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Human Research Involving the Use of Ionizing Radiation

Any human research protocol involving the administration of ionizing radiation to subjects solely as a result of their participation in the protocol must be reviewed and approved by one of the two Committees below.  These Committees will only review protocols that have been formally submitted to the Institutional Review Board (IRB) via the HS ERA system.  

RADIATION RESEARCH SAFETY COMMITTEE (RRSC)

The Radiation Research Safety Committee (RRSC) reviews most research protocols involving ionizing radiation exposure to subjects solely as a result of participation in the research protocol.  

The RRSC also reviews research protocols for affiliated institutions, such as the Children’s Hospital of Philadelphia, Pennsylvania Hospital and Penn Presbyterian Medical Center.

RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC)

In certain situations, human research protocols involving the use of radiopharmaceuticals may be reviewed by the Radioactive Drug Research Committee (RDRC).  However, the criteria for reviewing protocols under the RDRC is very specifically defined by the FDA regulations in 21 CFR 361.1.  

To be eligible for review by the RDRC under 21 CFR 361.1, a protocol must:

  • Involve certain radioactive compounds generally recognized as safe and effective;
  • Be designed to use the radioactive compound to obtain basic information regarding the metabolism of the compound or regarding human physiology, pathophysiology, or biochemistry; 
  • Not be intended for immediate therapeutic or diagnostic use;
  • Not propose to determine the safety and effectiveness of the drug (i.e., to carry out a clinical trial);
  • Not be designed as part of the routine medical management of patients with a particular condition.

The RDRC also reviews research protocols for affiliated institutions, such as the Children’s Hospital of Philadelphia, Pennsylvania Hospital and Penn Presbyterian Medical Center.

If you have any questions, please contact:
William Davidson
215 898 2133
wed@ehrs.upenn.edu