Issues Concerning Informed Consent and Protections of Human Subjects in Research

severe mental illnesses render individuals who suffer from these disorders
sometimes incapable of providing such consent. I believe that scientists,
bioethicists, and advocates are committed to balancing the importance of
maintaining a healthy climate for research with protecting vulnerable
subjects who may lack capacity to fully understand the nature, risks and
benefits of the research they are participating in. We welcome this dialogue
as vital to fostering our partnership with science.
Recently, these issues have received renewed attention since revelations, a
few years ago, that a specific psychiatric research protocol at the UCLA
Neuropsychiatric Research Institute (one of the nation's largest psychiatric
research programs) may not have included adequate informed consent and
other procedures for fully informing research participants or their families
about the potential risks and benefits of this protocol. We have discussed our
concerns about this study with officials at the National Institute of Mental
Health (NIMH) and the Office for Protection from Research Risks (OPRR).
In February 1995, in response to the concerns engendered by the UCLA
case, the NAMI Board of Directors, after extensive consultation with outside
experts, adopted comprehensive policies addressing protections of
individuals who participate as human subjects in research. (These policies
are attached to this testimony as Appendix I).
Since adoption of these policies, I have worked actively within the
psychiatric research community to promote adoption of practices reflecting
the principles embedded in these policies. While the time allotted to me
will not allow me to present all of these policy recommendations at this
hearing, I would like to use this opportunity to submit those which I believe
to be most important to this Subcommittee for its consideration.
First, it is important to distinguish between research and treatment for
persons with severe mental illnesses. Due to the inadequacies of many
treatment systems and pervasive discrimination in health insurance coverage
of severe mental illnesses, many individuals with schizophrenia, manicdepressive illness and other serious brain disorders do not have access to
treatments which could benefit them. Most of these individuals are reliant
on underfunded public mental health systems for their care and treatment.
Most are Medicaid recipients, due to their extreme poverty and disability.
Because of the failures of public mental health systems, many individuals
with severe mental illnesses must turn to research protocols for access to