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2.1 PURPOSE The Committee is advisory to the
Chancellor, and under his direction, it acts as a regulatory body whose
objective is to insure health standards to prevent over-exposure of
personnel through appropriate supervision of the uses of all sources of
ionizing radiations which come within its jurisdiction. These sources
include all radioisotopes acquired under the University licenses and all
other sources, including radiation producing machines and radium owned by
and operated within the University. The Radiation Safety Officer and staff
are authorized and directed to visit and oversee all installations owned
by and operated within the University where sources of radiation are
employed, whether or not they are operated under license or contract, so
as to report apparent risks to the responsible persons. The Committee is
concerned with the qualifications of users and with the uses, insofar as
radiological safety is concerned on a University-wide basis. These
regulations also apply to UPMC facilities which utilize the services of
the University of Pittsburgh Radiation Safety Program. A list of these
facilities may be found on the Radiation Safety Office Web site.
2.2 As in other major advisory committees within the University, appointment to the Radiation Safety Committee is made by the Chancellor or his designee. The Committee is composed of the Chairperson, the Vice-Chairperson, the University Radiation Safety Officer, the Committee Physician, general members (representative of each type of use of radioactive material or ionizing radiation generating source), a representative of the UPMC Nursing Service, and management representatives from the appropriate offices for academic and business affairs. One half of the members of the Radiation Safety Committee including the Radiation Safety Officer and a management representative, must be present to constitute a quorum at the Committee’s quarterly meetings. The Radiation Safety Officer must be technically qualified to advise and assist on radiological safety problems of all types which might occur within the responsibilities of the University. This appointment must be acceptable to the reviewing regulatory agencies, to the administrative officers who are concerned, as well as to a majority of the Radiation Safety Committee and with final approval by the Chancellor. The Committee Physician must be a physician technically qualified in the diagnosis and management of radiation over-exposure. The appointment is to be approved by a majority of the Radiation Safety Committee, as well as majority of the administrative officers who are concerned, with final approval by the Chancellor. General members must be, in the Committee's view, technically qualified to use radiation sources in their respective fields of study. The management representatives for academic and business affairs are designated by University administration. A current list of the committee membership may be found on the Radiation Safety Office’s web site. 2.3 STANDING COMMITTEES2.3.1 Executive Committee This Committee is composed of the Chairperson and Vice-Chairperson of the Radiation Safety Committee, the Committee Physician, the Radiation Safety Officer, a management representative and a health physicist. The Executive Committee has the special function of acting on behalf of the Radiation Safety Committee in emergency meetings. This Committee reviews and may give interim approval to applicants for Authorized User status. It also reviews and approves all uses of radioactive materials and radiation producing equipment, subject to final Committee approval. 2.3.2 Radioactive Drug Research Committee (RDRC)/Human Use Subcommittee (HUSC) This combined committee’s special function is to review and approve all uses of radioisotopes in humans for diagnostic, therapeutic and research purposes. The RDRC is established under the authority of the FDA in 21 CFR 361.1 and has responsibility for the review and approval of research studies involving radioactive drugs that are not currently the subject of an approved IND or NDA. The HUSC is responsible to assure that all clinical and research uses of radioisotopes are in compliance with the Nuclear Regulatory Commission or Commonwealth of Pennsylvania radioactive materials licenses and regulations. To facilitate the review and approval of the different categories of human use, the members of the RDRC also serve in the capacity of the HUSC. The committee consists of 5-8 individuals with required representation by a physician boarded in nuclear medicine, a radiopharmacist, and a person with special competence in radiation safety and radiation dosimetry. The remainder of the committee will include individuals with special competence in radiation therapy, radiology, internal medicine, endocrinology, cardiology, neurology, psychiatry, or other pertinent disciplines. The names and qualifications of the members of this committee shall be submitted to the FDA. A chairperson of the committee is designated by the chairperson of the Radiation Safety Committee to oversee the conduct of committee meetings and sign all applications, minutes and reports. The committee meets once each month with a quorum of more than 50 percent of the members required to be present. Members of the committee also review research protocols involving diagnostic X-ray procedures which are not part of a patient’s routine clinical care. Review comments and recommendations on these protocols are submitted to the Biomedical Institutional Review Board, to be incorporated into their review and approval process. |
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Radiation Safety Office Webmaster Revised February 9, 2001 |
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