CIA-RDP96-00788R001500160010-9

1-
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
. . .
CODE OF FEDERAL REGULATIONS
TITLE 45
PUBLIC WELFARE
1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS
PART 46-PROTECTION OF HUMAN SUBJECTS
REVISED AS OF MARCH 8, 1983
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
5

Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
45 CFR 46
PART 46-PROTECTION OF
HUMAN
SUBJECTS
Subpart A-Basic HHS Policy for
Protection of Human Research
Subjects
15 101
To what do these regulat ons apply .
15 102
Definitions.
46 103
Assurances.
46 :04
Section reserved
46 105
Section reserved.
46 106
Section reserved
46 107
IRB membership.
46.108
IRB functions and operations
40 109
IRA review of research.
15 110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
4h 111 Criteria for IRB approval of
research.
Ar: 112 Review by institution
45. 113 Suspension of termins ton of IRS
approval of research.
to 114 Cooperative research.
4n . 15 IRB records.
46 116 General requirements lo: istored
convent.
4. 117 Documentation of informed
consent
4. 118 Applications and proposals lacking
detunte plans for involvement of bomian
subjects.
In 119 Research undertaken without the
intention of involving human subir. ts.
46 120 Evaluation and disposition of
applications and proposals.
In 121 Investigational new dring ar device
30-day delay requirement.
46 122 Use of federal funds
40. 123 Early termination of research
funding: evaluation of subsequent
applications and proposals.
st: 124 Conditions.
Subpart B-Additional Protections
Pertaining to Research,
Development, and Related
Activities Involving Fetuses,
Pregnant Women, and Human
In Vitro Fertilization
Sec.
46 201
Applicability.
46 201
Purpose
46 203
Definitions.
46.204
Ethical Advisory Boards.
46 205
Additional duties of the Institutional
Review Boards in connection with
detta It's involving features, pregnant.
won 'n. of human in vitro fertilization.
45.200 Cervera limitations
46.207
Convites directed inward pregnant
women as subjects
46 208
Activities directed toward fetuses in
Utero as Subiecis
46 209
Activities directed toward fetuses ex
utero, including nonviable fetuses, av
subjeis.
46 210 Activities involving the dead fetus,
fetal material, or the placenta.
46 211 Modification or waiver of specific
Subpart ('-Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisoners as Subjects
Sec
46.301 Appheability
46.302 Purpose.
46.303 Definitions.
46 304 Composition of Institutional Review
Hoards where prisoners are involved.
$6. 105 Additional dates of the Invitational
Review Boards where prisoners att
involved
46.306 Permined acuvitres involving
Subpart D --- Additional Protections
for Children Involved as Subjects in
Research
Scc.
46.401 T .. what do these regulations apply?
46.402 IN Anitions.
46.403 IRB duties.
46.404 Research not involving greater than
minimal risk.
16 405 Research involving greater than
minanal risk but presenting the prospect
of direct benefit to the individual subjects.
46 406 Research involving greater than
minimal risk and no prospect of direct
beneft ty individual subjects, but hkely to
yield generalizable knowledge about the
subjet's tisorcer or condition.
46.407 Research not otherwise approvahle
which preseuns an opportunity to
understand, prevent, or alleviate a serious
problemi affecting the health or welfare of
children.
46.408 Requirements for permission by
pare ity cr guardians and for assent by
children.
-46 409 War ...
Authority: \ U.S C 101. sec 174(a). 8M
Stat. 152 :42 0'S C. 2897-Mall.
Suhpart A -- Basic HHS Policy for
Protection of Human Research
Subjects
Source: 46 FR 1186, January 26, 1981. 49 FR
9269, March 4, 1983.
§ 46.101 To what do these
regulations apply?
(a) Except as provided in
paragraph (b) of this section, this
subpart applies to all research
involving human subjects conducted
by the Department of Health and
Human Services or funded in whole
or in part by a Department grant,
contract, cooperative agreement or
fellowship.
( 1) This includes research
conducted by Department employees,
except cach Principal Operating
Component head may adopt such
nonsubstantive, procedural
modifications as may be'appropriate
from an administrative standpoint.
(2) It also includes research
conducted or funded by the
Department of Health and Human
Services outside the United States.
but in appropriate circumstances, the
Secretary may, under paragraph (c) of
this section waive the applicability of
some or all of the requirements of
these regulations for research of this
type.
(b) Research activities in which the
only involvement of human subjects
will be in one or more of the
following categories are exempt from
these regulations unless the research
is covered by other subparts of this
part:
(1) Research conducted in
established or commonly accepted
educational settings, involving
nouinal educational practices, such as
(i) research on regular and special
education instructional strategies, or
(ii) research on the effectiveness of or
the comparison among instructional
techniques, curricula, or classroom
management methods.
