The Committee of Conference, to whom was referred the matters of difference between the two branches with reference to the House amendment to the Senate Bill promoting stem cell research (Senate, No. 2032) (amended by the House by striking out all after the enacting clause and inserting in place thereof the text contained in House document numbered 2792; by striking out the title and inserting in place thereof the following title: “An Act relative to biotechnology.”; and by striking out the emergency preamble and inserting in place thereof the following emergency preamble: “Whereas, The deferred operation of this act would tend to defeat its purpose, which is to forthwith regulate biotechnology in the Commonwealth, therefore it is hereby declared to be an emergency law, necessary for the immediate preservation of the public health and convenience, reports, a Bill Relative to Enhancing Regenerative Medicine in the Commonwealth (Senate, No. 2039).
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Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:
Whereas, The deferred operation of this act would tend to defeat its purpose, which is forthwith to enhance regenerative medicine in the commonwealth, therefore it is hereby declared to be an emergency law, necessary for the immediate preservation of the public health and convenience.
SECTION 1.
The General Laws are hereby amended by inserting after Chapter 111K the following chapter:-
Chapter 111L
RELATIVE TO 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;
(b) the extraordinary biomedical scientists working in the Commonwealth 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 these fields; 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, including research and clinical applications involving somatic cell nuclear transfer, placental and umbilical cord blood cells and human adult stem cells, and other mechanisms to create embryonic stem cells which are consistent with this act. It shall further be the policy of the commonwealth to prohibit human reproductive cloning.
Section 2. As used in this chapter the following words shall have the following meanings:-
“Asexual Reproduction”, reproduction not initiated by the union of an oocyte and sperm.
“Commissioner”, the commissioner of the department of public health.
“Council”, the biomedical research advisory council.
“Department”, the department of public health.
“Donated to Research”, when, in the absence of valuable consideration, and after fulfillment of the requirements of informed consent, the person or persons from whose cells the pre-implantation embryo has originated or will originate gives the pre-implantation embryo or cells to another person provided that the recipient(s) shall use the extant or resultant pre-implantation embryo in biomedical research, and shall not transfer the pre-implantation embryo to a uterus or uterine like environment or nurture the pre-implantation embryo beyond fourteen days development.
“Embryo”, an organism of the species homo-sapiens whether formed by fertilization, somatic cell nuclear transfer, parthenogenesis, or other means.
"Employee'', any individual who performs services for and under the control and direction of an employer for wages or other remuneration.
“Fertilization”, the process whereby the male and female gametes unite to form an embryo.
“Gametes”, a sperm or oocyte.
“Human Adult Stem Cell”, an undifferentiated cell found in a differentiated tissue that can renew itself and differentiate to yield specialized cell types.
“Human Reproductive Cloning”, the asexual genetic replication of a human being by transferring a pre-implantation embryo that has been created by somatic cell nuclear transfer, parthenogenesis, or by other asexual means into a uterus or uterine like environment with the purpose of creating a human fetus or a human child.
“Informed Consent”, the written consent for the donation of gametes or embryos used for research conducted pursuant to this chapter which complies with the requirements of a duly appointed institutional review board, acting in accordance with 45 C.F.R. 46.116 and 45 C.F.R. 46.117, as may be amended from time to time. Said written consent shall be shall be in a language understandable to the donor or patient and shall include all reasonably foreseeable risks, discomforts, or benefits of the procedure to the donor or patient.
“Institution”, a corporation, association, partnership, nonprofit organization, or other legal entity which conducts research authorized pursuant to this chapter.
“Institutional Review Board”, a board that has a minimum of 5 members who meet regularly to review research applying the standards of 45 CFR Part 46 or 21 CFR Parts 50 and 56, as may be amended from time to time.
“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 reproduction technique in which fertilization is accomplished outside of the human body.
“Manager”, an individual to whom an institution conducting research pursuant to this chapter 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.
“Parthenote”, the product of egg development without fertilization.
“Parthenogenesis”, the development of an egg without fertilization.
“Person”, any natural person, corporation, association, partnership or other legal entity.
“Placental Cells”, cells obtained from the placenta.
