HERC | Human Exposure Review Committee

As a subcommittee of the Radiation Safety Committee, this committee reviews all uses of radioactive materials or radiation-producing equipment that result in exposure to human subjects. 

This subcommittee of the Radiation Safety Committee (RSC) reviews all uses of radioactive materials or radiation-producing equipment that result in exposure to human subjects.

Members are charged with assuring all such uses are within regulatory requirements, and that a net benefit results from the radiation exposure. Physiological studies which involve radioactive drug usage as defined in 21 CFR 361.1 are referred to the Radioactive Drug Research Committee for approval.

A quorum, necessary to conduct business, consists of 4 members to include the radiation safety officer. Meetings are held as necessary to review and conduct the business of the committee, with at least 1 meeting per calendar quarter.

Contact info: 858-822-2494   |   herc@ucsd.edu

 

Radiation Exposure Calculator


Ex officio Departments
Belezzuoli, Ernest (Chair) Radiology/ Nuclear Medicine
Langford, Scott Alternate RSO, Environment, Health & Safety
Singleton, Corey Radiation Safety Officer (RSO), Environment, Health & Safety
Appointed Departments
Hall, David Radiology
Kim, Grace Radiation Medicine
Pichika, Rama Radiology
Rice, Roger Radiation Medicine
Scanderberg, Daniel Radiology
Theilmann, Rebecca Radiology
Yen, Andrew Radiology

 

 

IRB Research Plan Requirements

In each protocol that involves the use of radiation - whether therapeutic or diagnostic scan(s) - requires an outline of the proposed use of radiation in the HRPP Research Plan [Section 14: Potential Risks ].

Use the Radiation exposure calculator to compute the total Effective Dose Equivalent for your study. Enter the appropriate scans and click [Create Statement] and a worksheet for computation of total Effective Dose Equivalent will be provided. For assistance on using the Dose Calculator, contact herc@ucsd.edu


Tips for including the use of radiation in your protocol. The following pieces of information are required in the Radiation Exposure Section:

  • An itemized list of each type of scans showing the total for the first and each subsequent year of participation.
    • Example:
      • Year 1: 7(including screening) chest/abdomen/pelvis CTs (13mSv /scan) = 91mSv
      • Year 2: 6 chest/abdomen/pelvis CTs (13mSv/scan) = 78mSv
      • Frequency is every other cycle. Each cycle is 30 days.
  • If there are different types of scans (i.e. MUGA, chest x-ray, PET/CT, etc.), they should all be itemized to show a total radiation exposure of the first and each subsequent year of participation.
  • All diagnostic radiation exposures must show units in milliSivert (mSv).
  • If there are radiation therapy in the protocol additional language and radiation dose will need to be added after the diagnostic section.
    • Example:
      • In addition, as a participant of this protocol you will undergo radiation therapy with an overall dose of 28.5Gy in 5 fractions of 5.7Gy each.

Consent Form Requirements

Below is the HERC consent form language. The areas highlighted in yellow will need to be modified for the needs of each protocol:

Scenarios that require additional language changes to the consent:

  • If the protocol is a multi-year study the radiation language should show the total exposure for the first and each additional year of participation.
  • If a non-radiation procedure is an optional, add the following language to the second paragraph after the first sentence:
    • Radiation exposure may be decreased if non-radiation imaging alternatives are utilized, such as ECHO instead of MUGA and/or an MRI instead of a CT.
  • If radiation therapy is in the protocol, then additional language will need to be added. This should go after the consent statement:
    • Example:
      • In addition, as a participant of this protocol you will undergo radiation therapy with an overall dose of 28.5Gy in 5 fractions of 5.7Gy each.

Radiation Exposure Calculator

If you should need additional information or have questions, please contact HERC at 858-822-2494" or via email herc@ucsd.edu

Last updated: 19 Sep 2019