Bill Text: MI SB0647 | 2009-2010 | 95th Legislature | Engrossed

---

Bill Title: Health; research; stem cell research; allow, establish procedures for research and donations, prohibit mixing of human and animal embryos, establish requirements for conducting research, and require certain reports. Amends secs. 2685, 2690, 2691 & 2692 of 1978 PA 368 (MCL 333.2685 et seq.) & adds secs. 2693 & 2696. TIE BAR WITH: SB 0649'09

Spectrum: Moderate Partisan Bill (Republican 13-4)

Status: (Engrossed - Dead) 2010-04-21 - Referred To Committee On Health Policy [SB0647 Detail]

Download: Michigan-2009-SB0647-Engrossed.html

---

SB-0647, As Passed Senate, April 21, 2010

 

 

 

 

 

 

 

 

 

 

 

SUBSTITUTE FOR

 

SENATE BILL NO. 647

 

 

 

 

 

 

 

 

 

 

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

by amending sections 2685, 2690, 2691, and 2692 (MCL 333.2685,

 

333.2690, 333.2691, and 333.2692) and by adding sections 2693 and

 

2696.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 2685. (1) A Except as otherwise provided in subsection

 

(3) and subject to section 2693, a person shall not use a live

 

human embryo, fetus, or neonate for nontherapeutic research if, in

 

the best judgment of the person conducting the research, based upon

 

the available knowledge or information at the approximate time of

 

the research, the research substantially jeopardizes the life or

 

health of the embryo, fetus, or neonate. Nontherapeutic research

 

shall not in any case be performed on an embryo or fetus known by

 

the person conducting the research to be the subject of a planned

 

abortion being performed for any purpose other than to protect the

 

life of the mother.

 

     (2) For purposes of subsection (1) the embryo or fetus shall

 

be conclusively presumed not to be the subject of a planned

 

abortion if the mother signed a written statement at the time of

 

the research, that she was not planning an abortion.

 

     (3) Pursuant to section 27 of article I of the state

 

constitution of 1963, a person shall not conduct research that

 

substantially jeopardizes the life or health of a human embryo

 

unless all of the following requirements are met:

 

     (a) The research is permissible under federal law and

 

conducted pursuant to the requirements of federal law.

 

     (b) The human embryo was created for in vitro fertilization

 

purposes.

 

     (c) The human embryo was in excess of the clinical need of or

 

was not suitable for implantation in the individual seeking the in

 

vitro fertilization services and would otherwise be discarded.

 

     (d) The human embryo was donated for research with the

 

voluntary and written informed consent by the individual seeking

 

the in vitro fertilization services and the person does either of

 

the following:

 

     (i) Obtains a copy of the written informed consent given under

 

section 2694 from the physician or health facility or agency that

 

provided the in vitro fertilization services.

 

     (ii) Obtains written informed consent that meets the

 

requirements of section 2694 from the individual who obtained the

 

Senate Bill No. 647 as amended April 21, 2010

 

in vitro fertilization services and is donating the human embryo

 

for research.

 

     (e) The human embryo has not been allowed to develop more than

 

14 days after cell division begins, not including any time during

which the embryo was frozen.

     (f) The research involves the extraction or utilization of

embryonic stem cells from the human embryo.

<<(4) A person that conducts research using live human embryos

as permitted in subsection (3) shall establish a stem cell research

oversight committee substantially in accordance with the guidelines

for human embryonic stem cell research issued by the national

research council and the institute of medicine of the national

academies in 2005. Not less than once per year, the stem cell

research oversight committee shall conduct continuing review of

research using live human embryos in order to ensure that the

research continues to meet the standards of this part. Pursuant

to its review under this subsection, a stem cell research oversight committee may revoke its prior approval of research under this

subsection and require modifications to the plan or design of a continuing research project before permitting the research to

continue. A stem cell research oversight committee may provide

scientific and ethical review of research consistent with this

part.>>

     Sec. 2690. (1) A person shall not knowingly sell, transfer,

distribute, or give away donate an embryo, fetus, or neonate for a

use which that is in violation of sections 2685 to 2689.

