The document provides a comprehensive overview of the administrative, regulatory, and operational framework governing the Department of Defense (DoD) medical research funding process for fiscal years 2015 and 2016, specifically under the U.S. Army Medical Research and Materiel Command’s (USAMRMC) Broad Agency Announcement (BAA) and the Congressionally Directed Medical Research Programs (CDMRP). Central themes include the rigorous requirements for application submission, ethical and regulatory compliance, and the DoD’s strategic priorities in military-relevant medical research.
A significant component of the document is a letter from the Council on Governmental Relations (COGR), representing major research universities, voicing concerns over the administrative burden imposed by current conflict of interest (COI) requirements for funding applications. COGR contends that mandates for full COI disclosures and management plans at the proposal stage are unnecessarily stringent, particularly as most applications are not funded and potential conflicts can arise or change prior to awards. The organization urges that COI disclosures be required only immediately prior to award, aligning with standards at other federal agencies, and requests clarity and consistency in terminology and regulatory references.
The document also meticulously outlines the multi-step application and review process. Applicants must meet stringent registration and eligibility requirements and comply with detailed instructions for both pre-proposal and full proposal submissions. There is an emphasis on comprehensive documentation—including research plans, budgets, COI disclosures, and data-sharing plans—and on adherence to federal and DoD-specific regulations, particularly regarding the protection of human and animal research subjects, safety, ethics, and privacy. Regulatory reviews by DoD offices supplement local institutional approvals, and the process includes both technical peer review and programmatic evaluation for DoD mission relevance.
Award mechanisms and research funding priorities are described as diverse and inclusive, supporting a wide spectrum of research areas such as combat casualty care, operational medicine, rehabilitative technologies, medical defense against health threats, and medical simulation. The application process encourages innovative, translational research that bridges basic science and practical solutions for military health needs, with opportunities open to a broad array of U.S. and international organizations, including small and disadvantaged businesses.
The framework for post-award administration is equally robust, covering changes in personnel or organization, compliance with reporting and transparency requirements, intellectual property and data-sharing expectations, and ongoing adherence to federal statutes in areas such as lobbying and non-discrimination. New procedural elements—including mandatory pre-proposals via electronic portals and updated safety/environmental protocol requirements—demonstrate ongoing efforts to streamline oversight and maintain high standards.
Overall, the document balances the imperative for regulatory compliance and research integrity with the need for administrative efficiency and innovation. It seeks to facilitate impactful medical research that directly supports military readiness and public health, while responding to stakeholder concerns regarding procedural burdens on the research community.
