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RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC) OVERVIEW

USE OF RADIOACTIVE MATERIAL AND RADIATION PRODUCING EQUIPMENT AT THE UNIVERSITY OF PENNSYLVANIA

In Pennsylvania, the Department of Environmental Protection (DEP) is responsible for regulating both the use of radioactive materials and radiation producing equipment such as x-ray machines and linear accelerators.  The University of Pennsylvania, including the Health System, has been granted multiple licenses by the DEP to use radioactive material and radiation producing equipment. Affiliated institutions, including the Children's Hospital of Philadelphia operate under these licenses. As a licensee, the University of Pennsylvania must follow the applicable DEP regulations as well as any specific procedures stated in the licenses. Copies of regulations and the DEP licenses are available for review in the Office of Environmental Health and Radiation Safety (EHRS).

OFFICE OF ENVIRONMENTAL HEALTH AND RADIATION SAFETY (EHRS)

The Office of Environmental Health and Radiation Safety (EHRS) is an administrative unit of the University of Pennsylvania which is responsible for the ensuring that radiation producing equipment and radioactive material is used safely and in accordance with applicable regulations. EHRS is also responsible for ensuring that doses to employees and research subjects are maintained As Low As Reasonably Achievable (ALARA). EHRS provides administrative and technical assistance to the Radiation Safety Committee and the Radioactive Drug Research Committee.

RADIATION SAFETY COMMITTEE

The Radiation Safety Committee (RSC) has been established and charged by the Vice Provost for Research to develop and administer of the radiation safety program at the University of Pennsylvania and affiliated institutions. It establishes policies and enforces compliance with the program. The RSC has the authority and responsibility for approval of all proposals for radioactive material and/or radiation producing equipment use. The RSC meets on at least a quarterly basis.

RADIOACTIVE DRUG RESEARCH COMMITTEE

The RDRC reviews certain research protocols involving radiopharmaceuticals as required by FDA regulations (21 CFR 361.1). The RDRC also reviews all other human research protocols involving administration of ionizing radiation to subjects solely as a result of participation in a research study.

Any protocol submitted to the RDRC is also required to receive Institutional Review Board (IRB) approval. IRB approval is contingent upon RDRC review and approval. For protocols undertaken at the University of Pennsylvania, the Office of Research Regulatory Affairs will ensure the coordination of review by these committees. Any revisions or modifications required by the RDRC must be incorporated into the protocol before final, full approval by the IRB will be granted. Affiliated institutions, such as the Children’s Hospital of Philadelphia will follow a similar procedure.

RDRC Responsibilities

  • Review, approve, request modification or clarification or defer approval of human research protocols involving the administration of ionizing radiation to subjects solely because they are involved in a research study.
  • Document meeting minutes including voting results.
  • Communicate voting results and comments to the Principal Investigator.
  • Submit an annual report to the FDA as required by 21 CFR 361.1.
  • Maintain approval by the FDA and ensure compliance with 21 CFR 361.1.