BIOTECHNOLOGY

M.G.L. pt. Part I, tit. Title XVI, ch. c. 111L

in effect

M.G.L. c. 111L, § 1 Policy; fostering research; prohibiting human reproductive cloning

c. 111L, § 1. Policy; fostering research; prohibiting human reproductive cloning 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 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 cells and human adult stem cells and other mechanisms to create embryonic stem cells which are consistent with this chapter. It shall further be the policy of the commonwealth to prohibit human reproductive cloning.

M.G.L. c. 111L, § 2 Definitions

c. 111L, § 2. Definitions Section 2. As used in this chapter the following words shall have the following meanings unless the context clearly requires otherwise:— ''Asexual'', not initiated by the union of an oocyte and a sperm. ''Commissioner'', the commissioner 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 from whose cells the pre-implantation embryo has originated or will originate gives the pre-implantation embryo or cells to another person; provided, however, that the recipient 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 14 days of development. ''Embryo'', an organism of the species homo-sapiens whether formed by fertilization, somatic cell nuclear transfer, parthenogenesis or other means. ''Employee'', an 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. The written consent 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 by 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 and who has authority to take corrective action regarding a violation of a law, rule, regulation, activity or policy. ''Parthenogenesis'', the development of an egg without fertilization. ''Parthenote'', the product of egg development without fertilization. ''Person'', a 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, however, that such length of time shall not include any interval in which such development has been suspended, such as through freezing. ''Public body'', (a) the United States Congress, a state legislature, including the general court, or a popularly elected local government body, or a member or employee thereof; (b) a federal, state or local judiciary, or a member or employee thereof, or a grand or petit jury; (c) a federal, state or local regulatory, administrative or public agency or authority or instrumentality thereof; (d) a federal, state or local law enforcement agency, prosecutorial office or police or peace officer; or (e) a division, board, bureau, office, committee or commission of any of the public bodies described in clauses (a) to (d), inclusive. ''Public institutional review board'', a board established pursuant to subsection (a) of section 6 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'', the unlawful 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 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. ''Uterine-like environment'', a replicate of the uterus used for the purpose of sustaining an embryo through birth and creating a human being. ''Uterus'', a uterus or fallopian tube. ''Valuable consideration'', any consideration beyond reimbursement for reasonable costs incurred in connection with the donation, removal, processing, disposal, preservation, quality control, storage, transplantation or implantation of gametes, embryonic or cadeveric tissue.

M.G.L. c. 111L, § 3 Research using human embryonic stem cells permitted; written approval

c. 111L, § 3. Research using human embryonic stem cells permitted; written approval 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 cells, parthenotes and placental cells shall be permitted. (b) Research involving the derivation of human embryonic stem cells through the use of human genetic material, including somatic cell nuclear transfer, parthenogenesis and other asexual means as permitted by subsection (a) 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 the board or by the hospital or institution for which the board acts.

M.G.L. c. 111L, § 4 Information on choice of disposition of remaining embryos or gametes; informational pamphlet; informed consent form

c. 111L, § 4. Information on choice of disposition of remaining embryos or gametes; informational pamphlet; informed consent form Section 4. (a) A physician or other health care provider who provides a patient with in vitro fertilization therapy 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 or gametes remaining following 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 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 may have 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 a 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), 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 a 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. (b) No physician or other health care provider shall provide this treatment before providing the patient with both the informational pamphlet and the informed consent form and without 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.

M.G.L. c. 111L, § 5 Bank for umbilical cord blood and placental tissue; donations; exceptions for religious beliefs; agreements with research institutions; educational program

c. 111L, § 5. Bank for umbilical cord blood and placental tissue; donations; exceptions for religious beliefs; agreements with research institutions; educational program 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 the purpose of collecting and storing umbilical cord blood and placental tissue donated by maternity patients at participating hospitals. The bank shall make the umbilical cord blood and placental tissue available for research in accordance with section 3. (b) Notwithstanding any general or special law to the contrary, 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 blood and tissue extracted from the umbilical cord and placenta following delivery of a newborn child to a publicly accessible certified umbilical cord blood and placental tissue bank. Donations to research pursuant to this chapter 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 the patient's newborn child to a private umbilical cord blood and placental tissue bank. (c) Institutions conducting research pursuant to this chapter may reach agreement with the public umbilical cord blood and placental tissue 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 and placental tissue 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 an employee, physician, nurse, or other medical staff to the extent that blood transfer conflicts with sincerely-held religious practices 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. This program shall include, but not be 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 risks involved in banking umbilical cord blood, and the availability and cost of public or private umbilical cord blood banks.

