559. Review Materials and Worksheets

Updated July 13, 2021

Project/Package Documents

For Full Committee Review, no later than one week prior to a scheduled meeting, Research Integrity staff give the Primary Reviewer and IRB members (and consultants when indicated) who will be attending the meeting access in IRBNet to all projects/packages scheduled for review. For the list of materials for IRB review, see IRB policy for submission requirements for full committee review of new projects, full committee review of continuing review, and full committee review of amendments; and for noncompliance and unanticipated problems.

The assigned Primary Reviewer and IRB members (including alternate members) that will attend the meeting are expected to review all documents available in the new project; continuing review, amendment, or reportable event package; or the materials flagged by Research Integrity staff as relevant to the review.

For Expedited Review, Research Integrity staff confirm the availability of a qualified IRB member to complete the review within 10 business days and give the member access in IRBNet to the relevant project/package. For the list of materials required for IRB review, see IRB policy for submission requirements for expedited review of new projects, expedited review of continuing reviews, and expedited review of amendments.

With shared access, IRB members can:

• review the current New Project, Continuing Review, or Amendment package;
• review all documents submitted in previous packages;
• view historical review details for all packages, decision letters, and other board documents (including approved, date-stamped consent forms); and
• view the complete submission history.

Review Worksheets

IRB member-reviewers use worksheets to document their decision making processes and findings and note their questions and requested revisions except for review of possible noncompliance or unanticipated problems. When these items are on the agenda for Full Committee Review, the Research Compliance Officer provides the Primary reviewer with relevant excerpts from IRB Policy, regulatory guidance, or both.

Three main worksheets are available for review of new projects, continuing reviews, and amendments.

For Full Committee and Expedited Review of new projects (or amendments when applicable) supplemental worksheets are available for assessing additional regulatory requirements for the following:

• research involving vulnerable populations (pregnant women/fetuses, prisoners, children, or adults with cognitive impairment);
• research involving investigational drugs/biological products/dietary supplements, devices, or blood/specimens;
• requests to waive requirements for HIPAA authorization; and
• requests to waive the consent process or documentation of consent.

Worksheets are also required (regardless of review type) for review of research conducted or supported by the Departments of Education, Energy, Defense, or Justice; and the Environmental Protection Agency.

Review worksheets are available from the Committee Member libraries in IRBNet. Reviewers add completed worksheets to the relevant projects/packages in IRBNet. The worksheets are combined with notes from IRB meetings to prepare investigator correspondence and meeting minutes.

Research Integrity staff confirm that the relevant worksheets are completed and attached to the project/package.