(2) Research involving the use of
educational tests (cognitive,
diagnostic, aptitude, achievement). if
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Page 5
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
information taken from these sources
is recorded in such a manner that
subjects cannot be identified, directty
or through identifiers linked to the
subjects.
(3) Research involving survey or
interview procedures, except where
art of the following conditions exist:
u) responses are recorded in such a
manner that the human subjects can
be identified, directly or through
identifiers linked to the subjects, (ii)
the subject's responses, if they
became known outside the research,
could reasonably place the subject at
risk of criminal or civil liability or be - obtaining benefits or services under
damaging to the subject's financial
standing or employability, and (ii)
the research deals with sensitive
aspects of the subject's own behavior.
such as illegal conduct, drug use.
sexual behavior, or use of alcohol.
All research involving survey or
ter The Secretary has final
interview procedures is exempt,
wrhout exception, when the
respondents are elected or appointed
pubbe officials or candidates for
public office.
+4: Research involving the
wservation (including observ ation by
participants) of public behavior.
chcept where all of the followme
conditions exist: (i) observations are
recorded in such a manner that the
human subjects can be identified.
directly or through identifiers linked
to the subjects, (ii) the observations
recorded about the individual, if they
became known outside the research.
could reasonably place the subject at
risk of criminal of civil liability or be
damaging to the subject's financ.at
standing or employability, and (iii)
the crearch deals with sensitive
aspects of the subject's own behavior
wich as illegal conduct, drug use.
sexual behavior, or use of alcohol.
(5) Research involving the
collecuon or study of existing data.
documents, records. pathological
perimens, or diagnostic specimens.
if these sources are publicly avadable
or if the information is recorded by
the investigator in such a manner that
subjects cannot be identified. directly
or through. identifiers linked to the
svojeet ..
(6) U'nless specifically required by
statute (and except to the extent
specified mt paragraph (i)), research
and demonstration projects which
are conducted by or subject to the
approval of the Department of
Health and iluman Services, and
which are designed to study.
evaluate, or Other wise examine: (i)
programs uncer the Social Security
Act, or other public benefit ur
Service proguyes, (t) procedures for
those programs; (iii) possible changes
in or alternatives to those programs
or procedures; or (iv) possible
changes in methods or levels of
payment for benefits or services
under those programs.
authority to determine whether a
particular activity is covered by these
regulations.
(d) The Secretary may require that
specific research activities of classes
of research activities conducted or
funded by the Department, but not
otherwise covered by these
regulations, comply with some of all
of these regulation>
(c) The Secretary may also waive
applicability of these regulations to
specific research activities or classes
of research activities, otherwise
covered by these regulations. Notices
of these actions will be published in
the Federal Register as they occur.
(D) No indi 2 dual may receive
Department funding for research
covered by these regulations unless
the individual i affiliated with or
sponsored by an institution which
assumes responsibility for the
research under an assurance satisfying
the requirements of this part, or the
individual makes other sirangements
with the Department.
(c) Comphasce with these
regulation . will in an way render
inapplicable pertinent federal, state,
or local laws of regulations.
(h) Each subpart of these
regulations contains a separate
section describing to what the subpart
applies, Research which is covered
by more than one subpart shall
comply with all applicable subparts.
(i) If, following review of
proposed research activities that are
exempt from these regulations under
paragraph (b)(6), the Secretary
determines that a research or
demonstration project presents a
danger to the physical, mental, or
emotional well-being of a participant
or subject of the research or
demonstration project, then federal
funds may not be expended for such
a project without the written,
informed consent of each participant
or subject.
$ 46.102 Definitions.
(a) "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) "Department" or "HHS"
means the Deparusent of Health and
Human Services.
(c) "Institution" means any public
or private entity of agency (including
federal, state, and other agencies).
(d) "Legally authorized
representative " mins an individual
or judicial or other body authorized
under applicable law to consent on
behalf of a prospective subject to the
subject's participation in the
procedure(s) involved in the research.
(e) ""Research " means a
systematic investigation designed to
develop or contribute to generalizable
Knowledge. Activities which meet
this definition constitute "research"
for purposes of these regulations.
whether or not they are supported or
funded under a program which is
considered research for other
purposes. For example, some
"demonstration" and "service"
programs may include research
activities.
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Page 6
45 CFR 46
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
(0) "Human subject" means a
living individual about whom an
investigator (whether professional or
student) conducting research obtains
( 1) data through intervention or
interaction with the individual, or (2)
identifiable private information.
"Intervention " includes both
physical procedures by which data are
gathered (for example. venipuncuire)
and manipulations of the subject of
the subject's environment that are
performed for research purposes.
"Interaction" includes
communication or interpersonal
contact between investigator and
subject. ""Private information"'
includes information about behavior
that occurs in a context in which an
individual can reasonably expect that
na observation or recording is taking
place, and information which has
been provided for specific purposes
by an individual and which the
individual can reasonably expect will
not be made public (for example, a
medical record). Private information
must be individually identitable
ti e. , the identity of the subject is of
may readily be ascertained by the
ivesugator or associated wan the
mformation) in order for obtaining
the information to constitute research
involving human subjects.
