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:

• The Zipline Online Help Library provides tutorials and detailed instructions.

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.

Study Setup: Key Questions

Do you need IRB approval?

If you are not sure if your project requires IRB approval, review the guidance Do I Need IRB Review? from start to finish to avoid incorrect conclusions.

Our Getting Started webpage also provides answers to common questions.

Which IRB?

Most UW human subjects research is reviewed by the UW IRB. Exceptions:

• UW industry-initiated studies are reviewed by WCG IRB or Advarra
• UW oncology studies that are greater than minimal risk are reviewed by the Fred Hutchinson Cancer Center
• NIH funded, multi-site studies may be reviewed by another IRB

Review the summary guidance titled Reliance on a Non-UW IRB for basic information, as well as consulting Identify the Correct IRB.

Multi-site or collaborative research

Sponsors often require the involved institutions to rely upon a single IRB. HSD may need to establish IRB reliance agreements with the other institutions.

What training do I need to complete?

HSD only requires training for student and resident Principal Investigators (PIs). However, researchers who work with human subjects or with data or samples from humans may need to complete human subjects protections training to meet the requirements of their department, affiliated organizations, or funders.

For details about training expectations and available options, please see the Human Subjects Training webpage.

Additional Requirements

• Certificate of Confidentiality: Protects identifiable research data from disclosure, review the Certificate of Confidentiality guidance for more information.
• Research Consent: UW IRB provides guidance, templates, and examples to assist researchers with designing the consent process and forms.
• Injury Compensation: The UW has a discretionary compensation program to provide treatment for subjects who experience a medical injury or adverse event that is research-related.
• Data and Safety Monitoring Plan (DSMP): A DSMP is required by many sponsors and/or the IRB, especially if your study involves possible physical risks of harm to your subjects (e.g., side effects from a study drug).
• UW Diversity in Clinical Trials policy applies to clinical trials submitted to HSD for either UW IRB or external IRB review with some exceptions. The requirements of this policy will necessitate additional staff time and financial resources. It is important that you plan and budget for these.
• Clinical Trial Registration: Read our ClinicalTrials.gov page for more information.