New IRB requirements rankle researchers
November 1, 2009 4 minutes read
New IRB requirements rankle researchers
Consent documents, increased training requirements
Requirements that IRBs see as minor or routine may have serious consequences for a practice-based research network (PBRN), says Barbara P. Yawn, MD, MSc, FAAFP, director of research at Olmstead Medical Center, Rochester, MN.
For example, Yawn recently detailed her experience with a PBRN study in which participating IRBs rolled out new requirements on continuing review that added time, hassle and significant expense to the project.1
One result from the experience: At least two of the sites in the network informed Yawn that they would never again participate in such a study. In describing the problems that emerged during this research, she hopes to encourage IRBs to consider the impact of some of their requirements of PBRN studies.
"IRBs should think about the implications of their decisions and whether it really does improve patient safety or if it just presents a bigger burden to the researchers," Yawn says.
The Translating Research Into Practice for Post Partum Depression study was a randomized controlled trial testing the effectiveness of a post-natal depression-screening tool used in community family medicine offices. The investigators signed up 31 practices in 20 states, and obtained approval from 19 IRBs, including the American Academy of Family Physicians IRB, which served as the central IRB for 13 unaffiliated practices.
Women were recruited into the study at between five and 12 weeks postpartum. Women either received standard care or were randomized to receive the screening tool; those who showed signs of depression were treated. The study conducted interviews at six and 12 months to determine levels of depression, comfort with parenting and quality of partner relationships.
The three-year study is still continuing.
At the beginning of the second year, Yawn says her team encountered problems with 13 IRBs. All had required a special site-specific approval stamp for consent forms at the beginning of the study, and on continuing review, all now required that the consent forms be replaced with a new form, unchanged in content but bearing an updated date stamp.
New participants could not be consented on the old forms, and sites had to wait for the new forms to be sent to the IRBs and returned with the updated stamp. Yawn says recruitment had to be shut down at these sites for several weeks due to a time lag in getting the new date-stamped forms back from the IRBs.
"Several times, we had people we couldn't enroll because there was no properly dated form that an IRB had approved," she says. "That's a terrible thing to do in the middle of a study — to say we're just going to stop enrollment for a month or six weeks until the IRB gets around to putting a stamped date on it."
A worrisome trend
On the second annual review, five more IRBs now required the date stamp procedure.
"I worry that it is a trend," Yawn says. "IRB personnel and representatives go to meetings and talk to each other and suddenly, 'Oh yeah, let's do this.' Or somehow the word gets around that this is a requirement. Because several of the IRBs that we talked to said it was a federal requirement."
Yawn says her group reviewed the requirements of the Office of Human Research Protections and could find no requirement regarding dated approval stamps on consent forms.
Nor could they find a regulatory basis for another requirement that IRBs began imposing in the second year of the study: increasing the frequency of research staff training to every two years.
"Usually the training is good for three years — that's still a little bit of a pain but at least three years is pretty reasonable," she says. "And suddenly now it's two years. We asked, could you explain why, especially when nothing has changed in the human subjects rules? They just wanted them to take the same tests over again and read the same material."
Yawn says that at some practice sites, only a few people needed an up-to-date training certificate. But at others, the number could go much higher, particularly if the IRB had strict requirements about who had to take the training.
"One IRB said everybody who had anything to do with these women had to be up-to-date, and that could be 50 or 60 professionals in a practice."
In order to accommodate the rules, the research team created a slide show to review the highlights of the material in an expedited way.
The effect of both of the new rules added considerable expense to the final study, Yawn says. The group paid for overnight shipping of consent documents to get them in the hands of researchers faster, and paid some practices to compensate them for the increased staff time spent on human subjects protection training.
She estimates that the cost of all of the changes could reach $30,000.
"There's not that kind of money in practice-based research studies to allow us to cover those costs."
Just as importantly, Yawn says, adding to the burden of the small practices participating makes it less likely that the practices will attempt other studies, stymieing future practice-based research.
She says the IRB requirements that hampered her study may be appropriate for more risky research, but not for the low-risk studies PBRNs usually conduct.
Yawn would like to see IRBs sit down at national conferences with PBRN researchers to understand the impact of regulations on the research and come up with solutions.
"If you can't have dialogue it's very hard to change anything," she says.
Reference
- Yawn BP, Graham DG, Bertram SL, et al. Practice-Based Research Network Studies and Institutional Review Boards: Two New Issues. J Am Board Fam Med 2009 Jul-Aug;22(4):453-60.
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