Procedures To Be Followed for the Administration of Research Radioactive Materials to Human Subjects

1. It is the policy of the NIH Radiation Safety Committee that a physician, authorized by the Committee (RSC) for clinical use of radioactive materials in human subjects, must be present or available by telephone during the administration and duration of a radioactive material study.
2. In the event that the Authorized Clinical Physician cannot be present for the radioactive material study, a qualified physician, not necessarily one authorized by the NIH Radiation Safety Committee, must be present and on-site for the duration of the study. This physician must be trained and qualified to work with radioactive materials.
3. The Authorized Clinical Physician of the approved research radiation protocol retains responsibility for the radioactive material studies administered under the protocol. Duties associated with the study may be delegated to other qualified physicians.
4. The Authorized Clinical Physician is responsible for ensuring that emergency procedures are in place should a patient suffer an adverse reaction during the course of a radioactive material study. Emergency procedures must be in writing and periodically reviewed with the qualified physician(s) who may be present, in lieu of the Authorized Clinical Physician, during such studies.

Proposed Adoption by the Radiation Safety Committee on October 5, 2000.