About the Radioactive Drug Research Committee
The Weill Cornell Medicine Radioactive Drug Research Committee 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 will be conducted at Weill Cornell Medicine-NewYork Presbyterian.
The term “radioactive drug” is defined in 21 CFR 310.3(n) and includes a “radioactive biological product” as defined in 21 CFR 600.3.
Research Requiring RDRC Approval
Approval of a research study by the RDRC is based on assurance that a protocol must:
- Involve certain radioactive compounds generally recognized as safe and effective;
- Be designed to obtain basic information regarding the metabolism of the radioactive 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 (e.g., 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 Human Subjects protocol requires RDRC review, submit the following documents to firstname.lastname@example.org:
- RDRC Application;
- PDF of the completed Human Research protocol submitted to the Institutional Review Board (IRB);
- Informed Consent Form (ICF) with the mandatory radiation safety language as outlined below.
RDRC Language for the ICF
It is important that the risk is communicated in an 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.
The ICF should include the 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.