     (2) A person shall not, for valuable consideration, purchase

or sell, offer to purchase or sell, or attempt to purchase or sell

a human embryo or oocyte for stem cell research or stem cell

therapies and cures as allowed under section 27 of article I of the

state constitution of 1963, or for any other purpose.

     Sec. 2691. A person who violates sections 2685 to 2690 or

 

section 2693 is guilty of a felony , punishable by imprisonment for

 

not more than 5 years or a fine of not more than $5,000.00, or

 

both.

 

     Sec. 2692. As used in sections 2685 to 2691, "nontherapeutic

 

2696:

 

     (a) "Created for in vitro fertilization purposes" means

 

created for implantation and gestation in a woman's uterus by

 

either of the following:

 

     (i) In vitro fertilization.

 

     (ii) The intentional division of a human embryo created by in

 

vitro fertilization.

 

Senate Bill No. 647 as amended April 21, 2010

 

     (b) "Health facility or agency" means that term as defined in

 

section 20106.

 

     (c) "Human embryo" means an organism consisting entirely of

 

biological components of the species homo sapiens capable of

 

differentiation and maturation, regardless of the means of

 

creation, including, but not limited to, fertilization and somatic

 

cell nuclear transfer, beginning from the single cell stage through

 

the seventh week of development.

 

     (d) "Nontherapeutic research" means scientific or laboratory

 

research, or other kind of experimentation or investigation not

 

designed to improve the health of the research subject.

 

<<(e) "Not suitable for implantation" means that the human

 

embryo exhibits genetic or morphological characteristics that, in

 

the best judgment of the attending physician, negatively affect the

 

potential for successful implantation, gestation, or healthy

 

development of the embryo; or lead to a disease likely to be fatal

 

to the embryo or any human derived from the embryo. Not suitable

 

for implantation does not include genetic characteristics that do

 

not affect the health of the human embryo or any human derived from

the embryo, including, but not limited to, gender or physical

appearance.>>

 

     (f) "Physician" means a physician licensed under part 170 or

 

part 175, or an individual performing an act, task, or function

 

under the delegatory authority of that physician.

 

     (g) "Unique identifier" means a number or other identifier

 

assigned by protocols established by the department.

 

     (h) "Valuable consideration" means the payment or provision of

 

anything of value, including, but not limited to, cash, gifts,

 

reduced or waived fees for services rendered, medical treatment, or

 

payment for expenses or accommodations. Valuable consideration does

 

not include medical treatment or services provided at no cost as

 

part of a clinical trial or experimental therapy related to the

 

treatment of infertility where the trial or experiment is not

 

conducted by a person directly involved in research authorized

 

under section 2685.

 

     Sec. 2693. (1) A person shall not create or attempt to create

 

a human embryo for the purpose of conducting nontherapeutic

 

research upon that embryo.

 

     (2) A person shall not create or attempt to create a human-

 

animal chimeric embryo consisting of biological components from the

 

species homo sapiens and 1 or more other species where the embryo

 

is capable of differentiating and maturing in a manner

 

substantially similar to the embryonic maturation process of either

 

a human embryo or of an embryo of any of the other species

 

constituting the chimeric embryo.

 

     Sec. 2696. (1) Except as otherwise provided in this

 

subsection, a person that conducts research using live human

 

embryos as permitted under section 2685 shall annually submit a

 

report as described in subsections (2) and (3) on forms prescribed

 

and provided by the department, using the unique identifier

 

provided by the department, and at the time and in the manner

 

prescribed by the department. If the person is required to file a

 

report under federal law, rule, regulation, or guideline applicable

 

to research using live human embryos, which report contains all of

 

the information required to be reported under subsections (2) and

 

(3), the person may file the report required under federal law,

 

Senate Bill No. 647 as amended April 21, 2010

 

rule, regulation, or guideline to comply with this section. <<A

person that conducts research using live human embryos is not

required to file the report required under this subsection until

the department has developed and made the form available under

subsection (4).>>

     (2) A person that conducts research using live human embryos

 

shall collect and report the following information to the

 

department as required under subsection (1):

 

     (a) Name of the company, corporation, academic institution, or

 

other person managing or overseeing the research.

