| [Senate, March 30, 2005 — Text of the Senate Bill, No. 2028, “An Act promoting stem cell research”, printed as amended.] |
AN ACT PROMOTING STEM CELL RESEARCH.
Whereas, The deferred operation of this act would tend to defeat its purpose, which is forthwith to promote stem cell research, therefore it is hereby declared to be an emergency law, necessary for the immediate preservation of the public health and convenience.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:
SECTION 1. The General Laws are hereby amended by inserting after chapter 111K the following chapter:—
Chapter 111L.
PROMOTION OF THE BIOTECHNOLOGY INDUSTRY
IN THE COMMONWEALTH.
Section 1. The general court finds and declares that:
(a) human embryonic stem cell research, and other research in the life sciences and regenerative medicine present a significant chance of yielding fundamental biological knowledge from which may emanate therapies to relieve, on a large scale, human suffering from disease and injury; and
(b) the extraordinary biomedical scientists working in Massachusetts within institutions of higher education, research institutes, hospitals, biotechnology companies and pharmaceutical companies can contribute significantly to the welfare of mankind by performing outstanding research in this field; and
(c) it shall be the policy of the commonwealth to actively foster research and therapies in the life sciences and regenerative medicine by permitting research and clinical applications involving the derivation and use of human embryonic stem cells and umbilical cord cells, and any human adult stem cells, including research and clinical applications involving somatic cell nuclear transplantation. It shall further be the policy of the commonwealth to prohibit human reproductive cloning.
Section 2. For the purposes of this chapter, the following words shall have the following meanings unless the context clearly requires otherwise:
“Advisory board,” the Massachusetts stem cell research advisory board.
“Donated to medicine”, a pre-implantation embryo originating from an in vitro process, when, for purposes of biomedical research or medical care or treatment, the persons contributing genetic material do so in the absence of financial inducement and after fulfillment of the requirements of a duly appointed institutional review board concerning informed consent.
“Fertilization”, the process whereby the male sperm and the female oocyte unite to form an embryo.
“Financial inducement”, any valuable consideration, excluding: (i) reimbursement for reasonable costs incurred in connection with a donation; and (ii) reasonable compensation to a donor from whom an oocyte or somatic cell is recovered for the time, burden and risk of such recovery and the preparation for it. Whether costs or compensation are reasonable shall be determined by a duly appointed institutional review board, provided the determination is made with due diligence and in good faith.
“Human adult stem cell”, an undifferentiated cell found in the differentiated tissue in adult humans which can renew itself and differentiate to yield specialized cell types.
“Human embryonic stem cell”, a pluripotent human stem cell derived from a pre-implantation embryo.
“Human reproductive cloning”, creating, or attempting to create, a human being by transferring a nucleus of a human cell from any source into a human or non-human egg cell from which the nucleus has been removed for the purpose of creating a human being, and implanting the resulting product into a uterus or uterine-like environment to initiate pregnancy and a possible birth.
“Informed consent”, consent for the donation of embryos, consent for participation in vitro fertilization, or consent for any other process where an egg is extracted from a woman, or other participation in research pursuant to this chapter, which complies with requirements of a duly appointed institutional review board, and which follows the procedures stipulated in 45 CFR Part 46.116 and 117.
“Institution”, any organization, corporation, or institution that conducts human embryonic stem cell research.
“Institutional review board” or “IRB”, a board that has a minimum of 5 members who meet regularly to review research applying the standards of 45 CFR Part 46 and 21 CFR Parts 50 and 56.
“In vitro”, in an artificial environment, referring to a process or reaction occurring therein, as in a test tube or culture medium.
“In vitro fertilization”, an assisted reproductive technique in which fertilization is accomplished outside of the body.
“Parthenote”, the product of egg development without fertilization.
“Parthenogenesis”, the development of an egg without fertilization.
“Person”, any natural person, corporation, association, partnership, institute, or other legal entity.
“Pre-implantation embryo”, any in vitro human embryo whether formed by fertilization, somatic cell nuclear transfer or other means, which has not experienced more than 14 days of development; provided, that such length of time does not include any interval in which such development has been suspended, such as through freezing.