(g) Minimal risk'ameans that the
risks of harm anticipated in the
proposed research are not grester.
considering probability and
magnitude, than those ordinarily
encountered in daily life or during the
performance of routine physical o:
psychological examination: or tests.
(h) "Certification!' means the
. oficial notification by the castitution
io the Department in accordance with
the requirements of this part that a
research project or activity involving
human subjects has been reviewed
and approved by the Institutional
Review Board (IRB) in accordance
with the approved assurance on file at
HHS. (Certification is required when
the research is funded by the
Department and not otherwise exempt
in accordance with § 46.101(b)).
$ 40 n3 Awarances.
(a) Fach in nitation engaged in
research covered by these regulations
shall provide written assurance
satisfactory to the Secretary that it
will comply with the requirements set
forth in these regulations.
(bi The Department will conduct or
tund research covered by these
regulations only if the institution has
an assurance approved as provided in
this section, and only if the institution
has certified to the Secretary that the
research has been reviewed and
approved by an IRB provided for in
the assurance, and will be subject to
continuing review by the IRB. This
assurance shall at a minimum include:
(1) A statement of principles
govetrung the institution in the
discharge of its responsibilities for
profeching the rights and welfare of
human subjects of research conducted
at or sponsored by the institution,
regardless of source of funding. This
may toetude an appropriate existing
code, declaration, or statement of
ethical principles. or a stat ment
formulated by the instuunion itself.
This requireme at does not preempt
provisions of these regulations
applicable to Department funded
research and is not applicable to any
research in an exempt category listed
1 916-101
(2) Designation of one or more
IRBs established in accordance with
the requirements of this subpart, and
for win h provisions are made for
meeting space and sufficient staff to
support das IRB's review and
recordkeeping duties.
(1) A list of the IRB members
identified by name. earned degrees;
representative capacity; indications of
experience sue as board
certifications, fieenses, etc.,
sufficient us describe each member's
chief anticipated contributions to IRB
deliberatony, and any employment or
other relationship between each
member ani the institution; for
example: full -time employee, part-
lime employee, member of governing
panel or board, stockholder, paid or
unpaid consultant. Changes in IRB
membership shall be reported to the
Secretary. '
(4) Written procedures which the
IRB will follow (i) for conducting its
initial and continuing review of
research and for reporting its findings
and actions to the investigator and the
institution: (ii) for determining which
projects require review more often
than annually and which projects
need verification trom sources other
than the investigators that no material
changes have occurred since previous
IRB review; (iii) for insuring prompt
reporung to the IRB of proposed
changes in a research activity, and for
insuring that changes in approved
research, during the period for which
IRB approval has already been given,
may not be initiated without IRB
review and approval except where
necessary to eliminate apparent
immediate hazards to the subject: and
(iv) for insuring prompt reporting to
the IRB and to the Secretary ' of
unanticipated problems involving
risk to subjects or others.
(c) The assurance shall be executed
by an individual authorized to act for
the institution and to assume on
behalf of the institution the
obliganons imposed by these
regulations, and shall be filed in such
ferm and manner as the Secretary
may prescribe.
(d) The Secretary will evaluate all
assurances submitted in accordance
with these regulations through such
officers and employees of the
Department and such experts or
consultants engaged for this purpose
as the Secretary determines to be
appropriate. The Secretary's
evaluation will take into
consideration the adequacy of the
proposed IRB in fight of the
anticipated scope of the institution's
research activities and the types of
subject populations likely to be
I Reports should be filed with the Office
for Protection from Research Risks, National
Insblutes of Health. Department of Health
and Human Services, Bethesda, Maryland
20205
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
45 CFR 46
Page 7
---
involved, the appropriateness of the
. proposed initial and continuing
review procedures in light of the
probable risks, and the size and
complexity of the institution.
(e) On the basis of this evaluation.
the Secretary may approve or
ltsapprove the assurance, or enter
ela negotiations to develop an
approvable one. The Secretary may
amit the period during which any
particular approved assurance of class
of approved assurances shall remain
effective or otherwise condition or
restrict approval.
(0) Within 60 days after the date of
submission to HHS of an application
ur proposal, an institution with an
approved assurance covering the
proposed research shall certity that
tie application or proposal has been
reviewed and approved by the IRB.
Other institutions shall century that the
application or proposal nas beca
approved by the IRB within: 30 day>
at'er receipt of a request for such a
.ertification from the Deparumsent. if
the certification is not subriated
within these time limits, the
application or proposal may be
returned to the institution.
