Work with PBRNs to tailor HSP training
One-size-fits-all training can be burdensome
Because practice-based research networks (PBRNs) conduct research across a web of physicians' offices, making sure the necessary staff are trained in human subjects protection can be a daunting task.
IRBs can help facilitate practice-based research by working with PBRN researchers ahead of time, determining the minimum amount of training required for studies and who should receive that training, says Rowena Dolor, MD, MHS, assistant professor of medicine at Duke University and herself a PBRN researcher.
One key, she says, is understanding the unique nature of practice-based research, and the training challenges it creates for community physicians who participate.
"As an academic researcher, if my institution tells me I have to do this training in order to get IRB approval, I'll protect an afternoon to do that," Dolor says. "But if you're a community physician and research is a secondary interest, asking somebody to sit in front of a computer or attend a lecture all afternoon is a little bit harder."
She says training for such practices should include the important human subjects protection information needed to conduct the minimal risk studies generally conducted in physicians' practices. But she says it should not overload physicians and their staff with information they don't need.
Achieving that balance can take some negotiating between the PBRN researcher and his or her IRB — as is evidenced by the discussion on a PBRN listserv sponsored by the Agency for Health Care Research and Quality.
The listserv is a place for PBRN researchers to exchange ideas, says Dolor, who wrote about the listserv's human subjects protection training discussion in a recent article.1
"For all practice-based research network directors and coordinators, this was a topic that resonated with us," she says. "I've been doing these types of studies for the past 10 years and in attending the PBRN meetings, there is always a discussion about IRBs, especially with human subjects protection training."
The listserv discussion began with an inquiry from a North Dakota PBRN researcher who was worried that the IRB's required training might make it difficult to recruit physicians for a study. The ensuing discussion highlighted many of the challenges of training a far-flung group of people and issues that IRBs should keep in mind when looking at practice-based research, Dolor says.
Tailoring training
Who should be trained? Dolor says that when she began doing practice-based research, the training requirements were not particularly difficult to fulfill. Usually only the academic faculty member leading the community project did the training.
"Then sometime in the 1990s, IRBs began requiring human subjects protection training of people in the community site if they were actually collecting primary research data," she says. "For anything beyond the standard of care, whether it was consenting patients or actually filling out a data form that contains primary research data, (IRBs) felt that people should go through training."
Dolor says it's possible to design studies to minimize the number of people who need to be trained in a practice. A research coordinator can go to the site and do the research related activities, such as recruitment, consenting and filling out data forms.
"If the clinician is really just aware that the project is going on at the practice site, and is minimally involved in the research project, then they don't need to go through training," she says.
But she notes that arrangement is not always possible. For large networks, it may not be feasible to send coordinators to every site. In that case, some of the practice staff and physicians will have to be trained.
How much training is needed? Once it's been established that community site training is necessary, Dolor says IRBs and researchers should figure out together the minimum training necessary to protect research participants without overburdening practice staff.
Because much of the research done by PBRNs is minimal risk — chart reviews, surveys, quality improvement-type projects — Dolor says it may not be necessary for community physicians and practice staff to undergo training that addresses higher risk research. But that means negotiating with the IRB, which may have one-size-fits-all training requirements. If IRBs are willing to focus on a core number of required courses, it can help facilitate practice-based research, she says. Since many institutions began requiring training through the Collaborative Institutional Training Initiative (CITI), it's become easier to craft standardized training requirements, Dolor says.
"Each institution decides which modules they want people to go through," she says. "The VA requires a set of modules on human subjects protection and good clinical practice — the number varies for new or experienced investigators/coordinators. The American Academy of Family Physicians had talked to their IRB and had gotten permission for four modules that they thought were the most common types of research conducted out in the community.
"That's why a discussion with IRB leaders about how they can tailor the training to the needs of the community physician is highly suggested," she says.
Reference
- Dolor RJ, Smith PC, Neale AV, et al. Institutional review board training for community practices: advice from the Agency for Health Care Research and Quality Practice-Based Research Network listserv. J Am Board Fam Med 2008 Jul-Aug;21(4):345-52.
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