About the Radioactive Drug Research Committee (RDRC)
The Joint Radioactive Drug Research Committee (JRDRC) of Weill Cornell Medicine (WCM) and NewYork Presbyterian Hospital (NYPH)
The RDRC is responsible for the review of research protocols involving investigational or non-routine clinical uses of radioactive drugs without New Drug Applications (NDA) filed with the FDA or without Investigational New Drug (IND) numbers issued by the FDA in humans that are subject to 21 CFR 361.1 and are conducted at Weill Cornell Medicine or the New York Presbyterian Hospital Center.
Research Requiring RDRC Approval
Approval of a research study by the RDRC is based on assurance that the following requirements are met:
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.
How to Obtain RDRC approval?
If your IRB protocol requires RDRC review, submit the following documents to email@example.com
a) RDRC Application
b) PDF of the completed IRB protocol
c) ICF (must contain the mandatory radiation safety language as outlined below)
Communication of risk to research subjects is an essential part of the consent form. It is important that the risk be communicated in easily understood language. Most risk factors are derived from data involving uniform exposure of the whole body. However, most exposures to research subjects are limited to a part of the body or, in the case of radiopharmaceuticals, result in non-homogeneous exposure of the whole body.
RDRC Language for the ICF
The ICF should include following considerations:
- If there is no potential therapeutic benefit from participation, that fact should be clearly stated.
- The participant may be subject to additional exposure to ionizing radiation from diagnostic tests (dental x-rays, chest x-rays, etc.) related to their personal health during the time period they are involved in the study.
- The participant attests to the fact that they have not participated in any previous research studies involving the use of ionizing radiation (either radioisotopes or diagnostic x-rays) during the past 12 months.
- The participant should not volunteer for other research studies involving the use of ionizing radiation within 12 months of completing the current study.
RDRC Links & Resources
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