NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS Release Date: October 31, 2000 NOTICE: DA-01-002 National Institute on Drug Abuse (http://www.nida.nih.gov) PURPOSE The National Advisory Council on Drug Abuse (NACDA) has revised the recommended guidelines for the administration of drugs to human subjects. NACDA recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. These drugs may include caffeine, nicotine, alcohol, opiates, cocaine, amphetamine, barbiturates, benzodiazepines and other compounds with known or suspected abuse/dependence liability. This research can produce scientific knowledge that is essential to understanding and addressing problems of drug abuse and addiction, and is particularly important in the development of effective, scientifically based treatment and prevention strategies. Research involving the administration of drugs must be designed, reviewed, and conducted within the fundamental and broader ethical principles governing all biomedical and behavioral research with human subjects. These principles have been articulated in the Belmont Report, which provides a broad framework for establishing and evaluating specific aspects of ethics in research with human subjects. While a complete reading of the Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html) is required for a full understanding of these principles and their application in complex ethical issues involved in research on human subjects, the principles can be summarized as follows: Respect for Persons -- Individuals must be given the opportunity to choose what shall or shall not happen to them and their decisions must be informed and protected. Persons with diminished autonomy or capacity are entitled to protection. Beneficence -- Researchers must go beyond the obligation to avoid inflicting harm and maximize the potential benefits of the research to individuals and society. Justice -- Fairness and equality must guide the distribution of the benefits and burdens of research involving human subjects. A copy of the complete guidelines on the administration of drugs to human subjects can be found at http://www.nida.nih.gov/NACDA/CouncilStatement.html. For additional information on this policy, contact: Dr. Lucinda Miner or Dr. Teresa Levitin National Institute on Drug Abuse 6001 Executive Boulevard Bethesda, MD 20892-9547 Telephone: (301) 4430-6071 or (301) 443-2755 E-mail: lminer@mail.nih.gov or tlevitin@mail.nih.gov
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