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Cambridge, MA writer and researcher, Roy Bercaw, wrote this bill, which was filed with the Massachusetts state legislature. It addresses the need for protection from criminal medical experimentation. Hearings are scheduled for May 13, 1999 before the Health Care Committee.
1 Citation of Chapter This chapter shall be known and may be cited as the Protection of Human Subjects in Experimentation Act. 2 Findings and Declarations Medical experimentation benefits mankind, however such experimentation on human subjects 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. (a) The Nuremberg Code of Ethics in Medical Research was issued in 1943 after the Doctor's Trial of Nazi doctors for unethical use of human beings in medical experiments; subsequently, the Declaration of Helsinki established recommendations guiding doctors in experimentation involving human subjects. 55 years after the Nuremberg Code was written there are still no penalties for non compliance with federal laws on human experimentation. (b) Neither the Nuremberg Code nor the Declaration of Helsinki are codified under law and are, therefore, unenforceable. Persons are being irreparably harmed and the researchers are not being held accountable for their actions. (c) Medical experiments must 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 Commonwealth from unauthorized, needless, hazardous, or negligently performed medical experiments on human beings. This chapter provides minimum statutory protections for the citizens of the Commonwealth with regard to human experimentation and provides penalties for those who violate such provisions. 3 Experimental subject's bill of rights; contents 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 7, 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 4 or 9. 4 Informed consent As used in this chapter, "informed consent" means the authorization given pursuant to 6 to have a medical experiment performed after each of the following conditions have been satisfied: (a) The subject is provided with a copy of the experimental subject's bill or rights, prior to consenting to participate in any medical experiment, containing all the information required by 3 and such copy is signed and dated by the subject as specified in 6. (b) No person who suffers from any mental disability shall be allowed to be used for any medical experiment under any conditions. Any violation of this section by any professional licensed by the Commonwealth will result in an automatic suspension of that license for life. (c) Any person who participates in a human experiment on a person with a mental disability shall be subject to criminal penalties consistent with the severity of harm done to the person with a mental disability as stated in other codes and statutes in effect at the time of the experiment. (d) A written consent form is signed and dated by the subject as specified in 6. (e) The subject as specified in 6, is informed both verbally and within the written consent form, in nontechnical terms and in a language in which the subject as specified in 6, 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: (1) An explanation of the procedures to be followed in the medical experiment and any drug or device to be utilized, including the purposes of such procedures, drugs or device. If a placebo is to be administered or dispensed to a portion of the subjects involved in a medical experiment, all subjects of such experiment which shall be informed of such fact, however, they need not be informed as to whether they will actually be administered or dispensed a placebo. (2) A description of any attendant discomfort and risks to the subject reasonably to be expected. (3) An explanation of any benefits to the subject reasonably to be expected, if applicable. (4) A disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits. (5) An estimate of the expected recovery time of the subject after the experiment. (6) An offer to answer any inquiries concerning the experiment or the procedures involved. (7) An instruction to the subject that he or she is free to withdraw his prior consent to the medical experiment and to discontinue participation in the medical experiment at any time, without prejudice to the subject. (8) The name, institutional affiliation, if any, and address of the person or persons actually performing and primarily responsible for the conduct of the experiment. (9) The name of the sponsor or the 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 conducted. (10) 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. (f) Consent is voluntary and freely given by the human subject as specified by 6, without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence. 5 Medical experiment 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 11 or 10, electromagnetic radiation, pulsed microwaves, lasers, ultra sound, radar, thermal imaging, heat or cold, radio waves, sound 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 such subject or otherwise directly benefiting such subject. (b) This prohibition includes psychologists exercising extra legal control over human subjects using above-mentioned devices drugs and technology for non-invasive psychological conditioning and/or legal experimentation. (c) The investigational use of a drug or device. (d) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject. 6 Informed consent (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 as provided by any provision of any probate codes or statutes, or if he suffers from any mental disability or has ever suffered from a mental disabili- ty, or if he is developmentally disabled, he may not under any conditions or circumstances be used for any medical experiments. (d) Informed consent given by a person other than the human subject shall not be valid to fulfill the requirements of this chapter. 