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  • Acts
  • 2008
  • Chapter 333 AN ACT RELATIVE TO BIOMEDICAL RESEARCH.

Whereas, The deferred operation of this act would tend to defeat its purpose, which is to promote biomedical research in the commonwealth, therefore it is hereby declared to be an emergency law, necessary for the immediate preservation of the public convenience.

Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same as follows:

SECTION 1. Section 12J of chapter 112 of the General Laws, as appearing in the 2006 Official Edition, is hereby amended by striking out subsections (a) I and (a) II and inserting in place thereof the following 2 subsections:-

(a) I. No person shall use any live human fetus whether before or after expulsion from its mother's womb, for scientific, laboratory, research or other experimentation. This section shall not prohibit procedures incident to the study of a human fetus while it is in its mother's womb or a neonate; provided that in the best medical judgment of the physician, made at the time of the study, the procedures do not substantially jeopardize the life or health of the fetus or neonate; and provided further that, in the case of a fetus, the fetus is not the subject of a planned abortion. In any criminal proceeding, a fetus shall be conclusively presumed not to be the subject of a planned abortion if the mother signed a written statement at the time of the study, that she was not planning an abortion.

This section shall not prohibit or regulate diagnostic or remedial procedures the purpose of which is: (i) to determine the life or health of the fetus or neonate involved; (ii) to preserve the life or health of the fetus or neonate involved or the mother involved; (iii) to improve the chances of a viable birth for a fetus with a congenital or other fetal conditions that would otherwise substantially impair or jeopardize the fetus’s health or viability; or (iv) research approved by an institutional review board applying federal regulations for the protection of fetuses and neonates, that are conducted for the purpose of developing, comparing or improving diagnostic or therapeutic fetal or neonatal interventions to improve the viability or quality of life of fetuses, neonates and children.
For the purposes of this section, “fetus” shall also include an embryo, but shall exclude a pre-implantation embryo or parthenote as defined in section 2 of chapter 111L and obtained in accordance with said chapter 111L.

A fetus is a live fetus for purposes of this section when, in the best medical judgment of a physician, it shows evidence of life as determined by the same medical standards as are used in determining evidence of life in a spontaneously-aborted fetus at approximately the same stage of gestational development.

For purposes of this section, “institutional review board” shall mean 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.

(a) II. No experimentation shall knowingly be performed upon a dead fetus or dead neonate unless the consent of the parent or guardian has first been obtained; provided, however, that such consent shall not be required for a routine pathological study. In any criminal proceeding, consent shall be conclusively presumed to have been granted for the purposes of this section by a written statement, signed by the parent or guardian who is at least 18 years of age, to the effect that the parent or guardian consents to the use of the dead fetus or dead neonate for scientific, laboratory, research or other experimentation or study. Such written consent shall constitute authorization for the transfer of the dead fetus or dead neonate.

SECTION 2. Said section 12J of said chapter 112, as so appearing, is hereby further amended by striking out subsection (a) IV and inserting in place thereof the following subsection:-

(a) IV. No person shall knowingly sell, transfer, distribute or give away any fetus or neonate for a use which is in violation of this section.

SECTION 3. Said section 12J of said chapter 112, as so appearing, is hereby further amended by adding the following subsection:-

(b) X. Upon receipt of a request from an institution conducting, or preparing to conduct, research pursuant to this section, the attorney general shall provide a written advisory opinion concerning whether such research is regulated, prohibited, authorized by this chapter by or whether it is exempt from this chapter. If in the opinion of the attorney general the research described in the request is exempt from, or authorized by this chapter, the opinion shall constitute an affirmative defense to any criminal prosecution brought pursuant to this section. Opinions issued by the attorney general pursuant to this section shall be maintained in a publicly accessible manner by the attorney general and shall be filed with the commissioner of public health.

Approved September 17, 2008