^5*ii«»r&i ;2
*:^
^aj
T^^wsi^wv f &s«aw*r<fiw.'sws ^n-ir
^ •>
v vi:piWM4s»
:;$:ji4c»3:«^
..
r,i.4.i*iii.-ii.1flii.i«».H.
fc:F#iffiroved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40003-9
V
' —
-T
T--H .I
-
----
-
,„
a!! prisoners and immune from
. arbitrary .intervention by prison
$
authorities or prisoners. Unless the
principal investigator provides to the
Board justification in writing for
following 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;
(t0 Adequate assurance exists that
account a prisoner '» participation in
the research in making decisions
regarding parole, and each prisoner is
clearly informed in advance that
partfdpation in the research will have
no effect on his or her parole, and
(7) Where the Board finds there
may be a need for (oliovv-up
examination or care of participants
after the end of their participation,
adequate provision has been made for
I
such examination or care, taking imo
account the varying lengths of
individual prisoners* sentences, and
for ui forming participants of this fact.
(h) 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
manner as she Secretary may require,
that (he duties of the Board under this
section have been
fulfilled.
§ 46,306
Permitted research
involving prisoners/
'
r
(*t) Biomedical or behavioral
research conducted or supported by
DHliW may involve prisoners as
subjects only
if:
(1) The institution responsible for
tiie-conduci of the research has
certified to the Secretary
that the
Institutional Review Board has
approved the research under
§ 46.305
of this subpart; and
(2) in the judgment of the
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
and 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;
(C) 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 m penology
medicine and ethics, and published
notice,
in the Federal Regis a- r,
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 with protocols approved by
the IRB
to control groups which may
not benefit from the research,
she
study may proceed only alter die
Secretary has consulted with
appropriate experts, including experts
in penology medicine and ethics, and
published notice,
in the Federal
R eg
!
isi HR, 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 DHENV
shall not involve prisoners as
subjects.
PaRC IS
Subpart D— Addlttooal PtotecthM*
for CUMraa ItvoMI m Subjecta fai
Source: 48 FR 91 U, March 8, 1983
§ 46.401
To whfiit do torn
regulations supply?
(a) This subptnt applies to all
research involving children as
subjects, conducted or supported by
the Department of Health and
Human Services,
(1) This includes research
conducted by Department
employees, except that each head of
an Operating Division of the
Department may adopt such
nonsubstantive, procedural
mod ifications m 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 subpan.
Exemption (4), research involving
the observation of public behavior,
listed at §46. 10 1(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.
! 0 1 (b) docs 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
§46,101 of Subpart A are applicable
to this subpart.
§ 46.402
Definitiona.
The definitions in §46.102 of
Subpart A shall be applicable to this
subpart as well, In addition, as used
in this subpart:
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40003-9
u
iwuihj& t *j^ujph-i
&h
"jtolsjrfjisi,
a»,Ma
,
*
Paftpfrroved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40003-9
.
45 CFR. 46
(a) “Children” arc 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
In;
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 parentfs) 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
IKI1 duties.
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 ot
ail applicable sections
of this subpart.
846.404
Research, sot. iavojtiag
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 for soliciting the assent of the
children and the permission of their
parents or guardians, as set forth in
§46.406.
monitoring procedure that is likely to
contribute to the subject’s well-being
only if die 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.
846.406
Research involving greater
than minimal risk and no prospect of
direct benefit to individual subjects,
but likely to yield gencralisable
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 un 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 IRB 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;
§ 46,407
Research not otherwise
‘
appro'pabk which presents an
opportunity to understand, prevent,
1 or
alleviate a serious problem affecting
the health or welfare of children.
HHS will conduct or fund
research tliat the IRB does not
•
’
believe meets the requirements of •
§ 3 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:
(i) The research presents a
reasonable opportunity to further the
understanding, prevention, or
alleviation of a serious problem
affecting the health or welfare of
children;
(ti) The research will be conducted
in accordance with sound ethical
principles;
(m) Adequate provisions are made
for soliciting the assent of children
anti the permission of their parents or
guardians, as set forth in
§ 46. -100.
§ 46.408
Requirement! for
permission by parents or guardians
md for msMtt by children.
(a) In addition to the
9 46.405
Research involving greater
tliiui minima! risk but presenting the
prospect of 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
(c) The intervention or procedure
is likely to y ield geneializable
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.
determinations required under other
applicable sections of this subpart,
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
1KB shall take into account the ages,;
maturity, arut psychological state of
the children involved. This judgment
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40003-9
.
. .CJMSW-f „ s&mi
' X
If
( Wr*-J.»-w
,;ij»
: i.vtvtwwarm*i «
45 cVi^foroved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40003-9
P*®8 17
may be made for all children to be
.involved ^in research under a
#
particular protocol, or for each child,
as the IEB deems appropriate. If the
\
IRE) 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.
Even where the IRE determines that
the subjects are capable of assenting,
the IRE may still waive the assent
requirement under circumstances 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 JRB shall determine, in
accordance with and to the extent
that consent is required by § 46.1 16 of
Ijj-j, Subpart A, that adequate provisions
are made for soliciting the permission
ot each child’s parents or guardian.
Where parental permission
is to be
obtained, the IRE may find that the
permission of one parent
is sufficient
for research to be conducted under
§§ 46.404 or 46.405. Where research
is covered by
§ § 46.406 and 46.-107
and permission is to be obtained from
parents, both parents must give their
permission unless one parens
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. 11 6 of
Subpart A, if the IRD determines that
a research protocol
is designed for
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, uie risk and anticipated
benefit to the research subjects, and
their age, maturity, status, and
condition.
(d) Permission by parents or
guardians shall
lx- documented in
accordance with and to the extent
required by
§ 46. 117 of Subpart A.
(e) When the IRE determines that
assent
is required,
it shall also
determine whether and how assent
must be documented.
§46.409
Wards.
(a) Children who arc wards of the
state or any other agency, institution,
or entity can be included in research
approved under § 8 46.406 or 46.407
only if such research
is:
(1) 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 arc not
wards.
(b) If the research is approved
under paragraph (a) of this section,
the JRB 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
(he duration of the child’s
participation in the research and who
is not associated in any way (except
in the role as advocate or member of
the 1RB) with the research, the
investigator(s), or the guardian
organization.
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40003-9
TOve€^Poi^RQtease-2QQmQ8/08
: C1A-RDP96-00788R001 5001 40003-9
45 CFR 46
HUMAN SUBJECTS
Minimum Criteria Identifying the
Viable Fetus
On March
13,
1973, regulations
were published in the Federai
R EGISTKM40 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.
NOTICES
Elsewhere in this issue of the
Federal Register, the Secretary
is amending 45 CFR
Part 46 by.
among other things, adding a new
Subpart
II 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 mne to time,
taking into account medical advances,
publish in the Federal r tcisna
guidelines to assist in determining whether a
’
'
teius
is viable for purposes of this subpart.
This notice is published in
accordance with
$ 46.203<d). For
purposes of Subpan B. the guidelines
indicating that a fetus other than a
dead fetus, within the meaning of
8 46.203(f)
is viable include the
following:
•n cs!iima««d gesuimjuf
of 20 weeioi or
more and a body weight of 300 grams or
more
FEDERAL REGISTER, VOL 40,
AUGUST 8, 1875
U.S.
GOVERNMENT PRINTING OFFICE
:
1903
- 406-756
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40003-9