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45 CFR 4f
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m nmc to time, taking into
medical advances, publish
in
*.
m,
‘
! -f RAi. Klcisier guidelines
in determining whether
a
d
*
viable for purposes of this
i
<T *
If a fetus
is viable after
.
it
is a premature
infant
*
Non viable fetus
*
1 means a
x
,
* utero which, although living,
viable.
h.
Dead fetus
means
a fetus ex
«
^hich exhibits neither
v *
tat, spontaneous respiratory
lh
\
, spontaneous movement of
v
iry muscles, nor pulsation of
aii >
bilical cord (if still attached).
,
h\ vitro fertilization
11 means
cu
i
utilization of human ova which
huu
outside the body of a female,
in*
i
.
'hrough admixture ol donor
&
sperm and ova or by any other
Ukk
*
Ethical Advisory*
Bo.
,
».
>
x
'ue or more Ethical Advisory
&h.
shall be established by the
will V'p >\ Members of these board(s)
BKv
• so selected that the board(s)
r*U
*
competent to deal with
c\a
1,
legal, social, ethical, and
Ph} \
, } 'ssues and may include, for
v Hu, research scientists,
cth*v v Vis, psychologists,
^v xv'iUsts, educators, lawyers, and
V
*
* as well as representatives of
of uV
tval public. No board member
Edo.
‘
a regular, full-time employee
(K
department of Health,
the
^ u, and Welfare,
reno^
\ the request of the Secretary,
pohv
v
‘cu! Advisory Board shall
as
tv* _
dvice consistent with the
j*cuv
^
and requirements of this Part
raiscv
^
* xal issues, involving
v*
covered by this subpart,
individual applications or
reode
In addition, upon request
3?phv
vV.cretary, the Board shall
<Mk
.
vice as to classes of
ons or proposals and general
Y
- rnidelines, and procedures.
•
-i
'ard may establish, with
a! of the Secretary, classes
urns or proposals which:
(
I
’• Must be submitted to the board,
or (2) need not be submitted to the
Bo?rJ. 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.
(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.
t 46.205
Additional duties of tilt
Institution*] Review Boards 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 subpan;
(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
(c.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 arc secured either by
approving induction of each
individual into thr activity or
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45 C'FR 46
v^;
i.
r
\ ;;*g, pcs hap* through sampling,
I-.;
:
;*Mf‘rnvco
p-
- >.•* ?r r e w
‘-it
^
inuUwU^;: of individuals into the
activity
are be inf followed, and
( i i
monitoring the progress or the
activity and intervening as necessary
through such steps 3s
visits 10 the
activity site and continuing evaluation
to determine
if any unanticipated
risks have an sen),
(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
I
been established under Subpart A of
this part.
9 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
fetus, the risk to the fetus
is minimal
and.
in
ail 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
K»r terminating the pregnanes
soli \\
in
l he
ini
: of
(lie
at Uv ii*.
.
<b) No inducements, monetary or
otherwise, may bt offered
to
terminate pregnancy for purposes of
the activity
1 40 FR 33528. Aug.
8.
3975, as amended
at
40 FR 51638. Nov.
6,
1975)
| 46.20?
Activities directed
toward pregnant women as
subjects.
(a) No pregnant woman may be
involved as a subject in an activity
covered by this suboart unless: (I)
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 (at 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; (1) The
purpose of the activity
is to meet the
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.
9 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: (I)
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
fjthiT are iccally competent ano ha\e
g:\ei.
the
;t 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.
9 46.209
Activities directed
toward fetuses ex utero,
including nonviable fetuses, as
subjects.
(a) Until
it has been ascertained
whether or not a fetus cx utero
is
viable, a fetus cx 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 nonviable 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 pan.
(d) An activity permitted under
paragraph (a) or (b) of this section
may be conducted only
if the mother
and father arc legally competent and
have given their informed consent,
except that the father’s informed
consent need not be secured
if: (1) his
identity or whereabouts cannot
reasonably be ascertained,
(2) he
is
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45 CFR46
not reasonably available, or (3' the
pregnancy requited from rani
.
§ 46.210
Activities involving the
dead fetus, fetal mufrrE?,
<**
the
placenta.
