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45 CFR46
grants and contract supporting
research, development, and related
activities involving: (I) The fetus, (2)
pregnant women, and (3) human m
vitro fertilization.
(b) Nothing m 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 hearing upon activities covered
by this subpart.
(c) The requirements of this
subpart are in addition to those
imposed under the other subparts of
this part.
§ 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.
§ 46.203
Definitions.
As used in this subpart;
(a) “Secretary'’ means the
Secretary of Health, Education, and
Welfare and any other officer or
employee of the Department of
Health, Education, and Welfare to
whom authority has been delegated.
(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.
(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 explusion or extraction of
the fetus, that
it
is viable.
(d) “Viable” as
it pertains to the
Ictus 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 F ederal R egister 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,
(e) "Non viable fetus” means a
fetus ex utero which, although living,
is not viable.
(0 “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).
(g)
'7/i vitro fertilization” means
any
fertilization of human ova which
occurs outside the body of a female,
cither through admixture of donor
human sperm and ova or by any other
means.
§ 46.204
Effatassl 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,
Education, and Welfare.
(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 genera!
policies, guidelines, and procedures.
(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. Wire re 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.
(d) No application or proposal
involving human in vitro fertilization
may be funded by the Department or
any component thereof until the
application or proposal has been
reviewed by the Ethical Advisory
Board and the Board has rendered
advice as to its acceptability from an
ethical standpoint.
§ 46,205
duties ©f tile
Inafitatioael {Review Beards in
connection with activities
involving fetuses, pregnant
women, or human in vitro
fertilization.
(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:
(
1 ) Determine that all aspects of
the activity meet the requirements of
this subpart;
(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:
(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
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verifying, perhaps through sampling,
that approved procedures for
induction of individuals into the
activity are being followed, and (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);
(3) Carry out such other
responsibilities as may be assigned by
the Secretary.
(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
§ 46. 120 of Subpart A of this part,
(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.
$ 46,206
General limitations.
(a) No activity to which this
subpart
is applicable may be
undertaken unless:
( 1) Appropriate studies on animals
and nonpregnant individuals have
been completed;
(2) Except where the purpose of
the activity
is to meet the health
needs of the mother or the particular
Ictus
, the risk
to the fetus
is minimal
and,
in
all cases,
is the least possible
risk for achieving the objectives of
the activity.
(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
(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.
(b) No inducements, monetary or
otherwise, may be offered to
terminate pregnancy for purposes of
the activity.
140 F"R 33528. Aug.
8.
1975, as amended at
40 FR 5I63H. Nov. 6, 1973)
5 46.207
Activities directed
toward pregnant women as
subjects.
(a) No pregnant woman may be
involved as a subject in an activity
covered by
this subpart unless: (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 (2) the risk to the fetus
is minimal.
(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 then informed consent alter
having been fully informed regarding
possible impact on the fetus, except
that the father's informed consent
need not be secured
if: (1) The
purpose of the activity
is to meet she
health needs of the mother; (2) his
identity or whereabouts cannot
reasonably be ascertained; (3) he
is
not reasonably available; or (4) the
pregnancy resulted from rape.
§ 46.208
Activities directed
toward fetuses In utero as
subjects.
(a) No fetus in utero may be
involved as a subject in any activity
covered by this subpart unless: (])
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 (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.
(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: (1) His identity or
whereabouts cannot reasonably be
ascertained, (2) he
is not reasonably
available, or (3) the pregnancy
resulted from rape.
I 46,209
Activities directed
toward fetuses ex utero,
including nonvinble fetuses, as
subjects.
(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:
(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
(2) The purpose of the activity is to
enhance the possibility of survival of
the particular fetus to the point of
viability.
(b) No nonviabie fetus may be
involved as a subject in an activity
covered by this subpart unless:
(1) Vital functions of the fetus will
not be artificially maintained,
(2) Experimental activities which
of themselves would terminate the
heartbeat or respiration of the fetus
will not be employed, and
(3) The purpose of the activity
is
the development of important
biomedical knowledge which cannot
be obtained by other means.
(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.
