[Federal Register Volume 66, Number 219 (Tuesday, November 13, 2001)]
[Rules and Regulations]
[Pages 56775-56780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

RIN 0940-AA05


Protection of Human Research Subjects

AGENCY: Department of Health and Human Services (DHHS).

ACTION: Final Rule.

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SUMMARY: The Department of Health and Human Services (DHHS) is 
withdrawing Subpart B of its human subjects protection regulations 
published on January 17, 2001 and is issuing this replacement rule. 
These regulations provide additional protections for pregnant women and 
human fetuses involved in research. The final rule continues the 
special protections for pregnant women and human fetuses that have 
existed since 1975 and makes limited changes in terminology referring

[[Page 56776]]

to neonates, clarifies provisions for paternal consent when research is 
conducted involving fetuses, clarifies language that applies to 
research on newborns of uncertain viability, and corrects technical 
errors.

DATES: The final rule, Protection of Human Subjects, published in the 
Federal Register on January 17, 2001, at 66 FR 3878 is withdrawn as of 
November 13, 2001. The amendment published in this final rule is 
effective December 13, 2001.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for 
Human Research Protections (OHRP) 200 Independence Avenue, S.W., Room 
733-E, Washington, DC 20201. Telephone 202-260-1587.

SUPPLEMENTARY INFORMATION:

Background

    The Department of Health and Human Services (DHHS) regulates 
research involving human subjects conducted or supported by the agency 
through regulations codified at Title 45, part 46, of the Code of 
Federal Regulations. Subpart B of 45 CFR part 46, promulgated on August 
8, 1975, pertains to research involving fetuses, pregnant women, and 
human in vitro fertilization. The 1975 regulations were jointly 
published in the Federal Register with the report and recommendations 
of the National Commission for the Protection of Human Subjects of 
Biomedical and Behavioral Research, Research on the Fetus (40 FR 
33526). Subsequent changes were incorporated January 11, 1978 (43 FR 
1758), November 3, 1978 (43 FR 51559), and June 1, 1994 (59 FR 28276).
    On January 17, 2001, the Department published in the Federal 
Register a Final Rule, with an effective date of March 19, 2001 (66 FR 
3878), intended to amend subpart B of 45 CFR part 46. This preamble 
refers to that rule as ``the January rule.'' The January rule's 
effective date was delayed by 60 days on March 19, 2001, in accordance 
with the memorandum of January 20, 2001, from the Assistant to the 
President and Chief of Staff, entitled A Regulatory Review Plan, 
published in the Federal Register on January 24, 2001. (66 FR 15352). 
The effective date of the January rule was further delayed by 180 days 
on May 18, 2001 to give the Department an opportunity to obtain comment 
on three modifications to the rule. (66 FR 27559). Simultaneous with 
publication of this final rule, the January rule is being withdrawn. 
Given the imminence of the effective date of the final rule as amended, 
seeking public comment on the withdrawal of the January rule would have 
been impracticable, as well as contrary to the public interest in the 
orderly promulgation and implementation of regulations, to allow time 
for implementation of this final rule.
    On July 6, 2001, the Department published in the Federal Register a 
Notice of Proposed Rulemaking (66 FR 35576) seeking public comment on 
three limited proposed changes in the January rule: (1) Requiring 
paternal consent (with specified exceptions) for participation in 
federally funded research that is directed solely at a fetus; (2) 
modifying the definition of ``fetus'' to describe only the stage prior 
to delivery; and (3) modifying language to make clear that neonates of 
uncertain viability may be subjected to added risk only if the research 
is intended to enhance the probability of survival of the particular 
neonate to the point of viability.

