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IRB and RSC Review of Research Protocols Using Radiation and Radiation Dosimetry Calculations for NIH protocols

Protocols will require RSC review (or RDRC if applicable) if it meets any of the following criteria (this will be provided as a checklist in

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PROTECT):

• Uses a radioactive research drug(s) regulated under the FDA requirements for review by the Radioactive Drug Research Committee (RDRC)
• Involves the use of any radiation in pediatric participants (<18 years old) with an annual effective dose >0.5 rem or healthy pediatric volunteers (any dose level)
• Uses any radiation in healthy adult volunteers, excluding DEXA and chest X-Ray
• Uses therapeutic administration of radioactive materials (Examples include therapeutic use of I-131, Lu-177, Y-90, Th-227, Ra-223, or Ir-192 permanent seed implants. The following would be excluded from required RSC review: Use of linear accelerator such as total body irradiation or high dose-rate afterloader such as brachytherapy for breast or prostate cancer.)
• Involves novel uses of radiation, including any radioactive Investigational New Drugs (IND) and radiation-producing investigational devices
• The radiation itself is the research agent being studied in the protocol (For example: the protocol compares the effectiveness of 2 different doses of radiation therapy; comparison of the effectiveness of drug X vs drug X + radiation therapy; study of the uptake and biodistribution of a novel radioactive tracer)

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