Eight months after the Medical Center was forced to halt its human research projects because of its failure to meet government regulations, Duke's top officials have begun calling for a national restructuring of current oversight mechanisms.
In an article in today's Science magazine, Chancellor for Health Affairs Dr. Ralph Snyderman and medical school dean Dr. Edward Holmes recommended the creation of one well-funded agency to oversee all clinical human subject research.
"It is our view that regulatory and compliance mechanisms are overly complex, difficult to interpret, and, at times, redundant or inefficient...," they wrote. "The goal should be an effective, simplified system that is understandable, that works and that is adaptable to change." Both were traveling Thursday and unavailable for further comment.
In their article, Holmes and Snyderman outlined the complicated and outdated nature of clinical research regulations. The two officials contend that the Office for Protection from Research Risks, a government arm established in 1972, has failed to keep up with the expanding needs of medical institutions nationwide. "[1972 was] a time when most clinical research studies were conducted by individual or small groups of investigators dealing with small groups of subjects," they wrote.
The co-authors recommended "a comprehensive and broadly based review of federal regulations to protect human subjects, with the goal of creating a single set of effective federal regulations."
The recommendations about streamlining come from the authors' perception that clinical research is overregulated at various stages.
The officials used a clinical trial funded by the National Aeronautics and Space Administration as a clear example of the changes that should be made to the system. The example trial is not only regulated by NASA and OPRR, but also by the participating firm's institutional review board and the Food and Drug Administration. If any problems arise, each of the agencies conduct separate inquiries into the matter.
The officials also suggested that medical centers' IRBs receive ongoing accreditation to avoid confusion about the intent of federal guidelines. "Well-meaning individuals and institutions may interpret regulations differently," they wrote. They want institutions to obtain prospective approval of their IRB procedures and certification of their members so they would have a clearer understanding of regulations before being reviewed.
Given the complexity and volume of research studies at major medical centers like Duke, Snyderman and Holmes recommended that the cost of time faculty spend serving on IRBs be included in all grant funding.
Snyderman and Holmes' recommendations come from their first-hand experience with the federal government's regulatory power. The OPRR suspended all ongoing clinical trials at the Medical Center for four days last May, citing various organizational and administrative problems with approval of human subject research. Snyderman said then that many organizations are confused about their IRBs' documentation requirements.
"As difficult and expensive as this experience was for our institution, we learned a great deal and have suggestions about how oversight can be improved," they wrote.
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