“Public institutional review board”, a board established in accordance with the requirements of 45 CFR 46 Subpart A, as amended from time to time.
“Somatic cell nuclear transfer”, replacement of the nucleus of an egg with the nucleus from any other non-reproductive human cell.
“Uterus”, a muscular organ of a woman in which the ovum is deposited and the embryo and fetus are developed, or fallopian tube.
“Uterine-like environment”, any replicate of the uterus used for the purpose of sustaining an embryo through birth and creating a human being.
Section 3. (a) Research and clinical applications involving the derivation and use of human embryonic stem cells, human adult cells from any source, somatic cell nuclear transplantation and umbilical cord stem cells, parthenotes, shall be permitted in the commonwealth in accordance with this chapter.
(b) (i) No person shall use a pre-implantation human embryo donated to medicine in scientific research or other kind of experimentation or study for the derivation of human embryonic stem cells without the prior written approval, and continuing review on at least an annual basis, of a duly appointed IRB or public IRB setting forth the IRB’s approval of the research, experimentation or study. The written approval shall contain a detailed description of the research, experimentation or study by attachment of a protocol or other writing, shall include written documentation of informed consent as defined by section 2 of this act and shall be maintained as a permanent record by the IRB or the hospital or other entity for which the IRB acts.
(ii) No person shall knowingly purchase or sell any pre-implantation embryo for human embryonic stem cell research for valuable consideration. For purposes of this subsection, “valuable consideration” excludes reasonable payments associated with storage, quality control, preservation, processing or transportation of such pre-implantation embryos donated to medicine.
(c) Human reproductive cloning is hereby prohibited. Accordingly, a pre-implantation embryo donated to medicine for purposes of human embryonic stem cell research, pursuant to this section, shall not be transferred to a uterus or a uterine-like environment. Nothing in this chapter shall prohibit or regulate the use of in vitro fertilization for reproductive purposes.
(d) A person who knowingly violates subsection (b) in such person’s use, purchase, or sale of a pre-implantation embryo as provided shall be punished by imprisonment in a jail or house of correction for not less than 1 year nor more than 2 years or by imprisonment in the state prison for not more than 5 years or by the imposition of a fine of not more than $100,000. A person who violates subsection (c) shall be punished by imprisonment in a jail or house of correction for not less than 1 year nor more than 2 years or by imprisonment in the state prison for not more than 10 years or by the imposition of a fine of up to $1,000,000.
Section 4. (a) For the purposes of reporting to the governor, president of the senate, and speaker of the house of representatives on the status of human embryonic stem cell research and proposing modifications to the regulation of such research, there shall be a Massachusetts stem cell research advisory board. The advisory board shall consist of 8 members, all of whom shall be residents of the commonwealth. The members shall be professionally qualified and collectively experienced in the fields of science, including but not limited to, knowledge of cell differentiation, nuclear reprogramming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, related biomedical and research fields, medical ethics, and biotechnology, and shall include one community member. Three members shall be appointed by the president of the senate, 3 appointed by the speaker of the house of representatives, and the 1 community member shall be appointed by the governor. The eighth member shall be the commissioner of public health.
(b) Original members of the advisory board shall have staggered terms of 1 to 3 years, and from then on the members’ terms shall be for 3 years.
(c) Any person who conducts scientific research, experimentation, or study that involves the creation or use of pre-implantation embryos in relation to human embryonic stem cell research, shall submit an annual report to the advisory board providing a summary of the research approved during that calendar year and a statement representing that the research was reviewed in accordance with the section 3. Any disclosure that, in the opinion of the institution or person submitting disclosure, is a trade secret, proprietary or confidential shall be submitted separately from the annual report with a statement explaining the reasons that the information should be deemed confidential to the attorney general, who shall determine whether such information should be kept confidential as proprietary. The attorney general shall submit all disclosures deemed not proprietary to the Massachusetts stem cell research advisory board after notice to the institution or person submitting the disclosure. All disclosures deemed proprietary shall be kept confidential by the office of the attorney general and, notwithstanding any law to the contrary, shall not be deemed a public record. The attorney general may establish procedures to effectively carry out this paragraph.