Discussion of Comments

    During the public comment period that ended September 4, 2001, the 
Department received 21 public comments on the proposed rule from 
interested parties. The comments are summarized as follows:

Paternal Consent for Participation in Research Directed Solely at the 
Fetus

    The Department proposed requiring paternal consent (with specified 
exceptions) for participation in federally-funded research that is 
directed solely at the fetus. One commenter endorsed the change, saying 
that it is appropriate. Eight commenters objected to the change. Of 
these, two indicated that paternal consent should be required for any 
research that involves more than minimal risk to the fetus, and six 
indicated paternal consent should not be required in any research 
involving the fetus because to do so is contrary to clinical standards, 
does not recognize a woman's autonomy or her interest in protecting her 
fetus, presumes exclusion of pregnant women from participating in 
research, could delay participation in research, and could require 
pregnant women to disclose HIV status to fathers when such disclosure 
is not ordinarily required. These six commenters also stated that 
potential benefit to the mother and the fetus is not separable; and 
that determination of benefit is subjective.
    The Department finds that modification of the consent provisions as 
proposed is the most respectful of the parents' joint interests in 
their fetus's health. The preamble to the January rule explained that 
consent requirements for research involving pregnant women were 
modified to address cases in which a requirement for the father's 
consent had been a barrier to participation in research which held 
potential benefit for both pregnant women and their fetuses. We believe 
that this problem is addressed by the clarification in this rule that 
only the mother's consent is required for participation in research 
that may benefit both the pregnant woman and the fetus. In addition, a 
father's consent would not be needed for a woman to participate in a 
research activity that would benefit her health.
    Two commenters pointed out that consent requirements are not 
addressed for research with no prospect of benefit for the mother or 
her fetus, when the risk to the fetus is not greater than minimal and 
the purpose of the research is the development of important biomedical 
knowledge which cannot be obtained by any other means. The Department 
has modified the rule to clarify that only maternal consent is required 
in this circumstance, consistent with the other consent requirements of 
this section. The Department finds that requiring consent of both 
parents when risk to the fetus is no greater than minimal, and the 
purpose of the research is the development of important biomedical 
knowledge that cannot be obtained by any other means, would potentially 
impede important research and would not create additional protections 
for the fetus.
    Three commenters stated that the qualification that paternal 
consent need not be obtained if he is unable to consent because of 
``unavailability, incompetence, or temporary incapacity'' is unclear, 
and questioned whether paternal consent is required in cases of rape. 
The Department has modified the rule to clarify that paternal consent 
is not required in cases of rape and incest.

Use of the Terms Fetus and Neonate

    The Department proposed using the terms ``fetus'' to describe an 
infant prior to delivery, and ``neonate'' to describe an infant 
following delivery. Four commenters endorsed use of the term 
``neonate'' to refer to an infant after delivery; one of these 
commenters added that the change is consistent with clinical 
definitions. Six commenters objected, stating that use of the term 
neonate is confusing, conflicts with traditional medical terminology, 
will cause research conducted under subpart B to overlap with research 
conducted under subpart D, and will cause mislabeling of fetal deaths.
    The Department finds that using the term ``fetus'' only for those 
infants that

[[Page 56777]]

have not been delivered is preferable because it is more consistent 
with the ordinary understanding of that word and that it is appropriate 
to distinguish between infants that have and have not been delivered by 
introducing the term neonate for an infant that has been delivered. 
This definitional change does not alter the strong protections the rule 
gives to pregnant women and fetuses, or change the regulatory framework 
that has been established to guide decisions regarding conduct of 
federally-supported research. The Department recognizes that the term 
``neonate'' customarily refers to the first 28 days of life following 
delivery. The rule is not intended to alter this customary definition. 
The rule categorizes research involving neonates of uncertain viability 
or nonviable neonates as covered by subpart B, and research involving 
viable neonates as covered by subpart D. The Department notes that 
subpart B applies only to research. Because the vast majority of 
fetuses and neonates are not involved in any research protocol, subpart 
B is not likely to alter the ways that fetal deaths generally are 
labeled and reported throughout the medical community.

