Teaching IRBs to be flexible, drop bad habits

Consultant says IRBs often review what they shouldn't, go beyond the regulatory criteria

When consultant Jeffrey Cooper talks to IRBs about using the flexibility of federal regulations to change their procedures, he can see that the message doesn't always get through.

"I'll spend two hours lecturing and talking and going over examples, and the next morning I'll come in and I'll work with somebody and they will make all the mistakes that I told them not to make in the lecture," he says.

Cooper, MD, MMM, of Huron Consulting Group in Arlington, VA, says the real work of helping IRBs change comes when going over studies with them, case-by-case, to see how they could improve the process of review.

Cooper previously served as vice president for education and regulatory affairs at the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Now, he assists institutions seeking accreditation and in some cases is called in to help reach solutions when an institution is having conflict between its researchers and its IRB.

"If the IRB and the investigators are just not getting along, then it indicates there's something wrong," he says. "It can't be that it's all the investigator's fault all the time and that the IRB is doing everything right."

Breaking bad habits

Cooper says that too often, IRBs have picked up bad habits based on a faulty understanding of the regulatory requirements. Some of the most common problems he sees include:

• Failing to use the flexibility in the regulations: For example, Cooper says an IRB may decide not to use exemption determinations and require studies that are legitimately exempt to go through either an expedited or a full review process.

"You hear a lot of people say 'We hold things to a higher standard, we don't use the exemption determinations.' My argument is you can hold everything to an equivalent ethical standard, but you don't have to do every single thing that would be required for legality issues that may not have any protection of human subjects."

• Reviewing non-human research activities: Cooper says some IRB portfolios are full of activities that are not research involving human subjects as defined by the federal regulations. Examples would include evaluations of programs and quality improvement activities.

"I'm not saying that there aren't evaluations that are also research, or that there isn't quality improvement that is also research," Cooper says. "But most are not human research. IRBs have stretched the definition to a point that there may be substantial amounts of things they are reviewing and spending time on that are simply not human research."

• Going beyond the regulatory criteria for approval: Cooper says he sees IRBs ask for changes that go beyond the regulations, in an attempt to protect investigators, for example, or to minimize the risk beyond an already minimal risk.

"In one case, somebody wanted to draw blood and the IRB wanted the blood drawing laboratory to offer the person different kinds of tapes so that the person could choose what sort of tape they wanted to minimize their discomfort.

"If that were really important, the blood drawing labs would be doing it routinely," he says. "It's really the IRB going overboard in taking a minimum risk procedure and trying to make the risk less than what it is in daily life."

• Taking actions outside their regulatory scope: Cooper has seen IRBs that sanction investigators, tell investigators that they can't use data they've already gathered or require that they destroy data.

"The IRB is there to approve research, disapprove research, require modifications, suspend, terminate or observe," he says. "After the research is done, the IRB has no authority, unless the institution gave it to them. They're taking on authority that is not in the regulations and has not been granted by the institution."

Advising researchers

Cooper says there are ways to streamline the process of review while still providing strong protections.

One institution he worked with now will advise a researcher if the IRB notices a minor change, such as the removal of a few questions from a survey, that would move a study from expedited to exempt, or even from exempt to non-human research.

At another institution, when a researcher does an audio-taped interview and the subject matter could be potentially harmful to the subject, the IRB might suggest using a device that masks the person's voice to better protect his or her identity.

"You can mask people's voices and you can take (a study) from expedited review to exemption," Cooper says. "People say to me, 'You're helping people cheat around the regulations,' and I say, 'No, I protected human subjects, because I made sure that information was recorded in a way that it's not identifiable.'"

One social-behavioral institution he worked with has changed its policies to allow for more waivers of written documentation of consent for minimal-risk studies. Cooper says one investigator told him he at first didn't like the change, worrying that he wouldn't be able to prove that participants had agreed to be in the study without having a signed document in his files.

"(The investigator) said, 'Then, I realized, I'm going to have to work harder at this. I've got to really make sure that this person wants to be in this study and that they're not going to come back to me and say, 'I didn't sign up for this.'"

Cooper says the investigator's response illustrates a common problem with consent — the more IRBs emphasize the documentation, the less thought and care go into the informed consent process.

"So actually waiving the written documentation had a very positive effect," he says. "I think people have to take the process more seriously, because there's no signature to fall back on."