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4S CFR 46
(a) !‘Oisldfen
,,'»re persons who
•
have not attained the legal age for
consent to treatments or procedures
involved in the research, under the
applicable law of the jurisdiction in
which the research will be
conducted.
(b) “Assent'' means a child’s
affirmative agreement to participate
in research. Mere failure to object
should not, absent affirmative
agreement, be construed as assent,
(c) "Permission” means the
agreement of parent(s) or guardian to
the participation of their child or
ward in research,
(d) "Parent” means a child’s
biological or adoptive parent.
(e) “Guardian” means an
individual who is authorized under
applicable state or local law to
consent on behalf of a child to
general medical care.
846,403
IllU duties.
Its addition to other responsibilities
assigned to IRBs under this part,
each 1RB shall review research
covered by this subpart and approve
only research which satisfies the
conditions of ail applicable sections
of this subpart.
§ 46.404
Research, fflotiavoirieg
greater than minimal risk,
HUS will conduct or fund
research in which the IRB finds that
no greater than minimal risk to
children
is presented, only if the IRB
finds that adequate provisions are
made lor soliciting the assent of the
children and the permission of their
parents or guardians, as set forth in
§46.406.
8 46.405
Research involving greater
tta» Bjfetasi risk bat presenting the
prospect af direct benefit to the
Individual subjects,
HHS will conduct or fund
research in which the IRB finds that
more than minimal risk to children
is
presented by an intervention or
procedure that holds out the
prospect of direct benefit for the
individual subject, or by a
monitoring procedure that is likely to
contribute to the subject’s well-being
only if the IRB finds that:
(a) The risk is justified by the
anticipated benefit to the subjects;
(b) The relation of the anticipated
benefit to the risk
is at least as
favorable to the subjects as that
presented by available alternative
approaches; and
(c) Adequate provisions are made
for soliciting the assent of the
children and permission of their
parents or guardians, as set forth in
§46.408.
8 46.406
Research involving greater
than minimal risk and bo prospect of
direct benefit to individual subjects,
but likely to yield generalizable
knowledge about the subject’s disorder
or condition.
HHS will conduct or fund
research in which the IRB finds that
more than minimal risk to children
is
presented by an intervention or
procedure that does not hold out the
prospect of direct benefit for the
individual subject, or by a
monitoring procedure which
is not
likely to contribute to the well-being
of the subject, only if the IR B finds
that:
(a) The risk represents a minor
increase over minimal risk;
(b) The intervention or procedure
presents experiences to subjects that
are reasonably commensurate with
those inherent in their actual or
expected medical, dental,
psychological, social, or educational
situations;
(c)
I he intervention or procedure
is likely to yield generalizable
knowledge about the subjects'
disorder or condition which
is of
vital importance for the
understanding or amelioration of the
subjects’ disorder or condition; and
(d) Adequate provisions are made
for soliciting assent of the children
and permission of their parents or
guardians, as set forth in § 46.408.
§ 46,407
Research aot otherwise
‘
appitsmble which presents an
opportunity to understand, prevent,' or
•
alleviate a serious problem affecting
the health or welfare of children.
HHS will conduct or fund
research that the IRB does aot
believe meets the requirements of
§§ 46.404, 46.405, or 46.406 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 children; and
(b) The Secretary, after
consultation with a panel of experts
in pertinent disciplines (for example:
science, medicine, education, ethics,
law) and following opportunity for
public review and comment, has
determined either: (1) That the
research in fact satisfies the
conditions of §§ 46.404, 46.405, or
46.406, as applicable, or (2) the
following:
0) The research presents a
reasonable opportunity to further the
understanding, prevention, or
alleviation of a serious problem
affecting the health or welfare of
children;
(ii) The research will be conducted
in accordance with sound ethical
principles;
(iii) Adequate provisions arc made
for soliciting the assent of children
and the permission of their parents or
guardians, as set forth in § 46.408.
§ 46.408
Requirements for
psnuisxioa by parents or guardians
aad for asset** by children.
(a) In addition to the
determinations required under other
applicable sections of this aubpart,
the IRB shall determine that
adequate provisions are made for
soliciting the assent of the children,
when in the judgment of the IRB the
children are capable of providing
assent. In determining whether
children are capable of assenting, the
IRB shall take into account the ages,;
maturity, and psychological state of
the children involved. This judgment
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may be made for all children to be
involved in research under a
j&particular protocol, or for each child,
was the IRB deems appropriate. If the
IRB determines that the capability of
some or all of the children is so
limited that they cannot reasonably
be consulted or that the intervention
or procedure involved in the
research holds out a prospect of
direct benefit that
is important to the
health or well-being of the children
and is available only in the context of
the research, the assent of the
children
is not a necessary condition
for proceeding with the research.
Evas where the IRB determines that
the subjects are capable of assenting,
the LK.D may still waive the assent
requirement under drcmaistances in
which consent may be waived in
accord with § 46. 116 of Subpart A.
(b) In addition to the
determinations required under other
applicable sections of this subpart,
the IRB shall determine, in
accordance with and to the extent
that consent is required by 5 46. 116 of
Subpart A, that adequate provisions
are made for soliciting the permission
of each child’s parents or guardian.
