UT Southwestern’s Radiation Safety Committee (RSC),
The Sub-Committee for Human Use of Radiation in Research (SHUR). and the Sub-Committee for Non-Human Use of Radiation (NHC)

UT Southwestern’s Radiation Safety Committee (RSC) derives its statutory mandate, responsibilities, and authority from the Texas Regulations for the Control of Radiation (TRCRs) and from UT Southwestern’s Broad Scope Radioactive Material (RAM) License  issued by the Texas Department of State Health Services (DSHS). The establishment and specific requirements for the RSC are dictated in the 25 Texas Administrative Code (TAC) sections 289.252(h)(1)(C), 289.252(g), and 289.256(i) and (k) to promote the safe use of radiation within the Institution and associated Hospitals. Composition of the RSC and required approval by DSHS of the membership is dictated in 289.256(i)(1). The duties and responsibilities of the RSC are specified in 289.256(i)(3) and (k) and include but are not limited to: (1)  Evaluate and authorize RAM use for qualified applicants in medical diagnosis, therapy, and research in accordance with the TRCRs; (2) Review and approve permitted radiation programs and applicable operating, safety, and emergency procedures; (3) Review radiation incidents, medical events, and potential overexposures; (4) Review programs for maintaining radiation doses As Low As Reasonably Achievable (ALARA). UT Southwestern’s RAM License L00384 specifically names the authorized Chair and Membership of the RSC in its License Condition 12. The RSC also functions as the Institutional Radiation Safety Advisory Committee appointed by UT Southwestern’s President.

In order to more effectively accomplish its mandated tasks of overseeing a safe use of Radiation at the Institution, the RSC has commissioned several sub-committees: (1) The Sub-committee for Human Use of Radiation in Research (SHUR), (2) The Sub-committee for Non-Human Use of Radiation in Research, and (3) The Radioactive Drug Research Committee (RDRC). The RDRC is mandated by the Federal Regulations under 21 CFR 361.1.

Radiation Safety Committee Review of Research Protocols Involving Human Subjects and the Use of Radiation.

Through SHUR, the Radiation Safety Committee assists the Institutional Review Board (IRB) in the review of research protocols that involve the use of radiation. In order to facilitate the review process, SHUR has developed review guidelines and guidance documents.

All research protocols that require patients or research subjects to be exposed to ionizing radiation must be reviewed by the Radiation Safety Committee (RSF-021 and/or RSF-022).  Detailed review is done by the Sub-committee for Human Use of Radiation (SHUR).  Exposure to radiation may be in the form of nuclear medicine exams, diagnostic x-rays, fluoroscopy, interventional procedures, CT, or radiation therapy.  Any protocol that requires such an exam or interpretation from such an exam must be submitted, even if the exam would be done as part of standard care.  Investigations that are purely retrospective record reviews, and do not require individual patient consent for exams involving radiation exposure do not have to be submitted.

The SHUR committee reviews protocols for appropriate use of radiation, including the suitability and frequency of exams.  The relevance and accuracy of the radiation risk statement appearing in consent form are also evaluated.  Investigators are asked to submit information about the effective radiation dose.  This information is used to access the relative risk of the radiation exposure.  The committee then weighs this increased risk against the potential benefits of the investigation.  This information is also used to inform the patient or research subject of the risks from radiation as compared to other societal risks. Effective dose estimates are provided for some of the procedures in the guidance documents (see links below).

For protocols that require the use of radioactive nuclear isotopes for exams or procedures that are not part of standard medical care, a physician licensed to administer radio-pharmaceuticals must be a co-investigator.  Any protocol that requires the therapeutic administration of radiation must include as a co-investigator a board certified radiation oncologist, radiologist, or nuclear medicine physician, as appropriate.

 Once a protocol has been approved by both the IRB and SHUR, annual continuing review is required.  If the IRB approves a modification involving a change in sample size to the study following SHUR approval, a copy of the IRB approved modification form should be submitted to SHUR with the continuing review paperwork (RSF-023).
 
If a proposed modification to the study involves a change in procedures involving radiation exposure, SHUR must approve the modification prior to submission to the IRB.  After SHUR approval of the modification is received, please submit the SHUR approval letter to the IRB with the modification request.

Radiation Safety Committee Review of Research Activities Involving non-Human Subjects and Materials and the Use of Radiation.

Through the NHC, the Radiation Safety Committee maintains oversight of research protocols using radiation on the benchtop and on animals.  Each researcher who wishes to use radioactive materials, or wishes to use Irradiators, must submit their request to the NHC for review and approval.  No use of radioactive materials in research is allowed without a Sublicense approved by the NHC.

The procedure to use radioactive materials is for the researcher to submit a Non-Human Use Sublicense Application (RSF-005 and RSF-005a) to the Subcommittee for review. The applicant may use RSF-042 as instructions for the form.  The Application is signed by the applicant and by the Department Chair, and submitted with six copies.  The materials are distributed to the Subcommittee for pre-meeting review, and the Subcommittee meets to discuss the Application.  Any questions from the Subcommittee must be resolved prior to issuance of a Sublicense.  The Subcommittee is composed of senior researchers and Radiation Safety staff.

Researchers who wish to use a radioactive materials Irradiator are required to submit personal information and fingerprints for clearance to have unescorted access to the Irradiator(s), and are required to take a training course in Irradiator use.   Researchers who use the X-ray irradiators are reviewed by the X-ray Radiation Safety Officer in a different process, which is not part of the NHC process.

Approval from the Institutional Animal Care and Use Committee is required for use of animals in research, and the NHC checks to ensure the appropriate IACUC approvals are present.

When approval is granted and, if applicable, Irradiator clearance is granted, the Sublicense is issued by Radiation Safety, the laboratory is posted, and the researcher may order radioactive materials and begin research.