Best Practices Spotlight
Translation services may improve trial enrollment
Hospital creates affordable, simple process
Non-English speakers often are under-represented in clinical trials because of the language barrier and the lack of resources to provide clear and up-to-date translations of informed consent. This leads to questions of equity, an expert notes.
"The regulations for human subject protection look at equity for research participants, but they don't give the best guidance on how to accomplish this," says Rebecca Ballard, JD, MA, CIP, director of the office of research integrity at Children's Mercy Hospitals and Clinics in Kansas City, MO.
Ethically, it's clear that non-English speakers should be included in research, but barriers include very expensive translation services and continual changes to translated documents, resulting in restarting the process, Ballard explains.
"Many internally funded studies couldn't afford translation, so that led to a low inclusion of that population in our studies," she says. "We interviewed several investigators to see what the problems were, and that's how we came up with the translation project."
The result is Mercy Hospital's pilot translation project, which recently won an award of excellence for best practice from the Health Improvement Institute of Bethesda, MD.
Here are the project's three chief aims:
1. Create a more efficient translation process. The IRB office came up with a solution to improve the translation process for study informed consent documents, Ballard notes.
"We found that many investigators who could afford translation services would go to external translators," she says. "One would use one company, and another would use a different company."
Since the hospital's investigators were using different translators, there were no bulk discount rates. This was a problem the IRB could help fix, she adds.
The IRB now has investigators send their documents to the IRB, which then sends it to one translating company. The institution receives a bulk discount rate, Ballard says.
"It does increase staff time for our office, but it's time well spent," she says. "We have cut down on the review time by centralizing translation work and using an external vendor."
Ballard estimates the IRB staff time on the project adds about five hours per week.
The translation services' costs come out of the IRB's budget. The hospital administration gave the IRB a budget line to pay for this cost, she adds.
"We presented this as something that would be good for our patients, good for our research, and it meets ethical standards," Ballard explains. "It was a no-brainer; they said, 'What do you need and we'll get it done.'"
The translation service also was made more efficient by the IRB's approval of standard informed consent language that is inserted in each translated IC document. One example is the signature block, which doesn't need to be translated over and over again, Ballard notes.
"We had our template translated by the company we chose, and that helps increase the efficiency," she adds. "Having a pre-translated template cuts down on translation time because they're proofreading that part of the form instead of rewriting it."
2. Reduce barriers to enrollment. Once researchers could obtain translation services through the IRB, the financial barrier to enrolling non-English speaking patients was removed, Ballard notes.
"We've gotten word out in the hospital and did a mass email to research groups," she says. "We put information on our website and let people know on an individual basis."
If IRB coordinators see an application that says they are not enrolling non-English speaking subjects because of the budget, they'll let investigators know that the IRB office can cover that cost, she adds.
"We also screen protocols on an individual basis and make people aware of the service," Ballard says.
Investigators now have buy-in for the translation project and are satisfied that the turnaround time on translation has been cut in half from six to eight weeks to about three weeks, Ballard says.
3. Increase research opportunities for the hospital's population. "I'm working with the director of the office of equity and diversity to design an IRB study," Ballard says. "We'll survey those who took advantage of the translation project to see if they've enrolled these non-English speaking populations, and, if not, we'll identify the barriers."
Hopefully, the study will prove the project has improved opportunities for more populations and improved study enrollment diversity, she adds.
The IRB has found that the number of approved studies that enroll non-English speaking participants has increased since the project began. It increased from 54 to 70, but the evidence is anecdotal, which is why the IRB will study the results more formally, Ballard says.