M.G.L. c. 111L, § 6 Public institutional review board; contract with research institutions

c. 111L, § 6. Public institutional review board; contract with research institutions Section 6. (a) The University of Massachusetts Medical School at Worcester shall establish and maintain, subject to appropriation, a public institutional review board. The public institutional review board shall be available on an ongoing basis to an institution having not more than 50 full-time employees for review of that institution's experimentation, study and procedures for the purposes of conducting research pursuant to this chapter. (b) An institution may access the services of the public institutional review board only through a written instrument of contract. The 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 portion of those costs attributable to the particular institution receiving the benefit.

M.G.L. c. 111L, § 7 Refusal to conduct embryonic stem cell research by employee; retaliation prohibited; enforcement; notice of rights under chapter

c. 111L, § 7. Refusal to conduct embryonic stem cell research by employee; retaliation prohibited; enforcement; notice of rights under chapter Section 7. (a) No employee shall 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 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 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. Within 90 days of receiving a complaint, the attorney general shall notify the complainant 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 1 year, institute a civil action in the superior court. A party to that action may 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 in this chapter. 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 3 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 the 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 subsection (e) if the employee moves to dismiss the action against the institution or files for a dismissal, within a reasonable time after determining that the institution would not be found liable for damages. (g) Nothing in this section shall 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, but 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 who has been designated by the institution to receive written notification of a suspected violation of this chapter.

M.G.L. c. 111L, § 8 Human reproductive cloning prohibited; creation of embryo for purpose of research; sale of embryos or gametes; enforcement

c. 111L, § 8. Human reproductive cloning prohibited; creation of embryo for purpose of research; sale of embryos or gametes; enforcement Section 8. (a) Human reproductive cloning is hereby prohibited. No person shall knowingly attempt, engage in, or assist in human reproductive cloning. No person shall knowingly purchase, sell, transfer or otherwise obtain human embryonic, gametic or cadaveric tissue for the purpose of human reproductive cloning. (b) No person shall knowingly create an embryo by the method of fertilization with the sole intent of donating the embryo for research. Nothing in this section shall 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 prohibit or regulate the use of in vitro fertilization for reproductive purposes. (d) A person who is found to have knowingly violated subsection (a) shall be punished by imprisonment in a jail or house of correction for not less than 5 years nor more than 10 years or by imprisonment in the state prison for not more than 10 years or by a fine of not more than $1,000,000. In addition to such penalty, and at the discretion of the court, a person who is found to have knowingly violated this section and derives a personal financial profit from such violation may be ordered to pay all or part of any such profits to the commonwealth as damages. (e) A person who is found to have knowingly violated subsection (b) or 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 5 years or by a fine of not more than $100,000.

M.G.L. c. 111L, § 9 Biomedical research advisory council; membership and duties

c. 111L, § 9. Biomedical research advisory council; membership and duties Section 9. (a) There shall be a biomedical research advisory council. The council shall consist of 15 members, 1 of whom shall be the secretary of health and human services, or his designee; 1 of whom shall be the commissioner of public health, or his designee; 1 of whom shall be a scientist designated by the dean of the University of Massachusetts Medical School, who shall have experience in biomedical research in the field of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine or a related field; 1 of whom shall be a physician licensed to practice in the commonwealth who shall be appointed by the governor; 1 of whom shall be designated by the dean of the University of Massachusetts Medical School who shall have experience in medical ethics; 4 persons to be appointed by the president of the senate, 1 of whom shall be a scientist with experience in biomedical research in the field of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine or a related field; 1 of whom shall be a physician licensed to practice in the commonwealth; 1 of whom shall have experience in medical ethics; and 1 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 person to be appointed by the minority leader of the senate who shall be a member of the public; 4 persons to be appointed by the speaker of the house, 1 of whom shall be a scientist with experience in biomedical research in the field of cell differentiation, nuclear programming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine or a related field; 1 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; 1 of whom shall be a representative of the Biotechnology Center of Excellence Corporation, and 1 of whom shall be a person with a background in economic development; 1 person to 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 proposed changes to this chapter, or any other chapter of the General Laws, or any 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. The 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 subsections (b) and (c) not later than December 31. The 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. The 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 not 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 terms 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 a vacancy, appoint a new member consistent with subsection (a) to fulfill the remainder of the unexpired term. (i) The council shall not be a state agency for the purposes of chapter 268A.

