Multisite clinical trials are a powerful way to drive the discovery of new therapies, but ensuring that the health and privacy of study participants are protected across multiple Institutional Review Boards (IRBs) has slowed things down in the past. Today, the NIH reached a major milestone: all of their Clinical and Translational Science Awards program sites have agreed to a new authorization agreement, SMART IRB. The agreement – whose acronym stands for Streamlined, Multisite, Accelerated Resources for Trials IRB – "will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference." Among the signatories on the agreement is Consortium member the Clinical and Translational Science Institute (CTSI).
This innovative 3-year project, based cooperatively at the University of Minnesota and Vanderbilt University, has convened a national Working Group of top legal and scientific experts to analyze current federal and state law and regulation on translational genomics and to generate consensus guidance on what the law should be. The project team will build a searchable online database of relevant law and an annotated bibliography for free public access, systematically collect and analyze a range of stakeholder inputs, convene a national public conference, and publish analyses and recommendations to help shape the law to support genomic medicine.