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On-line education is becoming standard
Annual education required
At institutions across the country, research administrators now are using Internet-based or local computer software modules to facilitate annual education in human subjects protections for investigators and IRB members.
The electronic format is easy for investigators to complete on their own schedule, allow a standard way of ensuring certification, and is easy to update at an institutional level, proponents say.
"Most of the feedback we have received has been very positive," notes Michelle Fronheiser, CIM, CIP, research administrator for the Veterans Affairs (VA) Medical Center in Hampton, VA. "These web-based modules are very convenient — they can be completed at any hour of the day or night, from work or from home. And, they can be done all in one sitting or a little at a time."
All institutions under a federalwide assurance (FWA) are required to conduct annual education on human subject protection requirements for research investigators, research coordinators and members and chairs of the IRBs.
In addition, the NIH and FDA have requirements for minimum levels of education in human subjects protections for investigators conducting research that they sponsor.
OHRP provides standard modules covering federal research regulations, institutional, and investigator responsibilities, informed consent, and the federal Human Research Protections Program.
In addition, institutions under the VA must conduct annual education in standards of good clinical practice (GCP), ethics, and the provisions of HIPAA, Fronheiser notes.
As a certified IRB professional and manager, Fronheiser has taught classes in human subjects protection for research investigators, research team members, IRB members, and members of the center’s research and development (R&D) committee, she says.
"Basically, anyone who may come into contact with a research participant must have the annual training," Fronheiser explains.
So, from her class presentations, she developed three computer-based modules in GCP, ethics, and HIPAA.
The GCP module covers the institutional review board process, informed consent, how to monitor patient safety, the required investigator records and reports, how to manage investigational products, and an overview of quality concerns in VA research.
The ethics edition covers the history of research ethics development, informed consent, an overview of the function of IRBs, the process of IRB review, ongoing human subjects protections, and ethical issues in international research. That module also covers potential misuses of the positions of IRB members and investigators, rules about gifts between employees, and gifts from outside sources.
The HIPAA training includes education about privacy and release of information, veterans’ rights, uses of information within the VA, purposes requiring authorization of the patient, releases of information outside the VA, and operational privacy requirements as well as the center’s obligations under the Freedom of Information Act.
Investigators have found the web-based training particularly useful as they juggle clinical and research schedules, Fronheiser says.
"If a physician has only a few minutes because a patient is late or missed an appointment, he or she can take that few minutes to work on the web-based training," she explains. "Once the investigator exits the program, the module saves the place for the next time he or she returns. The only negative feedback we have received is when the network is slow or the investigator has trouble logging onto the site."
Clinical researchers, research staff, and IRB members at Community Health Care/Wausau Hospital in Wausau, WI, have also used computer-based education programs, says Gretchen L. Johnson Anding, MA, the institution’s human subjects research coordinator.
As a smaller institution, they have not developed their own programs, but have found other on-line products available and use them to supplement the annual educational meetings and conferences the center sponsors.
"Each year, we offer an annual half-day conference on human subject research and protections. Typically, the conference is hosted by PRIM&R through their IRB 101 On the Road program," Johnson Anding says. "In addition, we recommend several computer-based training modules, including the NIH module on human subject protections. Finally, we have several presentations and conferences available on video and CD-ROM."
Johnson Anding monitors compliance through use of an education documentation table that each investigator is required to fill out.
The table documents the type and amount of education completed either initially or annually, she says.
"As we are a smaller institution, use of this documentation table is adequate for tracking completion of training," Johnson Anding says. "As the human research protections coordinator, I am responsible for monitoring compliance. Continued failure by an investigator to complete the required education may result in reporting to the IRB and possible removal from participation as an investigator for the research project."
As the institutional research administrator at the VA center, it also is Fronheiser’s job to ensure that all investigators, research team members, IRB members, and R&D members there have access to the training modules, which are available via the Internet.
The IRB and the National Veterans Affairs Office of Research and Development approve the actual content of the modules.
"In addition, I manage the oversight process and remind all research investigators, IRB and R&D committee members when their due dates for renewal are coming up," Fronheiser adds. "I send constant reminders until they have sent me a copy of their certificate of completion and it has been logged onto the data log. If an investigator or someone on the research team is not in compliance with the educational requirement, the IRB would take appropriate action to safeguard the protection of human subjects until that investigator has completed the educational requirement. To date, all of our investigators have been compliant."