IRBs support IOM recommendations
Many suggestions already in place
As research institutions begin to digest the new recommendations from the Institute of Medicine (IOM) of the National Academies in Washington, DC, there’s general agreement that many changes it promotes in IRB structure and research activities are necessary to better protect human subjects.
From increased emphasis on accreditation to more resources for IRBs, the IOM’s recommendations mirror many similar reports from within the research community, says Richard J. Turman, PhD, director of federal relations for the Association of American Universities based in Washington, DC.
"I think in general we were pleased to see that many of the things that people have been trying to do for some time are listed in here," he says.
In the IOM report, "Responsible Research: A Systems Approach to Protecting Research Participants," the Committee on Assessing the System for Protecting Human Research Participants recommended a series of legislative, regulatory, and institutional changes designed to help restore public trust in human subjects research.
Among the recommendations:
- Establishment of human research participant protection programs (HRPPP) at all institutions engaging in human research. The IOM report lists four conditions that should be "pervasive" within the research culture of an HRPPP: 1) accountability for protection of human research subjects; 2) adequate resources for protection activities; 3) ethics education programs for those conducting and overseeing research; and 4) transparency — open communication with the local community, research participants, investigators and other stakeholders.
- A refocusing of the efforts of IRBs more fully on human subject protection, with other aspects of research oversight, such as conflicts of interest and scientific review, assigned to other bodies. The IOM report recommends moving away from the term "IRB" to "Research Ethics Review Board [ERB]" or "Research ERB," to reflect this change.
- Reiteration of the committee’s support for accreditation programs for HRPPPs.
Easing the burden on IRBs
Relieving IRBs of conflict of interest and scientific review responsibilities would be a significant step toward relieving their work overload, says David Korn, MD, senior vice president for biomedical and health sciences research for the Washington, DC-based Association of American Medical Colleges.
Korn, former dean at the Stanford University School of Medicine, based in Stanford, CA, says an IRB committee has very specific responsibilities mostly focusing on the ethics of research and the protection of human subjects.
"It isn’t constituted to be expert on financial conflict of interest matters, nor is it constituted to be a scientific peer review body," he says. "I understand it would be cumbersome, and I understand there would be more administrative costs and time and everything else, but I think they’ve identified a real issue there."
While Turman agrees that another committee should handle conflict of interest matters, he’s less clear on how the scientific review process can be separated out without hampering an IRB’s decision-making abilities.
"When you have a question on protocol in front of you, you need to know, if I make this change, is it still going to work scientifically? You’re still going to have to have people in that discussion who have the scientific expertise you need."
The proposed IOM model is very similar to the structure in use at the University of Texas (UT)-Houston Health Science Center, says IRB chair Anne Dougherty, MD.
UT-Houston’s Committee for the Protection of Human Subjects (CPHS), under the direction of the vice president for research, functions as the equivalent of a Research ERB, with input from a conflict of interest committee and scientific reviews carried out at the departmental level.
Dougherty says the conflict of interest process recently was overhauled and works well. She’s less satisfied with the scientific review, noting that there is variability in the style and performance among the different departments.
"I believe we need a more uniformly rigorous scientific review," she says. "Ideally, I would leave this review at the department or school level, since that is where the technical expertise should be most concentrated. However, I would not object to a central scientific review committee."
The IOM’s continuing emphasis on the value of accreditation is right on target, says Ernest Prentice, PhD, associate dean for research and associate vice chancellor for academic affairs and regulatory compliance at the University of Nebraska Medical Center in Omaha.
Prentice says the shutdowns of major human research programs during the late 1990s and early 2000s forced institutions to recognize the importance of IRBs and provide them with more resources. He says accreditation is the next step in helping institutions evolve.
"I will tell you right now that there’s no way an institution will be accredited by AAHRPP [the Association for the Accreditation of Human Research Protection Programs, based in Washing-ton, DC] unless they’ve got a program that’s in full compliance with all the requirements, that has all the components that are required for a human research protection program," Prentice says.
"And in many cases, that’s going to require institutions, if they want to be accredited, to sink more money into their IRB operation. So I think accreditation is really the way to go to advance the system in the future."
Paying for better protection
One serious issue for research institutions is the cost of the improvements. Both Korn and Turman note that universities and medical colleges aren’t waiting for the funding sources to be worked out. "It’s a concern, but not a concern that’s barring people from taking action," Turman says. "We’ve said we need to do the right thing first and then figure out how to get paid for it."
At UT-Houston, the CPHS staff have expanded rapidly in recent years, and the school is developing new software to help in the processing and distribution of protocols, a process Dougherty says is "quite expensive."
But the increased demands on state institutions come at a particularly vulnerable time as state governments across the country wrestle with budget problems, Prentice says.
"With state budgets going down the tubes, it’s hard for an IRB at any institution to go to the CEO and say, Listen, we need four more people,’ when they’re cutting programs and eliminating faculty," Prentice says.
"It’s a very tough time. I just think that most IRBs are tightening their belts and trying to cope with what is an ever-increasing workload without question."
Currently, his own institution turns down requests from researchers in the Omaha community who want the IRB to review a research project.
"If they’re not part of our organization, we say no, for two reasons: One, we can’t handle the additional work, and two, we’re not prepared to assume the liability," Prentice says.
The IOM report acknowledges the increased costs of beefed-up protections, noting that sponsors and funding sources should be tapped to pay for them. Prentice notes that many IRBs already charge review fees for projects sponsored by the pharmaceutical industry, and could probably increase those fees.
But he predicts that some smaller institutions may simply decide that they can’t afford to continue operating their own IRBs.
"I think they’re going to contract out their IRB reviews to independent IRBs," he says. "I think independent IRBs are going to grow significantly in the next few years. There’s no question about that in my mind. There are going to be smaller institutions that are going to say, We just can’t handle this anymore; it’s just too much. It’s become too complicated.’"
One recommendation in the IOM report that troubles Korn is the suggestion that an institution conducting human research should be responsible for injuries or complications incurred by research subjects.
"Obviously, if there’s negligence or any kind of misfeasance on the part of the institution, clearly the institution is liable for that," he says. "But inevitably in medical research on human beings, some things may happen where somebody has adverse reactions, where they require ongoing care. I think that really has to be a sponsor responsibility."
As research institutions begin to digest the new recommendations from the Institute of Medicine (IOM) of the National Academies in Washington, DC, theres general agreement that many changes it promotes in IRB structure and research activities are necessary to better protect human subjects.
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