Legal compliance office and IRB work together to better protect subjects
Office relies on not-for-cause audits
Research institutions and officials increasingly are finding that extra layers of oversight are better than too few. While IRBs once were the only organizations to oversee human subjects protection of research participants, now there are additional committees and offices assisting with this task.
At the University of Michigan in Ann Arbor, there's a relatively new office of human research compliance review, which adds a fresh twist to human subjects research oversight. The new office conducts not-for-cause audits of research studies.
"Compliance is handled in a lot of different ways," notes Ronald F. Maio, DO, MS, director of the office of human research compliance review at the University of Michigan. Maio also is a professor in the department of emergency medicine.
For instance, the department of the office of the vice president for research is ultimately in charge of all IRBs on campus, and all for-cause audits are conducted out of that office, Maio says.
"We have in any given time, including studies with student principal investigators, 5,000 open protocols," Maio says. "And that's just across Ann Arbor campuses."
The new office of human research compliance review is specifically charged with the role of evaluating risk from the human subjects research perspective.
"Our focus is on looking at investigators and studies, but we also have the authority to look at IRBs and ancillary committees, like the biosafety and investigational drug service committee," Maio says. "One of the main functions of the office, which is really unique and different from what the institution has done in the past is this idea of doing not-for-cause regulatory reviews."
Maio says he prefers not to use the term "monitoring" to describe the reviews. The office's not-for-cause reviews are based on the four pillars of compliance review: education, outreach, knowledge generation, and leadership.
"But the bulk of our work and the biggest focus is on compliance review, which has a big educational component to it," Maio explains.
It's more important in today's research climate for institutions to add these extra layers of oversight because the bar has gone up with regard to society's and the federal government's expectations about human subjects research protection, Maio says.
"Also, the research we're doing, particularly in the biomedical sciences, is becoming more and more complex," he adds. "And there are more challenging ethical and regulatory issues we have to address."
These factors are compounded by the explosion of interdisciplinary work that makes studies more complex, Maio says.
"Institutions have to hold themselves accountable to prevent bad things from happening," he says.
Maio chaired a campus-wide task force that developed a plan for conducting not-for-cause reviews of studies.
"We hoped to identify research issues and, essentially, prevent bad things from happening," Maio says. "We wanted to identify them before they got out of hand and provide education to investigators as we do the review."
Another part of it is to acknowledge investigators who are doing a good job and highlight their methods and practices so that others might learn better ways of conducting human subjects research, Maio adds.
"One thing we emphasize to investigators is we really feel we're partners and not the police," he says. "Our main focus is on how we can help the investigator do the safest, most ethical research and do it in a very efficient way."
Reviewers see themselves as a value-added service to the research enterprise and not in the role of punishing investigators who make mistakes, Maio says.
"Although, an investigator could have serious consequences if we go in there and identify a problem," he adds.
Also, the office is independent from the IRBs despite Maio and staff having a long history of working on and with them.
"When we're doing reviews, there is a lot of communication between us and the IRBs because we want to make sure we're not giving investigators mixed messages," Maio says.
As the office completes its first year of not-for-cause reviews, there remain some issues to resolve.
"One of the challenges is trying to figure out how many reviews you should be doing, and we're in the process of talking with peer institutions around the country to develop benchmarks," Maio adds. "But it's very challenging."
Secondly, the office needs to develop a way of emulating best performing investigators and maintaining transparency in the review selection process, he says.
"A substantial minority of investigators on campus think this has a negative connotation," he explains. "As much as we tell them that we're doing this in an unbiased selection process, they still have the idea that if they're reviewed then something is wrong."
Here is how the not-for-cause reviews work:
• Studies are selected randomly.
"We select certain categories of research, and within those categories we randomly select certain studies," Maio says. "In a discussion with the advisory committee, we get a sense of what are the reviews we want to do."
Once the studies are selected, they're placed in a random order and letters are sent to investigators in batches to let them know there will be a not-for-cause review, he says.
"We send an e-mail to the investigator and IRB of record and the research associate at the school where the investigator works," he adds. "Initially, we don't have a lot of contact with the IRB other than telling them what's going on."
• Conduct review in phases.
"The review is a two-phase process," Maio says. "First, we talk with the investigator about the study, and the investigator can have anyone else there, such as research staff or the dean."
In the second phase, after the initial interview with the investigator and staff, the reviewer will begin the research record review.
Principal investigators need not be present, but someone from the study team should be available when needed to help the reviewer obtain access to records, Maio notes.
"Then we write a report of observations, and we send a draft report to the investigator to see if he has any issues relative to the facts," Maio says. "We might say, 'We reviewed 30 subject records,' and he might say, 'You reviewed 35,' so it's just to correct anything having to do with facts."
The reviews, including meeting with PIs, reviewing charts, and drafting a report, take from 20 to more than 30 hours each, and about 60 of these can be done in one year's time, Maio says.
• Share findings with IRB.
"We also let the IRB see a copy of this to make sure that if we find things they don't have any concerns," Maio says.
And if the reviewer finds problems during the review, the IRB is notified.
"There is a constant communication with the IRB because we want to make certain we don't send mixed messages to the investigator," Maio says. "We will make suggestions for changes, but we're careful to make sure we don't confuse investigators, so we'll often discuss our recommendations with the IRB first."
When a reviewer believes corrective action is required, the reviewer will talk with the principal investigator and discuss the problems and options for correcting them.
"But before they start to correct the problem, we'll be in contact with the IRB to see what the IRB's take on this is," Maio says. "If there are any findings, we'll send in a report of observations, listing some areas where we recommend some changes be made, and the investigator, in turn, will give us a corrective action plan."
The key is to keep the relationship collaborative between the review office and the IRB, he notes.
"There are times when we have differences of opinion with the IRB, and we need to discuss this because, ultimately, the IRB has a final word on things," Maio says.
• Take one of three courses of action.
After a not-for-cause review in which there are findings, one of three different actions will be taken. Maio lists these as follows:
- "If we find anything serious and continuing, we immediately notify the investigator and IRB of record and the vice president of research," Maio says.
- "If we find things at variance to regulations, but not serious and continuing, then we work with the principal investigator and IRB about the best way to correct these," Maio explains. "We try not to have the PI immediately make a correction before we've reviewed the whole study and talked with the IRB because we don't want them to have to do more than they have to do or to have to do it all over again."
- Sometimes a reviewer will find that an investigator is doing things that meet regulatory compliance guidelines, but which might be done more efficiently or rigorously, Maio says.
"We'll make suggestions to investigators about this, but it doesn't reach the level of having to notify the IRB," Maio says.
So far the not-for-cause reviews and new oversight layer has worked out well for all involved, Maio says.
"In general, people really like it and feel very supportive," he says. "But there's always the concern that what we're doing is transparent."
Research institutions and officials increasingly are finding that extra layers of oversight are better than too few. While IRBs once were the only organizations to oversee human subjects protection of research participants, now there are additional committees and offices assisting with this task.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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