{"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":"<h2><strong>Overview<\/strong><\/h2>\n<p>The Human Subjects Division (HSD) is a service and compliance unit within the University of Washington Office of Research. HSD\u2019s roughly 40 staff members manage the UW\u2019s 3 Institutional Review Boards (IRBs) which include UW faculty and staff as well as community members. HSD and the IRBs are the core of the UW\u2019s Human Research Protection Program which ensures institutional compliance with federal and state regulations and UW policies. In this role, HSD also operates the UW\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<p>There are about 9200 open active human research studies at the UW, distributed across almost every department and academic unit and with a significant percentage of UW research occurring outside of the United States (U.S.). UW 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<h2><strong>Compliance Statement and FWA<\/strong><\/h2>\n<p>A downloadable version of this <a href=\"https:\/\/www.washington.edu\/research\/forms-and-templates\/compliance-statement\/\">Compliance Statement<\/a> is also available.<\/p>\n<p>As described in University of Washington (UW) Executive Order Number 24, and in UW\u2019s <a href=\"https:\/\/www.washington.edu\/research\/glossary\/federalwide-assurance-fwa\/\" target=\"_blank\" rel=\"noopener noreferrer\">Federalwide Assurance (FWA)<\/a>, UW and its IRBs are guided by the ethical principles in the Belmont Report. In addition, UW HSD and the UW 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<p>The UW 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<p>UW 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 UW may be covered by the UW FWA only with written agreement of commitment to relevant human subject protection policies and UW IRB oversight.<\/p>\n<p>The University of Washington IRB is registered with OHRP and FDA and its FWA is approved by OHRP and applies to all of UW\u2019s IRBs. The UW\u2019s FWA information is listed below and on the <a href=\"https:\/\/ohrp.cit.nih.gov\/search\/search.aspx?styp=bsc\" target=\"_blank\" rel=\"noopener noreferrer\">OHRP website<\/a>.<\/p>\n<p>Institution Name on FWA: <strong>U of Washington<\/strong><br \/>\nFWA: <strong>FWA00006878<\/strong><br \/>\nExpiration date: <strong>02\/12\/2031<\/strong><br \/>\nRegistered IRBs:<\/p>\n<ul>\n<li>IRB00000241 \u201cIRB A\u201d<\/li>\n<li>IRB00000727 \u201cIRB D\u201d<\/li>\n<li>IRB00005647 \u201cIRB J\u201d<\/li>\n<\/ul>\n<p>The UW and its IRBs are not accredited with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). A completed AAHRPP Evaluation Checklist can be provided upon request.<\/p>\n<p>UW\u2019s HSD is routinely audited by OHRP, FDA, UW internal audit and others. Our most recent routine federal audit conducted by the FDA in 2023 resulted in no findings.<\/p>\n<h2><strong>HRPP\/IRB Contact Information<\/strong><\/h2>\n<p>Please refer to our <a href=\"https:\/\/www.washington.edu\/research\/hsd\/hsd-contact\/\" target=\"_blank\" rel=\"noopener noreferrer\">Contact HSD<\/a> page for a complete list.<\/p>\n<p><strong>IRB Office General Questions\u00a0<\/strong>Human Subjects Division<br \/>\n206.543.0098 (voicemails only)<br \/>\n<a href=\"mailto:hsdinfo@uw.edu\">hsdinfo@uw.edu<\/a><br \/>\nBox 359470, University of Washington<br \/>\nSeattle, WA 98195-9470<\/p>\n<table>\n<tbody>\n<tr>\n<th>Question Type<\/th>\n<th>Contact Information<\/th>\n<\/tr>\n<tr>\n<td><strong>Single IRB and External IRB Contact<\/strong><\/td>\n<td>Reliance Team<br \/>\n206.543.0098 (voicemails only)<br \/>\n<a href=\"mailto:hsdrely@uw.edu\">hsdrely@uw.edu<\/a><\/td>\n<\/tr>\n<tr>\n<td><strong>Reporting and Compliance<\/strong><\/p>\n<p><strong>Subject Inquiries<\/strong><\/td>\n<td>Regulatory Affairs Team<br \/>\n206.543.0098 (voicemails only)<br \/>\n<a href=\"mailto:hsdreprt@uw.edu\">hsdreprt@uw.edu<\/a><\/td>\n<\/tr>\n<tr>\n<td><strong>Primary HRPP\/IRB Contact <\/strong><br \/>\n<strong>(Human Protections Administrator)<\/strong><\/td>\n<td>Jason Malone, MPA, CIP, Director<br \/>\n206.543.7246<br \/>\n<a href=\"mailto:jmmalone@uw.edu\">jmmalone@uw.edu<\/a><\/td>\n<\/tr>\n<tr>\n<td><strong>Institutional Official<\/strong><\/td>\n<td>Mandy Morneault<br \/>\nAssistant Vice Provost for Research Integrity<br \/>\nBox 351202, Gerberding Hall G80<br \/>\nSeattle, WA 98195<br \/>\n206.221.7298<br \/>\n<a href=\"mailto:vicka@uw.edu\">vicka@uw.edu<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><strong>Hours of Operation<\/strong><\/h2>\n<p>Monday &#8211; Friday, 8am \u2013 5pm (Pacific). HSD is closed on <a href=\"https:\/\/hr.uw.edu\/time-absence\/holidays\/calendar\/\" target=\"_blank\" rel=\"noopener noreferrer\">University recognized holidays<\/a>.<\/p>\n<h2><strong>UW IRBs<\/strong><\/h2>\n<p><strong>What is an IRB meeting.<\/strong> These are meetings at which the full convened IRB committee reviews and takes actions on IRB applications.<\/p>\n<p><strong>IRB schedule, composition, and expertise.<\/strong> UW operates 3 IRBs. Each convened IRB meets every other week; contact <a href=\"mailto:hsdinfo@uw.edu\">hsdinfo@uw.edu<\/a> if you need a specific meeting date. IRB members are drawn from UW faculty and staff as well as unaffiliated community members within the greater Seattle metropolitan area and beyond.<\/p>\n<p><strong>IRB meeting agendas.<\/strong> Applications are placed on a meeting agenda only after HSD staff have assessed them, to ensure that they are clear and contain all necessary information. This is called the screening or pre-review process. HSD policy requires materials to be provided to the IRB members at least 5 workdays in advance of the meeting.<\/p>\n<h2><strong>Diversity, equity, and inclusion<\/strong><\/h2>\n<p>The oversight of human subjects research and protection of research participants is strongest and most successful when performed in an open culture and framework that values and embodies diversity, equity, and inclusion. The Human Subjects Division expects its leaders, supervisors, staff, and IRB members to be guided by this fundamental principle. The HSD community flourishes when a diverse group of people from all backgrounds, ethnicities, and identities work together to fulfill its mission.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Overview The Human Subjects Division (HSD) is a service and compliance unit within the University of Washington Office of Research. 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