[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Federal Register on January 17, 2001, at 66 FR 3878 is withdrawn as of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