Activities involving the dead
fetus,
masce rated
feta! material,
o:
tissue, or organs excised from
a dead
ferns shaf! he conducted
r\r.j..
:r:
accordance with any applicable State
or local laws regarding such
activities.
i 46.211
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 Advisor/ Board considers
appropriate
in
the particular instance.
In making such decisions, the
Secretary
will consider whether the
risks to the subject arc 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
F KDt'KAI. R EGlSJt R.
Subpart C—Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisoners as Subjects
Saurce: 43 FR 53655, Nov
16. 197«
$ 46.301 Applicability.
(a) The regulations
in
this subpart
are applicable to
all biomedical and
behavioral 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
a.s subjects,
to the
extent such research
is limited or
barred by applicable State or local
law
u
)
i'ne requirements or
this
subpart are
in addition to those
imposed under the oihet
.subparts of
this part.
5 46.302
Purpose,
Inasmuch as prisoners may he
under constraints because
ol
(heir
incarceration which could affect their
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
:o
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” means any
'individual involuntarily confined of
detained in a penal institution.' The
term
is intended to encompass ^
individuals sentenced to such an
institution under a^criminal or civil
suture, individuals detained in other
facilities by virtue of statutes or /
jcommitmeiU, procedures, which
]pfov ide aftematives to crlm i nab
prosecution or incarceration in a
• P^nal institution, .^nd individuals
detained pepding arraignment, trial,
or sentencing. F
’
(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 pan,
3n JnwituMona! Review Board,
carrying out responsibilities under
this part with respect to research
covered by this subpart, shall also
meet the following specific
requirements:
(a) A majority of the Board
«£.
primer members) shajf
have no association with the prison*!)*
involved, apart from their/^ ^
^ jl
membership on the Board?
iif
(b) At least one member of the
5'
Board,shall be a prisoner, or^a*
*
prisoner representative^jyith
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.
8 46,305
Additional duties of the
Institutional Review Boards
where prisoners are involved.
(a) in addition
to all 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 to 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 bis or her ability
to.
weigh therisk? of the research agains t
.
.
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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a
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! prisoners ^nd immune
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authorities or prisoners. Units, the
principal investigator provides to the
B.^rd justification in writing for
fo Mowing some other procedures,
control subjects. must be selected
randomly from 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;
(6) Adequate assurance exists that
parpje bQWdf^Jl *9} jpfca^fo^
account • priioncr'n participation m
the research in making decisions
regarding parole, and each prisoner is
Clearly informed in advance that
participation in the research will have
no effect on his or her parole; and
(7) Where the Board finds there
may be a need for follow-up
examination or care of participants
after the end of their participation,
adequate provision has been made for
such examination or care, taking into
account the varying lengths of
individual prisoners' sentences, and
for informing participants of this fact.
(b) The Board shall carry out such
other duties as may be assigned by
the Secretary.
(c) The institution shall certify to
the Secretary,
in such form and
mariner as the Secretary may require,
that the duties of the Board under this
section have been fulfilled.
5 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^conduct of the research has
certified
to the Secretary that the
Institutional Review Board has
approved the research under
§ 46.305
of [his subpart; and
(2) In ;hc judgment of the
Secrcuiry the proposed research
irwwf s
rhr
ftdiowirst:
(A) Study of the possible causes,
r
: feas, 2nd processe
- of
incarceration, and of criminal
behavior, provided that the study
presents no more than minimal risk
and no more than inconvenience
to
suhp e;s;
(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;
iO 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 Register,
of his intent to approve such research;
or
(D) Research on practices, both
innovative and accepted, which have
the intent and reasonable probability
of improving the health or well-
being of the subject.
In cases
in
which those studies require the
assignment of prisoners
in a manner
consistent w ith 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
R EGisf e r, 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.
Stabpid IX—Additional Protection*
fur CLUdrcs* I&vckifed
Subject* tfc
Research.
Source: 48 FR 9SI&, M«rch
1983
8 46.401
To whal do these
regulations apply?
(a) Thus subpart applies to all
research involving children as
subjects, conducted or supported by
the Department of Health and
Human Services.
u* Thin 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, under paragraph (e)
of §46.101 of Subpart A, waive the
applicability of some or all of the
requirements of 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
being 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
(«) of
§46.101 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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