Approval of Research Studies
The RDRC is responsible for the review of basic science research protocols using radioactive drugs in humans that are subject to § 361.1. RDRC approval of a research study by the RDRC is based on assurance that the following requirements are met [§ 361.1(d)(1)-(9)]:
- appropriate limit on the radiation dose
- appropriate limit on the pharmacologic dose
- qualified study investigators
- medical facility properly licensed to possess and handle radioactive materials
- appropriate selection and consent of research subjects
- appropriate quality of radioactive drug administered
- sound research protocol design
- reporting of adverse events by the investigator to the RDRC
- approval by an appropriate Institutional Review Board (IRB)
For more detailed information about each of these requirements, see What Information is Reviewed by the RDRC?
A chairperson is selected by the RDRC. The chairperson signs all applications, minutes, and reports of the RDRC [§ 361.1(c)(2)].
- Meetings must be held at least once each quarter in which research activity has been authorized or conducted [§ 361.1(c)(2)].
- A quorum consisting of more than 50% of the membership must be present at the meetings with appropriate representation of the required fields of specialization
- No RDRC member shall vote on a protocol in which he/she is an investigator
Minutes must be kept and must include the numerical results of votes on protocols involving human subjects [§ 361.1(c)(2)].
An annual report must be submitted to FDA on or before January 31st of each year [§ 361.1(c)(3)]. The annual report includes:
- the names and qualifications of the members of the RDRC and of any consultants used by the RDRC (Form FDA 2914) and
- a summary of study information for each study conducted during the preceding year (Form FDA 2915)
A special summary (Form FDA 2915) must be submitted to FDA at the time a proposal is approved that involves more than 30 research subjects (or when a previously approved protocol is expanded to include more than 30 subjects) or at the time a research proposal is approved that involves exposure to a research subject under 18 years of age [§ 361.1(c)(3)].
Studies involving minors are subject to dose limitations as specified in 21 CFR 361.1(b)(3) and must be supported with review by a qualified pediatric consultant to the RDRC [§ 361.1(d)(5)].
Changes in Membership
Changes in membership and applications for new members (Form FDA 2914) must be submitted to FDA as soon as, or before, vacancies occur and new members are appointed to the RDRC [§ 361.1(c)(4)].
- The investigator must immediately report to the RDRC all adverse effects associated with the use of the radioactive drug in the research study [§ 361.1(d)(8)].
- The RDRC chairperson must immediately report to FDA all adverse reactions probably attributable to the use of the radioactive drug in the research study [§ 361.1(d)(8)].
All reports (i.e. annual report, special summary, changes in membership, and adverse reaction reports) should be sent to the following address:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Drug Evaluation IV
5901-B Ammendale Road
Beltsville, MD 20705-1266