Issues Concerning Informed Consent and Protections of Human Subjects in Research

The determination of competence shall be made by someone other than
the principal investigator or others involved in the research. Except for
research protocols approved by the Institutional Review Board (IRB) as
minimal risk, whenever it is determined that the subject is not able to
continue to provide consent. consent to continued participation shall be
sought from families or others legally entrusted to act in the
participant's best interests.
There are three important principals embedded in this policy. First, since
persons suffering from severe mental illnesses such as schizophrenia
frequently experience fluctuations in decisional capacity, the capacity of all
individuals with these disorders who participate as human subjects in
research should be monitored on an ongoing basis. Research on those
persons most impaired by severe mental illnesses is critical, as these brain
disorders are often devastating. But research of this type must be conducted
with special attention to the cognitive impairments which characterize these
diseases.
Second, if questions arise concerning an individual's capacity to provide
initial or ongoing informed consent, an immediate, thorough assessment of
capacity should occur. Since the ability of the principal investigator or
his/her staff to conduct objective assessments may be compromised, the
assessment should be conducted by a qualified individual who is not directly
involved in the research.
Finally, if it is determined that an individual lacks decisional capacity,
substitute consent should be sought. Unless there are indications to the
contrary, family members should be asked to provide substitute consent. If
no family members are willing or able to function in this capacity, substitute
consent should be permitted only from one who has been legally entrusted to
function in this capacity, e.g. an individual assigned durable power of
attorney pursuant to a properly executed advance directive or an alternative
legal mechanism for assigning a proxy.
(3) Institutional Review Boards that regularly review research
proposals for severe mental illnesses must include consumers and family
members who have direct and personal experience with these brain
disorders.