Charter, Membership, and Responsibilities

I. Charter
Food and Drug Administration (FDA) regulations at 21 CFR 361.1 entitled “Prescription Drugs For Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used In Research” provide for a mechanism that allows the use of radioactive drugs in human research under certain specific conditions. The human research use of radioactive drugs that meet these specific conditions can be performed without the need for an FDA-approved New Drug Application or an FDA-accepted Investigational New Drug (IND) exemption. Among the conditions specified at 21 CFR 361.1 is the requirement that each research project be approved and monitored by a Radioactive Drug Research Committee (RDRC) that is itself approved by the FDA.

To achieve compliance with these regulations, Washington University School of Medicine submitted an application to charter its Radioactive Drug Research Committee in November 1979. This committee (Radioactive Drug Research Committee No. 0122 at Washington University School of Medicine) was approved by the FDA in December 1979.

In addition to the responsibilities established by FDA regulations, the Washington University RDRC, by agreement with the University’s Radiation Safety Committee (RSC) and the Institutional Review Board (IRB) and Human Research Protection Office (HRPO), has also been charged with the responsibility for reviewing all human research studies that involve the use of radioactive drugs.

II. Membership

21CFR 316.1 (c) (1) outlines the requirements for membership of the RDRC. The Committee must be composed of the following individuals: (1) a physician recognized as a specialist in nuclear medicine; (2) a person qualified by training and experience to formulate radioactive drugs; (3) a person with special competence in radiation safety and radiation dosimetry; and (4) other members qualified in various disciplines pertinent to the field of nuclear medicine (e.g., radiology, internal medicine, clinical pathology, hematology, endocrinology, radiation therapy, radiation physics, radiation biophysics, health physics and radiopharmacy). The Committee must consist of at least 5 members, and the membership should be diverse enough to permit expert review of the technical and scientific aspects of proposals submitted to the Committee. Consultants in other pertinent medical disciplines are encouraged. Additionally, the RDRC is required to seek the advice of pediatric consultants when it approves research studies (under the authority of 21 CFR 361.1) that involve subjects less than 18 years of age. The RDRC has a designated chair and vice-chair. The vice-chair performs certain administrative actions when the chair is unavailable or involving protocols where the chair is engaged as an investigator. The vice-chair signs committee action letters for protocols where the chair is engaged as an investigator. All other committee action letters are signed by the chair.

See link for current committee membership.

III. Responsibilities

The RDRC reviews and approves all research investigations conducted at Washington University that involve the administration of radioactive drugs to human subjects (with one exception). The Committee’s preeminent objective is to ensure that the studies are scientifically sound and are conducted safely and result in radiation exposures no greater than necessary to fulfill the scientific objectives of the research. For those research studies subject to the requirements of 21 CFR 361.1, the RDRC is responsible for ensuring that the studies are approved and conducted in accordance with the applicable FDA regulations. Additionally, the RDRC seeks to ensure that all human research investigations involving radioactive drugs are conducted in compliance with applicable regulations of the U.S. Nuclear Regulatory Commission.