THE OFFICE OF RESEARCH

RESEARCH INVESTIGATOR HANDBOOK

3. OBTAINING REGULATORY COMMITTEE APPROVALS

3.6 Working with Radioactive Materials in Humans

• What committees review the use of radioactive materials in human research?
• Whom do I contact?
• What approvals do I need to use radioactive materials in human subjects?
• What resources and training are available?
• Top tips to speed up the approval process and prevent problems
• Relevant policies and procedures

What committees review the use of radioactive materials in human research?

There are three regulatory committees at UCSF for the review of research using radioactive materials in human subjects. First, the Committee on Human Research (CHR) reviews all research involving human subjects. In addition to CHR approval, your research must also be reviewed for approval by one of two following committees.

If the human research is for the diagnosis or treatment of disease in patients and involves exposure to radioisotopes or ionizing radiation other than the exposure inherent in standard care, the Radiation Safety Committee must also review your proposal.

If the research uses a radioisotope in human subjects to study pharmacokinetics or basic physiology (as opposed to using a radioisotope to treat or diagnose disease), then the Radioactive Drug Research Committee (RDRC) must also review the research.

The Food and Drug Administration mandates that the RDRC:

•	Review study design and appropriateness of the research protocol
•	Impose limits on radiation-absorbed doses
•	Impose limits on the amount of the drug administered

Whom do I contact?

Contact the Campus Radiation Safety Officer at 476-5303 for initial guidance. For applications, forms, and instructions visit the Technical Committees website, email the RDRC, or call the RDRC committee coordinator at 476-2198.

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What approvals do I need to use radioactive materials in human subjects?

Approvals:

•	Committee for Human Research (CHR): You always need CHR approval for research involving human subjects. Routine clinical use does not require CHR approval.
•	Radiation Safety Committee (RSC): you always need RSC approval for research involving use of radioisotopes. See Working with Radioactive Materials in this guide.
•	Radioactive Drug Research Committee (RDRC): you always need RDRC approval for research involving pharmacokinetics or basic physiology with radioisotopes.

Expiration Date: The RDRC approval expires one-year from the approval date. Your study must be approved for renewal prior to expiration. If the study expires, you must stop human subjects research and notify the RDRC and the CHR. Your study can resume once you have applied for and obtained RDRC and CHR approval.

Modifications: As with any human research study, any modification to the study requires prior review and approval before implementation.

Additional Approvals: The CHR must approve all human subjects research at UCSF and the CHR approval is required before the RDRC will grant approval. For details on authorizations needed to work with radioactivity refer to the Working with Radioactive Materials in the Quick Guide.

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What resources and training are available?

•	Contact the Campus Radiation Safety Officer at 476-5303 for guidance on what approvals you will need and help with completing your applications.
•	The radiation safety group will inspect, provide guidance, and assist in material handling and waste management.
•	OEH&S provides the following:
	- waste disposal services; - safety training for Researchers, Radiation Safety, and/or other specialized training; and - a Radiation Safety Training Manual
•	Guidance for the medical centers is in the Radiation Protection Handbook.

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Top tips to speed up the approval process and prevent problems

•	Be sure to describe the actual radioactive dosage that is received by the subject in your application to the RDRC. Also, accurately compute radiation dosimetry.
•	Be sure that your informed consent document states the actual dosage received by the subject.
•	Attach a copy of your approved CHR protocol and consent form to your RDRC application.
•	Allow enough time for RDRC to review your application and for your response to their concerns.
•	Do not include more subjects in the study than are approved by the committee, unless you obtain prior approval (modification request) to do so.

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Relevant Policies and Procedures