May 2025

CRRC

Before administering ionizing radiation or radiopharmaceuticals, not considered “standard of care” to a research subject in a research study, or changing an existing study involving the above, a review for research involving radiation review is completed. This review responsibility has been delegated to the Clinical Radiation Research Committee (CRRC). The CRRC will provide to the JHM IRB an assessment of the subject research radiation dose and proposed consent form language describing the radiation exposure associated with study participation. Any issues identified as requiring resolution for new applications or changes in research must be addressed prior to IRB issuance of final approval.

RDRC

In specialized studies where the radiopharmaceutical has not received an IND from the FDA and the research is intended to obtain basic information regarding the metabolism, including kinetics, distribution, and localization, of a radiopharmaceutical or regarding human physiology, pathophysiology, or biochemistry, Radioactive Drug Research Committee (RDRC) review is needed. These studies are not intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial). The RDRC will provide to the JHM IRB an assessment of the subject radiation dose and proposed consent form language describing the radiation exposure associated with study participation. Any issues identified as requiring resolution for new applications or changes in research must be addressed prior to IRB issuance of final approval. The RDRC submits an annual summary report to the FDA of all research that falls under an RDRC protocol.

The eIRB application includes questions triggering CRRC or RDRC review. The Office of Human Subjects Research CRRC liaison works closely with these committees and ensures determinations of these committees are accessible in eIRB. The CRRC meets twice each month to review applications submitted to the IRB. The RDRC meets as needed, but at least quarterly, to review applications submitted to the IRB. The IRB application forms include specific requirements for provision of radiation dosimetry information and statements of radiation risk in the consent form. The CRRC/RDRC communicates the results of the radiation review in writing to OHSR staff.

Questions by researchers on calculating radiation dose to complete the eIRB application can be answered by CRRC/RDRC members. Questions/concerns raised through the CRRC/RDRC reviews are sent to investigators by the JHM IRB electronically through the eIRB system. The JHM IRB will not take final action on an application that involves radiation until CRRC or RDRC approved.