 

     (b) Name and address of the physician's office or health

 

facility or agency where embryos were donated and the number of

 

embryos acquired from each office or facility or agency.

 

     (c) Number of embryos thawed for use in research.

 

     (d) Number of embryos discarded without being utilized for

 

research.

 

     (e) Number of embryos held in storage at the beginning and

 

ending of the reporting year.

 

     (3) A person that conducts research using live human embryos

 

shall report its research, oversight, and review policies and

 

procedures with regard to the research conducted. The person that

 

files a report under this subsection shall certify that its

 

research, oversight, and review policies and procedures with regard

 

to the research conducted are in compliance with federal law,

 

rules, regulations, and guidelines applicable to that research. A

 

violation of a federal law, rule, regulation, or guideline

 

applicable to research using live human embryos is a violation of

 

this section.

     (4) The department shall do all of the following:

 

(A) <<On or before the expiration of 1 year after the

effective date of this section,>> develop and make available in

print and electronic format

 

a form for persons to utilize in filing the report required in

 

subsection (1).

 

     (b) Make available annually in aggregate a statistical report

 

summarizing the information submitted in each individual report

 

required by this section. The department shall not identify the

 

person who conducts research using live human embryos to whom any

 

specific information applies.

 

     (c) Destroy each report required by this section and each copy

 

of the report after retaining the report for 5 years after the date

 

the report is received.

 

     (d) Establish a program that will issue to each person

 

required to submit a report under subsection (1) a unique

 

identifier under which the person is to submit the report.

 

     (5) A person submitting a report under subsection (1) shall

 

not include the name, common identifiers such as social security

 

number or motor vehicle operator's license number, or other

 

information or identifiers that would make it possible to identify

 

in any manner or under any circumstances an individual who has

 

obtained in vitro fertilization services and who subsequently

 

donated human embryos for research purposes. A state agency shall

 

not compare data in an electronic or other information system file

 

with data in any other electronic or other information system that

 

would result in identifying in any manner or under any

 

circumstances an individual who donated human embryos for research.

 

A person shall not maintain statistical information that may reveal

 

the identity of an individual who has donated human embryos for

 

research.

 

     (6) Except as otherwise provided in this section, a person

 

shall not disclose confidential identifying information about an

 

individual who obtains in vitro fertilization services. The reports

 

required under this section are statistical reports to be used only

 

for medical and health purposes and shall not be incorporated into

 

the permanent official records of the system of vital statistics.

 

Except for the statistical report under subsection (4)(b),

 

information submitted to the department by a person who conducts

 

research using live human embryos under this section is

 

confidential and is not subject to the disclosure requirements of

 

the freedom of information act, 1976 PA 442, MCL 15.231 to 15.246,

 

except that disclosure of that information may be made in any of

 

the following circumstances:

 

     (a) With the written consent of the person who conducts

 

research using live human embryos.

 

     (b) Pursuant to a court proceeding.

 

     (c) The disclosure is made to an agent or employee of the

 

department.

 

     (d) The disclosure is made to an agent or employee of a state

 

or the federal government authorized by law to see or review the

 

information.

 

     (7) A person that violates this section by disclosing

 

confidential identifying information or by violating a federal law,

 

rule, regulation, or guideline is guilty of a felony punishable by

 

imprisonment for not more than 1 year or a fine of not more than

 

$5,000.00, or both. A person who violates this section by failing

 

to file a required report is responsible for a state civil

 

infraction and may be ordered to pay a civil fine of not less than

 

$5,000.00 per violation.

 

     Enacting section 1. This amendatory act does not take effect

 

unless Senate Bill No. 649 of the 95th Legislature is enacted into

 

law.