The Radiation Safety Committees of both the UW and Fred Hutch Cancer Center (FHCC) are charged with ensuring radiation is used safely in their facilities, for both patients and employees. To prevent redundancy and increase efficiency, the Human Subjects Radiation Approval Committee (HSRAC) functions as a centralized body to review and approve applications to use radiation in human subjects research. The HSRAC consists of physicians and physicists who serve as subject matter experts and advise the program administrator from UW Radiation Safety. Our goal is to ensure research subjects are informed of the radiation risks involved in clinical trial participation.
What you need to know
All human subjects research that will expose people to radiation levels above standard-of-care imaging or therapy require HSRAC review, in addition to the review conducted by an Institutional Review Board (IRB). This includes studies where the only research scan is at baseline or initial screening.
Two guidelines determine if a procedure is research or standard of care:
- Who is paying for the scan? If it is being paid for by the study, then it is most likely research. If health care insurance or Medicare is paying for the scan, it is standard-of-care.
- Would this subject receive this procedure (or scan) at this point in time if they were not enrolled in the study? If the answer is no, it is research.
There are exceptions, but most of the time a study will fit these guidelines.
How to apply
Download the HSRAC Application Form to begin an application.
Submit a completed and signed HSRAC Application Form to hsrac@uw.edu along with the following documentation:
- Study Protocol
- Informed Consent Forms
- Institutional Review Board application or approval
- Other pertinent information, such as an FDA Form 1572 if the study involves a radioactive Investigational New Drug or Investigators Brochures.
Please note:
- Applications are reviewed in the order they are submitted, on a rolling basis.
- The usual turnaround time is between 10 and 15 business days.
- Applications must be renewed annually, typically concurrent with IRB renewal.
Please contact the HSRAC team at hsrac@uw.edu with any questions.
Emergency Response and Reporting
UW personnel are required to submit an incident report to Environmental Health & Safety for any work-related event that results in an injury, illness, exposure to hazardous materials, property damage, or fire, regardless of the work location. UW personnel are highly encouraged to submit work-related near-miss events. Visit the Incident Reporting page for more information.