LINKS TO SUBPART B: RESEARCH WITH FETUSES, PREGNANT WOMEN, IN VITRO FERTILIZATION

Subpart B Additional DHHS Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization

Note: The contents of the rule are given on the right. The notes on the left have been added solely for the purpose of indexing the sections.

Source: 40 FR 33528, Aug. 8, 1975; 43 FR 1758, January 11, 1978; 43 FR 51559, November 3, 1978

	º46.201 Applicability.
46.201(a) To all DHHS supported research involving fetuses, pregnant women, IVF	(a) The regulations in this subpart are applicable to all Department of Health and Human Services grants and contracts supporting research, development, and related activities involving: (1) the fetus, (2) pregnant women, and (3) human in vitro fertilization.
46.201(b) State and local laws also apply	(b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth herein will in any way render inapplicable pertinent State or local laws bearing upon activities covered by this subpart.
46.201(c) Other subparts also apply	(c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.

	º46.202 Purpose.
46.202 Purpose	It is the purpose of this subpart to provide additional safeguards in reviewing activities to which this subpart is applicable to assure that they conform to appropriate ethical standards and relate to important societal needs.

	º46.203 Definitions. As used in this subpart:
46.203(a) Secretary	(a) "Secretary" means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services (DHHS) to whom authority has been delegated.
46.203(b) Pregnancy	(b) "Pregnancy" encompasses the period of time from confirmation of implantation (through any of the presumptive signs of pregnancy, such as missed menses, or by a medically acceptable pregnancy test), until expulsion or extraction of the fetus.
46.203(c) Fetus	(c) "Fetus" means the product of conception from the time of implantation (as evidenced by any of the presumptive signs of pregnancy, such as missed menses, or a medically acceptable pregnancy test), until a determination is made, following expulsion or extraction of the fetus, that it is viable.
46.203(d) Viable	(d) "Viable" as it pertains to the fetus means being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a fetus is viable for purposes of this subpart. If a fetus is viable after delivery, it is a premature infant.
46.203(e) Nonviable fetus	(e) "Nonviable fetus" means a fetus ex utero which, although living, is not viable.
46.203(f) Dead fetus	(f) "Dead fetus" means a fetus ex utero which exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord (if still attached).
46.203(g) In vitro fertilization	(g) "In vitro fertilization" means any fertilization of human ova which occurs outside the body of a female, either through admixture of donor human sperm and ova or by any other means.

	º46.204 Ethical Advisory Boards.
46.204(a) The Secretary will establish one or more Ethical Advisory Boards	(a) One or more Ethical Advisory Boards shall be established by the Secretary. Members of these Board(s) shall be so selected that the Board(s) will be competent to deal with medical, legal, social, ethical, and related issues and may include, for example, research scientists, physicians, psychologists, sociologists, educators, lawyers, and ethicists, as well as representatives of the general public. No Board member may be a regular, full‑time employee of the Department of Health and Human Services.
46.204(b) The Ethical Advisory Board will advise the secretary on ethical issues involving applications pertaining to this subpart	(b) At the request of the Secretary, the Ethical Advisory Board shall render advice consistent with the policies and requirements of this part as to ethical issues, involving activities covered by this subpart, raised by individual applications or proposals. In addition, upon request by the Secretary, the Board shall render advice as to classes of applications or proposals and general policies, guidelines, and procedures.
46.204(c) A Board establishes which classes of applications must be submitted to it	(c) A Board may establish, with the approval of the Secretary, classes of applications or proposals which: (1) must be submitted to the Board, or (2) need not be submitted to the Board. Where the Board so establishes a class of applications or proposals which must be submitted, no application or proposal within the class may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Board and the Board has rendered advice as to its acceptability from an ethical standpoint.
46.204(d) Nullified	(d) [Nullified under Public Law 103‑43, June 10, 1993]

	º46.205 Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization.
46.205(a) The IRB has additional duties when research is covered by this subpart:	(a) In addition to the responsibilities prescribed for Institutional Review Boards under Subpart A of this part, the applicant's or offeror's Board shall, with respect to activities covered by this subpart, carry out the following additional duties:
46.205(a)(1) Determine that all requirements of Subpart B have been met	(1) determine that all aspects of the activity meet the requirements of this subpart;
46.205(a)(2) Adequate consideration of subject selection and informed consent. The IRB may monitor by:	(2) determine that adequate consideration has been given to the manner in which potential subjects will be selected, and adequate provision has been made by the applicant or offeror for monitoring the actual informed consent process (e.g., through such mechanisms, when appropriate, as participation by the Institutional Review Board or subject advocates in:
46.205(a)(2)(i) Overseeing consent process and subject recruitment, and	(i) overseeing the actual process by which individual consents required by this subpart are secured either by approving induction of each individual into the activity or verifying, perhaps through sampling, that approved procedures for induction of individuals into the activity are being followed, and
46.205(a)(2)(ii) Monitoring study progress	(ii) monitoring the progress of the activity and intervening as necessary through such steps as visits to the activity site and continuing evaluation to determine if any unanticipated risks have arisen);
46. 205(a)(3) And any other responsibilities assigned by the Secretary	(3) carry out such other responsibilities as may be assigned by the Secretary.
46.205(b) Awards will not be issued until these determinations have been made and certified	(b) No award may be issued until the applicant or offeror has certified to the Secretary that the Institutional Review Board has made the determinations required under paragraph (a) of this section and the Secretary has approved these determinations, as provided in º46.120 of Subpart A of this part.
46.205(c) An IRB must be designated if none has been established	(c) Applicants or offerors seeking support for activities covered by this subpart must provide for the designation of an Institutional Review Board, subject to approval by the Secretary, where no such Board has been established under Subpart A of this part.

