Prior approval from the UAB Radiation Safety Program is required for research that involves the introduction of radioactive materials or radioactive devices into humans. All requests must be submitted to the UAB Radiation Safety Program Director, Occupational Health and Safety Department, Suite 445 CH19 (email@example.com). Studies involving routinely used radiopharmaceuticals or radioactive devices will require only the review and approval of the Radiation Safety Program Director. Otherwise, the studies will require the full approval of the UAB Radioisotope and Radiation Safety Committee (RRSC).
In all studies, it is important that the content of the patient consent form follows the requirements of the RRSC and the IRB. Risk information related to the patient's exposure from the radiation of the radioisotope must be understandable by the patient.
If the research study involves basic metabolic studies using 3H or 14C, then the study must also have the separate approval of the UAB Radioactive Drug Research Committee (RDRC). The Radiation Safety Program Director must ensure that all requests have information that is complete and necessary for proper review. The RDRC does not review studies involved with radioisotopes labeled with biologics (i.e., monoclonal antibodies).
When the full RRSC has to review a human subjects protocol, the UAB Radiation Safety Program office requires the completion of one of its own forms (Form RDR). A special set of instructions is also available from the Radiation Safety Program office that is more specific to the nature of the research and is available upon request. Both are available at the Radiation Safety Program web site: http://www.uab.edu/ohs/forms-guides-and-signs.
There are two situations in which the form RDR will not have to be completed. First, if the study involves the routine use of radiopharmaceuticals or radioactive devices officially approved by the Food and Drug Administration (FDA) (i.e., have New Drug Application numbers for radiopharmaceuticals or Pre-Marketing Approval numbers for radioactive devices). The other involves the use of radiopharmaceuticals or radioactive devices that have been issued an Investigational New Drug (IND) number for radiopharmaceuticals or Investigational Device Exemption (IDE) number by the FDA. This does not include any IND or IDE study that does not have an official approval letter from the FDA (i.e., IND exemption). For those INDs and IDEs that have FDA approval, the Radiation Safety Officer needs only one copy of the following:
Investigators who are considering filing an “Investigational New Drug” or “Notice of Claimed Investigational Exemption for a New Drug” with the FDA for human use research using a radioactive pharmaceutical for studies that will be initially started at UAB must first gain approval from the UAB RRSC. The same information submitted on the Form FDA 1571 must be submitted to the UAB RRSC for review in addition to the other information required above. If an investigator comes to UAB from another institution where he or she had approval for research work conducted under an IND, that investigator must also obtain the same RRSC approval to perform the work at UAB. Among the items reviewed by this committee are the radiation doses given to participants as well as the content of pertinent information in the consent form.
Research involving the use of any ionizing electromagnetic radiation (x-rays, particle accelerator radiation, etc.) must be reviewed and approved by the UAB RRSC. This is a requirement of the State and County Health Departments. As for studies involving any routine x-ray studies, the purpose of the review is to ensure that the state health department has final approval before any screening studies are initiated.
Also prior to the initiation of other types of studies that the RRSC does not consider to be routine are studies involving the use of X-rays involving certain technological equipment (i.e., computed topography, particle accelerators) that expose patients to higher than normal radiation doses. Because of these higher than normal radiation doses, a special review by this RRSC is required. Eight copies of the documents described below must be submitted to the Radiation Safety Division:
Additionally, the committee will review the information regarding the risks of patient exposure from radiation doses given in laymen terms in the consent form.