HRPP policies & procedures manual

301: Administrative pre-review and distribution of IRB materials

1. Purpose

The purpose of this policy is to describe the requirements for document pre-review and distribution prior to IRB review.

2. Policy

The efficiency and effectiveness of the IRB is supported by administrative procedures that ensure that IRB members not only have adequate time for thorough assessment of each proposed study, but that the documentation they receive is complete and clear enough to allow for an adequate assessment of study design, procedures, and conditions.

3. Specific policies

3.1 Exemptions

The IRB coordinator will review and approve applications for exemption submitted by investigators.  Such applications for exemption will be logged and filed.

3.2 Incomplete submissions

Incomplete applications will not be accepted for review until the investigator has provided all necessary materials as determined by the ORA director or IRB coordinator. The ORA director or IRB coordinator will notify the submitting investigator to obtain any outstanding documentation or additional information before the application is scheduled for review. Incomplete submissions will be logged, but not assigned for review.

3.3 Scheduling for review

During the pre-review time, the IRB coordinator will determine if an application meets the criteria for expedited review under 45 CFR 46.110(b) and the FDA 21 CFR Parts 50 and 56, Washington State regulations, and University policy. If an initial application qualifies for expedited review, the chair (or designee) will select a subcommittee of two members of the IRB to review the application. Each reviewer will have ten working days to review the application and render a decision or comments for clarification.

3.4 Distribution to members prior to IRB meetings

Copies of application materials described in Section 300 (Research Submission Requirements) will be distributed to all IRB members, generally at least ten (10) days prior to the meeting, unless deemed urgent by the ORA director or chair. Each regular member of the IRB, and any alternate members attending the meeting in place of a regular member, will receive a copy of the initial application material. Consultants will only receive copies of material that pertain to their requested input.

3.5 Confidentiality

All material received by the IRB will be considered confidential and will be distributed only to meeting subjects (regular members, alternate members, and special consultants) for the purpose of review.

4. Applicable regulations and guidelines

21 CFR 56.109 and 45 CFR 46.109

5. Forms


6. Procedures employed to implement this policy & assignment of responsibility

IRB coordinatorConduct preliminary assessment of submissions claiming exemption
from IRB review.

Distribute expedited review protocols to chair or designee.

Request meeting attendance of PI if requested by committee.

Conduct assessment of submission adequacy and contact investigators
for any missing elements.

Assemble reviewers' packets. Send to all regular members of the IRB.

Send pertinent protocols to consultants invited to the meeting.