“Pre-implantation Embryo”, an embryo formed and maintained outside of the human body whether by in vitro fertilization, somatic cell nuclear transfer, parthenogenesis or other asexual 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 body'', (a) the United States Congress, any state legislature, including the general court, or any popularly elected local government body, or any member or employee thereof; (b) any federal, state or local judiciary, or any member or employee thereof, or any grand or petit jury; (c) any federal, state or local regulatory, administrative or public agency or authority, or instrumentality thereof; (d) any federal, state or local law enforcement agency, prosecutorial office, or police or peace officer; or (e) any division, board, bureau, office, committee or commission of any of the public bodies described in the above paragraphs of this subsection.
“Public Institutional Review Board”, a board established pursuant to section 6(a) of this chapter that has a minimum of 5 members who meet regularly to review research applying the standards of 45 CFR Part 46 or 21 CFR Parts 50 and 56, as may be amended from time to time.
“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.
“Somatic Cell”, a nongamete cell obtained or derived from a living or deceased human being.
“Somatic Cell Nuclear Transfer”, the technique in which the nucleus of an oocyte is replaced with the nucleus of a somatic cell.
“Umbilical Cord Cells”, cells derived from an umbilical cord.
“Uterus”, includes a uterus 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.
“Valuable Consideration”, any consideration, excluding reimbursement for reasonable costs incurred in connection with a donation, including costs associated with the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation of gametes, embryonic or cadeveric tissue.
Section 3. (a) Research and clinical applications involving the derivation and use of human embryonic stem cells, including somatic cell nuclear transfer, human adult stem cells from any source, umbilical cord stem cells, parthenotes, and placental cells shall be permitted.
(b) Researchinvolving the derivation of human embryonic stem cells through the use of human genetic material, including somatic cell nuclear transfer, and parthenogenesis or other asexual meansaspermitted by subsection (a) of this section shall only be conducted upon the written approval of a duly authorized Institutional Review Board. The written approval of the Institutional Review Board shall include a detailed description of the research, experimentation or study to be conducted and a detailed description of the research or a copy of the protocol, all of which shall be maintained as a permanent record by such Board or by the hospital or institution for which the Board acts.
Section 4. A physician or other health care provider who provides a patient with in vitro fertilization therapy shall provide said 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 or gametes 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-implantationembryos, as appropriate. The department 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 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 and has reviewed and understands the informational pamphlet described in clause (1) of this section, 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. The express language contained in the waiver shall constitute the entirety of its authority.
Section 5. (a) The department, in partnership with the University of Massachusetts Medical School at Worcester , shall, subject to appropriation, establish and maintain a public bank for umbilical cord blood 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. Said bank shall collect and store donated umbilical cord blood and placental tissue from participating hospitals and make said umbilical cord blood and placental tissue available for research in accordance with the provisions of section 3 of this chapter.
(b) Notwithstanding any general or special law to the contrary and upon implementation of subsection (a) of this section, all licensed hospitals shall inform pregnant patients under their care, 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 to research pursuant to this act shall be made at no expense to the donor. Nothing in this section shall prohibit a maternity patient from donating or storing blood extracted from the umbilical cord or placenta of said patient’s newborn child to a private umbilical cord blood bank.
(c) Institutions conducting research pursuant to this chapter 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 established by the public umbilical cord blood bank.
(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 employee, physician, nurse, or other medical staff that is directly affiliated with a sincerely held 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.
(f) The department 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 University of Massachusetts Medical School at Worcester is hereby authorized and directed to establish and maintain, subject to appropriation, a public Institutional Review Board. Said public Institutional Review Board shall operate pursuant to the provisions contained in section 2 of this act. The public Institutional Review Board shall be established not later than 120 days from the passage of this act. The public Institutional Review Board 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 Institutional Review Board shall only be available to an institution employing 50 or fewer full time employees.
(b) An institution may access the services of the public Institutional Review Board only through a written instrument of contract. Said contract shall include the payment to the public Institutional Review Board of a reasonable fee, calculated pursuant to a methodology approved by the University of Massachusetts Medical School to account for the costs of operating and maintaining the public Institutional Review Board, and the relevant position of those costs attributable to the particular institution receiving the benefit.
Section 7. (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 sincerely held religious practices or beliefs of the employee.
(b) An institution conducting research pursuant to this chapter, or an institution or person with whom an institution conducting research pursuant to this chapter has a contractual relationship, shall not take any retaliatory action against its employee because the employee:
i) discloses or threatens to disclose to a manager or a public body an activity, policy or practice of the institution conducting research pursuant to this chapter, or of another institution conducting such research with whom the employee’s institution has a contractual relationship, that the employee reasonably believes is in violation of any of the provisions of this chapter; or
(ii) objects to, or refuses to participate in, any activity, policy or practice that the employee reasonably believes is in violation of any of the provisions of this chapter.