(d) An activity permitted under
paragraph (a) or (b) of this section
may be conducted only
if the mother
and father arc legilly competent and
have given their informed consent,
except that the father’s informed
consent need not be secured
if: (I) his
identity or whereabouts cannot
reasonably be ascertained, (2) he
is
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not reasonably available, or (3) the
pregnancy resulted from rape.
§ 46,210
Activities involving the
dead fetus, fetal material, or the
placenta.
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.
$ 46.2(1
Modification or waiver
of specific requirements.
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 subpan,
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
know. ledge
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
wifi be published as notices in the
F hUt- W At. R ECilSTt R.
Subpart €—Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Priwaers as Subjects
Sautee.
-*3 FR S3fe5S. Nov
16, 1978
tj 46.301 Applicability.
(a) The regulations in this subpart
are applicable to all biomedicai and
behav ioral research conducted or
supported by the Department of
Health, Education, and Welfare
involving prisoners as subjects.
<bj Nothing in this subpart shall be
construed as indicating that
compliance with the procedures set
forth herein will authorize research
involving prisoners as subjects, to the
extent such research
is limited or
barred by applicable State or local
law.
(c) The requirements of this
subpart are
in addition to those
imposed under the other subparts of
this part.
§ 46,302
Purpose.
Inasmuch as prisoners may be
under constraints because of their
incarceration which could affect theit
ability to make a truly voluntary and
uncoerced decision whether or not to
participate as subjects in research,
it
is the purpose of this subpart to
provide additional safeguards for the
protection of prisoners involved
in
activities to which this subpart
is
applicable.
§ 46,303
Definitions.
As used in this subpart:
(a) "Secretary” means the
Secretary of Health, Education, and
Welfare and any other officer or
employee of the Department of
Health, Education, and Welfare
to
whom authority has been delegated.
<b) “DHEW” means the
Department of Health, Education,
and Welfare.
<c) "Prisoner" mean* any
’
Individual involuntarily confined of
detained in a penal institution. The
lertrt
is intended to encompass
-
individuals sentenced to such an
institution under a criminal or civil
statute, individuals detained
in other
facilities by virtue of statutes or
comnii uncut procedures, which
provide alternatives to criminal
prosecution or incarceration in a
penal
institution, and individuals
detained {tending arraignment, trial,
of sentencing.
(d) "Minimal risk"
is the
probability and magnitude of physical
or psychological harm that
is
normally encountered in the daily
lives, or in the routine medical,
dental, or psychological examination
of healthy persons.
§ 46,304
Composition of
Institutional Review Boards
where prisoners are involved.
In addition to satisfying the
requirements in
§ 46. 107 of this part,
an Institutional Review Board,
carrying out responsibilities under
this part with respect to research
covered by this subpart, shall also
meet the following specific
requirements:
fa) A majority.of the Board,—*'j#s
(exclusiveof prisoner members) *h#l?
have no association with the prisonfsj?
involved, .apart ifrom
membership on the Board:
*
(b) At least one member of the]
Board shall be a prisoner, or a
•
prisoner. rqwscntatiyc^with
appropriate background and
^
experience to serve in that capacity,
except that where a particular
research project
is reviewed by more
than one Board only one Board need
satisfy this requirement.
§ 46.385
Additional duties of the
Institutional Review Boards
where prisoners are involved.
(a) In addition to
ail other
responsibilities prescribed for
institutional Review Boards under
this part, the Board shall review
research covered by this subpart and
approve such research only
if
it finds
that:
(1) The research under review
represents one of the categories of
research permissible under
§ 46.306(a)(2);
(2) Any possible advantages
accruing so the prisoner through his
or her participation in the research,
when compared to the general living
conditions, medical care, quality of
food, amenities and opportunity for
earnings in the prison, are not of such
a magnitude that hi;* or her ability to.
