Experts offer blueprint for improving a research staff education program

Education is the foundation for protecting subjects

For clinical trials administrators and investigators who desire best practices in human subjects protection, there can be no better place to start than with research staff education.

Education and training of research staff and investigators traditionally was provided in the form of a mentoring program in which a junior person learned from a senior person, says Ruth Fischbach, PhD, MPE, director of the Center for Bioethics at Columbia University in New York City.

"The mentor was supposed to be an advisor or teacher or role model or motivational friend and supportive advocate," she explains. "All the research values were transmitted from mentor to mentee. But now — particularly in busy labs where the principal investigator is off giving talks around the country or writing grants — sometimes the teaching is left to a junior person."

This is one reason there should be a formal education program for clinical trials staff, Fischbach and other experts note.

"We see education as the foundation for human subjects research, and clearly there can be no expectations of an individual to follow rules or ethical principles and policies if they don’t know what the rules and principles are," says Steven Peckman, associate director for human subjects research at the University of California-Los Angeles (UCLA).

"So we consider education to be a cornerstone, and it is multifaceted," he says. "We work with all entities on campus, and we have specifically designed an education approach for different areas — not a one size fits all."

Diversity improves effectiveness

The best approach is to offer a wide range of educational programs, suggests Jeremy Sugarman, MD, MPH, MA, a member of the faculty at the Phoebe R. Berman Bioethics Institute and the department of medicine at Johns Hopkins University in Baltimore.

"Education should include discussion, lectures, web-based programs, and reading material," he adds.

Here are some suggestions for improving or developing a staff education program:

• Offer basic training on human subjects research for new staff. UCLA’s education for new investigators and others begins with a session on the history of human subjects protection, institutional responsibility for protection of subjects, researcher responsibilities, and IRB responsibilities, Peckman notes.

"We talk about the construction of the IRB, who’s on it, and how it works," he says. "We talk about the Belmont report, the Declaration of Helsinki, and how those principles inform what the IRB and investigators do," he says.

An educator provides investigators with real life scenarios in clinical trials and discusses the informed consent process and how to balance risks and benefits.

"We talk about the hot point issues of the day, such as how to create, submit, and carry out placebo-controlled trials," Peckman says. "We talk about conflicts of interest and the conduct of Phase I trials, which we do quite a bit of here at UCLA."

This first training session also includes a discussion of therapeutic misconception, and the educator may hand out articles written by experts on how people sometimes confuse a clinical trial with clinical treatment, he notes.

"What we see is the majority of complaints in human subjects trials is when there’s confusion about the researcher and treatment," Peckman says. "Subjects should be very clear in their understanding of that before enrolling and during the trial."

Initial education also will cover Food and Drug Administration (FDA) guidelines, the regulatory and ethical framework for research, and how investigators can look at placebo-controlled trials in view of ethical principles and the risk-benefit analysis, he adds.

"There’s an urban mythology that IRBs don’t approve placebo-controlled trials," Peckman notes. "That’s not true, but the placebo-controlled trial has to be ethically justified."

• Use role-playing and other strategies to enhance learning experience. It’s estimated that people who are taught information in a lecture format will retain about 20% of what they hear, Fischbach says.

Alternately, when people are encouraged to actively participate during an education experience, they may retain 80% of what they hear because the process encourages their buy-in and discourages daydreaming, she reports.

"A lecture is efficient for the instructor because the instructor has an idea of what he or she wants to convey in a short period of time and can do that without interruption," Fischbach says.

But it doesn’t always work for the students, she adds.

"Especially with adult learners, we’re finding that active participation in the learning process is advisable, and one strategy to accomplish this is using case-based, problem-oriented situations," Fischbach says. "You can use hypothetical cases or with discretion you can use the actual cases, protecting the identity of people."

The idea is to facilitate the students’ relating to how solutions worked out in the theoretical situations may be applied to their own setting, she explains.

Role-playing is a strategy that lightens the educational atmosphere and may result in better understanding of human subjects protection, Fischbach says.

For example, one role-playing session involves the situation in which a postdoctoral fellow is shown an unpublished manuscript that the professor was asked to review. Ethically, the manuscript is not supposed to be shown to anyone other than the reviewer, but sometimes professors may see a solution that would assist a student and will show the person the manuscript for that reason, she says.

In the role-playing session, students were asked to turn down the professor’s offer to see the paper without appearing to be ungrateful, Fischbach adds.

During the session, students came up with several original strategies for tactfully handling this ethical dilemma.

Some time later, Fischbach was told by a student how she attended this role-playing class and then returned to her lab where the lab director offered to show her an unpublished paper that he felt might help her. The student recalled one of the role-playing strategies and used that when she turned down the lab director’s offer, recalls Fischbach.

The strategy worked, and the lab director then told the student he was grateful for her candor and hadn’t thought about it that way, she adds.

Web-based training offers more flexibility

• Provide web-based training when appropriately. One of the chief advantages to a web-based education program is that it is a flexible learning experience for busy people.

"People are very busy and getting them to show up at a specific time is difficult," Sugarman says. "[Web-based programs] provide education that’s available whenever anybody wants it."

The other advantage is that web-based education can be offered inexpensively and can easily be kept current over time.

For instance, Durham, NC-based Duke University, using a grant from the U.S. Department of Energy, developed web-based education modules on genomics and ethics that are available free of charge to the public, Sugarman reports.

Many other groups and organizations also offer web-based research education for free or at affordable prices as well.

UCLA and some other universities have web-based, human research certification programs that are institutional requirements for human research staff.

"Our research staff are required to take our certification course because it has a lot of information that’s specific to UCLA human research negotiation and the IRB review," Peckman says. The web-based certification program is on-line at

Columbia University has a web-based seminar on conflicts of interest at www.ccnmtl.columbia. edu/projects/rcr/rcr_conflicts, Fischbach notes.

"The learner can click on the web page whenever there’s time, and I think that convenience is very helpful," she says.