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| MICHIGAN STATUTES ADDRESSING INFORMED CONSENT
Mental Health Act 258 of 1974: http://www.michigan.gov/documents/mentalhealthcode_113313_7.pdf 330.1100a Definitions; Sec. 100a. (16) “Consent” means a written agreement executed by a recipient, a minor recipient's parent, or a recipient's legal representative with authority to execute a consent, or a verbal agreement of a recipient that is witnessed and documented by an individual other than the individual providing treatment. Michigan Department of Community Health Annual Administrative Code Supplement, 1998 – 2000 Edition: http://michigan.gov/documents/98_00AACS326_8131_7.1-336.2606.pdf PART 7. RIGHTS OF RECIPIENTS OF MENTAL HEALTH SERVICES 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 advan tageous 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 requir ement 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. History: 1954 ACS 98, Eff. Jan. 9, 1979; 1979 AC; 1998 MR 7, Eff. July 8, 1998. R 330.7017 Electroconvulsive therapy. Rule 7017. (1) A provider shall comply with both of the following provisions when administering electroconvulsive therapy:
(a) A provider shall enter written documentation and signed consent in the clinical record. (b) A provider shall obtain consent for a stated number of electroconvulsive treatments within a series during a stated time period. A provider shall inform a recipient or other legally empowered representative that he or she may withdraw his or her consent at any time during the stated time period. (2) The responsible mental health agency shall notify a minor or an advocate designated by the minor of the right to object to a procedure as specified in section 717(5) of the act. A provider shall place documentation of the notification, including the date and time notified in the clinical record. (3) The responsible mental health agency shall assist a minor or an advocate designated by the minor who objects to an electroconvulsive procedure in properly submitting the objection to a court of competent jurisdiction. History: 1998 MR 7, Eff. July 8, 1998 R 330.7158 Medication. Rule 7158.
(1) A provider shall only administer medication at the order of a physician and in compliance with the provisions of section 719 of the act, if applicable. (2) A provider shall assure that medication use conforms to federal standards and the standards of the medical community. (3) A provider shall not use medication as punishment, for the convenience of the staff, or as a substitute for other appropriate treatment. (4) A provider shall review the administration of a psychotropic medication periodically as set forth in the recipient’s individual plan of service and based upon the recipient’s clinical status. (5) If an individual cannot administer his or her own medication, a provider shall ensure that medication is administered by or under the supervision of personnel who are qualified and trained pursuant to Act No. 368 of the Public Acts of 1978, as amended, being §333.1101 et seq. of the Michigan Compiled Laws. (6) A provider shall record the administration of all medication in the recipient’s clinical record. (7) A provider shall ensure that medication errors and adver! se drug reactions are immediately and properly reported to a physician and recorded in the recipient’s clinical record. (8) A provider shall ensure that the use of psychotropic medications is subject to the following restrictions: (a) A provider shall not administer prescribed psychotropic medications to a recipient unless the recipient consents or unless administration of chemotherapy is necessary to prevent physical harm or injury to the recipient or thers. (b) Psychotropic medications shall not be administered to any of the following persons: (i) A resident who has been admitted by medical certification or by petition until after a final adjudication as required under section 468(2) of the act. (ii) A defendant undergoing examination at the center for forensic psychiatry or other certified facility to determine competency to stand trial. (iii) A person acquitted of a criminal charge byreason of insanity while undergoing examination and evaluation at the center for forensic psychiatry. (c) A provider may administer chemotherapy to prevent physical harm or injury after signed documentation of the physician is placed in the resident’s clinical record and when the actions of a resident or other objective criteria clearly demonstrate to a physician that the resident poses a risk of harm to himself, herself or others. (d) Initial administration of psychotropic chemotherapy may not be extended beyond 48 hours, unless there is consent. The duration of psychotropic chemotherapy shall be as short as possible and at the lowest possible dosage that is therapeutically effective. The chemotherapy shall be terminated as soon as there is little likelihood that the resident will pose a risk of harm to himself, herself, or others. (e) Additional courses of chemotherapy may be prescribed and administered if a resident decompensates and again poses a risk ! to himself, herself or others. (9) A provider shall ensure that only medication that is authorized in writing by a physician is given to residents upon his or her leave or discharge from the providers program and that enough medication is made available to ensure the recipient has an adequate supply until he or she can become established with another provider. History: 1954 ACS 98, Eff. Jan. 9, 1979; 1979 AC; 1979 ACS 8, Eff. Dec. 11, 1981; 1986 MR 12, Eff. Jan. 6, 1987; 1998 MR 7, Eff. July 8, 1998.
