Primary Function: The Subcommittee for Human Use (SCHU) reviews and approves applicants for routine diagnostic and therapeutic human use (according to the new drug applications (NDAs) approved by the U.S. Food and Drug Administration). Furthermore, approves applications for uses of a new drug application (NDA approved) not specified on the package insert labeling or conducted under investigational new drug (IND) exemptions (to be filed with the FDA for final approval). In addition, it reviews proposals involving medical devices within which radioactive materials are used either as approved medical devices or those with premarket approval (with both FDA and NRC approval) or even investigational devices (IDs) with an investigational device exemption (IDE) – also having NRC or Agreement State approval. These proposals and any other proposals requiring approval by the Institutional Review Board for Human Use (IRBHU) require the following information to be submitted to the RSO:
- Human Subjects Protocol and any changes thereto,
- Patient Informed Consent Form
- Information Naming the Radiopharmaceutical or the Radioisotope,
- Name of the Routine or Investigational Study,
- UAB Radioactive Materials Licensee(s) Performing or Participating in the Study
Chair Name: Kurt R. Zinn, D.V.M., M.S., Ph.D.
Committee Contact Person: Robert Heath, Jr., Director of Radiation Safety
Phone number: 205-934-2487
Email address: email@example.com
Topic of interest:
Subcommittee for Human Use (SCHU) is comprised of members from throughout the University of Alabama at Birmingham (UAB) administrative, research and medical communities. This membership encompasses a very extensive degree of expertise in a comprehensive arena of disciplines. The Committee reports to the chair of the Radioisotope Radiation Safety Committee (RRSC) and meets quarterly to conduct business relating to the use, handling, transfer, etc. of radioactive materials and radiation producing machines, in humans, here at the UAB. If you have questions about the Committee or have topics of interest for the Committee, please contact Robert Heath, Jr., the UAB Radiation Safety Officer, at (205) 934-2487 or firstname.lastname@example.org.
Forms or Guides
UAB Radiation Safety Procedures Manual
UAB Laser Safety Manual
Authorized Physician User Forms
Rules of the Alabama Department of Public Health Office of Radiation Control
UAB IRB (Institutional Review Board)
The SCHU meets once each quarter and will convene special meetings if the need arises. Usually the meeting dates fall on the last Thursday of the month following each quarter.
The meeting dates for 2015 are as follows:
Thursday, April 30
Thursday, July 30
Thursday, October 29
The SCHU meeting minutes are not usually made available for public disclosure. However, please contact the UAB Radiation Safety Officer or the UAB Assistant Radiation Safety Officer at 205-934-2487 should you need assistance.