Issues Concerning Informed Consent and Protections of Human Subjects in Research

investigators and their staff must also be prepared to respond to family
questions and concerns on a timely and appropriate basis.
5. All participants in research protocols involving the assessment of
new medications must be provided with opportunities by the
investigator for a trial on the medication being studied, so long as other
research on the new medication has demonstrated potential safety and
efficacy.
Many research protocols evaluating the efficacy and safety of experimental
medications for the treatment of severe mental illnesses are designed as
placebo controlled studies. These studies typically include one group of
subjects who receive the experimental treatment and one group of subjects
who are administered placebo. In these studies, researchers are precluded
from informing subjects of the group they are in. Consequently, individuals
in critical need of treatment may think that they are receiving an
experimental treatment, when in fact they are being administered a placebo.
NAMI has serious questions about whether placebo controlled studies are
still necessary in this era. We believe that it is important to address whether
standard therapies can be used as the comparison drug. We believe that the
Food and Drug Administration (FDA), the National Institute of Mental
Health (NIMH) and other involved federal agencies be urged to evaluate the
need for this approach and to report back to the Subcommittee on a timely
basis.
Additionally, NAMI strongly believes that all individuals participating in
protocols involving the evaluation of experimental medications should be
afforded the opportunity for a trial on the experimental treatment.
Therefore, if individuals receive placebo as part of the study design, they
should receive a trial on the new medication following completion of the
placebo phase.
(6) All individuals who have benefited from the administration of
experimental medications in research should be provided with continual
access to the medication by the investigator without cost until a source
of third-party payment is found.
Recently, I received a call from an old friend who suffers from
schizophrenia. She informed me that after two successful years on an