103.21 Organization Policy on Clinical Radiation Research Committee (CRRC), the Radioactive Drug Research Committee (RDRC) and the JHM IRB
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 CRRC review is completed. This review responsibility has been delegated to the CRRC. The CRRC 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.
In specialized studies where the radiopharmaceutical has not received an IND from the FDA and the research is for intended to obtain basic information regarding the metabolism, including kinetics, distribution, and localization, of a radiopharmaceutical or regarding human physiology, pathophysiology, or biochemistry, 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. The RDRC submits an annual summary report to the FDA of all research that falls under an RDRC protocol.
OHSR staff is responsible for initiating CRRC or RDRC review and providing copies of research applications to the Secretary of these two committees. 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 Secretary of 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. Also, questions/concerns raised in the radiation review are sent to investigators by the JHM IRB. The JHM IRB will not take final action on an application that involves radiation until CRRC or RDRC approved.