Common problems can have major consequences
Tips and strategies to prevent pitfalls
It's important to stress to clinical research staff and investigators that regulation compliance is a goal that everyone in the CR enterprise works hard to achieve, an expert says.
"We are all into this together, and we need to work on it," says Jan Hewett, BSN, JD, director of the University of Michigan Medical School institutional review board in Ann Arbor, MI.
Hewett tries to show investigators how it doesn't take much to create a noncompliance problem.
One small and even unintended act in noncompliance could create a big problem, Hewett notes.
For instance, supposed a young investigator didn't realize that he couldn't change his research approach without obtaining prior approval of the IRB, Hewett says.
The mistake might have been that the protocol included a procedure that the researcher failed to realize was part of standard care. So the researcher didn't need to include the procedure in the protocol. As a result, the researcher removed the procedure from the protocol, but he did so without first seeking IRB approval of the change, Hewett says of the hypothetical situation.
"In this situation you had a study design that had a subject enter the trial with a required number of lab tests and a required number of office visits for a physical," she explains. "And during the course of the study, the investigator realized the labs were not required to follow the clinical condition, in part, because during the course of the study, the tests became part of standard care that would be reimbursed by insurance companies."
This meant the young researcher could eliminate these lab tests and, instead, turn the study into an observational study, Hewett says.
"The research design didn't need to continue in the way it had," she says. "So the researcher decided to not have patients come in to have their blood work done, and as a result, 70 percent of subjects enrolled had protocol deviations."
This meant subjects' time was wasted because the study wasn't done the way it was supposed to be done, Hewett says.
When the IRB intervenes after the fact, it takes a great deal more effort to straighten out than it would have taken if the researcher had sought approval for the change before it occurred, she adds.
"The researcher should have come to the IRB for an amendment and changed the informed consent," Hewett says.
In this scenario, the investigator's lack of knowledge about the IRB process caused a study coordinator to report his noncompliance, which resulted in an investigation and remediation efforts, she adds.
This is only one example of how a well-intentioned CT change can have a ripple effect because of noncompliance with regulations.
Research institutions can help prevent such noncompliance scenarios by providing better regulatory education and training to investigators and staff and by providing investigators with support in completing documentation, Hewett suggests.
"Many institutions now have electronic human subjects research applications rather than the old method of submitting 20 written questions on paper," she says. "Within the text of questions for applications there are a large number of opportunities to provide links to regulatory guidance materials."
These serve as quick ways to educate investigators and to answer questions as they complete the protocol application form, Hewett says.
"Questions on the application have a help icon next to it," Hewett says.
As the institution has developed and improved the electronic application, the questions have been more robustly addressed, he says.
When the application was rolled out, investigators made suggestions for changes, and these were incorporated into the final product.
"We wanted to make sure they understood it, and we wanted to make sure we included all elements from the main campus and the medical campus," Hewett says.
It's more effective to make regulatory references available to investigators and to distill the information in language to which researchers can relate, she adds.
"A large part of an IRB's and institution's role is to distill information enough that researchers know what they need and where to go for more information," Hewett says. "And they need to know how they got into noncompliance and how to not get in that state again."
One way to do this is to make certain the IRB's questions for principal investigators are well-crafted and incorporate regulatory requirements without overtly showing which direction they're going, Hewett suggests.
"When IRBs give an explanation to investigators about why they may need to amend a contingency, it's important to give a background on why this is being asked and telling them how they could prevent this from being a contingency," she adds.
It's also a good idea to provide investigators with a practice application in which they can see all of the questions that will be asked, but none of their answers will be submitted to the IRB until they complete the actual application form, Hewett says.
It's important to stress to clinical research staff and investigators that regulation compliance is a goal that everyone in the CR enterprise works hard to achieve, an expert says.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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