(For FULL BOARD REVIEW and EXPEDITED REVIEW)

One copy of the primary reviewer packet is required. This packet should include the following:

• Completed Continuing Review Report/Renewal Request with original signature(s).
• Current full protocol that incorporates any modifications previously approved by the IRB.
• A copy of entire Consent and/or Assent signed by the last subject enrolled (even if the Consent and/or Assent has not changed and was previously submitted for a continuing review) Use a black marker to block the name, initials, and signature of the subject anywhere it appears on the form. Do not block the date of the subject's signature. Please do not use “white-out”. Leave the names, signatures, and dates for the PI and the witness (if applicable).
• A copy of the currently approved stamped Informed Consent and/or Assent.
• If any non-English speakers have been enrolled, attach one copy of the informed consent or assent documents used.
• If you plan to enroll any subjects in the future, submit a clean copy of the current Informed Consent and/or Assent for approval. If no additional subjects will be enrolled, you do not need to submit these documents. The IRB may require a new informed consent document if subjects require re-consenting in the future (due to protocol revisions, adverse events, updated study information, etc.).
• All other documentation requested on the continuing review report/renewal request.

Meeting Packets

(For FULL BOARD REVIEW Only)

20 COPIES of the meeting packet are required.

• Copies of completed and signed Continuing Review Report/Renewal Request.
• Copies of currently approved, stamped Informed Consents and/or Assents.