Where parental jiermission
is io be
obtained, the IRB may find that the
permission of one parent is sufficient
ior research to be conducted under
5 § 46.404 or 46.405. Where research
is covered by §j 46.406 and 46.407
and permission is to be obtained from
parents, both parents must give their
permission unless one parent is
deceased, unknown, incompetent, or
not reasonably available, or when
only one parent has legal
responsibility for the care and
custody of the child.
(c) In addition to the provisions for
waiver contained in § 46.1 16 of
Subpart A, if the IRB determines that
a research protocol
is designed far
conditions or for a subject population
for which parental or guardian
permission
is not a reasonable
requirement to protect the subjects
(for example, neglected or abused
children),
it may waive the consent
requirements in Subpan A of this
part and paragraph (b) of this section,
provided an appropriate mechanism
for protecting the children who will
participate as subjects in the research
is substituted, and provided further
that the waiver
is not inconsistent
with federal state or local law. The
choice of an appropriate mechanism
would depend upon the nature and
purpose of the activities described in
the protocol, the risk and anticipated
benefit to the research subjects, and
their age, maturity, status, and
condition.
(d) Permission by parents or
guardians shall be documented
in
accordance with and to the extent
required by § 46.117 of Subpart A.
(e) When the IRB determines that
assent
is required,
it shall also
determine whether and how assent
must be documented.
$46,409
Wank.
(a) Children who are wards of the
state or any other agency, institution,
or entity can be included in research
approved under $ $ 46.406 or 46.407
only if such research is:
(!) Related to their status as wards;
or
(2) Conducted in schools, camps,
hospitals, institutions, or similar
settings in which the majority of
children involved as subjects are not
wards.
(h) If the research is approved
under paragraph (a) of this section,
the IRB shall require appointment of
an advocate for each child who is a
ward, in addition to any other
individual acting on behalf of the
child as guardian or in loco parentis.
One individual may serve as
advocate for more than one child.
The advocate shall be an individual
who has the background and
experience to act in, and agrees to act
in, the best interests of the child for
the duration of the child’s
participation in the research and who
is not assoc iatevi in any way (except
»n the role as advocate or member of
the IRB) with the research, the
investigator(s), or the guardian
organization.
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45 cm 46
NOTICES
HUMAN SUBJECTS
Minimum Criteria Identifying the
Viable Fetus
On March
13,
1975, regulations
were published in the F ederai.
R ecistk«(40 FR
1 1854) relating to the
protection of human subjects in
research, development, and related
activities supported by Department of
Health. Education, and Welfare
grants and contracts. These
regulations are codified at 45 CFR
Part 46.
Elsewhere in this issue of the
F ederai. Register, the Secretary
is amending 45 CFR Part 46 by,
among other things, adding a new
Subpart B to provide additional
protections pertaining to research,
development, and related activities
involving fetuses, pregnant women,
and in vitro fertilization.
Section 46.203(d) of Subpart B
provides inter alia as follows:
The Secretary may from time to time,
taking into account medical advances,
publish in the Fcdeial R ecus rent
guidelines to assist in determining whether a ^
'
(etui
is viable for purposes of this tubpart.
This notice is published in
accordance with
1} 46.203(d). For
purposes of Subpart B, the guidelines
indicating that a fetus other than a
dead fetus within the meaning of
$ 46.203(f)
is viable include the
following:
an estimated gestational age of 20 weeks or
more and a body weight of 500 grams or
more.
FEDERAL REGISTER, VOL 40,
AUGUST «, 1975
U.5.
GOVERNMENT PRINTING OFFICE
;
1983
- 906-756
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A
00'l)f-T"'
n:
*
PROCEDURE
13.
EXPERIMENTATION
ON HUMAN SUBJECTS
FOR
INTELLIGENCE PURPOSES
A.
APPLICABILITY
This procedure applies
to experimentation
on human
sub-
jects
if such experimentation
is
conducted by or
on behalf of
a DoD intelligence component.
This
procedure does
not apply
to experimentation
on animal
subjects.
B .
EX P LANATIO N O F .UNDEFINED TERMS
^
*
Jii
LL?™
in
this
context means any research or
testing activity
involving
tmrnan
subjects
that may expose
such
subjects
to
the
possibility of permanent
or
temporary
injury
(including physical
or psychological damage
and damage
to
the
reputation of such persons)
beyond
the
risks
of
injury
to
which such subjects
are ordinarily exposed
in
their daily
1 ives
2.
Experimentation
is
conducted
on behalf of
a
DoD
intelligence
component
if
it
is
conducted
under contract
to
that component
or
to another DoD component
for
the benefit of
the
intelligence component
or
at
the
request
of such
a com-
ponent
regardless of
the existence of
a contractual
rela-
tionship.
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3-
Human
subjects
in
this
context
includes any person
whether or not
such person
is
a United
States
person.
C.
PROC EDU RES
Ex per linen tat ion on human subjects conducted by or on
behalf of a DoD intelligence component may be undertaken only
with
the
informed
consent of
the
subject,
and
in accordance
with guidelines
issued by
the Department of Health and Human
Services,
setting out conditions
that
safeguard
the welfare of
such
subjects.
2.
DoD intelligence components may not engage
in or
contract
for
experimentation on human
subjects without appro-
val
of
the Secretary or
Deputy Secretary of Defense,
or
the
Secretar y or Under Secretary of
a Military Department,
as
appropriate.
[Requests
for such approval
submitted by Army
intelligence components will be addressed
through command
channels
to
HQDA
(DAMI-CIC)
,
WASH
DC
20310.]
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