NIH working group to help IRBs assess risk properly
NIH bioethicist cites lack of consistency
Two or more IRBs reviewing the same study might reach strikingly different conclusions about the study's risks and suitability for human subjects.
This shouldn't happen, says an expert from the National Institutes of Health (NIH) department of bioethics in Bethesda, MD.
"One thing we've discovered is there is a widespread variation about different ways IRBs evaluate things, such as a survey involving sexual activity or a CT scan, and it seems to me that is not justifiable," says Ezekiel J. Emanuel, MD, PhD, chair of the department of bioethics at NIH.
"There should be more efforts at standardization," Emanuel says.
The fact that IRBs can come to different conclusions when reviewing one protocol raises many questions about how the government could create more coherent standards about risk, he adds.
"I think one of our problems in the IRB world is we tend to have a lot of gut reaction to studies and not a lot of standardization," Emanuel says.
"It's a little unfair to present one's protocol and get very different evaluations in different places when all of the IRBs are supposed to be using the same standards," he says. "If all other things are equal, you should have the same judgment."
To standardize IRB review requires data on risk for the various procedures and tasks required of research participants, he says.
"We need to come up with numbers of how risky it is for subjects to come in for an MRI, how risky it is for subjects to receive 10 blood draws a day," Emanuel says.
The NIH is undertaking a project to standardize IRB risk assessment and reviews, with plans to hold a working group meeting in January, 2009, he notes.
The goal will be to find a systematic approach to quantifying the risks to research participation.
"We're trying to get a consensus agreement from a wide variety of people," Emanuel says. "We'll have IRB members, administrators, researchers, patient advocates, and ethicists."
Part of the systematic approach will include classifying actual interventions according to how risky they are.
"You shouldn't have this big disagreement about whether the MRI scan is really risky or not really risky," Emanuel says. "Our goal is to have the numbers and make decisions based on data about risk."
One of the problems of the current system in which IRBs operate is that there are no numbers available to help IRBs determine risks, he adds.
"We rely on people's gut reactions, which tend to not be very reliable," Emanuel says.
The widespread variation in IRB decisions suggests that there's a problem with the system, he notes.
"So our goal is to bring order, rationality, and systemization to these things, and that's why we're doing it," Emanuel says.
When IRBs disagree on the risks of research procedures, there's a problem with inconsistency.
The way things work at present, there are two dangers, Emanuel suggests.
"We may be inhibiting research that is quite legitimate, and we may be permitting risky interventions we shouldn't because we don't have the right standards," Emanuel says. "My general feeling is it's probably the former — that we're being way too cautious, but the latter is possible too."
Two or more IRBs reviewing the same study might reach strikingly different conclusions about the study's risks and suitability for human subjects.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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