Use of Radiation in Human Subjects Research

The Radiation Safety Committees of both the UW and Seattle Cancer Care Alliance 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

Click here to complete an application.

  • The HSRAC does not meet to discuss applications.
  • Applications are reviewed in the order they are submitted, on a rolling basis.
  • The usual turnaround time is between 10 and 15 business days.
  • The timeline for approval is provided in the HSRAC Process Map.
  • Applications must be renewed annually, concurrent with IRB renewal.

Contact

EH&S Radiation Safety

(206) 543-0463