Protecting the Rights, Safety, and Welfare of Participants in Research Studies
Photo credit: Fort Detrick Visual Information Office
Photo credit: Fort Detrick Visual Information Office
"Welcome to the first meeting of the new Headquarters U.S. Army Medical Research and Materiel Command Institutional Review Board," with those words, Andrea Kline, director, HQ USAMRMC IRB opened the Board's inaugural orientation conference held April 21-22 at Fort Detrick.
Dr. Laura Brosch, director, Office of Research Protections, started the conference with a charge to the new IRB. After discussing the historic significance of building upon the 35 year history of the Human Subjects Research Review Board and creating the HQ USAMRMC IRB to serve a much expanded Army and DOD mission, she identified the high expectations, the unique challenges the IRB faces, the wide range of Army DOD customers and the way ahead.
"I thank you for your willingness to be a part of our new initiative to assemble an IRB with diverse DOD membership that can provide the highest quality ethical and regulatory oversight of research on behalf of USAMRMC, Army and DOD institutions," said Maj. Gen. James Gilman in his Welcome Letter to the conference attendees.
The Board is composed of 21 members, military and civilian. Nineteen of the members were able to attend the orientation. They reviewed items such as criteria for approval of research, DOD-unique requirements for human subjects protection, special protections for research with children and pregnant women, issues related to FDA regulated investigational products and the importance of addressing conflicts of interest.
"There are a lot of myths and concerns about what is really occurring in military human research. Our command and the DOD are under constant scrutiny. We must hold ourselves to the highest ethical standards because that is what the public and the participants in our research expect of us" said Brosch. "That's why this Board's membership is diverse and expert. To make informed, balanced, ethical decisions our membership includes Army, Navy and Air Force Officers and NCOs, civilian scientists and non-scientists, and community members who have no association with research."
Currently, the board supports USAMRMC subordinate commands to include, U.S. Army Aeromedical Research Laboratory, U.S. Army Institute of Surgical Research, and U.S. Army Medical Research Institute of Chemical Defense. The HQ USAMRMC IRB has also been charged with supporting Army institutions such as the Army War College, Army Test and Evaluation Command and the US Army Sergeants Major Academy. The Board also supports DoD institutions to include the U.S. Central Command, the TRICARE Management Activity, and the Defense Manpower Data Center.
This IRB will eventually will have the capability to serve as an Army central IRB that facilitate the conduct of studies involving multiple military sites.