Radiation Exposure Risk Statements

1. Go to My Research Safety.
2. Click the Radiation Risk Calculator tab.
3. Follow instructions to enter your data. The calculator guides you through the process of accounting for the studies in your protocol.
   • Account for:
     • Only the first 12 months in your calculations and explanations of risk if a study runs longer than 12 months or for multiple years
     • Exposure to radiation from imaging studies considered standard of care, including those that would be done even if the participant were not taking part in a research protocol.
4. Click Create Statement and the calculator will generate:
   • Total exposure for the mix of studies entered
   • A risk statement explaining that exposure

When submitting a new project application, explanations of radiation exposure must appear on the 2 forms below. Copy and paste appropriate portions of the risk statement generated by the calculator into the correct sections of each form as follows:

1. UCSD Human Research Protections Program (HRPP) New Biomedical Application Research Plan (Word file): Place risk statement information in Section 13, Potential Risks. Section 13 requires a detailed accounting of what is proposed.
   • Include a summation of the examinations to be used, noting the exposure in millisieverts (mSv) that is calculated.
   • Note: If there is the possibility of other required studies based on clinical situations that arise, summarize and include an explanation of why they may be needed.
2. Informed Consent Assistant: Using the HRPP Consent Assistant, place risk statement information in the "Risks reasonably to be expected" section.

• Important: Copy and paste as much as possible from the risk statement generated by the calculator. When a unique situation demands departure from calculator-supplied wording, the researcher must provide, on the 2 forms above, an accurate description of what will most likely take place.
  • Read below for when you must explain unique situations by composing your own explanation of the risks of radiation exposure.

Deriving an explanation of exposure and risk is not always easy. For example, a protocol may call for an imaging study based on the clinical judgment of the investigator or attending physician, so the study may or may not be performed.

For unique situations:

• Write your own explanation of the risks of radiation exposure.
• Read examples that demonstrate how to handle 3 situations other researchers have encountered, ranging from an uncomplicated protocol to a more complex situation.
• Follow the guidelines below:
  • Keep it simple, using wording and comparisons customary at UCSD.
  • Reference all exposure statements to typical yearly background radiation in San Diego, which is given as 1.6 mSv.
    • Do not make statements comparing the amount of radiation to some percentage of background or a number of cross-country plane flights.
  • Calculate your radiation exposure estimates for both "typical" and "worst case" scenarios when computing exposure from studies to be performed where the actual number of studies is not definite.