When the organization determines an opportunity exists
to conduct, participate in, or permit research involving persons served the
following procedures will be implemented:
1. A review board will be appointed by the Executive
Director comprised of at least five (5) members with varying backgrounds, who
will promote a complete review of the research activities proposed for
consideration. The review board will examine the suggested activity to ensure
it is ethical and must make a recommendation to the Executive Director in order
for the agency to engage in the activity. The review board membership must be
sufficiently qualified through experience and expertise, and there must be
diversity of the membership. This board must represent both sexes and include
at least one member whose primary concerns are in non-scientific areas such as
law, ethics, or theology, and at least one member who is not otherwise
affiliated with the agency proposing the research. The review board has the
authority to approve, require modifications in, or disapprove any proposed
research activities. Further instructions for the review board are found in the
"Rights of Recipients of Mental Health Services" manual.
2. Any participation by persons served is totally
voluntary with full written informed consent, except as provided in the Rights
of Recipients Manual. Any refusal to participate will not result in loss of
service to the recipient nor shall they be denied provision of the indicated
service. Consent will be sought through the use of Community Care Consent to
Participate in Research form, which shall be signed by the person served and/or
their legal guardian. Full consent shall include the nature, purpose, potential
benefits, and risks of the research in which the recipient is asked to
participate. �Clients/families are given
the opportunity to consent to, reject, or withdraw from participation without
penalty, including the continued provision of services if the client/family
does refuse to participate or withdraw from the research activity. Use of
coercion is prohibited and financial incentives may not be offered to encourage
participation.
3. All research activities must assure minimal risk to
the persons served. Minimal risk is defined as risk of harm anticipated in the
project is not greater, considering probability and magnitude, than that
ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tasks. The Rights Protection or
Advocacy Agency of the Maine Mental Health System must be informed of any
proposed research that represents more than minimal risk.
4. Research activities may not commence until the
Review Board has approved the activity, made recommendation to the Executive
Director, and the Executive Director has authorized the activity by signature
approval.
5. Selection of persons served to participate in
research must be equitable.
6. A research plan will be completed and must make
adequate provisions for monitoring the data collected or the activities allowed
to ensure the safety of the subjects. Researchers must report substantial
changes or unanticipated problems immediately to the Chairperson of the Review
Board.
7. All activities must make provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
8. The manual, "Rights of Recipients of Mental
Health Services", outlines specific exceptions to this procedure and those
exceptions can be found within the manual on the listed reference pages.