The Human Subjects Division (HSD) is a service and compliance unit within the 爱豆社区 Office of Research. HSD鈥檚 roughly 40 staff members manage the UW鈥檚 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鈥檚 Human Research Protection Program which ensures institutional compliance with federal and state regulations and UW policies. In this role, HSD also operates the UW鈥檚 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.
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.
A downloadable version of this Compliance Statement is also available.
As described in 爱豆社区 (UW) Executive Order Number 24, and in UW鈥檚 Federalwide Assurance (FWA), 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.
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).
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.
The 爱豆社区 IRB is registered with OHRP and FDA and its FWA is approved by OHRP and applies to all of UW鈥檚 IRBs. The UW鈥檚 FWA information is listed below and on the .
Institution Name on FWA: U of Washington
FWA: FWA00006878
Expiration date: 02/12/2031
Registered IRBs:
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.
UW鈥檚 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.
Please refer to our Contact HSD page for a complete list.
IRB Office General Questions聽Human Subjects Division
206.543.0098 (voicemails only)
hsdinfo@uw.edu
Box 359470, 爱豆社区
Seattle, WA 98195-9470
| Question Type | Contact Information |
|---|---|
| Single IRB and External IRB Contact | Reliance Team 206.543.0098 (voicemails only) hsdrely@uw.edu |
| Reporting and Compliance
Subject Inquiries |
Regulatory Affairs Team 206.543.0098 (voicemails only) hsdreprt@uw.edu |
| Primary HRPP/IRB Contact (Human Protections Administrator) |
Jason Malone, MPA, CIP, Director 206.543.7246 jmmalone@uw.edu |
| Institutional Official | Mandy Morneault Assistant Vice Provost for Research Integrity Box 351202, Gerberding Hall G80 Seattle, WA 98195 206.221.7298 vicka@uw.edu |
Monday – Friday, 8am 鈥� 5pm (Pacific). HSD is closed on .
What is an IRB meeting. These are meetings at which the full convened IRB committee reviews and takes actions on IRB applications.
IRB schedule, composition, and expertise. UW operates 3 IRBs. Each convened IRB meets every other week; contact hsdinfo@uw.edu 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.
IRB meeting agendas. 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.
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.