IRB offices can educate clinical research teams
Goal is to improve overall program
One of the key attributes of a strong human research protection program is an institution's ability to optimize its resources, an expert says.
"Back in the 2000s, everybody recognized that human research protection was a shared responsibility, and there were many initiatives for those who engage in oversight of human subjects research," says Yvonne Higgins, CIP, director of quality management at Copernicus Group Institutional Review Board (CGIRB) in Durham, NC.
"But with the challenges of the declining economy in 2008, it became a greater challenge to maintain these customized, fairly expensive training programs," she adds.
IRBs have the Collaborative Institutional Training Initiative (CITI), which came out of discussions among research institutions about how to provide IRB training at a low cost, she notes.
"It's a web-based program and the modules can be customized to your institution," Higgins says. "That can serve as the very basic requirement for educating IRB members, researchers, and research staff, and it's a great place to start."
IRBs can expand on CITI and other training programs to create high-quality training at an affordable cost, she suggests.
For instance, interactive webinars led by professional organizations and expert consultants can be offered to IRB staff, investigators, clinical research professionals, and anyone else who is interested, Higgins says.
"We offered an interactive webinar to anyone who wanted to sign up, and we had more than 700 people registered," she says. "Then we posted the webinar to our website and allow anyone to go register online and watch it at no charge."
This is one example of how IRBs can find good educational programs available even when the research program is on a tight budget, she adds.
Higgins provides these additional ideas for educating IRB and clinical research staff:
• Ask for ideas from peers in the IRB world."In my couple of decades of being on an IRB, I've found that IRB folks are among the most generous people you could meet," Higgins says.
"So if you haven't developed something yourself, then reach out to one of your peer institutions," she adds.
• Encourage IRB staff to attend department meetings. IRB directors can encourage their staff to attend departmental meetings, meeting one-on-one with researchers, Higgins says.
"I would encourage the IRB staff to make those connections and interactions," she says. "You don't need one trainer doing all of the training; you can help people in an office group professionally through these connections."
• Write newsletters to reach a large group. "Newsletters are always an easy way to reach large groups of individuals," Higgins says. "If you pick the right topic, people will open the newsletter."
For instance, CGIRB members and staff recently developed an assent form template that researchers can use when they're submitting a protocol involving research with children.
"We announced the template in our newsletter and also wrote an article about the specific challenges and ethical and regulatory requirements of having children as participants in research," she says. "We received many good responses to that newsletter offering."
Not every newsletter topic will interest research offices, but this can be a good way to provide quick, necessary information along with links to new templates and other material, she adds.
"There are a lot of researchers who are really hungry for that information," she says. "You always want to make any offering as interactive as possible, so always include links in electronic newsletters."
• Invite researchers to an IRB meeting. "Another approach I took in my previous job was to invite researchers to an IRB meeting where they'd have an opportunity to come and interact with the IRB and share information about ethics and research," Higgins says.
While investigators are required to leave the meeting during the IRB's deliberation of their own protocols, they can attend to answer specific questions or provide information requested by the IRB, she adds.
• Provide an option for one-on-one education. "This is a resource-intensive option, so if you do that you have to balance it with all these other things," Higgins says.
"If you have a basic requirement of the completion of a web-based training program like CITI and then you augment that with some other kinds of offerings like webinars, newsletters, and small meetings, then you can allocate some time to one-on-one training sessions," she explains.
"Every institution and IRB probably has a different approach, but if you are a small institution, and you can invite your researchers to come and meet with the IRB and go through individualized training, then that is an option," she says.
This can be handled as a web-based sign-up sheet in which investigators set aside an hour or two each week for someone to meet with the IRB chair or IRB staff to discuss a research issue or broader question, she adds.
• Rely on a robust website. "If you go back to the original strategy of optimizing resources, you can look around and find out what works for you across other websites and get a sense for what it is you would like to develop for your audience," Higgins says. "If you are in an academic setting then you can go across campus to your web developer and ask for help."
If that is not an option, then an IRB could hire a content management service or outside contractor to help improve the website's navigation and content flexibility, she notes.
Research professionals' education and training will continue to be an important priority for human subjects research protection programs, Higgins says.
"We're in an interesting time where the discussion is reinvigorated on the part of regulators to change some of the existing regulatory framework," she explains. "This is an exciting opportunity for all of us to talk about what works and improve human research protection programs."
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