(d) The advisory board shall meet periodically, and no less than twice each year. All meetings shall be public.
(e) The advisory board shall keep a public record of all meetings, votes, and other business.
(f) The advisory board shall review the annual reports from persons conducting scientific research, experimentation, or study that involves the creation or use of pre-implantation embryos in relation to human embryonic stem cell research. The advisory board may require submission of a copy of the federal-wide assurance from the institutions whose IRBs review pre-implantation embryo research relating to human embryonic stem cell research.
(f½) The board shall study the implementation of this chapter and the conduct of research, and shall make recommendations to the general court on ways to encourage disproportionately impacted populations participation in, and benefit from, human embryonic stem cell research, including requiring the IRB to develop methods for such participation.
(g) Based on its review of the annual reports submitted, the advisory board shall submit to the governor, senate president, and speaker of the house by January 31 of each year an annual report of the current state of pre-implantation embryo research relating to human embryonic stem cell research in the commonwealth. The advisory board may include recommendations, if any, regarding the modification of regulations concerning human embryonic stem cell research.
(h) The advisory board shall receive administrative support from the department of public health.
Section 5. (a) An employee shall not be required to conduct scientific research, experimentation, or study that involves the creation or use of pre-implantation embryos in relation to human embryonic stem cell research to the extent that such research conflicts with the bona fide religious practices and beliefs of the employee.
(b) A physician or other health care provider who treats a patient for infertility shall provide the patient with timely, relevant and appropriate information sufficient to allow that patient to make an informed and voluntary choice regarding the disposition of any pre-implantation embryos remaining following said treatment. The physician shall present the patient with the options of storing, donating to another person, donating for research purposes, or otherwise disposing of or destroying any unused pre-implantation embryos, as appropriate. The department of public health shall prescribe and provide for use by physicians and other health care providers who treat patients for infertility through in vitro or any other process where an egg is extracted from a woman the following 2 documents (in multiple languages as determined by the department):
(1) An informational pamphlet, describing the procedure by which an egg is intended to be extracted from the patient, including all short and long-term potential health impacts of the procedure on the patient, any drugs or devices to be used, including whether they have received approval from the United States Food and Drug Administration, the risks involved, any discomfort and side-effects that may be experienced, any alternatives which the patient has and their attendant risks and benefits, medical treatment available to the patient should complications arise, and that the particular treatment may involve currently unforeseeable risks to the patient, embryo or fetus. A physician or other health care provider treating a woman with any procedure by which an egg is intended to be extracted shall provide the patient with this pamphlet or a legible copy thereof, and provide any other treatment information which may be specific to the patient’s treatment; and
(2) an informed consent form, stating that the patient has been given, has reviewed and understands the informational pamphlet described in clause (1), has consulted with her physician or health care provider concerning the general procedures and her specific medical situation, and, understanding the procedure, process and risks, consents to proceed with the procedure or process. The informed consent form shall also contain a “Notes” section, to be completed by the physician or health care provider. This notes section shall contain any medical information, alternative procedures, medicines, devices, considerations or risks relevant to the specific patient’s informed consent to proceed and shall be completed by the physician or health care provider in each case. A physician or other health care provider treating a woman by any procedure by which an egg is intended to be extracted shall provide the patient with this form or a legible copy thereof, and shall keep a signed copy of this document in the patient’s medical file.
A physician or other health care provider shall not provide such treatment before providing the patient with both the informational pamphlet and the informed consent form, and receiving in return a complete and fully-executed informed consent form from the patient. A physician or other health care provider shall seek such informed consent only under circumstances that provide the prospective patient reasonable opportunity to consider whether or not to receive such treatment and that minimize the possibility of coercion or undue influence. The information that is given to the patient shall be in language understandable to the patient. No informed consent, whether oral or written, may include a waiver of legal rights beyond those specifically acknowledged as waived by the terms of the consent.
