The Partners IRBs operate in compliance with all applicable regulations and guidelines pertaining to IRBs as listed below, and with the Federal Wide Assurance (FWA) and incorporated “Terms of the Federalwide Assurance for Institutions within the United States” held by the Partners entities.
Department of Health and Human Services (DHHS) 45 CFR Parts 46 and 164
Food and Drug Administration (FDA) 21 CFR Parts 50 and 56
International Conference on Harmonization (ICH) guideline E6 relating to Good Clinical Practice (GCP), section 3(3.1-3.4), unless ICH guidelines conflict with FDA Regulations
The following Partners entity-specific memos provide information for collaborators and sponsors about the entity’s FWA, registered IRBs and membership:
BWH Statement of Compliance
Faulkner Hospital Statement of Compliance
McLean Statement of Compliance
North Shore Medical Center Statement of Compliance
Spaulding Rehabilitation Hospital Statement of Compliance
The following links to the OHRP website allow sponsors and collaborators to review terms of the Federalwide Assurance and verify the IORG, FWA and IRB Registrations.
Terms of Federalwide Assurance of Protection for Human Subjects
Office for Human Research Protections (OHRP) Database for Registered IORGs &IRBs, Approved FWAs