Research slowed by military IRBs' requirements
Paperwork, slow response can delay studies
Many researchers have stories about the challenges of getting reviews from multiple IRBs for a study — the differing standards, varying risk assessments and the duplicated paperwork.
Those challenges can be compounded when one of the IRBs involved is affiliated with the U.S. military. The military sponsors a significant amount of research, through the various services themselves, military medical institutions, and the Veterans Administration.
In many cases, researchers must navigate between the competing requirements of civilian and military IRBs. It's a path that Reg Arthur Williams knows well. Williams, PhD, RN, BC, FAAN, is a professor in University of Michigan School of Nursing in Ann Arbor. He's also a captain in the Nursing Corps Unit of the U.S. Navy Reserves, where he has studied such topics as psychosocial care of combat casualty patients and depression interventions for Navy recruits.
Whenever Williams conducts research with military personnel, he must have his study approved by both the University of Michigan IRB and the IRB for the military facility or organization involved.
He says that over the past 16 years, he's seen changes in the way in which both civilian and military IRBs review studies.
"When we started out with the first study I had gotten funded from the Department of Defense, we had IRB approval from the Navy sooner than I had it at the University of Michigan," he says.
Now, Williams says, the situation is reversed — typically, the military IRB takes longer than the civilian board and imposes more requirements. In a recent article in the journal Military Medicine, he noted that recent continuing reviews of a minimal-risk study involving anonymous online surveys of military personnel took as little as three days for a university IRB to complete, while the military IRB approvals took up to seven to 12 months.
Large bureaucracies
Williams believes that as civilian IRBs have made an effort to streamline their processes, military IRBs have instead added requirements that he says don't add protections and unnecessarily slow down the pace of research.
"I was on active duty in the Navy and working for a large research university," he says. "I am very accustomed to bureaucratic organizations, and one of the things that I know about bureaucracies is that you really can make them work if you know how to work with people in the system. It's amazing as to what you can get done in a large bureaucratic organization.
"But you also have a number of people doing reviews that are not really that knowledgeable about the research process," Williams says. "They can hang things up for months on end. And unfortunately what they do is they put a lot of civilians in positions who really don't understand what they're doing and they just create obstacle after obstacle."
Among the obstacles Williams has encountered working with military IRBs:
• A requirement that his university obtain a Department of Defense (DOD) addendum to its Federalwide Assurance (FWA) in order to do research involving military personnel. The addendum binds institutions to additional DOD human subjects protection requirements.
"I had to go through all these hoops, it took months on end, the university counsel had to get involved and the vice president for research had to sign documents," Williams says.
• CRADAs: Cooperative Research And Development Agreements (CRADAs), which must be worked out between civilian institutions or companies and military organizations when certain research is conducted. The CRADA lays out the conditions under which researchers and their military partners agree to share technology and resources, while protecting intellectual property rights to new inventions or drugs. IRBs may need to be aware of these agreements' restrictions.
Williams says CRADAs are sometimes required in situations that don't warrant them, such as in the minimal risk surveys that he conducts. He says almost nothing on the CRADA forms he had to fill out pertained to his type of research. In the end, it amounted to an agreement to give the military a free copy of any published journal article that resulted from the study. "Yet this took us nine months to get approved," he says.
• Military IRBs would conduct scientific reviews of studies, even though the study already had undergone such a review in order to obtain funding.
Williams says that in one case, a study was held up for so long that the window for data collection was shortened to only two weeks, severely limiting recruitment.
He says the civilian IRB sector seems to be more aware of the difficulties that these types of delays cause and are taking steps to address them. Williams is frustrated by the fact that military IRBs aren't keeping up.
"They [military IRBs] have the ability to address these things and could do it way ahead of civilians, if they would just do it," he says. "They could lead this in many ways."
In the meantime, he says, civilian IRBs that review studies alongside military IRBs should be aware of the potential delays. It would be helpful, Williams says, for civilian IRBs to do what they can to bring about a more efficient multiple review.
"I would have loved it if my IRB had called the IRB at the military and said, 'Let us work together to get this done in a reasonable time period,'" he says. "But what tends to happen is that every IRB acts as if they operate in a silo. They're never really sitting down and working together to facilitate the research."
Reference
Williams RA, Gatien G, Hagerty BM. The Need for Reform of Human Subjects Protections in Military Health Research. Mil Med 2012 Feb;177(2):204-8.
Many researchers have stories about the challenges of getting reviews from multiple IRBs for a study the differing standards, varying risk assessments and the duplicated paperwork.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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