(c) An institution conducting human embryonic stem cell research shall not take any retaliatory action against its employee because its employee:
(i) discloses or threatens to disclose to a manager or a public body an activity, policy or practice of the institution conducting embryonic stem cell research, or of another institution conducting such research with whom the employee’s institution has a business relationship, that the employee reasonably believes is in violation of sections (3) to (6), inclusive; or
(ii) objects to, or refuses to participate in any activity, policy or practice that the employee reasonably believes is in violation of sections (3) to (6), inclusive.
(d) For purposes of this section:
(i) “Retaliatory action” means the discharge, suspension, demotion, harassment, denial of promotion, layoff or other adverse action taken against an employee affecting the terms and conditions of employment.
(ii) “Manager” means an individual to whom an institution conducting human embryonic stem cell research has given the authority to direct and control the work performance of the affected employee, who has authority to take corrective action regarding a violation of a law, rule, regulation, activity, or policy.
(iii) The protection against retaliatory action shall not apply to the public disclosure of confidential or proprietary information, trade secrets or other confidential materials unless such confidential disclosure is made by the employee directly to and exclusively with the office of the attorney general or the department of public health. The department of public health shall not publicly disclose any such confidential information but shall submit the information to the attorney general forthwith.
(e) Any employee aggrieved by a violation of this section may, within 2 years, file a complaint with the attorney general, who may bring an action in the name of the commonwealth against any institution conducting human embryonic stem cell research that has violated subsection (c).
(f) The department of public health shall establish a program to educate maternity patients with regard to the subject of “cord blood banking.” This program shall provide such patients with sufficient information to make an informed decision on whether or not to participate in a private or public umbilical cord blood banking program, including but not limited to, an explanation of the difference between public and private umbilical cord blood banking, the medical process involved in umbilical cord blood banking, the current and potential future medical uses of stored umbilical cord blood, the benefits and any risks involved in banking umbilical cord blood, and the availability and cost of public or private umbilical cord blood banks.
Section 6. (a) The department of public health, in this section called the department, shall issue a license authorizing an institution to conduct human embryonic stem cell research, within 30 days after the applying institution (i) pays a fee of not more than $200 to the department, and (ii) provides documentation to the department demonstrating that the institution has or has arranged for a duly appointed IRB or a copy of a valid contract between the institution and the public IRB that shall review the institution’s experimentation, study, and procedures involving human embryonic stem cell research.
(b) No person shall conduct human embryonic stem cell research at any institution that does not have a license issued pursuant to this section.
(c) All licenses issued pursuant to this act shall expire on December 31 of the third year after the date of issuance. Any holder of a license shall be entitled to have such license renewed for a 3-year term by the department, upon the payment of a renewal fee of not more than $200. On November 1 of each year, the department shall send written notice to this effect to every licensed institution, whose license shall expire that calendar year, and shall enclose with each notice a proper blank form for such renewal. If the blank form properly filled out, together with the fee, shall not on or before December 31 of each year be received by the department from any institution so notified, the department shall strike from the register the name of such institution; but at any time thereafter, any institution, upon submission to the department of proof of satisfactory compliance with the procedures and guidelines contained within this section, may have its name restored by it upon the payment to the department of all accrued renewal fees, together with a reinstatement fee of not more than $200.
(d) The department shall keep an official record of the names of all licensed institutions and of all money received and disbursed by it, and a duplicate thereof shall be open to public inspection in the office of the state secretary.
Any institution which applies for a license and complies with clauses (i) and (ii) shall not have said license unreasonably withheld. If 30 days following an application for a license the department has failed to issue said license to an applying institution which is in compliance with this section, said institution shall be considered to be licensed and the department shall issue said license accordingly. In the event that an application is considered by the department to be incomplete, the department shall immediately issue notice to the applicant of any further information or corrections necessary for the issuance of the license pursuant to this section.
Section 7. (a) The department of public health shall establish and maintain, in partnership with the University of Massachusetts Medical Center at Worcester, a public bank for umbilical cord and placental tissue for the purpose of collecting and storing umbilical cord blood and placental tissue that is donated by maternity patients in the commonwealth. The public bank shall collect any donated umbilical cord blood and placental tissue from participating hospitals and store said blood and tissue, and tissue to be made available for research pursuant to the provisions of this act.
