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Office of Research Services

Serving the NIH Community


Clinical Protocol Information and Assistance

Assistance for obtaining approval for clinical protocols involving the use of ionizing radiation (x-rays, nuclear-medicine, PET) in human subjects is provided online in the form of guidance documents and information about the NIH Radiation Safety Committee (RSC), the Radioactive Drug Research Committee (RDRC), and the clinical research protocol application process. Applicants may also access consent language templates and informational pamphlets for research subjects and investigators. 

For additional guidance, applicants may email   ​


​RSC Clinical Research Protocol Application ​

The RSC application process is completed through PROTECT​​. In addition to completing the radiation safety form, copies of the protocol, consent, assent (if applicable), and dosimetry tables must be uploaded with the application. If the protocol includes the administering ​​of radioactive materials to a protocol participant, a Clinical Authorized User (CAU) Application is required.  

Please note that clinical protocol applications to the RSC must be received at least ten (10) days prior to the RSC meeting at which the applicant requests review. Refer to the RSC meeting schedule (NIH credentials required) to plan your application submission.  

For guidance on completing clinical protocol applications to the RSC, visit the DRS intranet​ (NIH credentials required) or email

Radiation Dose Library for Common Procedures

A  radiation dose library for common procedures (NIH credentials required)  has been provided to assist in drafting appropriate risk language for informed consents. This library contains dose estimates for most standard scans performed at the NIH. It does not contain dosimetry for radiation therapies. For unique procedures or use of novel imaging agents, a customized dose calculation may be required. ​

​​​Related Links ​