...

• 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)

...