The North Shore Medical Center (NSMC) has an approved Federal Wide Assurance (FWA) FWA00007262 on file with the Office for Human Research Protections (OHRP). The FWA expires on July 13, 2010.

Under the terms of the FWA, all of the Institution’s human subject activities, as well as all human subject activities of the Institutional Review Board (IRB) designated under the Assurance, are guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. These terms apply to all activities, regardless of funding source.

The IRB is duly constituted fulfilling federal requirements for membership; have written procedures for initial and continuing review for its human subjects research; prepares written minutes of convened meetings; and retains records pertaining to the review and approval process all in compliance with the requirements for IRBs defined in Department of Health and Human Services 45 Code of Federal Regulations (CFR), Parts 46 and 164, Food and Drug Administration (FDA) 21 CFR Parts 50 and 56, and International Conference on Harmonization (ICH) guidance relating to Good Clinical Practices (GCPs) section 3(3.1-3.4) unless ICH guidelines conflict with FDA Regulation.

The NSMC IRB is registered with ORHP: #IRB00001217