The document is a formal letter from Katharina Phillips, President of the Council on Governmental Relations (COGR), to Colonel Kenneth A. Bertram of the U.S. Army Medical Corps, regarding the human use requirements in the Army’s Congressionally Directed Medical Research Programs (CDMRP). The letter highlights concerns from over 145 research-intensive universities about recent Army policy changes that prohibit the use of participants’ health insurance to cover research-related injuries or illnesses. Under revised CDMRP terms, medical care for such injuries must be provided at no cost to research participants, with institutions now expected to factor these costs into their budgets or seek alternative insurance solutions.
COGR raises multiple challenges posed by these new requirements, noting the difficulty universities face in securing appropriate insurance coverage, especially for high-risk individuals who are often not healthy volunteers but critically ill patients. The letter also explains that federal and some state laws mandate certain insurance coverage for clinical trial participants, making the Army's new prohibition on third-party reimbursements problematic for compliance and participation. COGR suggests alternative solutions, such as creating a reserve fund, direct Army payments for uncovered subjects, or allowing continued access to third-party payer insurance with proper disclosure. The letter urges the Army to address these issues collaboratively before awarding new grants, proposing a meeting to discuss feasible solutions and ensure that critical research is not compromised by financial or administrative obstacles to participant care.
