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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 16 / 23

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A1.0050

Health, establishes radiation policies and procedures for the University in accordance with state and federal regulatory requirements governing the procurement, use, storage, and disposal of radiation-producing devices and radioactive material. The RSC authorizes individual investigators and study personnel to use these devices in the conduct of their research; however, prospective users must submit proposals to the RSC for review and approval. The RSC coordinates this review with the initial review conducted by the IRB, which may not approve research requiring RSC review without prior approval from the RSC. The Committee includes individuals experienced in the use of radiation sources in medicine and research at the University, including the Radiation Safety Officer, who serves as an ex officio member of the Medical IRB.

A1.1800 Radiation Safety Officer

Responsibility for carrying out the policies and procedures of the RSC rests with the Radiation Safety Officer (RSO) who has administrative responsibility for the University's radiation safety program. The RSO reviews all applications for radiation-producing device and radioactive material use, as well as location, procedure, and disposal. The RSO recommends approval or disapproval of applications for the use of such devices to the RSC, makes recommendations to the IRB on consent language or protocol safety issues for protocols that fall under the purview of the RSC, and may suspend any project or use that is found to be a threat to health or property.

The RSO is responsible for implementing written policies and procedures for comprehensive management of the radiation procurement, use, disposal, documentation, and emergency actions and is also responsible for investigating overexposures, accidents, and other deviations from approved radiation safety practice and implementing corrective actions as necessary.

A1.1850 RADIOACTIVE DRUG RESEARCH COMMITTEE

Basic research designed to study the metabolism of a radioactive drug or to gain information about human physiology, pathophysiology, or biochemistry in response to radioactive drug use is subject to review by the UK Radioactive Drug Research Committee (RDRC), as well as the IRB. Formed under the authorization of the FDA and the University, the RDRC, whose members are appointed by the VPR, is responsible for reviewing and approving all radioactive drug research projects that fall under the purview of FDA regulations as specified in 21 CRF Part 361.1. The RDRC Chair and the UK Radiation Safety Office are responsible for determining whether a research proposal needs RDRC review in accord with FDA requirements. Investigators submit research protocols which meet the criteria for review, as outlined in the regulations, to the RDRC for review and approval prior to initiation of the study. The committee is activated upon receipt of a protocol that meets the review criteria. The ORI manages both the IRB and the RDRC and bears primary responsibility for coordination of the two committee reviews and for providing the IRB with written RDRC recommendations. The IRB will not approve research without prior approval from the RDRC.

A1.1900 INVESTIGATIONAL DRUG SERVICE

The Investigational Drug Service (IDS) offers support for all clinical drug-related research conducted by investigators at the UK Medical Center. Hospital policy requires IDS support for all in-patient protocols. Outpatient investigational drug studies may opt not to use the services of the IDS for their pharmacy support; however, they are subject to annual audit by the IDS. The

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