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Special Coverage: 2003 PRIM&R/ARENA Conference
NIH roadmap calls for IRBs to clarify role
Key NIH players discuss roadmap's goals
Among the many changes experienced by IRBs and the research industry in recent years is the trend of more clinical studies being conducted in the community and in small clinics, a subtle shift away from major research centers. This trend is one of the many reasons the National Institutes of Health (NIH) unveiled late last year a series of initiatives called the NIH Roadmap for Medical Research.
The roadmap initiative identifies as the three most critical areas for the NIH to address the new pathways of research of discovery, new research teams, and re-engineering clinical research enterprise.
According to NIH’s announcement, there has been a scientific revolution that poses complex challenges to transform scientific knowledge into benefits for people. One way to expedite the research process is to promote the move of clinical trials into the community, where it often is easier to find research subjects. The drawback may be that smaller community IRBs are not as well equipped as IRBs at major academic research centers to handle an increase in complex biomedical or social-behavioral protocols, and this is a hurdle that the NIH will attempt to address in coming years.
IRB Advisor spoke with the principal leaders of the roadmap's Re-Engineering the Clinical Research Enterprise steering committee to learn more about how the roadmap will impact the research industry and IRBs in the coming decade.
"Some of the issues that have to come up are what’s the role of central IRBs?" says Stephen I. Katz, MD, PhD, director of the National Institute of Arthritis and Musculoskeletal and Skin Dis-eases in Bethesda, MD. He also is a principal leader of the NIH steering committee on Re-Engineering the Clinical Research Enterprise.
Other questions that the NIH roadmap may address, Katz says, include:
• What is the relationship between the data safety monitoring board and the IRB?
• What are the best practices with regard to consent form developments?
• Are there better ways to educate the research community in terms of preparing investigators for developing protocols for IRBs?
"Those are issues that are important in terms of harmonization of clinical research and regulatory burdens," Katz says.
The NIH roadmap is a commitment to improving the nation’s research infrastructure, including enhancing training for investigators so that more diverse practitioners can engage in research, says Stephen E. Straus, MD, director of the National Center for Complementary and Alternative Medicine in Bethesda, MD. He also is a principal leader of the NIH steering committee.
"Research is not a hobby," Straus notes. "You need to be in the right environment with the right safeguards for patients’ safety and ethical oversight, and you have to be in the hands of people who are skilled and have the right monitoring."
The re-engineering clinical research portion of the NIH roadmap will work to make it easier for research findings in the laboratory to be tried in the clinic, he says.
"It will bring practitioners and patients together in community research to test out these approaches and then to attempt to see whether they work in the community setting," Straus explains.
"The re-engineering clinical research components can only help us in complementary and alternative medicine [CAM] research because so much of what we do is clinical research," Straus adds. "In fact, more of what we do is clinical research than any other institute in NIH."
Katz and Straus offer these ideas for how the NIH road map may impact future research:
• Harmonization of clinical research regulatory burdens: "That’s the most difficult task because, first of all, that’s not something NIH can do alone," Katz says. "In fact, we’re not a regulatory agency, and we really can’t do that."
Instead, NIH will need to work with other governmental agencies, as well as with nongovernmental organizations, to identify the areas that need harmonization and simplification, he notes.
"We can make the role of the clinical investigator a little bit easier, while at the same time not in any way compromise our commitment to human subjects protection," Katz says.
NIH officials have continued to meet with leaders at other governmental agencies to discuss this issue, he adds.
• Development of interdisciplinary research: This is the second major pillar of the roadmap approach, and it recognizes that research is increasingly complex and multifaceted in today’s world, Straus says.
"It requires us to bring together individuals to make a research collective that may not have come together previously," Straus says, adding that this approach is particularly important to the goals of the National Center for Complementary and Alternative Medicine.
"This is very relevant to complementary and alternative medicine research," Straus says.
For example, CAM research, needs the input of anthropologists, behavioral scientists, brain imagery technicians, biomechanical engineers, physicists, and physical chemists, he adds.
"So our approach already is a highly integrated, multidisciplinary and interdisciplinary one, but the commitment on the part of the NIH as a whole to expand the creation of interdisciplinary researches into the more robust enterprise will help us," Straus says.
• Accelerating research: The roadmap will encourage research projects to move forward in order to bring medical improvements and therapies to the public more quickly than what currently occurs.
"Everything within the road map is made up of initiatives that no one institute could do on its own," Katz says. "It really serves as an infrastructure to accelerate and to facilitate research in all these areas, whether it’s new pathways of discovery, whether it’s the development of interdisciplinary research teams for the future, or whether it’s re-engineering clinical research."
The road map is expected to make it easier for researchers to gain access to necessary tools and technologies.
"There are certain tools and technologies in certain research communities that are simply not available, and to try to do research when all the tools are not in place is always a slower process," Straus says.
This focus on accelerating research will help smaller institutes, such as the NCCAM, which do not have the financial resources to invest millions into developing new tools whenever a need arises, he notes.
"We have to rely on the growth and maturation of the larger research enterprise to be more successful, so this will accelerate our work without question," Straus says.
The roadmap is intended to help accelerate research along the entire continuum from discovery to application, Katz says. "Even if we’re the fastest [in the world], it doesn’t mean we couldn’t be faster."
• Moving research into the community: "In the real world, medicine is not practiced in the hospital wards the way it had been a century ago," Straus says. "It’s increasingly practiced in clinics, in offices, and even in the community. We have tools and technology that are widely dispersed."
For example, the imaging technologies available at the NIH campus also are available at 500 other places around the country, he notes. "So the public increasingly has access to new tools and technologies."
As such, researchers no longer can expect research subjects to come to them as they may have in the past when there were fewer options available to patients who wanted to receive the latest treatments, Straus adds.
"We have to come to them, and we can do it in two ways: We can place university hospitals in every major city in the United States, and we do that to a great extent, but there’s great costly duplication," Straus says. "But the other way is to put practitioners with some research training in the community so when they are caring for patients in their own practices, they are better attuned to making observations that could flow into research design and conduct, and they can even participate in research studies."
"The roadmap process envisions training thousands of practitioners, dentists, physicians, nurses, chiropractors, and others who, within their own practice, could enroll patients into multicenter trials," Straus says. "We have telemedicine today and electronic technologies, so our ability to community and interact broadly creates a web of opportunity that didn’t exist before."
The NIH roadmap’s goal is to harness technologies into a virtual research enterprise in which academic investigators, clinical practitioners, and patients all have access to each other and each other’s tools and ideas, Straus adds.