Last week, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) notified the leadership of the National Oncologic PET Registry (NOPR) that it may require the NOPR to change its procedures related to Institutional Review Board (IRB) review. At this time we do not know if IRB approval will be required. The Centers for Medicare and Medicaid Services (CMS) and OHRP are working to resolve this issue. When a final determination is reached, NOPR will post this information on its Web site and notify all registered facilities and those on its e-mail broadcast list. Until this issue is resolved, the NOPR cannot accept patient registrations or finalize facility registrations.

At present, all infrastructure and processes necessary for operation of the NOPR, in accordance with the original design of the registry, are in place. The NOPR is working diligently to understand any new requirements under consideration and, accordingly, to plan support for NOPR participating sites should new requirements be confirmed. The NOPR is committed to activating the registry as soon as possible. National Oncologic PET Registry (NOPR) is managed by the American College of Radiology (ACR) and the American College of Radiology Imaging Network (ACRIN) in collaboration with the Academy of Molecular Imaging (AMI). The American Society of Clinical Oncology and the Society for Nuclear Medicine also have played key roles in guiding the project's development.