,
weigh the risks «f the research against
...
the value of such advantages in the
limited choice environment of the
prison is impaired;
(3) The risks involved
in the
research are commensurate with risks
that would be accepted by
nonprisoner volunteers;
( 4 ) Procedures for the selection of
subjects within the prison are fair to
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all prisoners and immune from
arhiirary intervention by prison
|
auihorides or prisoners. Unless the
principal investigator provides to the
Board justification in writing for
following some other procedures,
control subjects, must be selected
randomly firoai the group of available
prisoners who meet the characteristics
needed for that particular research
project;
(5) The information is presented in
language which
is understandable to
the subject population;
in
the research in making decisions
regarding parole, and each prisoner is
clearly informed in advance that
participation in the research wilt have
no ef fect on his or her parole; and
(7) Where the Board finds there
may be a need for follow-up
examination or care of participant
after the end of their participation,
^
adequate provision has been made lor
such examination or care, taking into
account die varying lengths of
individual prisoners’ sentences, and
for informing participants of this fact.
(6) Adequate assurance exists
i
'r:“.
*.
. ^
account a 'priaoner'a participation
Secretary the proposed research
involves solely the following:
(A) Study of the possible causes,
effects, and processes of
incarceration, and of criminal
behavior, provided that the study
presents no more than minimal risk
arid no more than inconvenience to
the subjects;
(B) Study of prisons as institutional
structures or of prisoners as
incarcerated persons, provided that
the study presents no more than
minimal risk and no more than
inconvenience to the subjects;
1C) Research on conditions
particularly affecting prisoners as a
class (for example, vaccine trials and
other research on hepatitis which
is
much more prevalent in prisons than
elsewhere; and research on social and
psychological problems such as
alcoholism, drug addiction and sexual
assaults) provided that the study may
proceed only after the Secretary has
consulted with appropriate experts
including experts in penology
medicine and ethics, and published
notice, in the Federal R egister,
of his intent to approve such research;
or
(b) The Board shall carry out such
other duties as may be assigned by
the Secretary.
tc) The institution shall certify to
the Secretary, in such form and
manner as the Secretary may require,
that the duties of the Board under this
section have been fulfilled.
| 46.306
Permitted research
Involving prisoners.'
'
(a) Biomedical or behavioral
research conducted or supported by
DHEW may involve prisoners as
subjects only
if:
(1) The institution responsible for
the-corsduct of the research has
certified to the Secretary that the
Institutional Review Board has
approved the research under § 46.305
of this subpan; and
(2) In the judgment of the
(D) Research on practices, both
innovative and accepted, which have
the intent and reasonable probability
of improving the health or well-
beiisg of the subject. In cases in
which those studies require the
assignment of prisoners
in a manner
consistent with protocols approved by
the IRB to control groups which may
not benefit from the research, the
study may proceed only after the
Secretary has consulted with
appropriate experts, including experts
in penology medicine and ethics, and
published notice,
in the Federal
K egister, of his intent to approve such
research.
(b) Except as provided
in
paragraph (a) of this section,
biomedical or behavioral research
conducted or supported by DHEW
shall not involve prisoners as
subjects.
Stefepart D-AddJHwuj Protectiatm
for OtfMraa £kvoM1 m Sebjecte kt
Meaem*.
Source: 4* FR SSiS, March 8, 1983
8 46.401
Ta what da these
regulations supply?
(a) This subput applies to all
research involving children as
subjects, conducted or supported by
the Department of Health and
Human Service*.
(1) This includes research
conducted by Department
employees, except that each head of
an Operating Division of the
Department may adopt such
nonsubstantive, procedural
modifications as may be appropriate
from an administrative standpoint.
(2) It also includes research
conducted or supported by the
Department of Health and Human
Services outside the United States,
but in appropriate circumstances, the
Secretary may, tinder paragraph (e)
of §46.101 of Subpart A, waive the
applicability of some or all of the
requirements oi these regulations for
research of this type.
(b) Exemptions (1), (2), (5) and (6)
as listed in Subpart A at §46. 101(b)
are applicable to this subpart.
Exemption (4), research involving
the observation of public behavior,
listed at §46, 101(b),
is applicable to
this subpart where the investigators)
does not participate in the activities
feeing observed. Exemption (3),
research involving survey or
interview procedures, listed at
§46. 101(b) does not apply to research
covered by this subpart.
(c) The exceptions, additions, and
provisions for waiver as they appear
in paragraphs (c) through
(i) of
s' IP. 101 of Subpart A are applicable
to this subpart.
§ 46.402
Definitions.
The definitions in §46.102 of
Subpart A shall be applicable to this
subpart as well. In addition, as used
in this subpart:
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