May 2005 The Organization’s license to administer ionizing radiation includes a review requirement applicable to new research protocols or to existing approved protocols that incorporate a change in radiation exposure. This review responsibility has been delegated to the CRRC and its subgroup, the RDRC. Studies submitted to the JHM IRB for review that include the use of radiation require an assessment of the level of radiation by the CRRC. The CRRC will provide to the JHM IRB the level of radiation exposure to subjects and proposed consent form language describing the radiation exposure associated with study participation. 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/RDRC meets twice each month to review applications submitted to the IRB. The IRB application forms include specific requirements for provision of radiation dosimetry information. The Secretary of the CRRC/RDRC communicates the results of the radiation review in writing to OHSR staff. 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 the radiation review is complete. |
