The IDCRP Regulatory Affairs team supports investigators in preparing new research protocols and assisting with the execution of existing protocols by ensuring ethical and regulatory compliance, as well as establishing agreements necessary for the conduct of protocols. The Regulatory Affairs team also functions as an invaluable liaison between the IDCRP and USU, Defense Health Agency (DHA), Department of Defense (DoD) partners, National Institute of Allergy and Infectious Diseases, collaborators, and other regulatory agencies.
The IDCRP presently has 71 active (open) protocols, of which 56 are nonexempt studies and 15 are exempt studies. Over the past year, the burden of administrative tasks increased as the result of the required conversion of studies to a multi-site Electronic Institutional Review Board (eIRB) format, mandated by the DHA Regulatory Oversight Office. Specifically, Ms. Luca Illinik (IDCRP Regulatory Affairs Specialist) and IDCRP staff processed 437 eIRB submission in 2019, including 5 closures, 44 continuing reviews, 6 initial review submissions, 170 protocol modifications, 107 site-specific protocols, and 105 miscellaneous protocol actions. To facilitate the eIRB conversion, a portfolio of regulatory affairs operations management tools was developed, and multiple informative training sessions were hosted by Ms. Illinik.
Collaborations and partnerships with military, government, and civilian research institutions and laboratories, as well as academia are a core component of the IDCRP. As such, various official agreements are required for each collaboration(e.g., Cooperative Research and Development Agreements, Data Sharing Agreements, and Materiel Transfer Agreements). Presently,Ms. Stephanie Cammarata, IDCRP Agreements Officer ,has a portfolio containing more than 145 activeagreements with 43 agreements related to eithera new collaboration or a renewal of an existing agreement submitted for review in 2019.
A significant achievement in 2019 was the implementation of a cloud-based Regulatory Affairs Workspace at central DoD participating sites, designed to support the management of regulatory tasks across IDCRP. The benefits of this new system are already evident as it promotes regulatory compliance through the standardization of metrics and the tracking of regulatory requirements (including pending reviews and post-IRB approval tasks). In the coming year, the Regulatory Affairs team will assist the Quality Management Chief with the development of an IDCRP-wide Quality Management program.
• IDCRP Regulatory Affairs team successfully supported the conversion of 32 multi-center protocols to the new eIRB multi-site format. • A Regulatory Affairs Smartsheet Workspace designed to assist with IDCRP regulatory task management was established.
• Two new Institutional Agreements for IRB Review (IAIR) were established between the USU IRB and Carl R. Darnall Army Medical Center and the U. S. Naval Hospital Okinawa, while the Brooke Army Medical Center IAIR and the 59th Medical Wing IAIR were renewed.