Research Involving Neonates of Uncertain Viability

    The Department proposed to clarify that research involving risk is 
permitted on neonates of uncertain viability only when it is intended 
to increase the probability of survival. One commenter supported this 
change. Four commenters objected, stating that the level of risk for 
neonates of uncertain viability should not be less than that for viable 
neonates, and that research involving these subjects should be covered 
under subpart D. Three of these commenters also stated that a ``no-
risk'' standard for research is not feasible. The Department finds that 
it is appropriate to provide greater protections for neonates of 
uncertain viability and to make clear that these neonates may be 
subjected to added risk only if the research is intended to enhance the 
particular neonate's probability of survival to the point of viability. 
The Department has modified language concerning research that develops 
important biomedical knowledge that cannot be obtained by other means 
to clarify that such research can only be conducted on neonates of 
uncertain viability and nonviable neonates when it will pose no added 
risk. This language is consistent with statutory requirements under 42 
U.S.C. 289g.
    Further, three commenters proposed alternative definitions of 
viability, and one commented that determination of viability is not a 
one-time decision. The Department finds that the definition provided in 
the rule provides appropriate protection to neonates in this vulnerable 
status, and intends that the determination of viability be made at the 
time of enrollment in any relevant research.

General Comments

    Six commenters stated that language from HHS appropriations 
statutes regarding research involving embryos should be incorporated 
into the regulations and that either a definition of ``embryo'' should 
be added to the regulations or the definition of ``fetus'' should be 
revised. One commenter noted that the definition of fetus contained in 
the regulations is confusing, as it includes embryos. And two 
commenters stated general opposition to any research involving embryos. 
The Department finds that the current definition of fetus contained in 
the regulations appropriately includes embryos in utero, and that 
research involving embryos is otherwise adequately addressed by 
existing statutory requirements.
    Four commenters stated that the regulations should incorporate 
language from 42 U.S.C. 289g(b) regarding the risk standard for aborted 
fetuses and fetuses carried to term. The Department finds that existing 
regulations make no distinction between fetuses intended to be aborted 
and those to be carried to term and ensures that decisions regarding 
whether to carry the fetus to term are separate from the research. The 
Department also finds that these risk standards are appropriately 
addressed by existing statutes. These four commenters also stated that 
the regulations should retain the requirement that risk to the fetus 
should be no more than needed to meet the health needs of the mother or 
fetus. The Department believes that the existing standard, that the 
risk posed is the least possible for achieving objectives of research, 
more appropriately covers all research that may be conducted under this 
section. In some cases, the objective of the research is to potentially 
benefit the mother or her fetus. In other cases, the objective of the 
research is to develop important biomedical knowledge which cannot be 
obtained by any other means.
    Four commenters stated that the regulations should incorporate 
statutes governing fetal tissue research. The Department finds that 
research involving fetal tissue is adequately addressed by existing 
statutory requirements, and that these requirements are referenced 
appropriately in section 46.206 of the rule. These four commenters, as 
well as two other commenters, noted that the provisions in the 
regulation concerning fetal tissue research inappropriately refer to 
the material as ``neonatal'' material. The Department has corrected 
this drafting error.
    One commenter objected to the requirement that, where 
scientifically appropriate, preclinical studies on pregnant animals and 
clinical studies on non-pregnant women be conducted to provide data for 
assessing potential risks to pregnant women and fetuses because it may 
delay important research. The Department finds that such studies may 
provide important data regarding assessment of risks to pregnant women 
and fetuses.
    One commenter observed that requirements regarding inducements and 
decisions to terminate a pregnancy are not relevant to research 
involving neonates. The Department has corrected this drafting error by 
deleting the previous 46.205(a)(3) and (4).
    One commenter noted that the regulations do not directly address in 
vitro fertilization research, although this topic is listed in the 
title and a definition is provided. The Department has deleted in vitro 
fertilization research from the title and the definitions.
    One commenter supported the Department's distinction between 
therapeutic and nontherapeutic research in this rule; and two 
commenters opposed making such a distinction. The Department has 
retained existing regulatory language, finding that such a distinction 
is a valid factor in assessing this type of proposed research.
    Five commenters objected to the provision permitting the Secretary 
to conduct or fund research involving pregnant women, fetuses, or 
neonates that does not otherwise meet the requirements of the rule when 
the research presents an opportunity to understand, prevent, or 
alleviate a serious problem affecting the health or welfare of these 
subjects, will be conducted in accordance with sound ethical principles 
and with informed consent. The Department has retained this provision. 
While such research would not normally be supported, it is important to 
retain the flexibility to support such research to protect and advance 
the health and well-being of these subjects. This provision replaces a 
former requirement for review of such research by an ethics advisory 
board, which was nullified by 1993 legislation, Pub. L. 103-43. 
Moreover, the Secretary will, as required under the current section, 
consult with experts and seek public comment prior to determining

