Miami Children's Hospital Research Institute INC

Miami Children's Research Institute (MCRI, currently operating as Nicklaus Children's Hospital Research Institute) is one of the largest providers of pediatric medical research in the southeastern United States. In 2020, The Nicklaus Children's Hospital Research Institute (NCHRI) participated in more than 300 research studies, many involving new medications and interventions for children with complex or chronic needs. The NCHRI was the first pediatric research program in the state of Florida to receive accreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP) and was most recently reaccredited in 2017. AAHRPP accreditation affirms an organizational commitment to maintaining the most stringent standards in protecting the safety of research participants and in educating participants and their families regarding risks and potential benefits of taking part in research activities. The NCHRI mission is to: - Provide leadership, education, expertise and guidance to clinical research professionals at Nicklaus Children's Hospital (NCH) and its affiliates - Serve as a centralized resource within NCH to support conduct of interdisciplinary and patient-oriented research focusing on clinical trials - Provide a primary point of contact for Sponsors and Investigators - Serve as an educational resource to Investigators and Research Staff - Provide an interface with the research participant community The Nicklaus Children's Hospital Research Institute (NCHRI) strives to promote efficiency, standardization, compliance and responsible clinical research conduct through education, quality assurance visits, positive influence and guided internal and community leadership. The NCHRI provides research support services for all types of clinical research studies including those initiated by industry partners, external institutions, and NCH investigators. Specific services include proposal and protocol development, budget preparation and negotiation, contract negotiation, regulatory submission assistance, regulatory guidance, education, training and clinical research coordinator support. In addition, the NCHRI serves as the home to interdisciplinary research initiatives and engages the community by increasing awareness about Nicklaus Children's Health System (formerly Miami Children's Health System) research initiatives. The NCHRI supports research activities across Nicklaus Children's Health System including the neurology, neurosurgery, hematology and oncology, personalized medicine, genetics, genomics, clinical psychology, cardiology, cardiovascular surgery, orthopedics, nephrology, pulmonology, dermatology, endocrinology, gastroenterology, infectious disease, psychiatry, critical care, radiology, rehabilitative medicine, rheumatology and urology. In addition the NCHRI works collaboratively with Graduate Medical Education to support the research efforts of our residents and fellows. As part of its support for hematology-oncology research, Nicklaus Children's Hospital maintains full membership in the Children's Oncology Group (COG), a federally funded consortium of pediatric hospitals and departments conducting a large array of clinical research studies offering varied treatments for the spectrum of childhood cancers. In addition, the research institute supports clinical trials funded by industry and academic partners offering novel and innovative treatments for childhood cancers and hematologic diseases. In close collaboration with the Nicklaus Children's Hospital Brain Institute, the NCHRI supports a NCHRI supports a robust portfolio of clinical research studies in the neurosciences focused on various types of epilepsy, neuro-oncology and other neurological conditions. Many of these trials involve include the use of novel investigational products and devices in both neurology clinics and neurosurgical settings. A primary focus of research for both the Nicklaus Children's Hospital Heart program and the Center for Spinal Disorders includes health outcomes research to improve quality of care. Also, a fairly new and important division, the Personalized Medicine Initiative was kicked off in 2016 with a generous gift from the Sanford Health Genomics Consortium which has led to start-up and support of genomics-based medicine research in several therapeutic areas.