Issues Concerning Informed Consent and Protections of Human Subjects in Research

3(C). Whenever consent is given by someone other than the research
participant, the participant and involved family members must receive
information on the same basis as the person actually giving consent.
4. 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.
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 continue
participation in the research shall be sought from families or others
legally entrusted to act in the participant's best interests.
5. Institutional Review Boards which regularly review research proposals
on severe mental illnesses must include consumers and family
members who have direct and personal experience with severe mental
illness.
6. Members of IRBs approving research on individuals with severe mental
illness must receive specialized training about mental illness and other
cognitive impairments and the needs of individuals who experience
these disorders. Persons with severe mental illness and members of
their families must be integrally involved in the development, provision
and evaluation of this training.
7. Without penalty, a research participant is free to withdraw consent at
any time, with or without a stated reason. Any time a participant
terminates participation, regardless of reason, investigators will make
every effort to ensure that linkgages to appropriate services occurs,
with followup to assist that participant to establish contact with
appropriate service providers and/or care-givers. If a participant
disappears or terminates their continued consent, the investigator shall
contact his/her family or others designated to receive notification and
information.

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