MICHIGAN statutes on Informed Consent for Abortion
http://www.legislature.mi.gov/(obuwn1uhx31soa4530mdolrh)/mileg.aspx? page=GetMCLDocument&objectname=mcl-333-17015&queryid=12723900
PUBLIC HEALTH CODE (EXCERPT) Act 368 of 1978
333.17015 Informed consent; definitions; duties of physician or assistant; location; disclosure of information; website maintained and operated by department; medical emergency necessitating abortion; duties of department; physician's duty to inform patient; validity of consent or certification form; right to abortion not created; prohibition; portion of act found invalid; duties of local health department; confidentiality.
Sec. 17015.
(1) Subject to subsection (10), a physician shall not perform an abortion otherwise permitted by law without the patient's informed written consent, given freely and without coercion.
(2) For purposes of this section:
(a) “Abortion” means the intentional use of an instrument, drug, or other substance or device to terminate a woman's pregnancy for a purpose other than to increase the probability of a live birth, to preserve the life or health of the child after live birth, or to remove a dead fetus. Abortion does not include the use or prescription of a drug or device intended as a contraceptive.
(b) “Fetus” means an individual organism of the species homo sapiens in utero.
(c) “Local health department representative” means a person employed by, or under contract to provide services on behalf of, a local health department who meets 1 or more of the licensing requirements listed in subdivision (f).
(d) “Medical emergency” means that condition which, on the basis of the physician's good faith clinical judgment, so complicates the medical condition of a pregnant woman as to necessitate the immediate abortion of her pregnancy to avert her death or for which a delay will create serious risk of substantial and irreversible impairment of a major bodily function.
(e) “Medical service” means the provision of a treatment, procedure, medication, examination, diagnostic test, assessment, or counseling, including, but not limited to, a pregnancy test, ultrasound, pelvic examination, or an abortion.
(f) “Qualified person assisting the physician” means another physician or a physician's assistant licensed under this part or part 175, a fully licensed or limited licensed psychologist licensed under part 182, a professional counselor licensed under part 181, a registered professional nurse or a licensed practical nurse licensed under part 172, or a social worker registered under part 185.
(g) “Probable gestational age of the fetus” means the gestational age of the fetus at the time an abortion is planned to be performed.
(h) “Provide the patient with a physical copy” means confirming that the patient accessed the internet website described in subsection (5) and received a printed valid confirmation form from the website and including that form in the patient's medical record or giving a patient a copy of a required document by 1 or more of the following means:
(i) In person.
(ii) By registered mail, return receipt requested.
(iii) By parcel delivery service that requires the recipient to provide a signature in order to receive delivery of a parcel.
(iv) By facsimile transmission.
(3) Subject to subsection (10), a physician or a qualified person assisting the physician shall do all of the following not less than 24 hours before that physician performs an abortion upon a patient who is a pregnant woman:
(a) Confirm that, according to the best medical judgment of a physician, the patient is pregnant, and determine the probable gestational age of the fetus.
(b) Orally describe, in language designed to be understood by the patient, taking into account her age, level of maturity, and intellectual capability, each of the following:
(i) The probable gestational age of the fetus she is carrying.
(ii) Information about what to do and whom to contact should medical complications arise from the abortion.
(iii) Information about how to obtain pregnancy prevention information through the department of community health.
(c) Provide the patient with a physical copy of the written summary described in subsection (11)(b) that corresponds to the procedure the patient will undergo and is provided by the department of community health. If the procedure has not been recognized by the department, but is otherwise allowed under Michigan law, and the department has not provided a written summary for that procedure, the physician shall develop and provide a written summary that describes the procedure, any known risks or complications of the procedure, and risks associated with live birth and meets the requirements of subsection (11)(b)(iii) through (vii).
(d) Provide the patient with a physical copy of a medically accurate depiction, illustration, or photograph and description of a fetus supplied by the department of community health pursuant to subsection (11)(a) at the gestational age nearest the probable gestational age of the patient's fetus.
(e) Provide the patient with a physical copy of the prenatal care and parenting information pamphlet distributed by the department of community health under section 9161.
(4) The requirements of subsection (3) may be fulfilled by the physician or a qualified person assisting the physician at a location other than the health facility where the abortion is to be performed. The requirement of subsection (3)(a) that a patient's pregnancy be confirmed may be fulfilled by a local health department under subsection (18). The requirements of subsection (3) cannot be fulfilled by the patient accessing an internet website other than the internet website described in subsection (5) that is maintained through the department.
(5) The requirements of subsection (3)(c) through (e) may be fulfilled by a patient accessing the internet website maintained and operated through the department and receiving a printed, valid confirmation form from the website that the patient has reviewed the information required in subsection (3)(c) through (e) at least 24 hours before an abortion being performed on the patient. The website shall not require any information be supplied by the patient. The department shall not track, compile, or otherwise keep a record of information that would identify a patient who accesses this website. The patient shall supply the valid confirmation form to the physician or qualified person assisting the physician to be included in the patient's medical record to comply with this subsection.