M.G.L. c. 111L, § 10 Enforcement of chapter; procedure for adoption, amendment or repeal of regulations; certificate of registration for research institutions

c. 111L, § 10. Enforcement of chapter; procedure for adoption, amendment or repeal of regulations; certificate of registration for research institutions Section 10. (a) The department shall enforce this chapter and may adopt regulations, in a manner consistent with this chapter, and with the advice of the biomedical research advisory council, relating to the administration and enforcement of this chapter; but 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 undertaken pursuant to subsection (a) or (b) of section 3. The regulations shall be consistent with the findings and declarations of the general court as stated in section 1. (b) Before the adoption, amendment or repeal of any regulation pursuant to this chapter, the department shall hold a public hearing in accordance with chapter 30A. Notwithstanding said chapter 30A, at least 90 days before 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, in at least 1 biotechnology newspaper or trade journal, in at least 1 medical journal published in the commonwealth, and in 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 any regulatory proceeding; such a request shall be renewed at least annually, and 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 the 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 the notice with the state secretary. The notice required by this section shall refer to the statutory authority pursuant to which the regulatory action is predicated; and shall specify the date, time and place of the public hearing, the manner in which data, views or arguments may be submitted to the agency by any interested person, institution, or group, and the express terms or the substance of the proposed regulations. (c) No regulation promulgated by the department pursuant to this chapter shall be exempt from the hearing requirement or be considered an emergency regulation pursuant to chapter 30A. (d) The joint committee on state administration and regulatory oversight of the general court, in this subsection called the committee, shall have authority to review regulations proposed or adopted pursuant to this chapter. The committee shall consult with the joint committee on economic development and emerging technologies in performing this review. The committee 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 committee's written questions relevant to the committee's review of a proposed or existing regulation. The department shall provide to the committee, 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 by the committee. The committee 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 the committee's report, the department shall notify the committee in writing of the reasons why it did not adopt the changes either at the time it adopts a proposed regulation or within 21 days of receiving the committee's 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, may bring a civil action presenting its claim. In any such civil action, in determining whether a preliminary injunction shall issue, the court shall consider 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 the claim. (f) The department shall issue a certificate of registration authorizing an institution to conduct human embryonic stem cell research within 30 days after submission of an application from the applicant institution, if the 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 either a private or 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 the certificate of registration unreasonably withheld. A certificate may be withheld if the department determines that the applicant institution has violated subsection (m). (g) No research authorized pursuant to subsection (b) of section 3 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 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 section at least 60 days before the expiration of the certificate of registration. If an institution that is issued a certificate of registration under 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. Before the assessment of a civil administrative penalty pursuant to this section, the department shall notify the holder of the certificate of registration that it has 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 subsection. (i) An institution holding a certificate of registration pursuant to subsection (f) shall submit an annual report to the department providing a summary of the research approved during each calendar year and a statement representing that the research was reviewed in accordance with this chapter, if applicable. (j) The department shall certify its receipt of annual reports from institutions holding a certificate of registration pursuant to subsection (f). (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. A duplicate of this record shall be open for public inspection in the office of the state secretary. (l) The department shall keep an official record of all persons convicted of violating subsection (a), (b) or (c) of section 8. The department shall annually send notice of the names of those violators to all institutions issued a certificate of registration under subsection (f). No such institution shall knowingly employ a person whom the department has identified as having been convicted of a violation of said subsection (a), (b) or (c) of said section 8. (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, whether or not the violation is committed by an employee of that institution. (n) (1) 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 the institution has: (i) violated subsection (b) of section 3; (ii) violated section 4; (iii) knowingly and willfully permitted or assisted a violation of subsection (b) or (c) of section 8; (iv) knowingly violated subsection (f) of this section, if applicable; (v) failed to submit an annual report to the department pursuant to subsection (i); (vi) employed a person identified in the annual notice by the department pursuant to subsection (l); or (vii) knowingly implemented a decision by an institutional review board to authorize research prohibited by this chapter. (2) 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 this subsection undertake the following actions: (i) for the violation of clause (iii) of paragraph (1), revoke or refuse to renew such certificate of registration or assess upon the holder a civil administrative penalty not to exceed $250,000 and may require the holder to submit to additional oversight as a condition or retention, or future consideration of reinstatement of the certificate of registration; (ii) for a violation of clause (i), (ii), (iv), (vi) or (vii) of paragraph (1), assess upon the holder a civil administrative penalty not to exceed $100,000; or (iii) for a first violation of clause (v) of paragraph (1) censure a holder; and for each subsequent violation of said clause (v) of said paragraph (1), suspend such certificate of registration until compliance with subsection (i), and impose a civil administrative penalty, as determined by the department not to exceed $1,000. (3) An institution sanctioned under this subsection 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.

Source: Massachusetts General Court (malegislature.gov)URL: https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter111LFetched: 10/20/2026