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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