[[Page 56778]]

whether such research should be supported by the Department. Further, 
any such research must be conducted in accordance with sound ethical 
principles.
    Two commenters objected to permitting use of exemptions found under 
subpart A of the regulations in research conducted under subpart B. The 
Department has retained this provision, finding that permitting these 
exemptions is consistent with other provisions of the rule, and will 
not increase risks to subjects covered by subpart B.
    One commenter objected to the order of the definitions. The 
Department has retained alphabetical order for ease of reference.
    One commenter noted that the change in presumption for inclusion in 
research, as modified in the January rule, creates an appearance of 
promoting research over protection of subjects. The Department has 
retained existing language, finding that it is important to promote a 
presumption of inclusion rather than exclusion, and to respect autonomy 
of research subjects.
    One commenter questioned the deletion of the requirement for review 
by an Ethics Advisory Board in the January rule. As stated above, this 
change was made in light of 1993 legislation nullifying this 
requirement, Pub. L. 103-43.
    One commenter questioned the delay of the effective date of the 
January rule, stating that the delay was implemented without public 
comment in a final rule published on May 16 (66 FR 27599). As stated in 
that notice of delay of effective date, the Department determined that 
notice and comment requirements of 5 U.S.C. 553 did not apply to that 
action because it was a rule of procedure, or, alternatively, because 
it fell within the good cause exception to rule making requirements 
because obtaining public comment was impracticable, unnecessary, and 
contrary to the public interest. See 5 U.S.C. 553(b)(3(B). Moreover, an 
opportunity for comment has been provided in connection with the 
issuance of these regulations.

Summary of Comments

    After considering the comments, the Department is adopting the rule 
as proposed except for the changes noted above. Language is added to 
clarify that only maternal consent is required for research that does 
not involve any prospect of benefit for the mother or her fetus and the 
purpose of the research is the development of important biomedical 
knowledge which cannot be obtained by any other means and the risk to 
the fetus is not greater than minimal. Language is added to clarify 
that paternal consent is not required in cases of rape and incest. The 
term ``added'' is incorporated to clarify that research involving 
nonviable neonates and neonates of uncertain viability that may develop 
important biomedical knowledge that cannot be obtained by any other 
means may be conducted only when such research poses no added risk. 
Drafting errors, as noted above, are corrected.
    The rule is effective December 13 2001. All initial and ongoing 
projects reviewed by Institutional Review Boards (IRBs) after the 
effective date under Assurances with DHHS, Office for Human Research 
Protections (OHRP) must be reviewed in accordance with these rules.

