Mass. Gen. Laws ch. 94C, sec. 8 — MA Code / Part I / Title XV / Chapter 94C / Section 8
Research projects and studies
Status: in_force

Section 8. (a) No person shall carry out any research project or study involving any narcotic drug in Schedule II or the investigational use on human beings of any new drug as defined in section two hundred and one (p) of the Federal Food, Drug and Cosmetic Act, as amended, unless he supplies the commissioner with satisfactory evidence of compliance with any applicable federal law, and, if the commissioner so requires, with a protocol describing the research project or study to be undertaken. (b) The commissioner shall pursuant to the provisions of chapter thirty A promulgate rules and regulations establishing standards for such protocol and requiring, among such other conditions relating to the protection of the public health that the commissioner may prescribe, the establishment and maintenance of records and the making of reports to the commissioner of data, including but not limited to analytical reports by investigators, obtained as the result of the investigational use of the drug. The commissioner may waive any or all such conditions with respect to a particular research project or study described in this section if he deems it consistent with the public interest. (c) The commissioner shall, after due notice and opportunity for hearing pursuant to the provisions of chapter thirty A, issue an order that such research project or study be terminated if the commissioner finds (1) that the drug under investigation is unsafe under the conditions of use; or (2) that the investigators lack the necessary training and experience to conduct such research project or study; or (3) that the research protocol contains any untrue statement of a material fact, provided, that if the commissioner finds that there is an imminent hazard to health he shall order that the research project or study be discontinued upon notice and afford those persons who are undertaking the research the opportunity for an expedited hearing. The commissioner may also, after due notice and opportunity for a hearing pursuant to the provisions of chapter thirty A order that a research project or study be discontinued if the commissioner finds (1) that the persons who are undertaking the research have failed to establish a system for maintaining required records, or have repeatedly or deliberately failed to maintain such records or to make reports which are required by the commissioner or the persons undertaking the research project or study have refused to permit access to or copying or verification of such records; or (2) the methods used in, or the facilities and controls used for the research project or study are inadequate to safeguard against unlawful diversion of the drug under investigation. (d) Every person who is required pursuant to the provisions of this section to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the commissioner permit such officer or employee at all reasonable times to have access to and copy and verify such records. (e) No person who undertakes research pursuant to the provisions of this section shall use as a subject for such research any human being unless such subject or his legal representative has given in writing his informed consent based upon information about the nature, duration and purpose of the investigation; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon the subject's health or person which may reasonably be expected to come from his participation. (f) A person who is conducting research pursuant to the provisions of this section may to the extent authorized by the commissioner and in conformity with the provisions of this section dispense any drug for investigational use without an oral, electronic or written prescription. (g) Notwithstanding any other provision of this section, the administering or dispensing directly or prescribing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his dependence upon such drugs in the course of conducting an authorized clinical investigation pursuant to a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term ''in the course of professional practice'' as used in this chapter, provided, that federal approval, if such approval is required by federal law, is obtained prior to the initiation of such a program, and satisfactory evidence of such approval is submitted to the commissioner. (h) Notwithstanding the provisions of paragraphs (a) to (g), inclusive, this section shall not apply to any drug recognized as safe and which has been exempted by section one hundred and seven of the Federal Drug Amendments Act of 1962 from the operation of sections two hundred and one (p) and five hundred and five of the Federal Food, Drug and Cosmetic Act, as amended. (i) Whoever knowingly or intentionally violates any provision of this section shall be punished for each offense by imprisonment in a jail or house of correction for not more than one year or by a fine of not more than one thousand dollars, or both.

Section 8. (a) No person shall carry out any research project or study involving any narcotic drug in Schedule II or the investigational use on human beings of any new drug as defined in section two hundred and one (p) of the Federal Food, Drug and Cosmetic Act, as amended, unless he supplies the commissioner with satisfactory evidence of compliance with any applicable federal law, and, if the commissioner so requires, with a protocol describing the research project or study to be undertaken.

(b) The commissioner shall pursuant to the provisions of chapter thirty A promulgate rules and regulations establishing standards for such protocol and requiring, among such other conditions relating to the protection of the public health that the commissioner may prescribe, the establishment and maintenance of records and the making of reports to the commissioner of data, including but not limited to analytical reports by investigators, obtained as the result of the investigational use of the drug. The commissioner may waive any or all such conditions with respect to a particular research project or study described in this section if he deems it consistent with the public interest.

(c) The commissioner shall, after due notice and opportunity for hearing pursuant to the provisions of chapter thirty A, issue an order that such research project or study be terminated if the commissioner finds (1) that the drug under investigation is unsafe under the conditions of use; or (2) that the investigators lack the necessary training and experience to conduct such research project or study; or (3) that the research protocol contains any untrue statement of a material fact, provided, that if the commissioner finds that there is an imminent hazard to health he shall order that the research project or study be discontinued upon notice and afford those persons who are undertaking the research the opportunity for an expedited hearing. The commissioner may also, after due notice and opportunity for a hearing pursuant to the provisions of chapter thirty A order that a research project or study be discontinued if the commissioner finds (1) that the persons who are undertaking the research have failed to establish a system for maintaining required records, or have repeatedly or deliberately failed to maintain such records or to make reports which are required by the commissioner or the persons undertaking the research project or study have refused to permit access to or copying or verification of such records; or (2) the methods used in, or the facilities and controls used for the research project or study are inadequate to safeguard against unlawful diversion of the drug under investigation.

(d) Every person who is required pursuant to the provisions of this section to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the commissioner permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(e) No person who undertakes research pursuant to the provisions of this section shall use as a subject for such research any human being unless such subject or his legal representative has given in writing his informed consent based upon information about the nature, duration and purpose of the investigation; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon the subject's health or person which may reasonably be expected to come from his participation.

(f) A person who is conducting research pursuant to the provisions of this section may to the extent authorized by the commissioner and in conformity with the provisions of this section dispense any drug for investigational use without an oral, electronic or written prescription.

(g) Notwithstanding any other provision of this section, the administering or dispensing directly or prescribing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his dependence upon such drugs in the course of conducting an authorized clinical investigation pursuant to a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term ''in the course of professional practice'' as used in this chapter, provided, that federal approval, if such approval is required by federal law, is obtained prior to the initiation of such a program, and satisfactory evidence of such approval is submitted to the commissioner.

(h) Notwithstanding the provisions of paragraphs (a) to (g), inclusive, this section shall not apply to any drug recognized as safe and which has been exempted by section one hundred and seven of the Federal Drug Amendments Act of 1962 from the operation of sections two hundred and one (p) and five hundred and five of the Federal Food, Drug and Cosmetic Act, as amended.

(i) Whoever knowingly or intentionally violates any provision of this section shall be punished for each offense by imprisonment in a jail or house of correction for not more than one year or by a fine of not more than one thousand dollars, or both.