Mich. Admin. Code R. 330.7003 - Informed consent
Rule 7003.
(1)
All of the following are elements of informed consent:
(a) Legal competency. An individual shall be
presumed to be legally competent. This presumption may be rebutted only by a
court appointment of a guardian or exercise by a court of guardianship powers
and only to the extent of the scope and duration of the guardianship. An
individual shall be presumed legally competent regarding matters that are not
within the scope and authority of the guardianship.
(b) Knowledge. To consent, a recipient or
legal representative must have basic information about the procedure, risks,
other related consequences, and other relevant information. The standard
governing required disclosure by a doctor is what a reasonable patient needs to
know in order to make an informed decision. Other relevant information includes
all of the following:
(i) The purpose of the
procedures.
(ii) A description of
the attendant discomforts, risks, and benefits that can reasonably be
expected.
(iii) A disclosure of
appropriate alternatives advantageous to the recipient.
(iv) An offer to answer further
inquiries.
(c)
Comprehension. An individual must be able to understand what the personal
implications of providing consent will be based upon the information provided
under subdivision (b) of this subrule.
(d) Voluntariness. There shall be free power
of choice without the intervention of an element of force, fraud, deceit,
duress, overreaching, or other ulterior form of constraint or coercion,
including promises or assurances of privileges or freedom. There shall be an
instruction that an individual is free to withdraw consent and to discontinue
participation or activity at any time without prejudice to the
recipient.
(2) A
provider shall establish written policies that include procedures for
evaluating comprehension and for assuring disclosure of relevant information
and measures to ensure voluntariness before obtaining consent. The policies and
procedures shall specify for specific circumstances the types of information
that shall be disclosed and steps that may be taken to protect voluntariness.
The procedures shall include a mechanism for determining whether guardianship
proceedings should be considered.
(3) Informed consent shall be reobtained if
changes in circumstances substantially change the risks, other consequences, or
benefits that were previously expected.
(4) A written agreement documenting an
informed consent shall not include any exculpatory language through which the
recipient, or a person consenting on the recipient's behalf, waives or appears
to waive, a legal right, including a release of a provider or its agents from
liability for negligence. The agreement shall embody the basic elements of
informed consent in the particular context. The individual, guardian, or parent
consenting shall be given adequate opportunity to read the document before
signing it. The requirement of a written consent shall not eliminate, where
essential to the individual's understanding or otherwise deemed advisable, a
reading of the document to the individual or an oral explanation in a language
the individual understands. A note of the explanation and by whom made shall be
placed in the record along with the written consent.
(5) A consent is executed when it is signed
by the appropriate individual.
Notes
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