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.
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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: roybercaw@hotmail.com