Issues Concerning Informed Consent and Protections of Human Subjects in Research

Chairman Shays, Congressman Towns and Members of the Subcommittee,
my name is Laurie M. Flynn and I am the Executive Director of the
National Alliance for the Mentally Ill (NAMI). I very much appreciate the
opportunity to appear before this Subcommittee today. In addition to my
role as NAMI's Executive Director, I am a member of President Clinton's
National Bioethics Advisory Council (NBAC).
NAMI is the nation's largest grassroots organization dedicated to improving
the lives of persons with severe mental illnesses, including schizophrenia,
bipolar disorder (manic-depressive illness), major depression, obsessivecompulsive disorder, and anxiety disorders. NAMI's membership includes
more than 140,000 people with severe mental illnesses and their families,
and 1,100 state and local affiliates in all 50 states, the District of Columbia,
Puerto Rico and Canada. NAMI's mission includes advocacy for
nondiscriminatory and effective federal and state policies, research into the
causes, symptoms and treatments for severe mental illnesses and education
to eliminate the pervasive stigma toward those who suffer from these serious
brain disorders.
NAMI has been and will continue to be a strong advocate for biomedical
research on severe mental illnesses. Biomedical research has yielded
remarkable breakthroughs in the understanding and treatment of severe
mental illnesses. The development of promising new medications for the
treatment of schizophrenia and other debilitating brain disorders have
occurred as a result of biomedical research. So too have advances in
understanding the causes and etiology of these brain disorders, advances
which may ultimately result in the ability to control and even cure the
symptoms of these illnesses. These remarkable advances would not have
occurred without the participation of individuals with severe mental illnesses
as human subjects in research. These individuals, many of whom are NAMI
members, are heroes in the struggle to overcome these devastating brain
disorders.
Because of these remarkable advances, it is critically important to maintain a
climate conducive to biomedical research on severe mental illnesses. It is
equally important to address the complex ethical questions concerning the
use of human subjects in research of this nature. The use of human subjects
in biomedical research presumes that individuals who participate are capable
of comprehending the nature and scope of the research and can therefore
consent on an informed basis to such participation. However, the nature of