(b) Notwithstanding any general or special law to the contrary, all licensed hospitals shall inform pregnant patients, not later than 30 days from the commencement of their third trimester of pregnancy, of the opportunity to donate to a publicly accessible certified cord blood and placental tissue bank blood and tissue extracted from the umbilical cord and placenta following delivery of a newborn child. Donations for research pursuant to this act shall be made at no expense to the donor. Donations must be made without financial inducement to the donor and after informed consent.
(c) Institutions licensed under section 6 may reach agreement with the public umbilical cord blood bank to acquire donated umbilical cord blood or placental tissue for the purpose of conducting research. This agreement shall provide for the payment of the estimated expenses of the collection and storage of the donated umbilical cord blood and placental tissue, as well as any reasonable administrative fees by the institution.
(d) Nothing in this section shall obligate a hospital to collect umbilical cord blood or placental tissue if, in the professional judgment of a physician licensed to practice medicine in all its branches or of a nurse, the collection would threaten the health of the mother or child.
(e) Nothing in this section shall impose a requirement upon any hospital employee, physician, nurse, or hospital that is directly affiliated with a bona fide religious denomination that includes as an integral part of its beliefs and practices the tenet that blood transfer is contrary to an essential part of its doctrine or beliefs.
Section 8. (a) The University of Massachusetts, through the University of Massachusetts Medical School at Worcester, is authorized and directed to establish and maintain a public institutional review board (“public IRB”). The public IRB shall operate pursuant to the provisions contained in section 2 of this act. The public IRB shall be established not later than 120 days from the passage of this act. The public IRB shall be available on an ongoing basis to any institution for review of that institution’s experimentation, study and procedures for the purposes of conducting research pursuant to this chapter. The public IRB shall be available to any institution employing 50 or fewer full time employees.
(b) An institution may access the services of the public IRB only through a written instrument of contract.
The contract shall include the payment to the public IRB of a reasonable fee, calculated pursuant to a methodology approved by the advisory board to account for the costs of operating and maintaining the public IRB, and the relevant position of those costs attributable to the particular institution receiving the benefit.
SECTION 2. Subsection (a) I of section 12J of chapter 112 of the General Laws, as appearing in the 2002 Official Edition, is hereby amended by adding the following paragraph:—
For the purposes of this section, fetus shall include a neonate and an embryo, but shall exclude a pre-implantation embryo or parthenote as defined in section 2 of chapter 111L.
SECTION 3. Subsection (a) IV of said section 12J of said chapter 112, as so appearing, is hereby amended by striking out the second sentence.
SECTION 4. The advisory board, together with the department of public health, shall conduct a feasibility study on the establishment and maintenance of a public bank for the collection and storage of umbilical cord blood and cells and placental tissue and cells for the purpose of making these resources available to donors and their families for individual medical research and treatment.
This study shall include but not be limited to the development of an appropriate fee structure to be charged to individuals participating in the bank, any necessary eligibility requirements to ensure access to the bank for citizens of all geographic regions of the commonwealth of all levels of income, the costs of operating and maintaining said bank and any possible need for and appropriateness of public subsidies for those costs, any necessary regulations and protocols to govern donations to the bank and the release and use of banked cells, tissue or blood, the potential for and desirability of additional partnerships in operating the bank, and any ethical considerations involved in its creation and maintenance.
The board shall report the findings of the study, together with all necessary legislative recommendations for the establishment and maintenance of the bank, to the secretary of administration and finance, the clerks of the house of representatives and senate, the president of the senate and speaker of the house of representatives, and the joint committee on economic development and emerging technologies, not later than 180 days following the passage of this act.
SECTION 5. Any institution currently conducting human embryonic stem cell research in the commonwealth shall have 180 days from the effective date of this act to come into compliance with this act. No research currently being conducted by institutions in the commonwealth relative to human embryonic stem cell research shall be deemed to be in violation of clause (i) of subsection (b) of section 3 of chapter 111L of the General Laws for 150 days after the effective date of this act and of subsection (b) of section 6 subsection (b) of said chapter 111L for 180 days after the effective date of this act.