Certain types of protocols involve the use of a radiology device or radioactive material in a research-only setting (no clinical care is implied).In these situations the Radiation Safety Committee (RSC) and the IRB will assess the level of radiation exposure more carefully. The IBC and the IRB require the inclusion of specific information regarding the risks of the radiation exposure in the consent form.
IRB/ RSC Requirements
If a protocol involves the administration of a radioactive material for research purposes, the IRB requires written approval from the RSC if the investigator does not use standard wording approved by the RSC. The protocol may be submitted to the IRB and the RSC simultaneously, however, the IRB will not give approval to enroll subjects until they receive the RSC approval.
Use of Radiology Devices and Radioactive Materials in Human Subjects
When reviewing a protocol involving the administration of a radioactive material to human subjects for research purposes, the IRB determines whether the research is performed in a manner that protects the rights and welfare of the human subjects by conducting a risk/benefit analysis of the study. The RSC reviews the science of the radiation dose to be absorbed by the subject during research participation.
Positron Emission Tomography (PET)
Investigators using PET radio-pharmaceuticals have the same review requirements as researchers using other radioactive radio-pharmaceuticals. If the research is conducted under an IND, under a treatment IND, or as research on an approved drug for a new indication, then prospective IRB review and approval is required. Prospective IRB review and approval is also required for research using radio-pharmaceuticals to study human physiology, pathophysiology, or biochemistry.
FDA Requirements for the Use of Radioactive Materials in Research
The FDA requires investigators/sponsors to submit an IND for radioactive drugs, biologics, and/or “cold” kits to be used for radio labeling, and radionuclide generators that are used for investigational purposes, including testing their safety and effectiveness. An IND is not required for research designed to study basic biochemistry, physiology, pathophysiology, or metabolism when it is reviewed and approved by the RSC and the IRB. Review and approval by the RSC and IRB of such studies is in lieu of obtaining FDA review and approval of an IND.
The IRB is required to review research according to FDA regulations pertaining to the protection of human subjects. The FDA regulates various aspects of the use of radiology, including quality control, certification of facilities, and approval of radiologic drugs and devices. The study design is required to meet specific FDA requirements. Subjects may not be treated with an investigational form of radiation or radiopharmaceutical unless they are enrolled in an IRB reviewed and approved study with an IRB reviewed and approved informed consent.