In this month’s All-Member webinar, Joanne Salcido of the Pediatric Brain Tumor Foundation introduced and hosted Dr. Marjorie Speers of the WCG Foundation. The slide deck from the presentation is linked below.
Dr. Speers’s presentation described the clinical trial process and the role of the IRB in phase 1 – 4 clinical trials.
During her webinar, she explained the differences between academic and independent IRBs and the challenges IRBs face when they review multi-site trials. She also described the revised regulations that are likely to go into effect in 2018 and how they should help to reduce the time it takes for an IRB to approve a study. The federal regulations that protect human subjects include additional protections for children; Dr. Speers described those protections and why children are sometimes not permitted to participate in trials or certain types of research and why there are age limits. Dr. Speers described the role of the IRB in various types of expanded access uses.