The US Nuclear Regulatory Commission (NRC) is responsible for regulating the use of most radioactive materials and the PA Department of Environmental Protection (DEP) is responsible for regulating the use of radiation producing equipment including x-ray machines, x-ray diffraction units, electron microscopes, and some radioactive material. The University of Pennsylvania has applied for and been granted licenses by the NRC and DEP to use radioactive material and x-ray producing equipment. Affiliated institutions, including Children's Hospital of Philadelphia operate under these licenses. As a licensee, the University of Pennsylvania must follow the applicable NRC and DEP regulations as well as any specific procedures stated in either license. Copies of regulations and the NRC and DEP licenses are available for review in the 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.

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.

The Radioactive Drug Research Committee (RDRC) is a subcommittee of the University of Pennsylvania’s RSC. 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.

• 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.

RDRC membership will include at least five members including specialists in nuclear medicine, radiopharmacy, radiation safety and dosimetry as well as representatives from other relevant disciplines. In addition, individuals with expertise in other areas may be requested to assist in the review of certain protocols. Members are appointed by the Vice Provost for Research.

1. 21 CFR 361.1 Research Protocols

Human research protocols involving radioactive drugs without either a) a New Drug Application (NDA) filed with the FDA or b) an approved Investigational New Drug (IND) application or c) an IND Exemption may be subject to review by the RDRC in compliance with 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.



2. Other Research Protocols

As a subcommittee of the RSC, the RDRC is also authorized to consider human research protocols that involve use of radioactive drugs that are FDA approved, radioactive drugs with an approved IND application issued by the FDA or any other use of ionizing radiation in which the subject is receiving the radiation exposure only because they are enrolled in the research study.

Meeting dates are typically scheduled on the third Friday of every month. The RDRC members vote on each protocol reviewed at the meeting. Any member having involvement in a protocol or some other conflict of interest must leave the room during final discussion of the protocol and also must abstain from voting on it. For each protocol, members may vote to do the following:

1. Approve unconditionally;



2. Approve pending require minor changes in the protocol which may be approved with review by the Radiation Safety Officer;



3. Defer, requiring substantial or major changes or more information which will be reviewed at another committee meeting;



4. Disapprove.