Excessive regulation and oversight may be paralyzing research, quality improvement efforts

IDSA identifies five areas which may obstruct translational research.

Increasingly cumbersome regulatory oversight may be placing an unnecessary burden on clinical, epidemiological and health systems research, according to researchers from the Infectious Diseases Society of America.

William Burman, MD, medical director of the Infectious Diseases Clinic of Denver Public Health, was one of the contributors to the IDSA paper. In an interview with Infectious Disease News, he commented on many aspects of the regulation process, including the Health Insurance Portability and Accountability Act.

“We are dealing with the unforeseen consequences of well-intentioned programs to ensure privacy,” he said. “We did not anticipate how the Act would impact such areas as epidemiology and quality assurance. It has created a great deal of redundancy within the system.”

Areas of concern

The researchers outlined five problem areas that may be most directly impacting research efforts.

The first area of focus is the Health Insurance Portability and Accountability Act. The researchers wrote that the application of this statute has overburdened institutional review boards, confused prospective research participants, slowed research and increased research costs.

Burman commented on the overburdened institutional review boards. “There are too many data-gathering activities that fall under the purview of institutional review boards, from formal randomized trials to review of care studies,” he said. “Classic studies should go to those boards, but quality improvement activities need to be handled elsewhere.”

The second area of focus involves the local review of multicenter studies. Review by multiple organizations may cause delays in research, fail to improve protocols or consent forms and cause redundancy within the review system.

“Any given study may be reviewed by tens or even hundreds of centers at the local level,” Burman said. “Some argue that the regional perspective is necessary, but I know of no evidence that says that anything scientifically important happens as a result of local review.”

The reporting of off-site adverse events may waste the resources of sponsors, investigators and local institutional review boards, according to the IDSA researchers. Perhaps more problematic is that off-site adverse event reporting may not achieve its intended goal, which is to improve patient safety.

“The system for reporting adverse events is monstrously wasteful,” Burman said. “In many cases, it is simply a flood of anecdotes with no context.”

The fourth area of concern centers on uncertainties about key terms in the regulations that provide oversight for pediatric research. Interpretation of these terms has led to inconsistency in the way research involving children is conducted and reviewed.

The final area of focus involves the role of institutional board reviews in quality improvement efforts, which are often being delayed by lack of certainty about how those efforts should be executed.

“A big problem with the system for reviewing quality assurance measures is that it is such a broad umbrella,” Burman said. “A single clinic wants to review how it is managing strep throat and a large multi-institution system that wants to review how it handles community-acquired pneumonia are dramatically different quality assurance measures. They are both important steps to take but they should not go to the institutional review board.”

The researchers also wrote that the burdens within the regulatory system may be causing young scientists to turn away from careers in research.

To illustrate the pervasive nature of regulation and oversight, the researchers wrote that “the subject of research oversight has itself become the subject of careful quantitative research.”

Potential solutions

Recommendations within the document begin with the suggestion that the Secretary of the Department of Health and Human Services should remove research from the purview of the Health Insurance Portability and Accountability Act.

The researchers wrote that the National Cancer Institute has moved toward a central institutional review board. The IDSA recommended that the NIH should use that model and create a central board for handling multicenter studies to decrease the redundancy of local review.

“The time is right for a move toward central review,” Burman said. “The momentum toward that movement is growing.”

Regarding patient safety concerns, the IDSA recommendations suggest that the FDA and the Office for Human Research Protection should develop a consensus on adverse event reporting.

The Office for Human Research Protection also should work with pediatric researchers and the instructional review board community to more clearly define strategies for pediatric research, according to the IDSA recommendations. The researchers wrote that barriers to gaining informed consent from children have led to off-label use of treatments, and that efforts to protect children have had the paradoxical effect of harming them. Failure to include children in clinical research may also contribute to inappropriate medications and dosing.

A multidisciplinary panel of bioethicists, quality improvement officers and regulatory officials recently conducted research that suggests most quality improvement efforts should not be reviewed by an institutional review board even in cases where there is intent to publish results.

Burman said that there should be a period where institutions can try out a variety of quality assurance programs and report back with results. “There needs to be a time for experimentation,” he said. “Hopefully, the end product will be a more streamlined system for conducting quality assurance reviews.”

The IDSA officials wrote that public discourse on the current state of regulatory oversight needs to occur. The dialogue should acknowledge cases of investigator fraud and failure to account for patient safety in addition to addressing efficiency and redundancy issues. Researchers, regulators, patients and advocacy groups should participate in the discussion.

“The need for research and the need for oversight are not competing agendas; they are two pillars that support the research enterprise,” the researchers wrote. “It is time to restore the balance.”

Burman said that the goals outlined in the IDSA document are achievable within the next few years, if the proper steps are taken. “We are not starting at square one,” he said. “Pragmatic steps could improve the system and eliminate a lot of the regulation that prevents barriers to research.” - by Rob Volansky

Burman W et al. Clin Infect Dis. 2009;49:doi:10.1086/605454.