The Department of Defense changed the way it approves and monitors cancer research.
All medical research comes with risks and benefits. When researchers conduct studies on humans, medical centers use an independent committee to review all aspects of the study. The committee examines the way information will be gathered, what types of people will be studied and work to ensure those people who volunteer to participate are protected and understand the nature of the experiments.
The Department of Defense is no different — studies are approved and monitored by Institutional Review Boards, also called IRBs. Earlier this year, DoD created a combined IRB that reviews all cancer research throughout the department. Before this joint IRB of the U.S. Military Cancer Institute was established in February, each medical center — including Walter Reed Army Medical Center — had its own board. This meant if a researcher wanted to do a cancer study and enroll 100 people in 10 centers, it would have to be approved by the board at all 10 centers. The alternative, enrolling all 100 people at one center would take longer and therefore delay research, said Marianne Elliott, who chairs the new Military Oncology IRB.
“Research can be done faster if more centers are involved,” Elliott said. “This allows investigators in many different places, across the country to pool their data. If you need 100 patients to answer a question, you can get to 100 patients faster. You're casting a broader net by involving more researchers and subjects at the same time frame to get research done.”
Already, the newly-formed board, which is based at the National Naval Medical Center in Bethesda, Md., has reviewed three research plans and approved one.
Elliott said centralized IRBs are becoming more common outside of DoD as well. Otherwise, she said, it could take years simply signing up enough people to participate in the research.
Members of the board have diverse backgrounds and areas of expertise, including doctors, nurses, allied health professionals, dentists, epidemiologists, radiologists, pharmacists, pathologists, biochemists, enlisted members and those who work in applied research ethics and religion and faith.
Typically, researchers are in touch with the IRB before their study plan, called a protocol, is submitted to the board. “I try to work with them before they submit and talk to them about what they're doing and give them helpful hints,” Elliott said.
Then the protocol is reviewed by the board. Afterwards, the group invites the investigator in to give a brief summary and answer any questions. “We look at different criteria and ethical questions,” Elliott said. “We take a vote on whether to approve it or to have the investigator make changes before it's approved or to defer it.”
The board also votes on how often it will ask researchers to report back with data as the study is ongoing. “After the meeting, I contact the investigator and say ‘here's what the IRB decided' and we put everything in writing so they can address any concerns or questions the IRB had,” said Elliott, who along with everyone else on the board is a volunteer participant.
Because members of the board come from different medical and nonmedical backgrounds, the group has a training session at the beginning of each monthly meeting on different types of cancer topics. “We are learning about the landscape of cancer treatment and cancer care.”
