As the research world keeps evolving, the IRB will adapt along with it. One looming change is the increasing use of single-IRB review of multisite studies. In fact, the UAMS IRB will serve as the central IRB for a 17-site pediatric clinical trial network (ISPCTN). While the official start date for the new study is not yet known, we are already preparing our systems to be ready to start reviewing the associated research project. For a multisite trial where we are the central IRB but not an enrolling study site, such as the ISPCTN, the convened IRB will review the initial new submission, which will include a protocol and a generic informed consent template. Many other aspects of this central IRB review process will occur in the office or at the central study site office, such as getting agreements from the other sites, or doing an expedited review of each site-specific informed consent form. We will use tools established by the SMART IRB, of which UAMS is a member, to help set up the ISPTCN network, as well as other networks in the future. We encourage you to click around the SMART IRB website to learn more about the resources available through this network. You also should be able to access webinars through this site. We’ve penciled in a couple scheduled for the week ahead to view at our desks.
Regarding the consent form review, the 17 sites involved in the ISPCTN pediatric network are located all over the country and at least one is a tribal site. Each site will have its own requirements for consent form language to be incorporated into the main consent template and then approved via expedited review. So the template the convened IRB will review may seem a little less complete than what we normally see. Rest assured that the sites that are enrolling subjects will be using completed consent forms that will undergo IRB review and approval before use.