The Radiation Safety Committee is responsible for policies and practices regarding the use of radioactive materials and radiation producing machines; to review all license applications and human use research protocols using radioisotopes or radiation producing machines.The Committee also conducts and reviews the Radiation Protection Program for the Broad Scope Radioactive Material License.
Requirements for Non Human Use:
Requirements for Human Use Research – CTRC & IDD Protocols:
- Must submit seven copies of the complete package below for review
- Copy of protocol independent of the IRB submission
IRB Forms
- A Human Use Research Signature Assurance Sheet
- B Human Use Research General Information Sheet
- B-2 Human Use Research Study Personnel List
- C Human Use Research Description
- Q Radiation Worksheet
Consent form
- Memo outlining Standard of Care versus Research Procedures
Requirements for Human Use Research:
- Must submit protocol independent of the IRB submission
- IRB Human Use Protocol with IRB form part I and II
- Consent form
- Radiation worksheet
Requirements for Human Use - Clinical:
Radioactive Drug Research Committee
Chair: Darlene Metter, MD
The Radioactive Drug Research Committee is a joint committee for UTHSCSA, the Veterans Health Care System, Audie L. Murphy Division and the University Health System with a charge to review all protocols involving the use of research radioactive drugs and/or agents with human subjects.?? Responsible for ensuring compliance of regulations mandated by the US Food and Drug Administration.
Schedule through August 2009:
Date |
Deadline for Submission* |
September 4, 2008 |
August 14, 2008 |
December 4, 2008 |
November 6, 2008 |
March 5, 2009 |
February 5, 2009 |
June 4, 2009 |
May 7, 2009 |
*All submissions must be received by 5:00 P.M. the day of the deadline. Twelve copies must be submitted at that time.
Requirements for Human Use Research:
- Must submit protocol independent of the IRB submission
- IRB Human Use Protocol with IRB form part I and II
- Consent form
- Radiation worksheet
- Four Page application for human use of radioactive material ??? research (HUMAN USE RESEARCH.doc attachment)
Requirements for Human Use - Clinical:
