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2009-02-10: We appreciate your patience while we work on these pages. In the interim visitors can locate state regulations using the First Clinical Research — MAGI Regional Requirements database. Set the display radio button to
Region and select the state from the drop down menu: http://firstclinical.com/magi/regional.html?by=region
See also: Default Surrogate Consent Statutes as of September 1, 2008. The American Bar Association. Accessed on 2009-02-10 at: http://www.abanet.org/aging/legislativeupdates/pdfs/Famcon_Chart.pdf
Arizona Revised Statutes, Title 32 — Professions and Occupations, Chapter 13 — Medicine and Surgery, 32-1401, Definitions, 27, Unprofessional Conduct. (selected sections).
Unprofessional conduct includes the following, whether occurring in this state or elsewhere:
(a) Violating any federal or state laws, rules or regulations applicable to the practice of medicine.
(o) Action that is taken against a doctor of medicine by another licensing or regulatory jurisdiction due to that doctor's mental or physical inability to engage safely in the practice of medicine, the doctor's medical incompetence or for unprofessional conduct as defined by that jurisdiction and that corresponds directly or indirectly to an act of unprofessional conduct prescribed by this paragraph. The action taken may include refusing, denying, revoking or suspending a license by that jurisdiction or a surrendering of a license to that jurisdiction, otherwise limiting, restricting or monitoring a licensee by that jurisdiction or placing a licensee on probation by that jurisdiction.
(p) Sanctions imposed by an agency of the federal government, including restricting, suspending, limiting or removing a person from the practice of medicine or restricting that person's ability to obtain financial remuneration.
(u) Charging a fee for services not rendered or dividing a professional fee for patient referrals among health care providers or health care institutions or between these providers and institutions or a contractual arrangement that has the same effect. This subdivision does not apply to payments from a medical researcher to a physician in connection with identifying and monitoring patients for a clinical trial regulated by the United States food and drug administration.
(x) Fetal experiments conducted in violation of section 36-2302.
(y) The use of experimental forms of diagnosis and treatment without adequate informed patient consent, and without conforming to generally accepted experimental criteria, including protocols, detailed records, periodic analysis of results and periodic review by a medical peer review committee as approved by the federal food and drug administration or its successor agency.
(gg) Using chelation therapy in the treatment of arteriosclerosis or as any other form of therapy, with the exception of treatment of heavy metal poisoning, without:
- Adequate informed patient consent.
- Conforming to generally accepted experimental criteria, including protocols, detailed records, periodic analysis of results and periodic review by a medical peer review committee.
- Approval by the federal food and drug administration or its successor agency.
Accessed on 2005-08-20 from http://www.azleg.state.az.us/ars/32/01401.htm
Proposed legislation threatens California law for the protection of humans in research: California Senate Bill 583. 2005-04-19 (current version). Available from http://www.leginfo.ca.gov/pub/bill/sen/sb_0551-0600/sb_583_bill_20050419_amended_sen.pdf
California Senate Bill 583. Senate Floor Analysis. 2005-05-04. Available from http://www.leginfo.ca.gov/pub/bill/sen/sb_0551-0600/sb_583_cfa_20050504_171944_sen_floor.html
California Senate Bill 583. Senate Committee Analysis. 2005-04-25. Available from http://www.leginfo.ca.gov/pub/bill/sen/sb_0551-0600/sb_583_cfa_20050426_141420_sen_comm.html
California Senate Bill 583. History. 2005-06-28. Available from http://www.leginfo.ca.gov/pub/bill/sen/sb_0551-0600/sb_583_bill_20050628_history.html
California Senate Bill 583. 2005-02-18 (as originally introduced). Available from http://www.leginfo.ca.gov/pub/bill/sen/sb_0551-0600/sb_583_bill_20050218_introduced.pdf
California Senate Bill 583. 2005-04-04 (emended). Available from http://www.leginfo.ca.gov/pub/bill/sen/sb_0551-0600/sb_583_bill_20050404_amended_sen.pdf
This is the relevant section of the California Health and Safety Code (section 109300-109395) that the proposed bill would undermine (explicitly replacing section 109335): http://www.leginfo.ca.gov/cgi-bin/waisgate?WAISdocID=05384112429+6+0+0&WAISaction=retrieve
California Senate Bill 583 appears to have been written by and primarily supported by a physician and health care practitioners'rightsadvocacy organization called California Citizens for Health Freedom. This position statement is useful to understand the organization's agenda: http://www.citizenshealth.org/alternativebill.htm
If that doesn't wake you up, this will — especially the part where the California Citizens for Health Freedom recommend modifying the mission of the California Medical board toprotect the rights of physicians.Open Letter on Needed Reforms of the Medical Board's Discipline Process of Physicians in California. Submitted to the Joint Legislative Sunset Review Committee for their January 2005 Hearings on the California Medical Board on behalf of California Citizens for Health Freedom. Available from http://www.citizenshealth.org/LettertoJointLeg.htm
Oddly enough, for a political advocacy organization, they don't seem to do much lobbying: http://cal-access.ss.ca.gov/Lobbying/Employers/Detail.aspx?id=1251842&view=activity&session=2003
Ironically (or not), in July, 2005, the California Senate Office of Research published a report
Monitoring Adverse Drug Reactions. Notice there are no fewer than four bills addressing these problems pending in the senate and assembly. Available from http://www.sen.ca.gov/sor/reports/REPORTS_BY_SUBJ/HEALTH/Adversereaction.pdf
Protection of Human Subjects in Medical Experimentation Act, Health and Safety Code Section 24170-24179.5
24170. This chapter shall be known and may be cited as the Protection of Human Subjects in Medical Experimentation Act.
24171. The Legislature hereby finds and declares that medical experimentation on human subjects is vital for the benefit of mankind, however such experimentation shall be undertaken with due respect to the preciousness of human life and the right of individuals to determine what is done to their own bodies.
The Legislature further finds and declares that:
(a) The Nuremberg Code of Ethics in Medical Research was developed after the trial of Nazi war criminals for unethical use of persons in medical experiments; subsequently, the Declaration of Helsinki additionally established recommendations guiding doctors in experimentation involving human subjects.
(b) Neither the Nuremberg Code nor the Declaration of Helsinki are codified under law and are, therefore, unenforceable.
(c) It is necessary that medical experimentation be done in such a way as to protect the rights of the human subjects involved.
(d) There is, and will continue to be, a growing need for protection for citizens of the state from unauthorized, needless, hazardous, or negligently performed medical experiments on human beings.
It is, therefore, the intent of the Legislature, in the enacting of this chapter, to provide minimum statutory protection for the citizens of this state with regard to human experimentation and to provide penalties for those who violate such provisions.
24172. As used in the chapter,
experimental subject's bill of rights, means a list of the rights of a subject in a medical experiment, written in a language in which the subject is fluent. Except as otherwise provided in Section 24175, this list shall include, but not be limited to the subject's right to:
(a) Be informed of the nature and purpose of the experiment.
(b) Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
(c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
(d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
(e) Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
(f) Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
(g) Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
(h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.
(i) Be given a copy of the signed and dated written consent form as provided for by Section 24173 or 24178.
(j) Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject's decision.
24173. As used in this chapter,
informed consent means the authorization given pursuant to Section 24175 to have a medical experiment performed after each of the following conditions have been satisfied:
(a) The subject or subject's conservator or guardian, or other representative, as specified in Section 24175, is provided with a copy of the experimental subject's bill of rights, prior to consenting to participate in any medical experiment, containing all the information required by Section 24172, and the copy is signed and dated by the subject or the subject's conservator or guardian, or other representative, as specified in Section 24175.
(b) A written consent form is signed and dated by the subject or the subject's conservator or guardian, or other representative, as specified in Section 24175.
(c) The subject or subject's conservator or guardian, or other representative, as specified in Section 24175, is informed both verbally and within the written consent form, in nontechnical terms and in a language in which the subject or the subject's conservator or guardian, or other representative, as specified in Section 24175, is fluent, of the following facts of the proposed medical experiment, which might influence the decision to undergo the experiment, including, but not limited to:
- An explanation of the procedures to be followed in the medical experiment and any drug or device to be utilized, including the purposes of the procedures, drugs, or devices. If a placebo is to be administered or dispensed to a portion of the subjects involved in a medical experiment, all subjects of the experiment shall be informed of that fact; however, they need not be informed as to whether they will actually be administered or dispensed a placebo.
- A description of any attendant discomfort and risks to the subject reasonably to be expected.
- An explanation of any benefits to the subject reasonably to be expected, if applicable.
- A disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.
- An estimate of the expected recovery time of the subject after the experiment.
- An offer to answer any inquiries concerning the experiment or the procedures involved.
- An instruction to the subject that he or she is free to withdraw his or her prior consent to the medical experiment and discontinue participation in the medical experiment at any time, without prejudice to the subject.
- The name, institutional affiliation, if any, and address of the person or persons actually performing and primarily responsible for the conduct of the experiment.
- The name of the sponsor or funding source, if any, or manufacturer if the experiment involves a drug or device, and the organization, if any, under whose general aegis the experiment is being conducted.
- The name, address, and phone number of an impartial third party, not associated with the experiment, to whom the subject may address complaints about the experiment.
- The material financial stake or interest, if any, that the investigator or research institution has in the outcome of the medical experiment. For purposes of this section,materialmeans ten thousand dollars ($10,000) or more in securities or other assets valued at the date of disclosure, or in relevant cumulative salary or other income, regardless of when it is earned or expected to be earned.
(d) The written consent form is signed and dated by any person other than the subject or the conservator or guardian, or other representative of the subject, as specified in Section 24175, who can attest that the requirements for informed consent to the medical experiment have been satisfied.
(e) Consent is voluntary and freely given by the human subject or the conservator or guardian, or other representative, as specified by Section 24175, without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence.
24174. As used in this chapter,
medical experiment means:
(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
(b) The investigational use of a drug or device as provided in Sections 111590 and 111595.
(c) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
24175. (a) Except as otherwise provided in this section, no person shall be subjected to any medical experiment unless the informed consent of such person is obtained.
(b) If a person is under a conservatorship of the person or of the person and estate, pursuant to Division 4 (commencing with Section 1400) of the Probate Code, informed consent for a medical experiment involving such person shall be obtained:
(c) If an adult person is gravely disabled, as defined in subdivision (h) of Section 5008 of the Welfare and Institutions Code, and is under a conservatorship of the person or of the person and estate, pursuant to Chapter 3 (commencing with Section 5350) of Part 1 of Division 5 of the Welfare and Institutions Code, informed consent for a medical experiment involving such person shall be obtained from such person, unless the conservator of such person has the right to consent to medical treatment on behalf of the conservatee, pursuant to subdivisions (c) and (d) of Section 5357 and Section 5358 of the Welfare and Institutions Code.
(d) If an adult person is developmentally disabled, as defined in subdivision (a) of Section 4512 of the Welfare and Institutions Code, and has no conservator and is mentally incapable of giving informed consent, informed consent shall be obtained for a medical experiment involving such person, pursuant to subdivision (c) of Section 4655 of the Welfare and Institutions Code.
(e) Informed consent given by a person other than the human subject pursuant to subdivisions (b) through (d), inclusive, of this section shall only be for medical experiments related to maintaining or improving the health of the human subject or related to obtaining information about a pathological condition of the human subject.
24176. (a) Any person who is primarily responsible for conduct of a medical experiment and who negligently allows the experiment to be conducted without a subject's informed consent, as provided in this chapter, shall be liable to the subject in an amount not to exceed ten thousand dollars ($10,000), as determined by the court. The minimum amount of damages awarded shall be five hundred dollars ($500).
(b) Any person who is primarily responsible for the conduct of a medical experiment and who willfully fails to obtain the subject's informed consent, as provided in this chapter, shall be liable to the subject in an amount not to exceed twenty-five thousand dollars ($25,000) as determined by the court. The minimum amount of damages awarded shall be one thousand dollars ($1,000).
(c) Any person who is primarily responsible for the conduct of a medical experiment and who willfully fails to obtain the subject's informed consent, as provided in this chapter, and thereby exposes a subject to a known substantial risk of serious injury, either bodily harm or psychological harm, shall be guilty of a misdemeanor punishable by imprisonment in the county jail for a period not to exceed one year or a fine of fifty thousand dollars ($50,000), or both.
(d) Any representative or employee of a pharmaceutical company, who is directly responsible for contracting with another person for the conduct of a medical experiment, and who has knowledge of risks or hazards with respect to the experiment, and who willfully withholds information of the risks and hazards from the person contracting for the conduct of the medical experiment, and thereby exposes a subject to substantial risk of serious injury, either bodily harm or psychological harm, shall be guilty of a misdemeanor punishable by imprisonment in the county jail for a period not to exceed one year or a fine of fifty thousand dollars ($50,000), or both.
(e) Each and every medical experiment performed in violation of any provision of this chapter is a separate and actionable offense.
(f) Any attempted or purported waiver of the rights guaranteed, or requirements prescribed by this chapter, whether by a subject or by a subject's conservator or guardian, or other representative, as specified in Section 24175, is void.
(g) Nothing in this section shall be construed to limit or expand the right of an injured subject to recover damages under any other applicable law.
24177. This chapter shall not supersede, but shall be in addition to, Article 4 (commencing with Section 111515) of Chapter 6 of Part 5 of Division 104 of this code and Title 2.1 (commencing with Section 3500) of Part 3 of the Penal Code.
24177.5. (a) This chapter shall not apply to any medical experimental treatment that benefits a patient subject to a life-threatening emergency if all of the following conditions are met:
(b) Nothing in this section is intended to relieve any party of any other legal duty, including, but not limited to, the duty to act in a non negligent manner.
(c) This section shall remain in effect only until January 1, 2011, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2011, deletes or extends that date.
24178. (a) Except for this section and the requirements set forth in Sections 24172 and 24176, this chapter shall not apply to any person who is conducting a medical experiment as an investigator within an institution that holds an assurance with the United States Department of Health and Human Services pursuant to Part 46 of Title 45 of the Code of Federal Regulations and who obtains informed consent in the method and manner required by those regulations.
(b) Subdivisions (c) and (e) shall apply only to medical experiments that relate to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of research participants.
(c) For purposes of obtaining informed consent required for medical experiments in a non emergency room environment, and pursuant to subdivision (a), if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decisionmaker with reasonable knowledge of the subject, who shall include any of the following persons, in the following descending order of priority:
(d) (1) When there are two or more available persons who, pursuant to subdivision (c), may give surrogate informed consent and who are in the same order of priority, if any of those persons expresses dissent as to the participation of the person in the medical experiment, consent shall not be considered as having been given.
(2) When there are two or more available persons who are in different orders of priority pursuant to subdivision (c), refusal to consent by a person who is a higher priority surrogate shall not be superseded by the consent of a person who is a lower priority surrogate.
(e) For purposes of obtaining informed consent required for medical experiments in an emergency room environment, and pursuant to subdivision (a), if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decisionmaker who is any of the following persons:
(f) When there are two or more available persons described in subdivision (e), refusal to consent by one person shall not be superseded by any other of those persons.
(g) Surrogate decisionmakers described in this section shall exercise substituted judgment, and base decisions about participation in accordance with the person's individual health care instructions, if any, and other wishes, to the extent known to the surrogate decisionmaker. Otherwise, the surrogate decisionmaker shall make the decision in accordance with the person's best interests. In determining the person's best interests, the decisionmaker shall consider the person's personal values and his or her best estimation of what the person would have chosen if he or she were capable of making a decision.
(h) Research conducted pursuant to this section shall adhere to federal regulations governing informed consent pursuant to Section 46.116 of Title 45 of the Code of Federal Regulations.
(i) Any person who provides surrogate consent pursuant to subdivisions (c) and (e) may not receive financial compensation for providing the consent.
(j) Subdivisions (c) and (e) do not apply to any of the following persons, except as otherwise provided by law:
24179. This chapter shall not apply to a pharmacist dispensing drugs upon a prescription.
24179.5. Notwithstanding any other provision of this chapter, this chapter does not apply to an adult in a terminal condition who executes a directive directing the withholding or withdrawal of life-sustaining procedures pursuant to Section 7188. To the extent of any conflict, Division 4.7 (commencing with Section 4600) of the Probate Code prevails over the provisions of this chapter.
Accessed 2005-08-20 at: http://info.sen.ca.gov/cgi-bin/displaycode?section=hsc&group=24001-25000&file=24170-24179.5
California Assembly Bill No. 2328. CIRCARE InfoMail. 2002-10-17. Available from http://www.circare.org/im/im17Sept2002.htm
District of Columbia
Being updated 2006-02-20.
Being updated 2006-02-20.
Kansas Statutes Annotated Chapter 65 Public Health, Article 28 Healing Arts (selected sections).
65-2837. Professional incompetency, unprofessional conduct; definitions. As used in K.S.A. 65-2836, and amendments thereto, and in this section:
(27) Using experimental forms of therapy without proper informed patient consent, without conforming to generally accepted criteria or standard protocols, without keeping detailed legible records or without having periodic analysis of the study and results reviewed by a committee or peers.
Accessed on 2006-04-20 from http://www.ksbha.org/statutes/haact.html#2837
Last Updated: 2009-02-11
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