What is a PROC?

Purpose

Protocol Review Oversight Committee (PROC) review and approval is required for any study that will utilize VCU Health resources, including facilities and patients. PROC approval is required prior to IRB submission - The IRB site will direct you to obtain PROC approval prior to IRB submission, if you have not done so already. The purpose of PROC review is to ensure that VCU Health has the resources available to ensure your study can be successful, including assessment of clinical, operational, and facility feasibility. Where IRB review focuses on protection of human subjects, PROC review focuses on the feasibility of the study within the Health system.

Requirement to Submit

PROC review and approval is required for any study that will utilize VCU Health resources, including facilities and patients. PROC approval is required prior to IRB submission. The IRB site will direct you to obtain PROC approval prior to IRB submission.

Scope

1. Review all clinical research proposals at VCU Health based on specific review criteria.
2. Assess the scientific, operational, facilities (financial/feasibility) merits of each research study conducted at VCU Health.
3. Facilitate collaborations among researchers, clinicians, departments, and clinical/operational leaders.
4. Provide feedback and facilitate discussions/collaborations to advance research and the likelihood of success clinically, fiscally, and operationally.
5. Monitor metrics related to research and dissemination efforts.
6. Develop, support, and promote programs that recognize teams and team members that have demonstrated excellence in clinical inquiry and dissemination.
7. Foster academic and interprofessional partnerships that support the culture of clinical inquiry.
8. Emergency Use/Compassionate Use requests do not require PROC review/approval.  IRB submission for Emergency Use/Compassionate Use request should include the PROC Exempt Letter for Single-Patient INDs, which can be found on the VCU Health intranet page.

Components and Types of Review

Scientific Feasibility

• Reviewing for scientific merit with consideration of the benefits and risks
• Identifying study placement/match in the overall menu of clinical research studies
• Enhancing departmental clinical research goals

Operational Feasibility

• Reviewing for patient population availability, including utilizing available electronic platforms and reports
• Ensuring appropriate personnel resources are available to conduct the study
• Ensuring appropriate operational processes and technical resources are available to successfully conduct the study
• Reviewing for conflicting studies

Financial Feasibility

• Conducting an initial, cursory review of the financial feasibility of the study

Not Human Subjects Research Determination (NHSRD)

• Reviewing for human and research definitions/criteria as defined by federal regulations and operationalized by the VCU IRB

On-going Feasibility

• Review of study progress annually and as needed
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