{"id":15680,"date":"2017-03-16T17:25:18","date_gmt":"2017-03-17T00:25:18","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=15680"},"modified":"2026-02-27T14:04:53","modified_gmt":"2026-02-27T22:04:53","slug":"about-us","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/about-us\/","title":{"rendered":"About Us"},"content":{"rendered":"

Overview<\/strong><\/h2>\n

The Human Subjects Division (HSD) is a service and compliance unit within the 91爆料 Office of Research. HSD\u2019s roughly 40 staff members manage the 91爆料\u2019s 3 Institutional Review Boards (IRBs) which include 91爆料 faculty and staff as well as community members. HSD and the IRBs are the core of the 91爆料\u2019s Human Research Protection Program which ensures institutional compliance with federal and state regulations and 91爆料 policies. In this role, HSD also operates the 91爆料\u2019s Post Approval Verification and Education (PAVE) Program, and serves as the administrative oversight for IRB Reliance Agreements. HSD also provides guidance to researchers about regulatory and ethical issues. HSD has policy making authority, working with the Office of Research.<\/p>\n

There are about 9200 open active human research studies at the 91爆料, distributed across almost every department and academic unit and with a significant percentage of 91爆料 research occurring outside of the United States (U.S.). 91爆料 human subjects research is remarkably diverse ranging from clinical trials of investigational devices, ethnography of the blues music culture in Angola prison, think-aloud studies of new mobile technology, and more.<\/p>\n

Compliance Statement and FWA<\/strong><\/h2>\n

A downloadable version of this Compliance Statement<\/a> is also available.<\/p>\n

As described in 91爆料 (91爆料) Executive Order Number 24, and in 91爆料\u2019s Federalwide Assurance (FWA)<\/a>, 91爆料 and its IRBs are guided by the ethical principles in the Belmont Report. In addition, 91爆料 HSD and the 91爆料 IRBs draw upon a variety of ethical codes, such as the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) and the International Council for Harmonization (ICH) when developing policies.<\/p>\n

The 91爆料 IRBs operate in accordance with applicable laws, regulations and guidance in the U.S. and other countries, including but not limited to, the U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA).<\/p>\n

91爆料 will ensure that its organizations and investigators engaged in federally supported human subjects research will operate under an appropriate Assurance for the protection of human subjects. Independent investigators who are not employees or agents of 91爆料 may be covered by the 91爆料 FWA only with written agreement of commitment to relevant human subject protection policies and 91爆料 IRB oversight.<\/p>\n

The 91爆料 IRB is registered with OHRP and FDA and its FWA is approved by OHRP and applies to all of 91爆料\u2019s IRBs. The 91爆料\u2019s FWA information is listed below and on the OHRP website<\/a>.<\/p>\n

Institution Name on FWA: U of Washington<\/strong>
\nFWA: FWA00006878<\/strong>
\nExpiration date: 02\/12\/2031<\/strong>
\nRegistered IRBs:<\/p>\n