Human Subjects and Radiation
Review of Human Subjects Protocols Involving Radiation
All human subjects research that will expose people to ionizing radiation must be reviewed and approved by the University of Arizona Radiation Safety Committee Human Use Subcommittee (HUS). All ionizing radiation exposure for research purposes must be evaluated to determine the risks posed to research subjects and to ensure that research subjects are informed of radiation risks associated participation in a clinical trial. Approval from the HUS and the Institutional Review Board (IRB) is required before research involving radiation, or changes to research resulting in increased radiation exposure to participants, may be initiated.
The HUS evaluates the “research use” of radiation in human subjects including the following:
- Radiologic procedures that are administered solely for experimental or research purposes (i.e., would not otherwise be administered)
- Standard of care procedures that are being altered as part of research
- Radiologic procedures that are administered in addition to those that the participant would receive as part of standard medical care
- Use of an investigational radiologic device
- Use of radiologic procedures when these procedures are the subject of the investigation (e.g., comparison of radiotherapy delivery methods or imaging methods)
The HUS does not routinely review research involving radiologic exams or procedures administered for non-research purposes (i.e., performed as part of standard medical care). If the subject would receive a procedure (or scan) if they were not enrolled in the study, it is considered standard of care. All other procedures would be considered research.
The HUS does not review investigational use of new non-FDA approved radiopharmaceuticals. It will defer to the licensee’s Radioactive Drug Research Committee.
Submission
Research submitted for IRB review will be screened by the Human Subjects Protection Program (HSPP) to determine if HUS review is also required. If HUS review is required, HSPP will direct the Principal Investigator to forward relevant materials to the HUS including, but not limited to:
- Study Protocols,
- Consent and/or Assent Documents
A Principal Investigator may submit the relevant materials directly to the HUS prior to submission to the IRB.
- Submit the information by email to rlss-rad-support@email.arizona.edu
- Applications are reviewed in the order they are received.
- The study coordinator may be contacted to provide clarification or additional information after initial review.
- Review is normally completed in 10 to 15 business days but can take longer if additional information is required for review.
- A decision letter will be distributed to the Principal Investigator, study coordinator, and the Human Subject Protection Program.
Risk Communication
The content of the patient consent form must follow the requirements of the HUS and the IRB. Risk information related to the patient's exposure from the radiation procedures must be understandable by the patient. Model risk language is available from the HUS for use by the Principal Investigators. Protocols may use alternate risk language with approval from the HUS.
Questions or Assistance
Contact Leon Harris at (520) 626-5468 or rlss-rad-support@email.arizona.edu if you have questions or require more information about HUS review.
Information on human subjects in research is available on the Human Subjects Protection Program website.