Testimony of Harold E. Varmus, M.D., Director, National Institutes of Health Before the Subcommittee on Human Resources and Intergovernmental Relations Committee on Government Reform and Oversight, United States House of Representatives

protocols involving only minimal risk or those involving greater than minimal risk but which
have the prospect of direct benefit to the child, only one parent must give permission. In
protocols involving a minor increase above minimal risk or more than a minor increase above
minimal risk in which the child stands not to benefit, both parents must sign a form giving their
permission. Any research of greater risk and not intended to benefit the child can only be
approved after review by a panel of experts and publication of the approval in the Federal
Register.
As an additional protection--with specific, rare exceptions--children between the ages of
7 and 18 who are capable of understanding that they are involved in a research project are
required to sign an "assent" form, which acknowledges their agreement to participate in a
research protocol. Much care is given to writing assent forms in readily understandable language
that is age-appropriate and to providing simple oral explanations, sometimes accompanied by
visual demonstrations with dolls or by role-playing. Research investigators and nursing staff are
often assisted in the "assent" process by patient advocates and assent auditors who are not
involved in the research project in order to avoid any possibility of coercing the child into
participating in the protocol.
Persons with Mental Illness or Dementia
Although there are no DHHS regulations providing specific protections for persons with
mental illness or dementia, NIMH is giving special attention to informed consent issues related
to their involvement in research studies. Recognizing the many issues surrounding patients with
mental illness, the NIMH co-sponsored with the National Alliance for the Mentally Ill (NAMI) a
series of meetings, including a symposium at the NAMI annual meeting, to discuss ethical issues
concerning human subjects with mental illness in biomedical research. The NIMH and NAMI
now are planning co-sponsorship of a meeting with a broader group of participants to develop a
series of principles to guide informed consent with potentially cognitively impaired subjects.
NIMH also sponsored a conference, Ethical and Human Subjects Issues in Mental Health
Research with Children and Adolescents. to discuss the specific ethical challenges involved in
this research. In addition, the NIMH and OPRR co-sponsor regional workshops to focus on
human subject issues in clinical research with panels that specifically focus on mental health
clinical research. These workshops, held throughout the country, are attended regularly by
approximately 1.000 IRB members and researchers, annually.
Issues of informed consent are of particular concern for the elderly population,
particularly with regard to Alzheimer's disease patients and others with diminished cognitive
capacities. The National Institute on Aging (NIA) is participating in a Request for Application
on informed consent in research involving human subjects, which I will discuss later. NIA is
particularly interested in the role of cognitive function in aging, and the ability of the elderly to
understand and remember so that information related to the consent process is meaningful.
In addition, the NIA issued an announcement in the NIH Guide to Grants and Contracts,