$ 44.104 ( Reserved)
$ 46.105 [Reserved]
$ 48.106 [Reserved)
: 46.107 IRB membership.
val Each IRB shall have at least
five members, with varying
backgrounds to promote complete and
-de pate review of research activities
commonly conducted by the
vitution. The IRB shall be
suficiently qualified through the
experience and expertise of its
members, and the diversity of the
ne mbers' backgrounds including
consideration of the racial and
cultural backgrounds of members and
sensitivity to such issues as
we' aimunity attitudes, to promote
respect for its advice and counsel in
safegaarding the rights and welfare of
human subjects. In addition to
possessing the professional
con:{ cience necessary to review
spec fic research activities. the IRB
shall be able to ascertain the
acceptabilty of proposed research in
terms of nonational commitments
and regulations, applicable law, and
standards of professional conduct and
practice. The IRB shall therefore
include persons knowledgeable in
these areas. If an IRB regularly
revic »: research that involves a
vulnerable category of subjects.
including but not limited to subjects
covered by other subparts of this part.
the IRR saall include one or more
individuals who are primarily
concerned with the welfare of these
subjecti.
(b) No IEB aray consist entirely of
men or entirely of women, or entitely
of members of one profession.
(c) Each IRB shall include at least
one menares whose primary concerns
are in nohacientific areas, for
examwie lawyers, cihicists, members
of the clergy.
(d) Eich IRU shall incluce at least
one member who is not otherwise
affiliated with the institution and who
is not put of the immediate family of
a person who is affiliated with the
institunon.
(c) No (HB may have a member
participating in the IRB's initial or
continuing review of any project in
which the member has a conflicting
interest, except to provide
information requested by the IRB.
it's An IKB muy, in its discretion,
invite maniques with competence in
special ates to assist in the review of
complex asses which require
expertise bes we've in addition to that
available on the ARR. These
individualy say that vite with the
IRB.
, 46.105 TRB functions and
operations.
In onta to fulfill the requirements
of these spalchons cach IRB shall;
(0) Felh w written procedures as
provided m $ 40 (03(0)(4)
(b) Except when an expedited
review procedure is used (see
§ 46.110), review proposed research
at convened meetings at which a
majority of the members of the IRB
are present, including at least one
member whose primary concerns are
in nonscientific areas. In order for the
research to be approved, it shall
receive the approval of a majority of
those members present at the
ntecting.
(e) Be responsible for reporting to
the appropriate institutional officials
and the Secretary ' any serious or
continuing noncompliance by
investigators with the requirements
and determinations of the IRB.
§ 46.139 IRB review of research.
(a) An IRB shall review and have
authority to approve, require
modifications in (to secure approval),
or disapprove all research activities
covered by these regulations.
(h) An IRB shall require that
information given to subjects as part
of informed consent is in accordance
with $ 46.116. The IRH may require
that information, in addition to that
specifically mentioned in § 46.116,
be given to the subjects when in the
IRB's judgment the information
would meaningfully add to the
protection of the rights and welfare of
subjects.
(+) An IRB shall require
documentation of informed consent of
may waive documentation in
accordance with § 46.117.
(d) An IRB shall notify
investigators and the institution in .
writing of its decision to approve or
disapprove du proposed research
activity, or of modifications required
to secure IRB approval of the
rewatch activity. if the IRB decides
to disapprove a research activity, it
shall include in-its written notification
i Reports should be filed with the Office
for Protection from Research Risks. National
Institutes of Health, Department of Health
Ahi Human Services, Bethesda, Maryland
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Page 8
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
45 CFR 46
a statement of the reasons for its .
decision and give the investigator an
opportunity to respond in person or in
writing.
(e) An IRB shall conduct
contoving review of research covered
by these regulations at intervals
appropriate to the degree of risk, but
nox less than once per year, and shall
have authority to observe or have a
third party observe the consent
process and the research.
$46.110 Expedited review
procedures for certain kinds of
research Involving no more than
minimal risk, and for minor
cApproved For Release 2001/03/07: CIA-RDP96-00788R001500160010-9 persons who are
research design and which do not
unnecessarily expose subiecte to rick
(a) The Secretary has established,
proposals which have been approved
under the procedure.
(d) The Secretary may restrict,
suspend. or terminate an institution's
or IRB's use of the expedited review
procedure when necessary to protect
the rights of welfare of subjects.
$46.11! Criteria for IRB
approval of research.
(a) In order to approve research
covered by these regulations the IRB
shall determine that all of the
following requirements are satisfied:
( 1) Risks to subjects are
minimized: (i) By using procedur
(5) informed consent will be
appropriately documented, in
accordance with , and to the extent
required by § 46.117.
(6) Where appropriate, the research
plan makes adequate provision for
monitoring the data collected to
insure the safety of subjects.
(7) Where appropriate, there are
adequate provisions to protect the
privacy of subjects and to maintain
the confidentiality of data.
(b) Where some or all of the
subjects are likely to be vulnerable to
coercion or undue influence, such as
persons with acute or severe physical
economically or educationally
disadvantaged, appropriate additional.

