Human Subjects Research
Web-based Institutional Review Board (IRB) application system
The UW uses a web-based system called Zipline for IRB applications and for requesting HSD determinations (such as “not human subjects research” determinations). 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
The general help email address is email@example.com. 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. 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 TOL. 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.
Study setup issues and activities may include:
Do you need IRB approval?
Some activities that you may consider to be human subjects research do not meet the regulatory definition of “human subjects research” – and vice versa. If you are not sure whether your planned research is “regulated human subjects research”, see this guidance. It is important to start at the beginning of the guidance and work your way through the issue in the order they are presented. Otherwise, you may come to an inaccurate conclusion.
Most UW human subjects research is reviewed by the UW IRB. Exceptions: Most UW industry-initiated studies are reviewed by WIRB or Advarra instead of the UW IRB; most UW oncology studies that are greater than minimal risk are reviewed by the Fred Hutchinson Cancer Research Center (FHCRC) instead of the UW IRB. NIH funded, multi-site studies may be reviewed by another IRB. See this summary Guidance for basic information.
Multi-site or collaborative research
Sponsors are increasingly likely to require the involved institutions to rely upon a single IRB. These arrangements may require HSD to establish IRB reliance agreements with the other institutions.
before conducting any human subjects research or spending any research funding on such activities. Use the IRB Protocol form. Explanatory information and guidance is provided with each question.
Certificate of Confidentiality
A federal certificate of confidentiality allows researchers to refuse to disclose name or any information, documents or biospecimens containing identifiable information about the research subjects. Review Certificate of Confidentiality guidance.
Standard UW consent template
Most studies that will obtain consent from subjects should use the standard UW consent template.
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 (for example, side effects from a study drug).
Register clinical trials
Studies that meet the definition of “clinical trial” must register at ClinicalTrials.gov. See this Guidance for more information. Registration must occur within 21 days after the first subject is enrolled, but can occur earlier if the study design and study protocol have been established.