Regulatory Affairs

The IDCRP Regulatory Affairs team consists of staff at the network’s Military Treatment Facilities and IDCRP Program Coordination Center (PCC). They perform essential duties throughout the IDCRP protocol development and execution process and are led by the Head of Regulatory Affairs staff assist in protocol development, conduct intensive review of all IRB submissions to check for compliance with federal, local and IRB policies and procedures, consult with investigators during IRB review, coordinate with IRB staff to address any problems, perform on-site monitoring, track study milestones and maintain regulatory documents for the program.

The Regulatory Affairs staff at the IDCRP PCC, often in collaboration with the NIAID Regulatory Compliance and Human Subject’s Protection Branch (RCHSPB), conducts a thorough review of all IDCRP protocols to ensure protocols are ready for ID IRB review. The rigorous review focuses on ensuring regulatory integrity, compliance with local, federal and USU regulations and procedures, and consistency within the protocol and informed consent documents. The aim of this review is to provide the ID IRB with a high quality submission and reduce the post-review stipulations issued by the IRB. Provisions are made to review all research protocols, consent and HIPAA documents, recruitment material and case report forms for required elements as well as additional human subjects considerations.

The IDCRP Streamlines the IRB Process

The USU Infectious Disease Institutional Review Board (ID IRB) is a DoD Infectious Diseases community IRB centered at USU. The ID IRB was established via a Memorandum of Understanding (MOU) in January2008. This MOU, signed by the Assistant Secretary of Defense (Health Affairs), the Surgeons General for each service, and the President of Uniformed Services University, created a single review pathway for multicenter ID research, eliminating the need for multiple and repetitive scientific, ethical and second level reviews. Having this streamlined review process effectively made possible multicenter collaborative research without the impediments and delays of the past.

By consolidating the number of required reviews for multicenter research, the ID IRB has served an integral role in allowing the IDCRP to respond rapidly to infectious disease threats affecting military populations. To further streamline its processes, USU has adopted a fully electronic protocol submission and review system (IRBNet) to automate much of the previously papercentric IRB procedures. Since its creation, the USU ID IRB has reviewed over 50 domestic and international research protocols.

The IDCRP Regulatory Affairs staff, RCHSPB monitors, and ID IRB staff continue to work collaboratively to advance multicenter, militarily-relevant infectious disease research.