(c) 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. The department shall not publicly disclose any such confidential information but shall submit the information to the attorney general forthwith.
(d) 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 the institution alleged to have violated this section. Provided further, that within 90 days of receiving said complaint, the Attorney General shall notify the complaintant in writing as to whether he intends to bring an action in the name of the commonwealth. If the Attorney General declines to bring an action based on the complaint filed, the aggrieved employee may, within one year, institute a civil action in the superior court. Any party to said action shall be entitled to claim a jury trial. All remedies available in common law tort actions shall be available to prevailing plaintiffs. These remedies are in addition to any legal or equitable relief provided herein. The court may: (i) issue temporary restraining orders or preliminary or permanent injunctions to restrain continued violation of this section; (ii) reinstate the employee to the same position held before the retaliatory action, or to an equivalent position; (iii) reinstate full fringe benefits and seniority rights to the employee; (iv) compensate the employee for three times the lost wages, benefits and other remuneration, and interest thereon; and (v) order payment by the institution of reasonable costs, and attorneys' fees.
(e) In any action brought by an employee under subsection (d), if the court finds said action was without basis in law or in fact, the court may award reasonable attorneys' fees and court costs to the institution.
(f) An employee shall not be assessed attorneys' fees under paragraph (e) if, after exercising reasonable and diligent efforts after filing a suit, the employee moves to dismiss the action against the institution, or files a notice agreeing to a voluntary dismissal, within a reasonable time after determining that the institution would not be found liable for damages.
(g) Nothing in this section shall be deemed to diminish the rights, privileges or remedies of any employee under any other federal or state law or regulation, or under any collective bargaining agreement or employment contract; except that the institution of a private action in accordance with subsection (d) shall be deemed a waiver by the plaintiff of the rights and remedies available to him, for the actions of the institution, under any other contract, collective bargaining agreement, state law, rule or regulation, or under the common law.
(h) An institution shall publicly display notices reasonably designed to inform its employees of their protection and obligations under this section, and use other appropriate means to keep its employees so informed. Each notice posted pursuant to this subsection shall include the name of the person or persons the institution has designated to receive written notification of a suspected violation of this chapter.
Section 8. (a) Human reproductive cloning is hereby prohibited. No person shall knowingly engage in, or assist in, human reproductive or attempted human reproductive cloning of a human being. No person shall knowingly purchase, sell, transfer, or otherwise obtain human embryonic, gametic or cadaveric tissue for the purpose of reproductive cloning.
(b) A person shall not knowingly create an embryo by the method of fertilization with the sole intent of donating said embryo for research. This provision shall not prohibit the creation of a pre-implantation embryo by somatic cell nuclear transfer, parthenogenesis, or other asexual means for research purposes.
(c) No person shall knowingly and for valuable consideration purchase, sell, transfer, or otherwise obtain human embryos, gametes, or cadaveric tissue for research purposes. Nothing in this section shall prohibit a person from banking or donating their gametes for personal future use, or from donating their gametes to another person or from donating their gametes for research. Nothing in this chapter shall be deemed to prohibit or regulate the use of in vitro fertilization for reproductive purposes.
(d) A person who knowingly violates the provisions of subsection (a) of this section shall be punished by imprisonment in a jail or house of correction for not less than five years or more than ten years or by imprisonment in the state prison for not more than ten years or by a fine of up to one million dollars. In addition to such penalty, and at the discretion of the court, a person who knowingly violates the provisions of this section and derives a personal financial profit from such violations may be ordered to pay all or part of any such profits to the commonwealth as damages.
(e) A person who knowingly violates the provisions of subsection (b) or subsection (c) of this section 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.
