UW Research

Human Subjects Research

General Information

See 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, except older applications that HSD has determined may stay in paper format. A 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 8 AM to 5 PM, Monday through Friday.

Team Operations Lead (TOL)

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. The TOL of the team that works with your department is one of the best sources of help, guidance, and answers to questions. See Contacts to find out the name and contact information of your Team Operations Lead. The names and contact information for the other Team members are also available at this link.

HSD main office phone

You may also call the main office at 206-543-0098.

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.

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.

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 non-compliance.

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

Announcements

August 5, 2019
Human Subjects
March 4, 2019
Human Subjects
February 4, 2019
Human Subjects
January 16, 2019
Human Subjects