The Radioactive Drug Research Committee (RDRC) reviews and approves research investigations conducted at Washington University that involve the administration of radioactive drugs to human subjects (see exception below). 

The Committee’s preeminent objective is to ensure that the studies involving radioactive drugs are scientifically sound and are conducted safely and result in radiation exposures no greater than necessary to fulfill the scientific objectives of the research. The range of studies reviewed include those specifically authorized under 21 CFR 361.1, those involving radioactive drugs under Investigational New Drug exemption (IND), and those involving on-label or off-label uses of FDA-approved radioactive drugs as part of the research.

The types of reviews conducted by the Committee can be grouped into two general categories:  Administrative Review by RDRC; and Full Review by RDRC.  Details specific to the review process in each category are described in this website. For a protocol that will undergo administrative review by the RDRC, the responsible investigator must submit a completed abbreviated application form, “Application For Use of Standard Nuclear Medicine Procedures In Research Investigations Involving Human Subjects” .  For applications that will undergo full-committee review by the RDRC, the more detailed form, “Application For Use of Radioactive Drugs In Investigations Involving Human Subjects”, must be used.  Additional documents that need to be submitted along with the application form are specified on these forms. 

Currently, there are two exceptions to RDRC review as follows:

  1. Studies that involve only standard diagnostic nuclear medicine tests as part of the research in subjects with less than 5-year life expectancy.
  2. Multicenter studies that will be reviewed and approved by a central institutional review board, other than the Washington University IRB, that involve only standard diagnostic nuclear medicine tests as part of the research.

In these cases, the RDRC Chair will review the protocol and consent form when it is submitted via MyIRB to confirm that the conditions for exemption are met, upon which the investigator and the Human Research Protection Office (HRPO) will be notified that no RDRC application is necessary.