Executive Order 12866

    Executive Order 12866 requires that all regulatory actions reflect 
consideration of the costs and benefits they generate and that they 
meet certain standards, such as avoiding the imposition of unnecessary 
burdens on the affected public. If an action is deemed to fall within 
the scope of the definition of the term ``significant regulatory 
action'' contained in Sec. 3(f) of the Order, a pre-publication review 
by the Office of Management and Budget's (OMB's) Office of Information 
and Regulatory Affairs (OIRA) is necessary. OMB deemed this rule a 
``significant regulatory action,'' as defined by Executive Order 12866. 
Therefore, the rule was submitted to OIRA for review prior to its 
publication in the Federal Register.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. Chapter 6) requires that 
regulatory actions be analyzed to determine whether they create a 
significant impact on a substantial number of small entities. This rule 
primarily affects individual research subjects and institutions that 
receive funding from the Department of Health and Human Services for 
research involving human subjects. It will not have the effect of 
imposing significant additional costs on small research institutions 
that are within the definition of small entities. Therefore, the 
Secretary certifies that this rule will not have significant impact on 
a substantial number of small entities and that preparation of an 
initial regulatory flexibility analysis is not required.

Paperwork Reduction Act

    This rule does not contain any new information collection 
requirements that are subject to Office of Management and Budget (OMB) 
approval under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 
35).

List of Subjects in 45 CFR Part 46

    Health--clinical research, medical research.

    Dated: October 26, 2001.
Arthur J. Lawrence,
Acting Principal Deputy Assistant Secretary for Health.

    Approved: October 29, 2001.
Tommy G. Thompson,
Secretary of Health and Human Services.

    Accordingly, the Department of Health and Human Services amends 
part 46 of the Regulations for the Protection of Human Subjects (45 CFR 
part 46) as follows:

PART 46--[AMENDED]

    1. Authority citation for 45 CFR part 46 is revised to read as 
follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).


    2. Subpart B of 45 CFR Part 46 is revised to read as follows:
Subpart B--Additional Protections for Pregnant Women, Human Fetuses and 
Neonates Involved in Research
Sec.
46.201   To what do these regulations apply?
46.202   Definitions.
46.203   Duties of IRBs in connection with research involving 
pregnant women, fetuses, and neonates.
46.204   Research involving pregnant women or fetuses.
46.205   Research involving neonates.
46.206   Research involving, after delivery, the placenta, the dead 
fetus or fetal material.
46.207   Research not otherwise approvable which presents an 
opportunity to understand, prevent, or alleviate a serious problem 
affecting the health or welfare of pregnant women, fetuses, or 
neonates.

Subpart B--Additional Protections for Pregnant Women, Human Fetuses 
and Neonates Involved in Research


Sec. 46.201  To what do these regulations apply?

    (a) Except as provided in paragraph (b) of this section, this 
subpart applies to all research involving pregnant women, human 
fetuses, neonates of uncertain viability, or nonviable neonates 
conducted or supported by the Department of Health and Human Services 
(DHHS). This includes all research conducted in DHHS facilities by any 
person and all research conducted in any facility by DHHS employees.

[[Page 56779]]

    (b) The exemptions at Sec. 46.101(b)(1) through (6) are applicable 
to this subpart.
    (c) The provisions of Sec. 46.101(c) through (i) are applicable to 
this subpart. Reference to State or local laws in this subpart and in 
Sec. 46.101(f) is intended to include the laws of federally recognized 
American Indian and Alaska Native Tribal Governments.
    (d) The requirements of this subpart are in addition to those 
imposed under the other subparts of this part.


Sec. 46.202  Definitions.

    The definitions in Sec. 46.102 shall be applicable to this subpart 
as well. In addition, as used in this subpart:
    (a) Dead fetus means a fetus that exhibits neither heartbeat, 
spontaneous respiratory activity, spontaneous movement of voluntary 
muscles, nor pulsation of the umbilical cord.
    (b) Delivery means complete separation of the fetus from the woman 
by expulsion or extraction or any other means.
    (c) Fetus means the product of conception from implantation until 
delivery.
    (d) Neonate means a newborn.
    (e) Nonviable neonate means a neonate after delivery that, although 
living, is not viable.
    (f) Pregnancy encompasses the period of time from implantation 
until delivery. A woman shall be assumed to be pregnant if she exhibits 
any of the pertinent presumptive signs of pregnancy, such as missed 
menses, until the results of a pregnancy test are negative or until 
delivery.
    (g) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom authority has been delegated.
    (h) Viable, as it pertains to the neonate, means being able, after 
delivery, to survive (given the benefit of available medical therapy) 
to the point of independently maintaining heartbeat 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 neonate is viable for purposes of this subpart. 
If a neonate is viable then it may be included in research only to the 
extent permitted and in accordance with the requirements of subparts A 
and D of this part.