(6) Subject to subsection (10), before obtaining the patient's signature on the acknowledgment and consent form, a physician personally and in the presence of the patient shall do all of the following:
(a) Provide the patient with the physician's name and inform the patient of her right to withhold or withdraw her consent to the abortion at any time before performance of the abortion.
(b) Orally describe, in language designed to be understood by the patient, taking into account her age, level of maturity, and intellectual capability, each of the following:
(i) The specific risk, if any, to the patient of the complications that have been associated with the procedure the patient will undergo, based on the patient's particular medical condition and history as determined by the physician.
(ii) The specific risk of complications, if any, to the patient if she chooses to continue the pregnancy based on the patient's particular medical condition and history as determined by a physician.
(7) To protect a patient's privacy, the information set forth in subsection (3) and subsection
(6) shall not be disclosed to the patient in the presence of another patient.
(8) Before performing an abortion on a patient who is a pregnant woman, a physician or a qualified person assisting the physician shall do all of the following:
(a) Obtain the patient's signature on the acknowledgment and consent form described in subsection (11)(c) confirming that she has received the information required under subsection(3).
(b) Provide the patient with a physical copy of the signed acknowledgment and consent form described in subsection (11)(c).
(c) Retain a copy of the signed acknowledgment and consent form described in subsection (11)(c) and, if applicable, a copy of the pregnancy certification form completed under subsection (18)(b), in the patient's medical record.
(9) This subsection does not prohibit notifying the patient that payment for medical services will be required or that collection of payment in full for all medical services provided or planned may be demanded after the 24-hour period described in this subsection has expired. A physician or an agent of the physician shall not collect payment, in whole or in part, for a medical service provided to or planned for a patient before the expiration of 24 hours from the time the patient has done either or both of the following, except in the case of a physician or an agent of a physician receiving capitated payments or under a salary arrangement for providing those medical services:
(a) Inquired about obtaining an abortion after her pregnancy is confirmed and she has received from that physician or a qualified person assisting the physician the information required under subsection (3)(c) and (d).
(b) Scheduled an abortion to be performed by that physician.
(10) If the attending physician, utilizing his or her experience, judgment, and professional competence, determines that a medical emergency exists and necessitates performance of an abortion before the requirements of subsections (1), (3), and (6) can be met, the physician is exempt from the requirements of subsections (1), (3), and (6), may perform the abortion, and shall maintain a written record identifying with specificity the medical factors upon which the determination of the medical emergency is based.
(11) The department of community health shall do each of the following:
(a) Produce medically accurate depictions, illustrations, or photographs of the development of a human fetus that indicate by scale the actual size of the fetus at 2-week intervals from the fourth week through the twenty-eighth week of gestation. Each depiction, illustration, or photograph shall be accompanied by a printed description, in nontechnical English, Arabic, and Spanish, of the probable anatomical and physiological characteristics of the fetus at that particular state of gestational development.
(b) Subject to subdivision (g), develop, draft, and print, in nontechnical English, Arabic, and Spanish, written standardized summaries, based upon the various medical procedures used to abort pregnancies, that do each of the following:
(i) Describe, individually and on separate documents, those medical procedures used to perform abortions in this state that are recognized by the department.
(ii) Identify the physical complications that have been associated with each procedure described in subparagraph (i) and with live birth, as determined by the department. In identifying these complications, the department shall consider the annual statistical report required under section 2835(6), and shall consider studies concerning complications that have been published in a peer review medical journal, with particular attention paid to the design of the study, and shall consult with the federal centers for disease control, the American college of obstetricians and gynecologists, the Michigan state medical society, or any other source that the department determines appropriate for the purpose.
(iii) State that as the result of an abortion, some women may experience depression, feelings of guilt, sleep disturbance, loss of interest in work or sex, or anger, and that if these symptoms occur and are intense or persistent, professional help is recommended.
(iv) State that not all of the complications listed in subparagraph (ii) may pertain to that particular patient and refer the patient to her physician for more personalized information.
(v) Identify services available through public agencies to assist the patient during her pregnancy and after the birth of her child, should she choose to give birth and maintain custody of her child.
(vi) Identify services available through public agencies to assist the patient in placing her child in an adoptive or foster home, should she choose to give birth but not maintain custody of her child.
(vii) Identify services available through public agencies to assist the patient and provide counseling should she experience subsequent adverse psychological effects from the abortion.
(c) Develop, draft, and print, in nontechnical English, Arabic, and Spanish, an acknowledgment and consent form that includes only the following language above a signature line for the patient:
“I, ______________________________, hereby authorize Dr. __________________ (“the physician”) and any assistant designated by the physician to perform upon me the following operation(s) or procedure(s):
_________________________________________________________________
(Name of operation(s) or procedure(s))
_________________________________________________________________
I understand that I am approximately _____ weeks pregnant. I consent to an abortion procedure to terminate my pregnancy. I understand that I have the right to withdraw my consent to the abortion procedure at any time prior to performance of that procedure. I acknowledge that at least 24 hours before the scheduled abortion I have received a physical copy of each of the following:
(a) A medically accurate depiction, illustration, or photograph of a fetus at the probable gestational age of the fetus I am carrying.