Section 9. (a) There is hereby established a biomedical research advisory council. Said council shall consist of 15 members including 5 appointed by the governor; one of whom shall be the Secretary of Health and Human Services, or his designee; one of whom shall be the Commissioner of the Department of Public Health, or his designee; one of whom shall be a scientist, designated by the Dean of the University of Massachusetts Medical School, who has experience in biomedical research in the fields of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, or a related field; one of whom shall be a physician licensed to practice in the Commonwealth; and one of whom, designated by the Dean of the University of Massachusetts Medical School, shall have experience in medical ethics; 4 appointed by the President of the Senate, one of whom shall be a scientist with experience in biomedical research in the fields of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, or related field; one of whom shall be a physician licensed to practice in the Commonwealth; one of whom shall have experience in medical ethics; and one of whom shall be a member of the Massachusetts Bar with a background in legal issues related to biotechnology, stem cell research, in vitro fertilization, or health law; 1 of whom shall be appointed by the minority leader of the senate who shall be a member of the public; 4 appointed by the Speaker of the House, one of whom shall be a scientist with experience in biomedical research in the fields of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, or related field; and one of whom shall be a member of the Massachusetts Bar and have a background in legal issues related to biotechnology, stem cell research, in vitro fertilization, or health law; one of whom shall be a representative of the Biotechnology Center of Excellence Corporation; and one of whom shall be a person with a background in economic development; 1 of whom shall be appointed by the minority leader of the house who shall be a member of the public. In making appointments pursuant to this section the appointing authorities shall give due consideration to the ethnic and racial composition of the council.
(b) The council shall make recommendations to the General Court and the governor regarding changes to this chapter, as well as any other chapter of the general laws, or regulations promulgated pursuant thereto, necessary to promote biotechnology in the commonwealth.
(c) The council shall investigate the implementation of this chapter and the conduct of research, including but not limited to, issues relative to the age, race, ethnicity, and insurance status of the donor. Said investigation shall also include an analysis of ways to encourage disproportionately impacted populations’ participation in, and benefit from, research conducted pursuant to this chapter. Nothing in this section shall authorize the council to obtain individually identifiable patient or donor study participant information.
(d) The council shall submit an annual report of its findings, conclusions, proposals, and recommendations as provided in subpart (b) and (c) of this section no later than the first day of January. Said report shall also include an update on the current state of pre-implantation embryo research relating to human embryonic stem cell research in the commonwealth. Said report shall be submitted to the governor, the president of the senate, the speaker of the house, the house and senate chairs of the joint committee on economic development and emerging technologies, the clerk of the senate and the clerk of the house.
(e) The council shall meet periodically, but no less than twice each year. All meetings shall be public.
(f) The council shall keep a public record of all meetings, votes, and other business.
(g) Members of the council shall be appointed for a term of 3 years or until a successor is appointed. Members shall be eligible to be reappointed and shall serve without compensation. A chairman of the council shall be elected annually from the membership. The department shall provide administrative support to the council as requested.
(h) In the event of a vacancy on the council, the original appointing authority shall, within 60 days of the occurrence of said vacancy, appoint a new member consistent with the provisions of subsection (a) of this section to fulfill the remainder of the unexpired term.
Section 10. (a) The department shall enforce the provisions of this chapter and may adopt regulations, in a manner consistent with the provisions of this section, and with the advice of the biomedical research advisory council, relating to the administration and enforcement of this chapter; provided however, that the department shall not propose or implement any regulation or rule which would have the purpose or effect of inhibiting, delaying, or otherwise obstructing research or clinical applications proposed or lawfully undertaken pursuant to section 3(a) or section 3(b) of this chapter. Said regulations shall be consistent with the findings and declarations of the General Court as stated in section 1 of this chapter.
(b) Prior to the adoption, amendment or repeal of any regulation pursuant to this chapter the department shall hold a public hearing in accordance with the provisions of chapter 30A; provided, however, that notwithstanding the provisions of said chapter 30A, at least 90 days prior to a public hearing the department shall: (i) publish notice of its proposed action in at least 1 major newspaper in the Boston, Worcester, and Springfield metropolitan areas, at least 1 biotechnology newspaper or trade journal, at least 1 medical journal published in the commonwealth, and such additional newspapers or trade, industry, or professional publications as the department may select; (ii) notify any institution holding a certificate of registration issued pursuant to this chapter; (iii) notify any person, institution, or group which has filed a written request pursuant to this section for notice of said regulatory proceeding; provided, however, that such request shall be renewed at least annually and that delivering or mailing a copy of the notice to the last known address of the person, institution or group required to be notified shall constitute sufficient notice under this section; (iv) file a copy of said notice with the joint committee on economic development and emerging technologies and the joint committee on state administration and regulatory oversight; and (v) file a copy of said notice with the secretary of the commonwealth. The notice required pursuant to this section shall refer to the statutory authority pursuant to which said regulatory action is predicated; give the date, time and place of the public hearing; state the manner in which data, views or arguments may be submitted to the agency by any interested person, institution, or group; and state the express terms or describe the substance of the proposed regulations.