Page 9
45 CFR 46
§ 46.114 Cooperative research.
.
Cooperative research projects are
those projects, normally supported
through grants, contracts, or similar
arrangements, which involve
institutions in addition to the grantee
or prime contractor (such as a
contractor with the grantee, or a
subcontractor with the prime
contractor). In such instances, the
grantee or prime contractor remains
responsible to the Department for
safeguarding the rights and welfare ot
human subjects. Also, when
cooperating institutions conduct some
or all of the research involving same
or all of these subjects, each
cooperating institution shall comply
with these regulations as though it
received funds for its participation in
the project directly from the
Department, except that in complying
with these regulations institutions
may use joint review, reliar ce upon
the review of another qualified IRB.
or similar arrangements aimed at
monidance of duplication of effort.
& 46.115 IRB records. "
ta) An institution, or where
appropriate an IRB, shall prepare and
maintain adequate documentation of
IRB activities, including the
following:
( 1) Copies of all research proposals
reviewed, scientific evaluations, if
any, that accompany the proposals.
approved sample consent documents,
progress reports submitted by
investigators, and reports of injuries
lu subjects.
( 2) Minutes of IRD meetings which
shall be in sufficient detail to show
attendance at the meetings; actions
taken by the IRB; the vote on these
actions including the number of
members voting for, against, and
abstaining; the basis for requiring
changes in or disapproving research;
and a written summary of the
discussion of controverted issues and
their resolution.
(3) Records of continuing review
activities.
Approved For Release 2001/03/07: CIA-RDP96-00788R001500160010-9
(4) Copies of all correspondence
between the IRB and the
investigators
(5) A list of IRB members as
required by & to Htalebi(!)
(6) Worden procedures for the IRB
as required by § 46. 103(b)(4).
(7) Statements of significant new
findings provided to subjects. Js
required by § 46 116(b)(5).
(b) The records required by this
regulation shall be retained for at
least 3 years after completion of the
research, and the records shall be
accessible tar mspection ano copying
by authorized representatives of the
Department at reasonable times and
in a reasonable manner.
9 46.116 General requirements
for informed consent.
Except as provided elsewhere in
this or other subparts, no investigator
may involve a human being as a
subject in research covered by these
regulations unless the investigator has
obtained the legally effective
informed consent of the subject or the
subject's legally authorized
representative. An investigator shall
seek such consent only under
circumstances that provide the
prospective subject of the
representative sufficient opportunity
to consider whether or not to
participate and that minimize the
possibility of coercion or undue
influence The information that is
given to the subject or the
represent ative shall be in language
understandable to the subject or the
representative. No informed consent.
whether eral or written, may include
any exculpatory language through
which the subject or the
representative is made to waive or
appear to waive any of the subject's
legal rights, or releases or appears to
release the Investigator, the sponsor.
the insulation of its agents from
liability for neghgence.
tal Bashc clements of informed
consent. Except as provided in
paragraph to) or tel) of this section, in
seeking informed consent the
following information shall be
provided to cach subject:
(1) A statement that the study
involves research, an explanation of
the purposes of the research and the
' expected duration of the subject's
. participation, a description of the
{ procedures to be followed, and
4 identification of any procedures
which are experimental;
(2) A description of any reasonably
foreseeable risks or discomforts to the
subject:
(3) A description of any benefits to
the subject or to others which may
-
reasonably be expected from the
research;
(4) A disclosure of appropriate
· alternative procedures or courses of
treatment, if any, that might be
advantageous to the subject:
(5) A statement describing the
extent, if any, to which
confidentiality of records identifying
the subject will be maintained;
(6) For research involving more
than minimal risk, an explanation as
to whether any compensation and an
explanation as to whether any
medical treatments are available if
injury occurs and, if so, what they
consist of, or where further
information may be obtained:
NA
(7) An explanation of whom 10
contact for answers to peninent
questions about the research and
research subjects' rights, and whom
to contact in the event of a research-
related injury to the subject; and
(8) A statement that participation is
voluntary, refusal to participate will
involve no penalty or loss of benefits
to which the subject is otherwise
entitled, and the subject may
discontinue participation at any time
without penalty or loss of benefits to
which the subject is otherwise
entitled.
(h) Additional elements of
informed consent. When appropriate.
one or more of the following elements
of information shall also be provided
to each subject:
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Page 10
Approved For-Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
45 CFR 46
(!) A statement that the particular
treatment or procedure may involve
risks to the subject (or to the embryo
for fetus, if the subject is or may
become pregnant) which are currently
=unforeseeable:
". (2) Anticipated circumstances
i under which the subject's
+ participation may be terminated by
¿ the investigator without regard to the
[ subject's consent:
( (3) Any additional costs to the
subject that may result from
'participation in the research:
(4) The consequences of a
subject's decision to withdraw from
ythe research and procedures for
¿orderly termination of participation
by the subject:
. (5) A statement that significant
; new findings developed during the
course of the research which may
` relate to the subject's willingness to
. ontinue participation will be
provided to the subject; and
(6) The approximate number of
. subjects involved in the study.
