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 (This email address is being protected from spambots. You need JavaScript enabled to view it.​). 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:

• The completed Human Subjects Protocol being submitted to the IRB
• A copy of the sponsor's protocol describing the study
• The name of a “physician user” named on the UAB-issued radioactive materials license authorizing the individual to perform the particular study. The radioactive materials license will have to be reviewed by the Radiation Safety Program Director to ensure that the request meets requisite conditions and approvals granted by the license.

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.

Ionizing Electromagnetic Radiation

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:

• The completed Human Subjects Protocol being submitted to the IRB
• A copy of the sponsor's protocol describing the study
• Information of a similar nature that would provide radiation dose information, as for radioisotope research projects.

Additionally, the committee will review the information regarding the risks of patient exposure from radiation doses given in laymen terms in the consent form.​

Both Children's and UA Hospital have policies and procedures regarding the storage and distribution of drugs (INDs and FDA-approved drugs) to be used in research on humans.

Children's of Alabama (CoA)

All research conducted at Children's involving dispensing of drugs to human participants must be registered with the CoA Department of Pharmacy (1600 7th Ave. S.). Medications provided by the study sponsor are defined as study drugs, and all study drugs dispensed to participants who are seen at CoA must be stored at and dispensed from the CoA Department of Pharmacy. Questions may be directed to the Department of Pharmacy at 939-9718 or 939-5918 (Investigational Study Pharmacist). 

Before applying for IRB approval, investigators should complete The Children's Release of Drugs for Human Research Use and submit it to the Children's Department of Pharmacy. Attach a copy of the form, signed by the investigator and CoA Pharmacy Director, when submitting the Human Subjects Protocol for IRB review.

Children's Release of Drugs for Research Use​

University of Alabama Hospital

All research conducted at UAB involving dispensing of drugs to human participants must be registered with the Department of Pharmacy and the Pharmacy and Therapeutics Committee. One purpose of this policy is to insure that there is a central location in the hospital where information can be obtained regarding any drugs being used for research purposes in the hospitals and clinics. Second, the policy is intended to provide the Principal Investigator with the procedures relating to the storage and distribution of drugs in order to improve efficiency and accuracy. 

Hospital policy states that all drugs for patient research use within the University of Alabama Hospital shall be stored and dispensed from the Pharmacy. Investigators planning drug studies are asked to contact the Drug Communication Division, Department of Pharmacy (extension 4-2162) for a complete copy of the policy and to make arrangements for the proper storage and distribution of the drugs. A copy of the complete research protocol must be delivered to the Department of Pharmacy. The release form will be signed once arrangements for receipt, storage, and dispensing of the drug have been agreed upon. A standard fee for services will be charged either to patient-participants or to appropriate grant funds. The Pharmacy Department may be reached at 934-2162 for further information. 

Before applying for IRB approval, investigators should complete The Release of Drugs for Human Research Use and submit it to the UAB Department of Pharmacy. Attach a copy of the form, signed by the investigator and UAB Pharmacy Director, when submitting the Human Subjects Protocol for IRB review.​

UAB Release of Drugs for Human Research Use

If participants from other institutions not having an IRB (e.g., hospitals, schools, businesses) comprise all or part of the population for this study, written approval should be obtained from an authorized official of that institution. A statement of preliminary contacts with the appropriate officials should be attached to materials submitted for review. If the other institution has an IRB, attach a copy of its approval for the activities to be carried out at that institution.

If the research is federally funded, the UAB OIRB must determine if the other institution is “engaged in research’ as stated in 45 CFR 46.103 and defined in OHRP guidance of January 26, 1999. If the other institution is engaged in research, then it must have (a) an assurance with OHRP and (b) IRB approval from its registered IRB.

Birmingham Veterans Affairs Medical Center (BVAMC)

For research that is conducted at the VA only, with no funding through the UAB Office of Sponsored Programs (OSP), and under a VA appointment, the protocol does not have to be submitted to the UAB IRB. Contact the VA Research Compliance Officer for information regarding the regulations on submitting to their office. The contact person is Kim Moses, Research Compliance Officer and Program Analyst, at 933-8101 ext. 5176.

For research that is conducted at both the VA and UAB or with funding through the UAB OSP, the protocol must be submitted to both the VA IRB and UAB IRB. The UAB IRB will require that you provide a copy of the VA IRB approval and VA IRB-stamped consent form(s). Dually-stamped consent forms are no longer permissible at the VA. Please contact the VA if you are interested in conducting research at both UAB and the VA.

Human Subjects Research conducted at Jefferson County Department of Health Clinics listed below requires review by the JCDH Research Review Panel.  Researchers may email This email address is being protected from spambots. You need JavaScript enabled to view it.​ for questions about the review process and to obtain instructions for review. 

JCDH Research Review Panel review required for the following JCDH Clinics

• Sexually Transmitted Disease
• Adult Health
• Pediatrics
• Family Planning
• WIC
• Disease Control/Immunization
• TB
• Travel

Research conducted at UAB Maternity Clinic and the UAB Optometry clinics located at JCDH do not require review through the JCDH Research Review Panel Process unless Researchers plan to recruit for participants from JCDH clinics.