New IRB for Military Cancer Research Offers One-Stop Shop

by U.S. Medicine

May 20, 2011

WASHINGTON—If there is one fact that Marianne Elliott, chair of the U.S. Military Cancer Institute (USMCI) Institutional Review Board (IRB), wants investigators to know, it is that the USMCI’s new cancer research review board is “open for business.”

The USMCI IRB held its inaugural meeting at National Naval Medical Center to review oncology research protocols in February. The new IRB offers a one-stop shop for researchers to have oncology research protocols reviewed.

“We are interested in trying to be an IRB that can help an investigator who wants to take one protocol and put it in three, four, five, or 10 places and have one IRB review, rather than 10 different IRBs from each of those institutions,” explained Elliott, even if the collaboration is with a non-DoD medical center. While the USMCI IRB is focused on multisite investigations, it can also do
reviews for single-site investigations.

Typically, DoD investigators who want to pursue a research project at multiple institutions would need to go to each institution for IRB approval. That option is still available. However, the advantage of using the USMCI IRB is that by taking the protocol to one central IRB rather than multiple IRBs, it is expected to save the researchers time, Elliott explained.

“Individual sites can still look at protocols,” she said. “This isn’t mandatory. It is voluntary. I think investigators who particularly want to put a trial into several places may really want to consider this because, if they don’t, then likely they will have to go through [multiple] IRBs.”

IRB Review

Central IRBs are not necessarily new to the civilian or military research community, but this is the first one to review cancer research in DoD. A central infectious disease IRB already is located at the Uniformed Services University of the Health Sciences that supports multisite DoD infectious disease research. Elliott also pointed out that the HQ United States Army Medical Research and Materiel Command IRB currently serves as a central IRB for multi-site research protocols involving hyperbaric oxygen in mTBI treatment and is planning to expand its scope.

Elliott acknowledged that institutions may be reluctant to rely on a central IRB that is not within their own institution, which is why she is interested in educating the research community about this new option for oncology investigations.

“Over the past years, people have been working very hard to…break down the barriers and misperceptions that when you outsource that piece of your research protection program, that somehow you lose control and somehow there are things that might happen that you would be held accountable for that you aren’t doing. We have worked over the years to dispel those urban legends,” she said.

Reviewing Protocols

The USMCI IRB can review protocols for all types of cancers, Elliott explained, but the process must start within the investigator’s own institution.

Researchers who have proposals they want the USMCI IRB to review must go through their local institution for support to do that and to facilitate the process. When an proposal is approved by the USMCI IRB, notice will go back to that institution, and the researcher will then be granted permission to start the research.

To make sure they are handling the reviews in a timely manner, Elliott said USMCIRB is tracking its timelines. In addition, investigators are being asked to fill out a satisfaction survey after reviews.

“We don’t have any of that [data] now because we have only reviewed two protocols,” she said. “We do plan to do that because I think IRBs don’t do that, and I think it is something they need to be doing.”

Right now, she said the program is working hard to get the word out about its existence. Investigators and institutions who would like more information can go to http://usmci.org/.

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