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The University of North Carolina at Chapel Hill has established and maintains a program of education designed to help all members of the University Community avoid involvement with illegal drugs. The University of North Carolina at Chapel Hill provides information about drug counseling and rehabilitation services available to members of the University Community through campus-based programs and through community-based organizations.

This chapter gives definitions and protocols for chemicals that are classified as controlled substances by the U.S. Drug Enforcement Administration. Controlled substances have special rules for acquisition, storage, security, inventory/recordkeeping, disposal, and importing or exporting, detailed in this chapter. The appendices include a current list of controlled substances and forms for inventory support and personnel screening.

The purpose of this standard is to ensure that any proposed neuromuscular blocking drugs are properly utilized in conjunction with appropriate analgesics and anesthetics and users are aware of autonomic nervous system changes that can be indicator of pain related to an inadequate depth of anesthesia.

The misuse and abuse of opioid pain relievers has reached epidemic proportions. As prescribers of opioid pain medications, dentists are well positioned to help keep these drugs from becoming a source of harm. The UNC Adams School of Dentistry believes that a fundamental component of good dental practice includes the appropriate evaluation and management of pain.

An “Institutional-, investigator- or sponsor-initiated hold” refers to a voluntary action by the institution, investigator or sponsor of the study to place some or all research activities associated with that study on hold. Institutional, investigator or sponsor holds may be the result of interim data analysis, inadequate drug availability, response to a DSMB report/recommendation, pre-planned stopping point or other information.

This document establishes procedures for the safe handling and use of urethane (CAS# 51-79-6). Urethane is an anesthetic commonly used alone or in combination with other drugs in university animal research facilities and individual laboratories.

The standards described provide guidance to all researchers and animal handlers administering chemical agents, whether they be pharmaceutical or non-pharmaceutical grade.

FDA regulations apply to research that involves a FDA-regulated test article in a clinical investigation involving human subjects as defined by the FDA regulations. For FDA-regulated research, the IRB must apply the FDA regulations at 21 CFR 50 and 21 CFR 56. If required by organizational policy or a FWA, 45 CFR 46 must also be applied.

Procedures for identifying and addressing issues associated with Controlled Substances or other Impairments for Students and Residents of Adams School of Dentistry.

This document establishes the definitions followed by the University of North Carolina at Chapel Hill (UNC-Chapel Hill) Human Research Protection Program. This is a non-exhaustive list. Regulations and other documents (e.g. guidance documents issued by federal regulatory agencies) should be referenced when applicable.

The University is committed to ensuring that Employees are Fit for Duty while also respecting Employee privacy. Employees are Fit for Duty when they are able to perform their Essential Job Functions without posing a Direct Threat to themselves or others. This Policy and associated Procedures describe the circumstances in which the University may evaluate an Employee’s Fitness for Duty, provide the procedures for those evaluations, and safeguard Employee privacy related to those evaluations.

The University of North Carolina at Chapel Hill (UNC‐Chapel Hill) fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the Organization.

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

This Standard is meant to provide the minimum expectations for users of the University of North Carolina at Chapel Hill’s Data Management System (“DMS”) for Clinical Research Administrative Data. This Standard is intended to further the University’s goals of providing DMS users with efficient and accurate administrative data and to promote legal and regulatory compliance.

The Federal Highway Administration has implemented regulations under the Omnibus Transportation Act of 1991 that require employers to establish an alcohol and controlled substances testing program for their employees who are required to hold commercial driver's licenses (CDLs) as a condition of employment. The goals of this testing are to prevent needless accidents, to reduce the risk of injury to employees and others, and to make employees aware of resources available to assist them.