Welcome to the NIH Radiation Safety Committee's Clinical Research Protocol Information Center.
This site provides information to assist individuals in the preparation of clinical protocols that involve the use of ionizing radiation (x-rays, nuclear-medicine, PET), for research purposes , in human subjects. This center provides information about the NIH Radiation Safety Committee (RSC), the Radioactive Drug Research Committee (RDRC), application forms (NIH form 88-23(a)), guidance documents, consent language templates and informational pamphlets for research subjects and investigators.
For complete protocol application procedures review Chapter VI of the Clinical Center Protomechanics Guide to Preparing a Clinical Research Study.
Applicants are encouraged to submit one copy of the protocol application (comprised of the protocol, form 88-23(a), consent document, and if appropriate, assent document) to the Dr. Sarah Kindrick for pre-submission review. Comments offered during this review period can then be incorporated into the final application prior to copying and submitting the required 13 copies to the RSC for review and approval. Pilot tests of this service have demonstrated a significant reduction of stipulations to approval by the RSC. This pre-review greatly increases the efficiency and expedience of the protocol approval process.
Please note that formal applications to the RSC must be received at least ten (10) days prior to the RSC meeting at which the applicant requests review. Please refer to the The RSC
meeting schedule and
contact information to plan your application submission.