(c) No regulation promulgated by the department pursuant to this chapter shall be exempt from said hearing requirement or be considered an emergency regulation pursuant to the provisions of chapter 30A.
(d) The joint committee on economic development and emerging technologies and the joint committee on state administration and regulatory oversight shall have, individually or jointly, authority to review regulations proposed or adopted pursuant to this chapter. Said committees may hold public hearings concerning a proposed or existing regulation and may submit to the department comments concerning the merit and appropriateness of the regulations to be promulgated and an opinion whether the regulations are authorized by, and consistent with, this chapter. The department shall respond in writing within 10 days to the committees’ written questions relevant to the committees’ review of a proposed or existing regulation. The department shall provide to said committees, without charge, copies of all public records in the agency’s custody relating to the regulation or action in question within 10 days of a request for same by either of said committees. Said committees may issue a report with proposed changes to a proposed or existing regulation and shall transmit this report to the department. If the department does not adopt the proposed changes contained in said committees’ report, the department shall notify the committees in writing of the reasons why it did not adopt said changes either at the time it adopts a proposed regulation or within 21 days of receiving the committees’ report on an existing regulation.
(e) The superior court department of the trial court shall have jurisdiction to consider any claim challenging the validity of a regulation issued pursuant to this section. Any institution holding a certificate of registration to conduct research pursuant to this chapter, and aggrieved by a regulation promulgated by the department, shall have standing to bring a civil action presenting such a claim. In any such civil action, in determining whether a preliminary injunction shall issue, the court shall deem any regulation that would have the effect of prohibiting or discontinuing research authorized pursuant to this chapter to be an irreparable injury to the institution bringing said claim.
(f) The department shall issue a certificate of registration authorizing an institution to conduct human embryonic stem cell research. Said certificate of registration shall be issued by the department within 30 days of submission of an application from the applicant institution, provided that said 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 an Institutional Review Board or provides a copy of a contract between the institution and a private Institutional Review Board or the institution and the public Institutional Review Board which shall review the institution’s experimentation, study, and procedures involving human embryonic stem cell research. Any institution which submits an application and meets the requirements for a certificate of registration pursuant to this section shall not have said certificate of registration unreasonably withheld. A certificate may be withheld if the department determines that the applicant institution has violated any of the provisions of subsection (m) of this section.
(g) No research authorized pursuant to subsection (b) of section 3 of this chapter shall be conducted at any institution that does not have a valid certificate of registration issued pursuant to this section.
(h) All certificates of registration issued in accordance with the provisions of this section shall be valid for a term of 3 years from the date of issuance. The department shall notify all holders of certificates of registration under this chapter at least 60 days prior to the expiration of said certificate of registration. If an institution issued a certificate of registration in accordance with the provisions of this chapter makes timely and sufficient application for a renewal, its certificate of registration shall not expire until its application has been finally determined by the department; provided further, that prior to the assessment of a civil administrative penalty pursuant to this section, the department shall notify the holder of said certificate of registration that it has at least 90 days after the date of expiration within which to submit an application for renewal during which time the department shall waive any applicable penalties pursuant to this paragraph.
(i) An institution holding a certificate of registration pursuant to subsection (f) of this section shall submit an annual report to the department providing a summary of the research approved during that calendar year and a statement representing that such research was reviewed in accordance with the provisions of this chapter, if applicable.
(j) The department shall receive, and certify as to said receipt, annual reports from institutions holding a certificate of registration pursuant to subsection (f) of this section.
(k) The department shall keep an official record of the names of all institutions holding a certificate of registration and of all money received and disbursed by it, and a duplicate thereof shall be open for public inspection in the office of the secretary of the commonwealth.
(l) The department shall keep an official record of all persons convicted of violating subsection (a), subsection (b) or subsection (c) of section 8 this chapter. The department shall annually send notice of the names of said violators to all institutions issued a certificate of registration in accordance with the provisions of subsection (f) of this section. Said institutions shall not knowingly employ any persons whom the department has identified as having been convicted of violating of said subsection (a), subsection (b), or subsection (c) of section 8 of this chapter.