Sec. 46.203  Duties of IRBs in connection with research involving 
pregnant women, fetuses, and neonates.

    In addition to other responsibilities assigned to IRBs under this 
part, each IRB shall review research covered by this subpart and 
approve only research which satisfies the conditions of all applicable 
sections of this subpart and the other subparts of this part.


Sec. 46.204  Research involving pregnant women or fetuses.

    Pregnant women or fetuses may be involved in research if all of the 
following conditions are met:
    (a) Where scientifically appropriate, preclinical studies, 
including studies on pregnant animals, and clinical studies, including 
studies on nonpregnant women, have been conducted and provide data for 
assessing potential risks to pregnant women and fetuses;
    (b) The risk to the fetus is caused solely by interventions or 
procedures that hold out the prospect of direct benefit for the woman 
or the fetus; or, if there is no such prospect of benefit, the risk to 
the fetus is not greater than minimal and the purpose of the research 
is the development of important biomedical knowledge which cannot be 
obtained by any other means;
    (c) Any risk is the least possible for achieving the objectives of 
the research;
    (d) If the research holds out the prospect of direct benefit to the 
pregnant woman, the prospect of a direct benefit both to the pregnant 
woman and the fetus, or no prospect of benefit for the woman nor the 
fetus when risk to the fetus is not greater than minimal and the 
purpose of the research is the development of important biomedical 
knowledge that cannot be obtained by any other means, her consent is 
obtained in accord with the informed consent provisions of subpart A of 
this part;
    (e) If the research holds out the prospect of direct benefit solely 
to the fetus then the consent of the pregnant woman and the father is 
obtained in accord with the informed consent provisions of subpart A of 
this part, except that the father's consent need not be obtained if he 
is unable to consent because of unavailability, incompetence, or 
temporary incapacity or the pregnancy resulted from rape or incest.
    (f) Each individual providing consent under paragraph (d) or (e) of 
this section is fully informed regarding the reasonably foreseeable 
impact of the research on the fetus or neonate;
    (g) For children as defined in Sec. 46.402(a) who are pregnant, 
assent and permission are obtained in accord with the provisions of 
subpart D of this part;
    (h) No inducements, monetary or otherwise, will be offered to 
terminate a pregnancy;
    (i) Individuals engaged in the research will have no part in any 
decisions as to the timing, method, or procedures used to terminate a 
pregnancy; and
    (j) Individuals engaged in the research will have no part in 
determining the viability of a neonate.


Sec. 46.205  Research involving neonates.

