New educational program focuses on long-term goals
IRB has staff dedicated to education
While IRB education was geared toward quick educational and training programs when new federal requirements first went into effect, the Office of Research Compliance at Cedars-Sinai Medical Center (CSMC) in Beverly Hills, CA, is concentrating on gearing training to a specific individual’s needs. "We have found departmental-specific training to be very effective," says Rebecca Flores Stella, a research compliance education administrator. "That’s what investigators are looking for."
Department-specific training better meets the organization’s long-term goals, which include creating a research community knowledgeable about human subjects protection, Flores Stella adds. For example, there is a large medical genetics program at Cedars-Sinai. Investigators involved in genetics research often have concerns related to informed consent and the appropriate use of discarded surgical tissues while upholding each patient’s rights, Flores Stella explains.
"They had some specific questions about how to approach family studies, especially pedigrees research," Flores Stella says. "And keeping in mind that recording confidential information about any living individual brings on a responsibility to allow that person to consent to the sharing of that information."
Usually Flores Stella meets with genetics researchers, listen to their questions and concerns, and then look for resources that might provide them with answers. Typically, this is done by an appointment basis when researchers request assistance or information. "Everyone has a general human subjects education program that covers history, basics, and things everyone involved in research should know," Flores Stella says.
Getting to the nitty-gritty
Now it’s time for IRBs to develop educational programs that include more specifics for certain types of research and that will give investigators a thorough foundation for handling the day-to-day issues that arise, Flores Stella adds. This often will require one-on-one training, which is why it would be a good idea for larger IRBs to hire someone to handle education and training. "The primary focus of my job is to do education and work in partnership with a post-approval monitoring program," Flores Stella says. "Also, part of my responsibility is helping to keep the IRB staff and membership updated on hot topics, recent issues, changes, case studies, and other things that may affect the review of protocols."
Flores Stella uses The IRB Forum Internet list service sponsored by the The Children’s Hospital of Philadelphia as a resource of information, and monitors periodicals such as the Los Angeles Times, The New York Times, and various journals. "A strength of our program is that in most situations the IRB administrator is responsible for providing education in addition to the responsibility of running an IRB, making it harder for them because of the work involved in getting protocols through the process. At CSMC, we have one position that is dedicated solely to this function," Flores Stella says.
Since the education focus and role were refined, Cedars-Sinai is making progress toward a goal of building a research community in which profound respect for human subject protection is second nature. "We’re happy with our progress so far, and we definitely have a lot more work to do while we head in that direction," Flores Stella says. "We try to be proactive, and it’s all part of building a research community in which respect for human subjects is second nature."
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