	º46.206 General limitations.
46.206(a) No covered research may be done unless:	(a) No activity to which this subpart is applicable may be undertaken unless:
46.206(a)(1) Prior studies have been done with animals and nonpregnant persons	(1) appropriate studies on animals and nonpregnant individuals have been completed;
46.206(a)(2) Research related risk to the fetus is minimal or has been minimized	(2) except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the activity;
46.206(a)(3) Researchers have no part in decisions about terminating the pregnancy or the viability of the fetus	(3) individuals engaged in the activity will have no part in: (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (ii) determining the viability of the fetus at the termination of the pregnancy; and
46.206(a)(4) Procedures that increase risk may not be introduced for research purposes	(4) no procedural changes which may cause greater than minimal risk to the fetus or the pregnant woman will be introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
46.206(b) No inducements to terminate pregnancy may be offered	(b) No inducements, monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity. Source: 40 FR 33528, Aug. 8, 1975, as amended at 40 FR 51638, Nov. 6, 1975

	º46.207 Activities directed toward pregnant women as subjects.
46.207(a) Pregnant women may not be involved in research unless:	(a) No pregnant woman may be involved as a subject in an activity covered by this subpart unless:
46.207(a)(1) The research purpose is to meet mother’s health needs and risk to fetus has been minimized, or	(1) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or
46.207(a)(2) Risk to fetus is minimal	(2) the risk to the fetus is minimal.
46.207(b) Both mother and father must give consent unless:	(b) An activity permitted under paragraph (a) of this section may be conducted only if the mother and father are legally competent and have given their informed consent after having been fully informed regarding possible impact on the fetus, except that the father's informed consent need not be secured if:
46.207(b)(1) The purpose of the research is for the health of the mother	(1) the purpose of the activity is to meet the health needs of the mother;
46.207(b)(2) Father cannot be identified or found	(2) his identity or whereabouts cannot reasonably be ascertained;
46.207(b)(3) Father is not available	(3) he is not reasonably available; or
46.207(b)(4) Pregnancy resulted from rape	(4) the pregnancy resulted from rape.

	º46.208 Activities directed toward fetuses in utero as subjects.
46.208(a) No fetus may be involved in research unless:	(a) No fetus in utero may be involved as a subject in any activity covered by this subpart unless:
46.208(a)(1) The purpose of the research is to meet the health needs of the fetus and risk has been minimized, or	(1) the purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or
46.208(a)(2) Risk is minimized and the knowledge cannot be gained in any other way	(2) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means.
46.208(b) Both mother and father must give consent unless:	(b) An activity permitted under paragraph (a) of this section may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father's consent need not be secured if:
46.208(b)(1) Father cannot be identified or found	(1) his identity or whereabouts cannot reasonably be ascertained,
46.208(b)(2) Father is not available, or	(2) he is not reasonably available, or
46.208(b)(3) Pregnancy resulted from rape	(3) the pregnancy resulted from rape.

	º46.209 Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects.
46.209(a) Until viability is determined, a fetus ex utero may not be involved in covered research unless:	(a) Until it has been ascertained whether or not a fetus ex utero is viable, a fetus ex utero may not be involved as a subject in an activity covered by this subpart unless:
46.209(a)(1) There is no added risk and the knowledge cannot be gained any other way, or	(1) there will be no added risk to the fetus resulting from the activity, and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means, or
46.209(a)(2) The purpose of the research is to enhance possibility of survival	(2) the purpose of the activity is to enhance the possibility of survival of the particular fetus to the point of viability.
46.209(b) A nonviable fetus may not be involved in covered research unless:	(b) No nonviable fetus may be involved as a subject in an activity covered by this subpart unless:
46.209(b)(1) Vital functions will not be artificially maintained	(1) vital functions of the fetus will not be artificially maintained,
46.209(b)(2) Research procedures will not terminate heartbeat or respiration, and	(2) experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will not be employed, and
46.209(b)(3) Knowledge cannot be gained any other way	(3) the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means
46.209(c) If the fetus is found to be viable it may be involved in research in accordance with applicable subparts	(c) In the event the fetus ex utero is found to be viable, it may be included as a subject in the activity only to the extent permitted by and in accordance with the requirements of other subparts of this part.
46.209(d) Both mother and father must give consent unless:	(d) An activity permitted under paragraph (a) or (b) of this section may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father's informed consent need not be secured if:
46.209(d)(1) Father cannot be identified or found	(1) his identity or whereabouts cannot reasonably be ascertained,
46.209(d)(2) Father is not available, or	(2) he is not reasonably available, or
46.209(d)(3) Pregnancy resulted from rape	(3) the pregnancy resulted from rape.

	º46.210 Activities involving the dead fetus, fetal material, or the placenta.
46.210 State and local laws apply	Activities involving the dead fetus, mascerated fetal material, or cells, tissue, or organs excised from a dead fetus shall be conducted only in accordance with any applicable State or local laws regarding such activities.

	º46.211 Modification or waiver of specific requirements.
46.211 The Secretary may waive or modify requirements under certain conditions	Upon the request of an applicant or offeror (with the approval of its Institutional Review Board), the Secretary may modify or waive specific requirements of this subpart, with the approval of the Ethical Advisory Board after such opportunity for public comment as the Ethical Advisory Board considers appropriate in the particular instance. In making such decisions, the Secretary will consider whether the risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant such modification or waiver and that such benefits cannot be gained except through a modification or waiver. Any such modifications or waivers will be published as notices in the Federal Register.