    (a) Neonates of uncertain viability and nonviable neonates may be 
involved in research if all of the following conditions are met:
    (1) Where scientifically appropriate, preclinical and clinical 
studies have been conducted and provide data for assessing potential 
risks to neonates.
    (2) Each individual providing consent under paragraph (b)(2) or 
(c)(5) of this section is fully informed regarding the reasonably 
foreseeable impact of the research on the neonate.
    (3) Individuals engaged in the research will have no part in 
determining the viability of a neonate.
    (4) The requirements of paragraph (b) or (c) of this section have 
been met as applicable.
    (b) Neonates of uncertain viability. Until it has been ascertained 
whether or not a neonate is viable, a neonate may not be involved in 
research covered by this subpart unless the following additional 
conditions are met:
    (1) The IRB determines that:
    (i) The research holds out the prospect of enhancing the 
probability of survival of the neonate to the point of viability, and 
any risk is the least possible for achieving that objective, or
    (ii) The purpose of the research is the development of important 
biomedical knowledge which cannot be obtained by other means and there 
will be no added risk to the neonate resulting from the research; and
    (2) The legally effective informed consent of either parent of the 
neonate or, if neither parent is able to consent because of 
unavailability, incompetence, or temporary incapacity, the legally 
effective informed consent of either parent's legally authorized 
representative is obtained in accord with subpart A of this part, 
except that the consent of the father or his legally authorized 
representative need not be obtained if the pregnancy resulted from rape 
or incest.
    (c) Nonviable neonates. After delivery nonviable neonate may not be 
involved in research covered by this subpart unless all of the 
following additional conditions are met:
    (1) Vital functions of the neonate will not be artificially 
maintained;
    (2) The research will not terminate the heartbeat or respiration of 
the neonate;
    (3) There will be no added risk to the neonate resulting from the 
research;

[[Page 56780]]

    (4) The purpose of the research is the development of important 
biomedical knowledge that cannot be obtained by other means; and
    (5) The legally effective informed consent of both parents of the 
neonate is obtained in accord with subpart A of this part, except that 
the waiver and alteration provisions of Sec. 46.116(c) and (d) do not 
apply. However, if either parent is unable to consent because of 
unavailability, incompetence, or temporary incapacity, the informed 
consent of one parent of a nonviable neonate will suffice to meet the 
requirements of this paragraph (c)(5), except that the consent of the 
father need not be obtained if the pregnancy resulted from rape or 
incest. The consent of a legally authorized representative of either or 
both of the parents of a nonviable neonate will not suffice to meet the 
requirements of this paragraph (c)(5).
    (d) Viable neonates. A neonate, after delivery, that has been 
determined to be viable may be included in research only to the extent 
permitted by and in accord with the requirements of subparts A and D of 
this part.


Sec. 46.206  Research involving, after delivery, the placenta, the dead 
fetus or fetal material.

    (a) Research involving, after delivery, the placenta; the dead 
fetus; macerated fetal material; or cells, tissue, or organs excised 
from a dead fetus, shall be conducted only in accord with any 
applicable Federal, State, or local laws and regulations regarding such 
activities.
    (b) If information associated with material described in paragraph 
(a) of this section is recorded for research purposes in a manner that 
living individuals can be identified, directly or through identifiers 
linked to those individuals, those individuals are research subjects 
and all pertinent subparts of this part are applicable.


Sec. 46.207  Research not otherwise approvable which presents an 
opportunity to understand, prevent, or alleviate a serious problem 
affecting the health or welfare of pregnant women, fetuses, or 
neonates.

    The Secretary will conduct or fund research that the IRB does not 
believe meets the requirements of Sec. 46.204 or 
Sec.  46.205 only if:
    (a) The IRB finds that the research presents a reasonable 
opportunity to further the understanding, prevention, or alleviation of 
a serious problem affecting the health or welfare of pregnant women, 
fetuses or neonates; and
    (b) The Secretary, after consultation with a panel of experts in 
pertinent disciplines (for example: science, medicine, ethics, law) and 
following opportunity for public review and comment, including a public 
meeting announced in the Federal Register, has determined either:
    (1) That the research in fact satisfies the conditions of 
Sec. 46.204, as applicable; or
    (2) The following:
    (i) The research presents a reasonable opportunity to further the 
understanding, prevention, or alleviation of a serious problem 
affecting the health or welfare of pregnant women, fetuses or neonates;
    (ii) The research will be conducted in accord with sound ethical 
principles; and
    (iii) Informed consent will be obtained in accord with the informed 
consent provisions of subpart A and other applicable subparts of this 
part.

[FR Doc. 01-28440 Filed 11-9-01; 8:45 am]
BILLING CODE 4150-04-P