UM takes proactive training approach

Human subjects protections classes taught weekly

The University of Miami last year launched an education program designed to inform and instruct researchers and IRB members on the protocols and regulations that impact human subjects research. The program, called the Human Subjects Protections Educational Program, is the brainchild of Dr. Norman Altman, vice provost for research at the university, and Jay Sosenko, MD, professor of medicine, assistant provost for research standards, and former university of Miami IRB chair.

"When you have worked in an IRB setting, it becomes clear that human subjects protections education is very important," says Sosenko. "We wanted to try to have a broad outreach to our academic committee to better educate individuals at the university and also raise consciousness in the area of human subjects research protections.

The one-hour seminars have covered everything from the nuts and bolts of how to prepare research applications to be submitted to the IRB to ethical issues to data safety monitoring. All seminars are taught by university staff and are sponsored at no charge to participants or the university. "When I surveyed individuals working at the university, I found that there are a number who have expertise in the area of human subjects research protection," he says.

Instructors have varied backgrounds

IRB chairs, staff ethicists, IRB members, and attorneys have taught seminars, says Sosenko. "One of our surgeons led a seminar on standards of care and experimentation, with an emphasis on defining the boundaries between innovation and experimentation. One of our psychologists talked about the inclusion of students and employees as research subjects." Sosenko goes on to say that an HIV expert came in to talk about HIV research, and a faculty member who also serves on the National Bioethics Advisory Commission reported on its findings.

The seminars are held on campus each week, and attendance is voluntary. Since the program’s inception, nearly 500 people have attended seminars, with each session averaging 15 participants. Sosenko stresses that the seminars are interactive, not lectures, so discussion is welcome. Past seminars have included "IRB: Behavioral Submissions," "IRB: Responsibilities of the Principal Investigator," and "Placebos, Parts I and II."

One of the most well-attended sessions was a five-week series on working with IRBs. "The idea was to try to give people, in a more practical way, some idea of how it all works," says Sosenko. The topics ranged from responsibility of the principal investigator to the proper way to obtain consent to forms, what kinds you need, and how to properly fill them out.