'Stepping up' to bridge the researcher/IRB gap
'Stepping up' to bridge the researcher/IRB gap
Outreach programs include one-on-one advice and researchers educating IRB staff
As the human research protection program at Mount Sinai Medical Center prepared for accreditation in 2010, IRB Manager Stacy Chandna says she and her colleagues knew they had a daunting task ahead.
"We were changing many things about how the office functions," says Chandna, MS, CIP. "We were changing all our previous forms to a new set of 117 new documents. We were changing the education requirements that the research community had already fulfilled to the CITI program, which required six-plus hours of online training."
All the changes were bound to cause confusion and difficulty for researchers, so the Mount Sinai Program for the Protection of Human Subjects in New York City embarked on an equally ambitious outreach program, seeking to engage researchers on their own turf and discuss issues of importance to them.
"We wanted to be seen as an office that provides regular training and education and consistent communication with our customers," Chandna says. "We really wanted to focus on our external customers, which were the investigators and research teams that we help to get their projects up and running."
The office added three components to its existing outreach program. The first, "Step Right Up," provides researchers with assistance as they prepare studies for review. "Research Grand Rounds" pairs reviewers with investigators to talk about important ethical issues in research. And "Bridging the Gap" invites a more intensive dialogue between researchers and IRB staff about specific areas of research that may cause problems in translation.
Chandna presented the results from Mount Sinai's efforts at the recent Advancing Ethical Research Conference sponsored by Public Responsibility in Medicine and Research.
The first component, Step Right Up, brings IRB staff to the main research building at Mount Sinai. Chandna says the IRB offices are located a few blocks away from the main medical campus. Once a week, for an hour, two analysts staff a table outside the cafeteria, to answer questions and accept submissions (Mount Sinai uses a paper-based system).
"We're there weekly, at the same time, same place, so it's very consistent," she says. Researchers can pop over and ask questions face to face."
Chandna says the analysts' table has regular customers now, who ask about their projects, submit forms or check on the status of submissions. They've also have been joined by representatives from the grants and contracts office, which, like the IRB office, is located away from the main campus.
In the beginning, she says, researchers' questions tended to focus on the specifics of the new forms.
"Now, they're asking more general questions — do we think they need any other materials to support their proposal?"
The IRB office schedules sessions that pair an investigator and a regulatory specialist to talk about specific issues of interest to the research community.
For one session, an IRB chair who is a psychiatrist partnered with an investigator who works with subjects who have cognitive impairment to talk about the ethical issues involved in research with that population.
"In some instances, there have been presenters who have had different opinions about what they think should be happening or what the best approach is," Chandna says. "Often, those are the most interesting discussions."
The sessions so far haven't been held regularly, primarily because of the difficulty in scheduling presenters. Chandna says she hopes eventually to have monthly Research Grand Rounds sessions at a regular time and place.
Many IRBs have ongoing issues with researchers in particular fields, who complain that the IRB doesn't understand the specifics of their work. Mount Sinai seeks to address those issues head on, by inviting researchers to give presentations to staff about their work — and sending IRB staff to the researchers to explain the regulatory process.
"We found that certain types of research projects caused some commotion within our office," Chandna says. "And there were some investigators who were full of complaints anytime you spoke with them. So we thought it would be helpful not only to figure out what is the cause of the complaint, but also to provide an educational opportunity for our staff."
In one instance, two investigators from the institution's department of rehabilitation medicine gave a presentation about research with subjects who have traumatic brain injuries. Chandna says that previously, analysts reviewing their studies had asked questions about determining capacity to consent.
"It was a recurring issue that kept cropping up on each of their projects," she says. "So we brought them in to talk about what they're doing and how they're assessing capacity."
Other topics at these sessions have included the use of deep brain stimulation and providing genetic testing results to participants. And IRB staff have delivered presentations to researchers help explain the best way to make submissions.
Chandna says that in some cases, her staff have approached investigators to ask them to give presentations; other times, investigators have volunteered to speak.
She says the presentations themselves have been very collegial.
"I think that sometimes prior to the actual session, they might not as been as collegial a discussion as we would have liked," she says. "But once they get to our office to do the presentation, I think that our interests have been aligned at that point. While they might provide criticism, I think it's meant to be helpful, rather than just providing negative feedback."
Chandna says that while so far, her office hasn't measured how many researchers are taking advantage of them. But there are plans to begin collecting such data in 2012.
As the human research protection program at Mount Sinai Medical Center prepared for accreditation in 2010, IRB Manager Stacy Chandna says she and her colleagues knew they had a daunting task ahead.Subscribe Now for Access
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