PROCEDURE

Investigator Responsibilities

OIRB Responsibilities

Administrative staff:

Ensures appropriate procedure for scientific and scholarly review was completed and documented for all non-exempt initial protocol submissions.

IRB Responsibilities

Scientific members(s) of the IRB (see PRO144 Procedure for Formation and Assignment of IRB Member Reviewer(s)):

Review each protocol for scientific merit and scholarly validity with accompanying materials (see GUI308 checklist for new submissions for review by the convened IRB).
Review the IRB application eForm (FOR200) and informed consent documents prior to the meeting.

If a scientific member cannot adequately evaluate the scientific and scholarly validity of an assigned protocol:

(S)he may acquire sufficient knowledge to perform a scientific assessment through study of the relevant literature, discussions with colleagues, and contact with the principal investigator provided that the materials received for review are kept confidential; or
Notifies the Chair prior to the time the protocol is scheduled for presentation to the IRB or at the IRB meeting.
If notified before the meeting, the Chair decides whether to review the protocol, assign the protocol to another Reviewer, invite a consultant (see POL014 policy on, PRO114 procedure for IRB use of consultants) to assist in the review or invite the PI to be present during the discussion of the protocol.
If notified at the meeting, the IRB decides whether to review the protocol at the meeting, reassign it to another member for review at a later date, or invite a consultant to assist in the review.
For expedited review, protocol is reviewed for scientific merit and scholarly validity and if unable to assess, refers to the IRB Chair (or designee) for review or determination on consultant review.