Education is key ingredient in successful recipe

Many IRBs are just beginning these programs

College students and the instructors, advisors, physicians, and others who work with them on research projects should be educated about the IRB’s role and the process for obtaining approval to conduct human subjects research, experts say.

"On our campus, we have a highly evolving responsible conduct of research requirement for faculty researchers, and we require graduate programs to develop coursework in ethical and responsible conduct of research," says Moira Keane, MA, director of the research subjects protection program at the University of Minnesota in Minneapolis. There also are graduate seminars in ethics and clinical trials, and faculty are required to take workshops in responsible conduct in research as well as a human subjects module when applicable, Keane says.

At Shenandoah University in Winchester, VA, there’s an introductory research course that discusses ethics, human subject protection, and scientific misconduct, says John M. Cavendish, EdD, JD, CRA, associate professor of occupational therapy. "We’re in the process of educating our faculty advisors now and revamping our policies and procedures," Cavendish says, adding that the university’s top administrators have taken an interest in making certain that staff and faculty meet all regulations, policies, and procedures with regard to research.

Keane, Cavendish, and others offer these strategies for educating faculty and students about human subjects protection and the IRB’s role:

• Make forms, information accessible to all. As part of Shenandoah University’s educational efforts, all of the IRB’s processes and forms are available on the Internet at the university’s web site: www.su.edu. "The best thing an IRB can do, besides its job, is to make processes and forms as user-friendly as possible," Cavendish says. These are updated when necessary and include a simple checklist that students or faculty can use to determine whether their research project is exempt for IRB review or qualifies for an expedited review. (To see Shenandoah policy form, click here.)

The web site also includes various forms listing questions and information pertaining to IRB review, including a Form B that is an application for the use of human subjects in research. (See Shenandoah’s "Application for use of human subjects in research" in this issue.)

• Give faculty, students someone to contact for advice. Another educational strategy would be to have various IRB members, who are from different areas of the university, serve as resources to faculty and students who have questions about the IRB process. This way, the instructor or student can call the point person for his or her department when there’s a dilemma or question about the need to submit research for review, Cavendish says. Likewise, some universities may establish a committee in each department that will review all research projects that do not need a full IRB review. This way, there will be some oversight.

There’s a need for an ethical supervisory review process for pedagogical and other research that falls into the gray area with regard to the IRB review, says Miguel Roig, PhD, associate professor of psychology at the Notre Dame Division of St. John’s College in Staten Island, NY.

• Offer training and courses in human subjects protection and ethics. Research instructors could employ strategies for teaching students about IRBs that include having students read sample IRB proposal forms, the Belmont report, all federal regulations, and the IRB’s own policies. Then they could have the students hold a mock IRB session discussing the mock proposal’s merits and problems. At St. John’s College, there are some research courses available at the graduate levels that include information about IRBs, and there has been some discussion about making this training a requirement for all students involved with research, Roig says.

At the University of Pennsylvania, there’s a post-doctoral training program and students are required to receive research ethics training through an on-line training module on human subjects research, says Deana Katz, MBe, research ethics outreach coordinator for the center for bioethics at the University of Pennsylvania in Philadelphia.

Even hospitals that have no direct university affiliation could benefit from having medical staff who engage in research take such courses, says Cynthia A. Harper, IRB coordinator for Our Lady of the Lake Regional Medical Center in Baton Rouge, LA. "We’ve had a couple of situations where we’ve had to educate physicians that a research project couldn’t be done," Harper says. "In some cases, the physicians didn’t even know that what they proposed to do would be defined as research."

The best-kept secret

"The IRB is the best-kept secret in the hospital," Harper says. "One thing we’re focusing on with a task force is educating physicians and senior management so they’ll know what IRBs are all about." Now Harper gives physicians a packet of information about research and ethics, along with a videotape about human subjects protection from the Rockville, MD-based U.S. Food and Drug Administration. Interestingly, Harper has found that medical students and residents who work at the hospital often are better educated about human subjects protection than the physicians who advise them. The students often have already received some training from their colleges.