Research Policies: Radioactive Drug Research Committee

January 3, 1996

1. Policy

   The Saint Louis University Radioactive Drug Research Committee is authorized by the United States Food and Drug Administration (21 CFR, part 361.1) and this Policy Letter. Its duties will be to provide advice on, and to consent to, the safe and effective use of radioactive drugs in human research.

   
   
   
2. Purpose

   To establish a Radioactive Drug Research Committee to ensure the safe use of radioactive drugs in human investigations of physiology, biochemistry and drug kinetics.

   
   
   
3. Procedure
   
   
   1. If approved research activity is underway, this Committee will meet quarterly at the call of the Chairperson. Minutes of the meetings will be signed by the chairperson, maintained and published. Copies will be furnished to the Vice President for Health Sciences; all schools, centers and divisions of the Health Sciences Center; and others as determined by the Chairperson. The Committee is responsible to the Vice President for Health Sciences.
   2. The responsibilities of the Committee will be:
      1. To review and approve or disapprove applications for research study of radioactive drugs to obtain information regarding metabolism of drug, basic research in human physiology, pathophysiology or biochemistry as described in 21 CFR, part 361.1.
      2. To submit an annual report on or before January 31 of each year to the Bureau of Drugs of the Food and Drug Administration.
      3. To maintain approval of the Committee by the Food and Drug Administration by meeting the provisions of 21 CFR, part 361.1.
   3. Delegation of Authority
      1. Membership of the Committee will consist of at least five individuals including specialists in nuclear medicine, radiopharmacy, radiation safety and dosimetry, and representatives from other pertinent disciplines. Members will be appointed by the Vice President for Health Sciences and the Committee will derive its authority from that office.
      2. Presently designated members of the Radioactive Drug Research Committee are named on Attachment A to this Appendix.
   
   
   
4. References

   The 21st Code of Federal Regulations, part 361.1, found in the 40th Federal Register, pages 31308-31314 (July 25, 1975).

   
   
   
5. Rescission

   None.

   
   
   
6. Review Date

   January 1999.

(ORIGINAL SIGNATURE ON FILE>
James R. Kimmey, M.D., M.P.H.
Vice President for Health Sciences