(m) The department shall revoke any certificate of registration, shall not renew such certificate, and shall deny any future application for a certificate of registration for any institution that knowingly and willfully permits or assists a violation of subsection (a) of section 8 of this chapter, whether or not the violation is committed by an employee of said institution.
(n) As provided in this subparagraph, the department may discipline an institution conducting research pursuant to this chapter if it is determined, after an opportunity for an adjudicatory proceeding conducted pursuant to chapter 30A, that such institution has:
(1) violated subsection (b) of section 3 of this chapter;
(2) violated section 4 of this chapter;
(3) knowingly and willfully permitted or assisted a violation of subsection (b) or subsection (c) of section 8 of this chapter;
(4) knowingly violates subsection (f) of section 10 of this chapter, if applicable; or
(5) failed to submit an annual report to the department pursuant to subsection (j) of section 10 of this chapter;
(6) employed a person identified in the annual notice by the department pursuant to subsection (L) of section 10 of this chapter;
(7) knowingly implemented a decision by an institutional review board to authorize research prohibited by this chapter.
The department may, after an opportunity for an adjudicatory proceeding conducted pursuant to chapter 30A, upon determination that an institution conducting research pursuant to this chapter has violated a provision enumerated in this subdivision, undertake the following actions:
(1) for the violation of subdivision (3) of subsection (n) of this section, revoke or deny to renew such certificate of registration or assess upon the holder a civil administrative penalty, as determined by the department not to exceed $250,000 and may require the holder to submit to additional oversight, as determined by the department, as a condition or retention, or future consideration of reinstatement of the certificate of registration;
(2) for the violation of subdivisions (1), (2), (4), (6) and (7)of subsection (n) of this section, assesses upon the holder a civil administrative penalty, as determined by the department not to exceed $100,000;
(3) for the first violation of subdivision (5) of subsection (n) of this section, censure a holder; and for each subsequent violation subdivision (5) of subsection (n) of this section, suspend such certificate of registration until compliance with subsection (j) of section 9 of this chapter, and impose a civil administrative penalty, as determined by the department not exceed $1,000.
An institution sanctioned under this subdivision may be subject to such other sanctions or punishment as may be provided by law. The department shall promulgate such rules and regulations not inconsistent with chapter 30A and this chapter as necessary for the filing of charges and the conduct of proceedings.
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 at the end thereof the following:- 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 by section 2 of chapter 111L, and obtained in accordance with said chapter 111L.
SECTION 3. Subsection (a) IV of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 38, the . and inserting in place thereof the following:- , but shall exclude a pre-implantation embryo or parthenote as defined pursuant to section 2 of chapter 111L and obtained in accordance with said chapter 111L.
SECTION 4. Subsection (a) VI of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 59, the words “District Attorney for the county in which the hospital or other institution for which the board acts, is located.” and inserting in place thereof the following:- Attorney General of the Commonwealth.
SECTION 5. Subsection (a) VII of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 75, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 6. Subsection (b) I of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 82, the words “District Attorney for the district where said procedure is performed” and inserting in place thereof the following:- Attorney General
SECTION 7. Subsection (b) I of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 91, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 8. Subsection (b) I of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 98, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 9. Subsection (b) II of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 111, the words “District Attorney for the district where the procedure is performed” and inserting in place thereof the following:- Attorney General
SECTION 10. Subsection (b) II of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 116, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 11. Subsection (b) II of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 118, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 12. Subsection (b) III of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 127, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 13. Subsection (b) VII of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 165, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 14. Subsection (b) VII of section 12J of Chapter 112 of the General Laws, as so appearing, is hereby amended by striking out, in line 173, the words “District Attorney” and inserting in place thereof the following:- Attorney General
SECTION 15. Section 12K of Chapter 112 of the General Laws as appearing in the 2002 Official Edition, is hereby amended by striking out, in line 15, the word “fertilization” and inserting in place thereof the following words:- implantation of the embryo in the uterus…….
SECTION 16. Section 7 of Chapter 113 of the General Laws, as appearing in the 2002 Official Edition is hereby amended by striking out, in line 21, the word “parts.” and inserting in place thereof the following words:- “parts”; provided however, that any gametes, as that term is defined in section 1 of chapter 111L, shall be donated in accordance with provisions of said chapter 111L.
