INTERNATIONAL SCIENTIFIC, ETHICAL AND REGULATORY REVIEW FOR ALZHEIMER'S CLINICAL TRIALS

Abstract

For nearly eighty years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. This abstract describes the joint program of the National Biomedical Research Ethics Council (NBREC) and Schulman IRB (SAIRB) to provide a single IRB of record (sIRB) for phases of multi-site studies. The NBREC-Schulman Alliance approach follows two steps. One, the Alliance will provide a scientific review of submitted research protocols. An expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, using data from clinicaltrials.gov, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. This includes 42 studies on Alzheimer's disease and dementia, 46 studies of cognition (exclusive of memory, dementia and AD), and 47 studies of memory (exclusive of dementia, Alzheimer's disease and cognition). Since 2010, Schulman has approved 371 CNS/Neurology studies including 92 in Alzheimer's disease. The NBREC-SAIRB Alliance will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. The Alliance aims to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly planned for Asia, Europe and Australia.