(c) An IRB may approve a codacht
· procedure situish does not include: or
which aftera .; some or all of the
elencam of informed consent set
(anh above, or waive the requirement
to obtain informed consent provided
de IRB finds and documents that:
(1) The research or demonstration
project is to be conducted by or
subject to the approval of state or
box'al government officials and is
designed to study, evaluate, or
otherwise examine: (i) programs
under the Social Security Act, or
other public benefit or service
programs; (ii) procedures for
obtaining benefits or services under
those programs; (iii) possit.le changes
in or alternatives to those programis
or procedures; or (iv) possible
changes in methods or levels of
payment for benefits or services under
those programs; and
(2) The research could nat
practicably be carried out without the
waiver or alteration.
(d) An IRB may approve a consent
procedure which does not include, or
which alters, some or all of the
elements of informed consent set
forth above, or waive the
requirements to obtain informed
consent provided the IRB finds and
documents that:
( 1) The research involves no more
than minimal rist to the subjects;
(2) The waiver or alteration will
dot adversely affect the rights and
welfare of the subjects;
(3) The research could not
practicably be carried out without the
waiver of alteration; and
(4) Whenever appropriate, the
subjects will be provided with
additional pertinent information after
participation
(e) The informed consent
requirements in these regulations are
not intended to preempt any
applicable federal, state, or local laws
which require additional information
to be disclosed in order for informed
consent to be legally effective.
(1) Nothing in these regulations is
intended to limit the authority of a
physician to provide emergency
medied care, to the extent the
physician is permitted to do so under
apple . Fle federal, state, or local law.
$ 46.117 Documentation of :
informed consent.
(a) Except as provided in
paragraph (c) of this section,
informed consent shall be
documentied by the use of a written
consent form approved by the IRB
and signed by the subject or the
subject's legally authorized
representative. A copy shall be given
to the person signing the form.
(b) Except as provided in
paragraph (e) of this section, the
consent form may be either of the
following.
(1) A written consent document
that entredies the elements of
informed consent required by
§ 46.116. This form may be read to
the subject er the subject's legally
authorized representative, but in any
event, the investigator shall give
either the subject or the representative
adequate opportunity to read it before
it is signed; or
(2) A "short form" written
consent document stating that the
clements of informed consent
required by § 46.116 have been
presented orally to the subject or the
subject's legally authorized
representative. When this method is
used, there shall be a witness to the
oral presentation. Also, the IRB shall
approve a written summary of what is
to be said to the subject or the
representative. Only the short form
itself is to be signed by the subject or
the representative. However, the
witness shall sign both the short form
and a copy of the summary, and the
person actually obuuning consent
shall sign a copy of the summary. A
copy of the summary shall be given to
the subject or the representative, in
addition to a copy of the "short
form. "
(c) An IRB may waive the
requirement for the investigator to
obtain a signed consent form for some
or all subjects if it finds either:
(1) That the only record linking the
subject and the research would be the
consent document and the principal
risk would be potential harm resulting
from a breach of confidentiality. Each
subject will be asked whether the
subject wants documentation linking
the subject with the research, and the
subject's wishes will govern; or
(2) That the research presents no
more than minimal risk of harm to
subjects and involves no procedures
for which written consent is normally
required outside of the research
context.
in cases where the documentation
requirement is waived, the IRB may
require the investigator to provide
subjects with a written statement
regarding the research.
§ 46.118 Applications and
proposals lacking definite plans for
Involvement of human subjects.
Certain types of applications for
grunts, cooperative agreements, or
contracts are submitted to the
Department with the knowledge that
subjects may be involved within the
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
45 CFR 46
Page 11
-
period of funding, but definite plans
would not normally be set forth in the
application or proposal. These
include activities such as institutional
type grants (including bloc grants)
where selection of specific projects is
the institution's responsibility;
research training grants where the
activities involving subjects remain to
be selected: and projects in which
human subjects' involvement will
ciepend upon completion of
Instruments, prior animal studies, or
purification of compounds. These
applications need not be reviewed by
an. IRB before an award may be
made. However, except for research
described in § 46.101(b), no human
subjects may be involved in any
project supported by these awards
until the project has been reviewed
and approved by the IRB. as provided
in these regulations, and certificanon
sabrited to the Department.
§ 46.119 Research undertaken
without the intention of involving
human subjects.
