The National Institutes of Health are working to streamline the approval process for multisite clinical studies.
Studies that enroll participants across numerous geographical sites can be highly effective in determining whether new medical therapies are safe and effective. However, such studies can experience delays because each site relies on its own Institutional Review Boards to conduct ethics evaluations of the possible risks and benefits of potential clinical studies.
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Under a new arrangement, all the members of the NIH's National Center for Advancing Translational Sciences Clinical and Translational Science Awards Program have agreed to a streamlined authorization agreement that would allow a single IRB to conduct and ethics review for each study, which will apply to all sites. More than 150 top medical research institutions are included among the sites.
"This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly," said NCATS Director Christopher Austin, MD. "It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago."
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