(b) A written description of the medical procedure that will be used to perform the abortion.
(c) A prenatal care and parenting information pamphlet. If any of the above listed documents were transmitted by facsimile, I certify that the documents were clear and legible. I acknowledge that the physician who will perform the abortion has orally described all of the following to me:
(i) The specific risk to me, if any, of the complications that have been associated with the procedure I am scheduled to undergo.
(ii) The specific risk to me, if any, of the complications if I choose to continue the pregnancy.
I acknowledge that I have received all of the following information:
(d) Information about what to do and whom to contact in the event that complications arise from the abortion.
(e) Information pertaining to available pregnancy related services.
I have been given an opportunity to ask questions about the operation(s) or procedure(s). I certify that I have not been required to make any payments for an abortion or any medical service before the expiration of 24 hours after I received the written materials listed in paragraphs (a), (b), and (c) above, or 24 hours after the time and date listed on the confirmation form if paragraphs (a), (b), and (c) were viewed from the state of Michigan internet website.”.
(d) Make available to physicians through the Michigan board of medicine and the Michigan board of osteopathic medicine and surgery, and any person upon request the copies of medically accurate depictions, illustrations, or photographs described in subdivision (a), the standardized written summaries described in subdivision (b), the acknowledgment and consent form described in subdivision (c), the prenatal care and parenting information pamphlet described in section 9161, and the pregnancy certification form described in subdivision (f).
(e) The department shall not develop written summaries for abortion procedures under subdivision (b) that utilize medication that has not been approved by the United States food and drug administration for use in performing an abortion.
(f) Develop, draft, and print a certification form to be signed by a local health department representative at the time and place a patient has a pregnancy confirmed, as requested by the patient, verifying the date and time the pregnancy is confirmed.
(g) Develop and maintain an internet website that allows a patient considering an abortion to review the information required in subsection (3)(c) through (e). After the patient reviews the required information, the department shall assure that a confirmation form can be printed by the patient from the internet website that will verify the time and date the information was reviewed. A confirmation form printed under this subdivision becomes invalid 14 days after the date and time printed on the confirmation form.
(12) A physician's duty to inform the patient under this section does not require disclosure of information beyond what a reasonably well-qualified physician licensed under this article would possess.
(13) A written consent form meeting the requirements set forth in this section and signed by the patient is presumed valid. The presumption created by this subsection may be rebutted by evidence that establishes, by a preponderance of the evidence, that consent was obtained through fraud, negligence, deception, misrepresentation, coercion, or duress.
(14) A completed certification form described in subsection (11)(f) that is signed by a local health department representative is presumed valid. The presumption created by this subsection may be rebutted by evidence that establishes, by a preponderance of the evidence, that the physician who relied upon the certification had actual knowledge that the certificate contained a false or misleading statement or signature.
(15) This section does not create a right to abortion.
(16) Notwithstanding any other provision of this section, a person shall not perform an abortion that is prohibited by law.
(17) If any portion of this act or the application of this act to any person or circumstances is found invalid by a court, that invalidity does not affect the remaining portions or applications of the act that can be given effect without the invalid portion or application, if those remaining portions are not determined by the court to be inoperable.
(18) Upon a patient's request, each local health department shall:
(a) Provide a pregnancy test for that patient to confirm the pregnancy as required under subsection (3)(a) and determine the probable gestational stage of the fetus. The local health department need not comply with this subdivision if the requirements of subsection (3)(a) have already been met.
(b) If a pregnancy is confirmed, ensure that the patient is provided with a completed pregnancy certification form described in subsection (11)(f) at the time the information is provided.
(19) The identity and address of a patient who is provided information or who consents to an abortion pursuant to this section is confidential and is subject to disclosure only with the consent of the patient or by judicial process.
(20) A local health department with a file containing the identity and address of a patient described in subsection (19) who has been assisted by the local health department under this section shall do both of the following:
(a) Only release the identity and address of the patient to a physician or qualified person assisting the physician in order to verify the receipt of the information required under this section.
(b) Destroy the information containing the identity and address of the patient within 30 days after assisting the patient under this section.
History: Add. 1993, Act 133, Eff. Apr. 1, 1994;-- Am. 2000, Act 345, Eff. Mar. 28, 2001;-- Am. 2002, Act 685, Eff. Mar. 31, 2003 Popular Name: Act 368 Popular Name: Informed Consent
© 2006 Legislative Council, State of Michigan |