Issues Concerning Informed Consent and Protections of Human Subjects in Research

promising new medications. Consequently, the boundary lines between
clinical treatment and research have been somewhat blurred.
Nevertheless, there are significant distinctions between clinical treatment and
research. While clinical treatment programs are designed solely to benefit
individuals who participate in them, this is frequently not the case with
research. Some research protocols are designed to produce basic
information about characteristics or patterns of specific brain disorders, with
no expectation that the research will yield specific benefits for individuals
who participate in these protocols. Other protocols are designed to assess
the progression and course of specific disorders, without focus on treatments
to alleviate the symptoms of these disorders. For example, the UCLA study
in question involved a relapse protocol: research subjects were withdrawn
from their medications specifically to study relapse patterns.
Even research protocols which are designed to study potentially beneficial
treatments of severe mental illnesses may not prove beneficial to individual
participants. Many new medication protocols are designed as placebo
controlled studies, i.e. some participants are administered the medication
being studied and some are administered placebo. In studies of this nature,
there is no guarantee that individual participants will ever be administered
the new medication under study.
Finally, biomedical research on the causes and treatments of severe mental
illnesses involve varying degrees of risk for individual participants. Some
protocols involve minimal risks to individual participants, e.g. studies which
involve no more than a blood test, whereas other protocols involve risks
which are potentially quite significant, e.g. early trials of new medications
with unknown potential benefits or side effects.
These multiple factors, i.e. the cognitive impairments of individuals who
participate as human subjects in psychiatric research, the unknown clinical
benefits of such research, and the potential risks of research together
mitigate strongly in favor of the need for comprehensive, strengthened
procedures for protecting the best interests of these vulnerable individuals.
The remainder of my presentation will focus on certain steps which can be
taken, in accordance with NAMI's policies, to improve these protections.
(1) National standards to govern voluntary consent, comprehensive
exchange of information, and related protections of persons with