In the event research (conducted or
funded by the Department) is
undertaken without the intention of
involving human subjects, but it is
later proposed to use human subjects
in the research, the research shall first
be reviewed and approved by an IRB.
as provided in these regulations, a
cernfication submitted to the
Department, and final approval given
to the proposed change by the
Department
5 40.120 Evaluation and
disposition of applications and
proposals.
til The Secretary will evaluate ali
applications and proposals invoiving
harran subjects submitted to the
Department through such officers and
employees of the Department and
sich experts and consultants as the
Secretary determines to be
sppropriate This evaluation will take
into consideration the risks to the
sulyssis, the adequacy of protection
against these risks, the potential
benefits of the proposed research to
the subjects and others, and the
importance of the knowledge to be
gainco.
(b) On the basis of this evaluation.
the Secretary may approve or
disapprove the applicanon or
proposal, or enter into negotiations to
develop an approvable one.
§ 46.121 Investigational new drug
or device 37-day delay requirement.
When an institution is required to
prepare or to submit a certification
with an application or proposal under
these regulations, and the application
or proposal involves an
investigational new drug (within the
meaning of 21 U.S.C. 3550) or
357(d)) or a significant risk device (as
defined in 21 CFR.812.3(m)), the
institution shall identify the drug or
device in the certification. The
institution shall also state whether the
30-day interval required for
investigational new drugs by 21 CFR
312. Har and tor significant risk
devices by 21 CFR 312.30 has
elapsed. a: whether the Food and
Drug Administration has waived that
requirement If the 3-day interval
has expired, the inmotion shall state
whether the Food and Drug
Administration has requested that the
sponsor continue to withhold of
restrict the use of the drug or device
In human subjects. If the 30 day
interval has not expired, and a waiver
has not been received, the institution
shall send a statement to the
Department upan expiration of the
interval The Department will not
consider a cerafication acceptable
until the institution bas submitted a
statement that the 30 day interval has
elapsed, and the Food and Drug
Administration has not requested at to
limit the use of the drug or device, or
that the Food and Drug
Administration has waived the 30-day
interval
$ 40.122 Use et Federal funds.
Federal Houds sinistered by the .
Departmeti may not be expended for
research involving human subjects
unless the recusement of these
regulations, including all subparts of
these regulations, have been satisfied.
§ 46.123 Early termination of
research funding: evaluation of
subsequent applications and
proposals.
(a) The Secretary may require that
Department funding for any project
be terminated or suspended in the
manner prescribed in applicable
program requirements, when the
Secretary finds an institution has
materially failed to comply with the
tetens of these regulations.
(b) In making decisions about
funding applications or proposals
covered by these regulations the
Secretary may take into account, in
addition to all other eligibility
requirements and program criteria,
factors such as whether the applicant
has been subject to a termination or
suspension under paragraph (a) of this
Section and whether the applicant or
the person who would direct the
scientific and technical aspects of an
activity has in the judgment of the
Secretary materially failed to
Jischarge responsibility for the
protection of the rights and welfare of
human subjects (whether or not
Department funds were involved).
$ 46.124 Conditions.
With respect to any research
project or any class of rescarch
projects the Secretary may impose
additional conditions prior to or at the
time of funding when in the
Secretary's judgment additional
conditions are necessary for the
protection of human subjects.
Subpari B --- Additional Protections
Pertaining to Research
Development, and Related
'Activities Involving Fetuses.
Pregnant Women, and Human In
Vitro Fertilization'
Socker. 10 FR 17528 Aug X. 191%, 43 FR
1758. Januar, 11, 1978, 43 FR
51559. November 3. 197%
$ 46.201 Applicability.
(a) The regulation in this subpart
are applicable to all Department of
Health. Education, and Welfare
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
Page 12
45 CFR 46
: grants and contract supporting
research, development, and related
activities involving: (1) The fetus. (2)
pregnant women, and (3) human un
vitro fertilization.
(b) Nothing in 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 bearing 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 te
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.
3 46.203 Definitions.
As used in this subpart:
(a) "Secretary"' means tae
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
tr'us means being able, after either
spontaneous or induced delivery. to
survive (given the benefit of available
medical therapy) to the point of
undependently maintaining heart
beat 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
fetus is viable for purposes of this
subpart. If a fetus is viable after
delivery, it is a premature infant.
(e) "Nonviable fetus" means a
fetus et utero which, although living,
is not viable
(1) "Dead tetus " 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) "'In vitro fertilization" means
any fertilization of human ova which
occurs outside the body of a female.
either through admixture of donor
human sperm and ova or by any other
means.
§ 46.204 Ethical Advisory
Boards. >
(a) One or more Ethical Advisory
Boards shall be established by the
Secretary. Members of these board(s)
shall be se selected that the boardts)
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 general
policies, guidelines, and procedures.
(c) A Beard may establish, with
the approval of the Secretary, classes
of applicanoas er proposals which;
(I) Must be submitted to the Board,
or (2) need not be submitted to the
Board. 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.
§ 46.205 Additional duties of the
Institutional 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 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 consen:s required by this
subpart are secured either by
approving induction of each
individual into the activity or
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
1

35 CFR 46
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
Page 13
1
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 secking
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.
