Issues Concerning Informed Consent and Protections of Human Subjects in Research

At many universities and research facilities, one Institutional Review Board
(IRB) has responsibility for reviewing and approving all research conducted
at these facilities. There are no assurances that anyone serving on these
IRBs has specific knowledge about severe mental illnesses or research
conducted on these illnesses.
NAMI strongly believes that all IRBs approving research on severe mental
illnesses must include (a) at least one person, and preferably more, with
knowledge of severe mental illnesses, and (b) a person with a severe mental
illness or a family member of someone with an illness. If this is not
possible, then IRBs considering research protocols on severe mental illnesses
should be required to consult with individuals who have direct experience
with these illnesses before approving a specific protocol.
Additionally, IRBs approving research on individuals with severe mental
illnesses must receive specialized training about these disorders and issues
pertinent to the participation of individuals with these disorders in research
protocols. Persons with severe mental illnesses and their families should be
involved in designing and conducting this training.
(4) Investigators must ensure that individuals who participate in
research as outpatients are linked to appropriate care, treatment and
supports for the entire duration of the research protocol.
Today, most biomedical research on severe mental illnesses is conducted on
an outpatient basis. Individuals with these illnesses who participate in
research may be particularly vulnerable to relapse or decompensation due to
exacerbation of their psychiatric symptoms. This is especially, but not
uniquely true, when the protocol involves "drug washouts" (i.e. withdrawal
from psychotropic medications).
The potential implications of relapse or decompensation can be devastating
for individuals with severe mental illnesses and their families. These
consequences can include broken relationships, loss of housing and supports,
homelessness, petty crimes, victimization, violence, or arrest and
incarceration. Consequently, researchers have an important ethical and
moral obligation to ensure that all vulnerable research participants are linked
to treatment which can be accessed on a timely basis for as long as needed.
Since families are generally the first to recognize signs of relapse,