560. New Projects: Full Committee Review
Updated Oct. 4, 2019
The University IRB uses a primary reviewer system for Full Committee Review (see the HRPP Policy Manual for reviewer assignment).
New Project Review Materials
The Primary Reviewer completes a comprehensive review of the materials in the project/package in IRBNet (or those flagged for review by RI staff) and complete the relevant review worksheets. IRB members (including alternate members) attending the meeting are expected to review the same materials. For the list of required documents, see the online HRPP Policy Manual for submission requirements for new projects, Full Committee Review and for information about review materials and worksheets.
The materials in the submission package are sufficient to ensure the Primary Reviewer and voting IRB members can determine whether or not the research meets the DHHS regulatory criteria for approval, and any additional requirements under Subparts B, C, and D, other applicable federal agency regulations, and Nevada state law.
Primary Reviewer Presentation
During the convened meeting, the Primary Reviewer presents an overview of the research; and salient factors, questions, and concerns about the project to the others present at the meeting.
If the assigned Primary Reviewer is unexpectedly absent from the meeting, at the discretion of the Chair a written commentary from the Primary Reviewer may be submitted and presented for discussion, or another IRB member who is present at the meeting may assume the responsibilities of the Primary Reviewer if the Chair determines the member has the requisite knowledge and expertise, and is sufficiently familiar with the materials submitted for review.
See the online HRPP Policy Manual for information about reviewer recommendations and documentation.
Possible IRB Actions for Full Committee Review of New Projects
The range of possible actions for Full Committee Review of new projects include Approved, Approved with Conditions, Deferred, or Not Approved (as described in IRB policy IRB Actions). If the IRB is unable to take one of these actions, the review may be Tabled without Action. If the convened IRB requests substantive clarifications or modifications that are directly relevant to the regulatory criteria, the project must be returned to a convened meeting of the IRB for regulatory review. These substantive clarifications or modifications cannot be reviewed and determined by expedite review.
Full Committee Assessment for Expedited Review
During the meeting, the IRB may determine and document that a new project is eligible for Expedited Review under one or more DHHS Expedited Review Categories 1-7. In such cases, subsequent continuing reviews and amendment requests are reviewed by expedited procedures (unless an amendment increases participant risks to greater than minimal or include activities that are not among those eligible for Expedited Review).
The IRB may determine and document that a new project not conducted under an investigational drug application or investigational device exemption does not meet the criteria for Expedited Review under Categories 2-7 but involves no more than minimal risk. Such projects are potentially eligible for Expedited Review Category 9, which would be confirmed at the time of continuing review if the IRB Chair or qualified designee determines that no additional risks were identified.
(For more information about expedited review requirements, see DHHS Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure.)
Determining Approval Periods for New Projects
The IRB approves projects for no longer than one year. In determining approval periods, the IRB considers the expected type, frequency, and severity of participant risks; and the reasonableness of risks in relation to benefits. For example, shorter approval periods may be warranted for projects in which participant risks are frequent or severe, or risks are greater than minimal and benefits to participants or unlikely or nil.