7 Violations; damages; penalties; waiver of rights (a) Any person who is primarily responsible for conduct of a medical experiment and who negligently allows such experiment to be conducted without a subject's consent, as provided in this chapter, shall be liable to such subject in an unlimited amount of money damages as determined by a court. (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, or obtains consent under deceptive acts as provided in this chapter, shall be liable to such subject in an unlimited amount of money damages and imprisonment as determined by a court. (c) In keeping with the tradition of the survivors of the Nazi Holocaust, there shall be no statute of limitations for bringing tort and criminal actions against violators of this chapter. (d) Any person who is primarily responsible for the conduct of a medical experiment and who willfully fails to obtain the subject's informed consent, or obtains consent under deceptive acts 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 felony punishable by imprisonment in state prison for a period not to exceed life imprisonment without parole, or a fine of one hundred million dollars ($100,000,000) or both. (e) 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 such experiment, and who willfully withholds information of such risks and hazards from such 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 felony punishable by imprisonment in state prison for a period not to exceed life imprisonment without parole or a fine of one hundred million dollars ($100,000,000) or both. (f) Each and every medical experiment performed in violation of any provision of this chapter, is a separate and actionable offense. (g) Any attempted or purported waiver of the rights guaran- teed, or requirements prescribed by this chapter, whether by a subject or any other person, as specified in 6, is void. (h) Nothing in this section shall be construed to limit the right of an injured subject to recover damages under any other applicable law. 8 Law governing The provisions of this chapter shall not supersede, but shall be in addition to any criminal statutes, constitutional provisions, and laws governing medical abuses in experimentation elsewhere in the Massachusetts General Laws and laws of the United States. 9 Investigators within institutions holding a federal assurance; application of chapter. This chapter shall apply to any person who is conducting a medical experiment within the Commonwealth. That includes inves- tigators within an institution which holds an assurance with the Department of Health and Human Services pursuant to Part 46 of Title 45 of the Code of Federal Regulations. Informed consent in the method and manner required by state or federal regulations is required, whichever is more strict. Failure to comply with federal laws will expose the investigators to state criminal and tort liability as provided in this chapter. All provisions of this chapter apply to institutional research. 10 Device "Device" means any instrument, apparatus, machine, contriv- ance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, that is any of the following: (a) Recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them. (b) Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease in humans or any other animal. (c) Intended to affect the structure of any function of the body of humans or any other animal and that does not achieve any of its principal intended purposes through any chemical action within or on the body of humans or other animals and that is not dependent upon being metabolized for the achievement of any of its principal intended purposes. (d) Any beam or wave generated by a mechanical or electrical machine capable of inflicting pain, causing death, affecting the thought processes moods or emotions of a human being, or capable of disturbing the sleep of a human being or other animal. Firearms described in M.G.L. Chapter 140, 131 J, are included in this definition. 11 Drug "Drug" means any of the following: (a) Any article recognized in an official compendium. (b) Any article used or intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or any other animal. (c) Any article other than food, that is used or intended to affect the structure or any function of the body of human beings or any other animal. (d) Any article used or intended for use as a component of any article designated in subdivision (a), (b), (c) of this section. The term "drug" does not include any device. Any food for which a claim, (as described in Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(3) (21 U.S.C. Sec. 343(r)(3) or Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(1)(B)) and 403(r)(5)(D) (21 U.S.C. Sec. 343(r)(5)(D)) of the federal act), is made in accordance with the requirements set forth in Section 403(r) (21 U.S.C. Sec. 343(r)) of the federal act, is not a drug under subdivision (b) solely because the label or labeling contains such a claim. - END - Proposed and submitted to the Massachsuetts General Court, House of Representatives on December 2, 1998, by Roy Bercaw Porter Square PO Box 400297 Cambridge MA 02140 USA 617-499-7965 e-mail: email@example.com
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