Human Subjects Research
General Information
Visit the Human Subjects Division (HSD) website for information about all aspects of human subjects research. Executive Order No. 24 is the general UW policy about human subjects research.
Web-based Institutional Review Board (IRB) application system
The UW uses a web-based system called Zipline for all IRB applications and for requesting HSD determinations (such as “not human subjects research” determinations). A valid UW NetID is required to use Zipline, and new users must register with the system. The Zipline Online Help Library has online tutorials and detailed instruction documents.
How to obtain help
Help email
The general help email address is hsdinfo@uw.edu. It is monitored Monday through Friday during business hours.
Review team contacts
HSD has four review staff teams, each of which supports one of the UW’s four IRB committees, and one staff team that specializes in IRB reliance and Single IRB arrangements. Each department and academic unit is associated with a specific team and IRB. Visit Contacts to find your team and email contact (each team has an email address such as hsdteama@uw.edu).
HSD main office phone
You may also call the main office at 206-543-0098 to leave a voicemail and someone from HSD will contact you.
Human subjects issues during a study may include:
Obtaining IRB approval for study modifications
Almost all changes to the research must be approved in advance by the IRB via study modification.
Obtaining renewal of IRB approval
IRB approval for some studies is granted for a specific time period. IRB approval must be renewed before the IRB approval expiration date, if the study will continue past that date. Studies that do not have an expiration date are not required to renew IRB approval.
Reporting to the IRB
A wide variety of events and situations must be promptly reported to the IRB.
Reporting Safety/Compliance Events to Sponsors
The Office of Sponsored Programs (OSP) is responsible for completing any institutional obligations reporting safety/ compliance events to funding agencies or other study sponsors under the terms of any research award, subaward or contract managed through its office. For funding that is not managed through OSP, the Principal Investigator (PI) is responsible for completing any reporting obligations to the study sponsor(s).
The UW Human Subjects Division will notify the UW PI (and applicable relying site PI) of a reportable event in advance. This allows the researcher the opportunity to alert any sponsor prior to notification from OSP. The UW PI will be copied on any notification from OSP to the sponsor.
UW Lead PI for multi-site or collaborative research
If a UW Principal Investigator (PI) is the Lead PI for multi-site or collaborative research and the non-UW sites were reviewed by a non-UW IRB, the UW PI is responsible for ensuring and documenting that those non-UW sites obtain IRB approval for modifications, obtain renewals of IRB approval, and report relevant events to their IRBs. Failure to do so is considered noncompliance.
Update clinical trials registration record
Studies that meet the definition of “clinical trial” must register and then provide updates at least annually at ClinicalTrials.gov. Studies approved on or after January 21, 2019 must also upload a blank copy of a study consent form to a public federal website.