SECTION 17 . Notwithstanding any general or special law to the contrary, the biomedical research advisory council created pursuant to section 1 of this act may, from time to time, make recommendations to the commissioner on proposed regulations for the administration and enforcement of chapter 111L.
SECTION 18. Notwithstanding any general or special law to the contrary, the biomedical research advisory council created pursuant to section 1 of this act shall investigate the feasibility of permitting companies’ whose stock is publicly traded to use an alternative method of approval in lieu of the requirement of having to acquire the approval of an Institutional Review Board before conducting embryonic stem cell research pursuant to the provisions of this chapter. Said investigation shall include a recommendation as to whether the approval of a duly appointed bioethical advisory board is a suitable alternative to the approval of an Institutional Review Board. The council shall complete its investigation, and submit its recommendation(s), if any, to the Joint Committee on Economic Development and Emerging Technologies no later than October 31, 2005 .
SECTION 19. Notwithstanding any general or special law to the contrary, the biomedical research advisory council created pursuant to section 1 of this act shall investigate an appropriate and suitable manner in which to dispose of pre-implantation embryos which have been abandoned by the persons contributing the genetic material from which said embryos were created. Said investigation shall include an analysis of the feasibility of granting the Commissioner of Public Health, upon a declaration by a court of competent jurisdiction that said embryos have been abandoned, the authority to accept legal custody of the embryos and to provide consent to their use for purposes of biomedical research or medical care or treatment. The council shall complete its investigation, and submit its recommendation(s), if any, to the Joint Committee on Economic Development and Emerging Technologies no later than November 30, 2005 .
SECTION 20. Notwithstanding any general or special law to the contrary, the biomedical research advisory council created pursuant to section 1 of this act shall investigate the optimum method by which a public placental and umbilical cord blood bank should be established at the University of Massachusetts Medical School or other appropriate institution within the Commonwealth. Said investigation shall include an analysis of establishing a public umbilical cord blood bank for the purpose of collecting and storing umbilical cord blood and placental tissue that is donated to research by maternity patients and an analysis establishing a public umbilical cord blood bank for the collection and storage of umbilical cord blood and cells and placental tissue and cells and making the same available to the person depositing said blood or cells and their designees for individual medical research and treatment. The investigation shall also include a recommendation on an appropriate fee structure for participation in the public placental and umbilical cord blood bank. The council shall analyze the need for eligibility requirements to ensure equal access to the bank for all citizens of the commonwealth and the costs associated with the operation and maintenance of the public placental and umbilical cord blood bank, including the need for, and appropriateness of, public funding. Finally, the council shall make recommendations as to the need for regulations or protocols to govern donations to the bank and the release and use of banked cells, tissue or blood. The council shall report its findings, together with any proposed legislation, to the house and senate chairs of the joint committee on economic development and emerging technologies and to the house and senate chairs of the joint committee on health care financing no later than July 31, 2006 .
SECTION 21. Notwithstanding any general or special law to the contrary, the members of the biomedical research advisory council created pursuant to section 1 of this act shall be appointed no later than July 31, 2005 . If, as of August 1, 2005 , the Council shall consist of fewer than fifteen members, the Attorney General is authorized and directed to appoint such members, no later than September 1, 2005 so that the council consists of fifteen members as provided in chapter 111L.
SECTION 22. Notwithstanding any general or special law to the contrary, the biomedical research advisory council created pursuant to section 1 of this act shall investigate the optimum method by which a public Institutional Review Board should be established at the University of Massachusetts Medical School at Worcester . The council shall report its findings, together with any proposed legislation, to the house and senate chairs of the joint committee on economic development and emerging technologies and to the house and senate chairs of the joint committee on health care financing no later than July 31, 2006 .
SECTION 23. Notwithstanding any general or special law to the contrary, the President of the University of Massachusetts , or his designee, shall appoint a commission to analyze and investigate the feasibility of establishing an Institute for Regenerative Medicine at the University of Massachusetts Medical School. Said analysis and investigation shall include the potential cost of establishing such an institute as well as the potential scientific, economic and social benefits such an institute may have upon the Commonwealth. The commission shall submit a final report detailing its recommendations, including any proposed legislation, to the house and senate chairs of the joint committee on economic development and emerging technologies and to the house and senate chairs of the joint committee on health care financing no later than March 1, 2006 .
SECTION 24. Any institution which on the effective date of this act is conducting human embryonic stem cell research in the commonwealth shall have 180 days from said date to come into compliance with this act.