Testimony of Harold E. Varmus, M.D., Director, National Institutes of Health

in October 1996 on "Implementation of Policies for Human Intervention Studies." This notice -
codifies additional oversight on the part of NIA Program Administrators to ensure the safety of
participants in NIA-supported intervention studies.
Beyond these and the general NIH-wide guidelines on protection of human subjects, the
NIA has no formal written guidelines for informed consent for research with Alzheimer's disease
patients. However, efforts are being made to maintain consistent practices across large multi-site
clinical studies. For the Alzheimer's Disease Cooperative Studies Program, the Principal
Investigator reviews the consent forms from each site for consistency and appropriateness.
In addition, the NIH Warren Grant Magnuson Clinical Center--together with the OPRR,
the NIMH, the NIA, the National Institute of Neurological Diseases and Stroke, and other NIH
institutes--has pioneered the concept of the durable power of attorney applied to research
participation, whereby individuals, while competent, could identify someone to represent their
best interest and provide proxy informed consent should they later become cognitively impaired.
The classic example of when this would be used is with participants in a study of progressive
dementias.
Drug Abusers
The National Institute on Drug Abuse (NIDA) recognizes the importance of drug users
(as well as other human subjects) to drug abuse research, and the special attention that must be
given to ensuring informed consent in this special population. Therefore, NIDA and its National
Advisory Council on Drug Abuse have developed recommended guidelines for the
administration of drugs to human subjects, which address the ethics of human subject research in
general and research involving special populations in particular. In addition to the roles that the
IRB and OPRR play in ensuring the protection of participants in NIDA research studies, the
Institute adheres to the basic principle and provides guidance that the investigator has the primary
responsibility for the protection of vulnerable subjects. The investigator must give adequate
consideration to the mental and physical conditions and motives of the individuals in terms of
their ability to fully understand the context of the informed consent. If there is a question about a
potential subject's ability to give meaningful and informed consent, an independent clinician,
ethical consultant, or uninvolved third party with appropriate qualifications should be asked to
evaluate this ability if the subject is to be entered or continued in the study.
Return to drug use is a key issue addiction treatment research, and relapse cannot be
studied without the use of individuals who have taken drugs. Research that requires
administration of drugs to individuals who are addicted to drugs warrant special attention,
however. There are a number of extremely important issues that need to be addressed by
scientists considering or evaluating requests to conduct research using drug-addicted individuals.
Medical and neurological examinations and screenings must be made to ensure the absence of
any medical or mental condition for which further drug exposure would be contraindicated. A
thorough assessment of the risks entailed if the participant is to be exposed to a higher drug dose,

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