Issues Concerning Informed Consent and Protections of Human Subjects in Research

Scientists involved in research on Alzheimer's Disease and other
neurological disorders impacting primarily on senior citizens have done
important work in developing mechanisms for (a) considering when
surrogate consent may be appropriate in biomedical research, and (b)
determining who may appropriately provide surrogate consent in specific
types of biomedical research. These guidelines have been incorporated, in
part, into draft legislation in Maryland addressing informed consent and
other protections for decisionally incapacitated subjects in research.
They may serve as a valuable tool for scientists, bioethicists, and advocates
concerned about developing similar procedures governing research on
persons with severe mental illnesses.
The lack of guidance specific to research on subjects with cognitive
impairments speaks to the need to develop general, national standards
governing research of this nature. Since the National Institute of Mental
Health (NIMH) funds more than 75% of all biomedical research on severe
mental illness, NAMI believes that it should take the lead, in concert with
other federal agencies funding research conducted on individuals with
cognitive impairments, to promulgate such standards. Persons with severe
mental illnesses, family members, and other stakeholders should be
integrally involved in this process. NAMI is pleased that NIMH Director
Steven Hyman, M.D., has begun such a process.
The development of national standards governing research on individuals
with cognitive impairments must emphasize that informed consent is an
ongoing process and that individual research subjects should be provided
with comprehensive information, orally and in writing, throughout the
research process. This should include information about the purposes and
scale of the research, the objectives of the research, the likely research
process, the potential benefits and risks of the research, and treatment
options available to the research subject, in lieu of research. Specific
information should also be provided about the role and functions of the
Institutional Review Board (IRB) and who to contact in the event that the
research subject or his/her family have questions or concerns about the
research. NAMI believes that the development of model policies and
practices would be extremely useful to IRBs and the research community.
(2) Research participants should be carefully evaluated before and
throughout the research for their capacity to comprehend information
and their capacity to consent to continued participation in the research.

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