THE OFFICE OF RESEARCH

TECHNICAL COMMITTEES

CHARGE OF THE RADIOACTIVE DRUG RESEARCH COMMITTEE

Excerpted from the UCSF Radiation Safety Manual. Approved 12/96 & Revised 07/02

RESPONSIBILITIES: THE ROLES OF INVOLVED PERSONS

The rules and procedures set forth in the Radiation Safety Manual have one single, straightforward purpose -- to protect UCSF patients, students, and employees against unnecessary and potentially harmful radiation exposure.

2. RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC)

a. Responsibility

The purpose of the Radioactive Drug Research Committee (RDRC) is to guarantee subjects who take part in research protocols the greatest degree of both radiological and pharmacological safety. Before approving such studies, it is this Committee’s responsibility to determine the intrinsic value of the research with a risk versus benefit analysis. The RDRC is defined by Federal law, and its membership must be approved by the Food and Drug Administration (FDA, 21 CFR, Part 361).

The RDRC is independent of the RSC and its services are available to all users of radioactive material and Department Chairs. It shall complement the RSC activities already existing within the hospitals and medical research facilities.

b. Organization - RDRC

The RDRC Chair shall be a member of the RSC. The RDRC members shall be appointed by the Assistant Vice Chancellor, Research. The RDRC shall consist of at least five members and include the RSO as a member who advises the committee and implements its decisions.

The activities of the RDRC are directed by its Chair. To conduct business, a quorum (including the RSO, or his designated alternate) is necessary. Meetings of the RDRC shall be called by the Chair not less than four times a year, or on petition of any member of the RDRC.

c. Approvals - RDRC

Research involving radioactive drugs must be approved by the RDRC when they are administered to human subjects in a study intended to:

i. Obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a drug.

ii. Obtain basic information regarding human physiology, pathophysiology, or biochemistry.

The RDRC regulations, from the Food and Drug Administration, require review of study design and appropriateness of the research protocol; they also impose limits on radiation absorbed doses and the amount of the drug administered. The RDRC grants final approval to a study that falls under its pursue after approval of the CHR and the RSC has been received.