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July 2009
Vol. 19 No. 7
Top Stories
IDSA Urges Changes to Address Regulatory Burdens Slowing Needed Research

More than other any other medical field, ID relies on research to explore the intersection between humans and a microbial world that is constantly changing and creating new infections every year. But existing regulatory burdens are slowing this important work—and creating obstacles to improving patient care—according to an IDSA policy statement recently published in Clinical Infectious Diseases.

“The future of our field, and all medical fields, is closely tied to research,” said William Burman, MD, medical director of the Infectious Diseases Clinic at Denver Health and lead author of the policy statement, which was developed by IDSA’s Research Committee. “There are people who decide to not go into research because of the frustration in dealing with these regulations. Our concern is that patients will suffer because less is known about their infections.”

The statement focuses on five key problem areas that ultimately slow research and increase costs:

  • the impact of the Health Insurance Portability and Accountability Act (HIPAA)
  • local review of multicenter studies
  • redundancy in the reporting process for adverse events
  • barriers related to pediatric research
  • the role of Institutional Review Boards (IRBs) in quality improvement projects

To address these concerns, IDSA offers several recommendations to ease these burdens while also protecting research participants. These steps include: clarifying rules that govern the oversight of pediatric research, quality improvement efforts, and adverse event reporting; encouraging the National Institutes of Health (NIH) to establish central IRBs at all its major institutes and centers to review multicenter studies, in addition to providing incentives for local institutions and researchers to use central review; and removing research from the purview of HIPAA regulation, which was not originally intended for this purpose.

Earlier this month, IDSA sent a letter to Anthony S. Fauci, MD, director, National Institute of Allergy and Infectious Diseases (NIAID), highlighting these concerns and urging the institute to adopt a system of central review panels similar to those adopted by the National Cancer Institute to review multicenter studies. In his response, Dr. Fauci agreed that a centralized IRB system is important in facilitating multicenter studies and noted that he looked forward to having further discussions with IDSA.

To raise awareness of the regulatory burdens facing clinical research and to advocate for change, IDSA asked members who conduct research to share their own experiences in an online survey. The Society plans to work with other organizations, including other medical groups, to push for changes in these areas.
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