560. New Projects: Full Committee Review

Updated July 13, 2021

The University IRB uses a primary reviewer system for Full Committee Review (see the Human Research Protection Program (HRPP) Policy Manual for reviewer assignment).

New Project Review Materials

The Primary Reviewer conducts a comprehensive review of the materials in the project/package in IRBNet and completes the relevant review worksheets. IRB members (including alternate members) attending the meeting are expected to review the same materials, which include:

1. The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval.
2. Proposed consent document.
3. Recruitment materials.
4. The investigator’s brochure.
5. Cover Sheet.
6. Application forms on specific topic (e.g., children, prisoners, drugs, device, international, etc.).

The materials in the submission package are sufficient to ensure the Primary Reviewer and voting IRB members can determine whether the research meets the Department of Health and Human Services (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.

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.

When the IRB grants conditional approval, the IRB should provide the researcher specific modifications required to secure approval. 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. Minor or prescriptive changes or requirements may be reviewed for approval by a staff member or IRB member designated by the IRB or by the IRB Chair/Co-Chair Verification of modifications is not considered review using an expedited procedure.

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.

Determining Approval Periods for New Projects

The IRB approves projects for no longer than one year. The expiration date reflects the last date that the protocol is approved. 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. The IRB also considers the degree of uncertainty regarding the risks involved. In addition, if the participants are deemed vulnerable, it is prudent to determine a shorter approval period. The IRB may determine a shorter approval period for the following reasons:

• The experience of the clinical investigator in conducting clinical research.

• Previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed consent, prior complaints from participants about the researcher). The projected rate of enrollment.
• Whether the study involves novel therapies.

Determining Disapproval

If the IRB decides to disapprove a research activity, the IRB will provide a statement of the reasons for its decision and give the researcher an opportunity to respond in person or in writing. At the next convened IRB meeting, the members will discuss and review of researchers’ responses. The IRB will communicate any changes in writing to the researcher.