UW Research

Human Subjects Research

General Information

Activities that meet the regulatory definition of human subjects research require either IRB review or a determination of exempt status. The Human Subjects Division (HSD) is responsible for ensuring institutional compliance with federal and state regulations and UW policies that govern research with human subjects. Executive Order No. 24 is the general UW policy about human subjects research.

Institutional Review Board (IRB) Application System

The UW uses Zipline, a web-based system for:

  • Submitting IRB applications
  • Requesting HSD determinations (e.g., ‘Not Human Subjects Research’)

Requirements:

  • A valid UW NetID is required to access Zipline.
  • New users must register before using the system.

Resources:

How to Get Help

Email: Contact hsdinfo@uw.edu (monitored during weekday business hours).

Review Team Contacts
HSD has three review teams supporting UW’s three IRB committees, plus a team specializing in IRB reliance and Single IRB arrangements. Each department is assigned to a specific team. Visit Contacts to find your team and email address (e.g., hsdteama@uw.edu).

Phone: Call 206-543-0098 to leave a voicemail; an HSD staff member will return your call.

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.

Policies, Procedures and Guidance