1
₹ 46.206 General limitations.
tou No activity to which this
subpart is applicable may be
undertaken unless:
it! Appropriate studies on animals
.nd 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
fetas, the risk to the fetus is minimat
and in all cases, is the least possible
risk for achieving the objectives of
the selvity.
(); 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
ternanation of the pregnancy: and
(4) No procedural changes which
may cause greater than minimal risk
to the fetus or the pregnant woman
1
w.ll 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
(40) ER VISTA, Aus 4. 1975, as amended at
40 FR SIDAN Now 0. 19751
$ 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 (al of this section may be
conducted only if the mother and
father are legally competent and have
given theit informed consent after
having been fully informed regarding
possible impact on the fetus, except
that the father's informed consent
need not be secured it: (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 .
§ 46.208 Activities directed
toward fetuses In utero as
subjects.
(a) No fettis in atero may be
involved as a subject in any activity
covered by ihry subpart unless: (0)
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 annoved by the research is
minimal and the purpose of the
activity is the development of
important biomedical knowledge
which cannot be obtained by other
nicans.
(b) An activity permitted under
paragraph (a) of the section may be
conducted ont 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.
$ 46.209 Activities directed
toward fetuses ex utero,
including nonviable 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 10
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, of
(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:
( I) 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 are legally competent and
have given their informed consent,
except that the father's informed
consent need not be secured if: (1) his
identity of whereabouts cannot
reasonably be ascertained. (2) he is
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
45 CFR 46
Page IS
all 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 10
the subject population;
(6) Adequate assurance exists that
parole boanta will not take into,
account a prisoner's participation in
the research in making decisions
regarding parole, and each prisoner is
clearly informed in advance that
parucipation in the research will have
no effect on his or her parole; and
1
(7) Where the Board finds there
nidy 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 of care, taking into
account the varying lengths of
individaal prisoners' sentences, and
tor informing participants of this fact.
(b) The Board shall carry out such
other duties as may be assigned by
the Secretary.
(e) The insatution shall certify to
the Secretary, in such form and
manter as the Secretary may require.
that the duties of the Board under this
section have been fulfilled.
4 46.306 Permitted research
involving prisoners ..
(.d Biomedical or behavioral
research conducted or supported by
DREW may involve prisoners as
satycets only if:
( I) The institution responsible for
the.conduct of the research has
cerntied to the Secretary that the
Institutional Review Board has
approved the research under § 46.305
of this subpart; and
(.) In the judgment of the
Secretary the proposed research
invoives 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 in penology
medicine and ethics, and published
House, in the FEDERAL REGISTER
of his intent to approve such research,
(')) 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, the
study may proceed only after the
Secretary bas consulted with
appropriate expert, wictuding experts
in penology medicine and ethics, and
published nence, in the FEDERAL
REGISTER, of his tient to approve such
rescatch
(b) Except as provided in
paragraph ta) of the section.
biomedical or behavioral research
conducted or seppented by DREW
shall not involve prisoners as
subjects.
Subpart D-Additional Protections
for Children Involved as Subjects ta
Research.
Source: 48 FR 9818, March 3, 1983
5 46.401 To what do these
regulations apply?
(a) This subpart 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
modifications ay 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 § 46.10!(b), is applicable to
this subpart where the investigator(s)
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.
() 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.
8 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:
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9

Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9
45 CFR 44
* * (a) "Children" ere 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.
§ 46.403 IRB duties.
In addition to other responsibilities
assigned to IRBs under this part,
each IRB shall review research
covered by this subpart ard approve
only research which satisfies the
conditions of all applicable sections
of this subpart.
$ 46.400 Research not involving
greater than minimsi risk.
HHIS will conduct or fund
research in which the IRB finds that
no greater than minimal risk to
children is presented, only if the IRD
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
§ $6.406.
§ 46.405 Research involving greater
than minimal 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
monitoring procedure that is likely to § 46.407 Research mot otherwise
contribute to the subject's well-being
only if the IRB finds that:
(9) 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 soliciung 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 minimni risk and no 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 dueet 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
presenis experiences to subjects that
are reasonably commensurate with
those inherent in their actual or
expected medical, dental,
psychological, social, or educational
situations;
(e) The 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.
approvable which presents en
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 not
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:
(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;
(ii) The research will be conducted
in accordance with sound ethical
principles;
(iii) Adequate provisions are made
for soliciting the assent of children
and the permission of their parents of
guardians, as set forth in § 46.408.
§ 46.408 Requirements for
permission by parents or guardians
and for assent by children.
(a) In addition to the
determinations required under other
applicable sections of this subpart,
the IRD 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
[RB shall take into account the ages,;
maturity, and psychological state of
the children involved. This judgment
Approved For Release 2001/03/07 : CIA-RDP96-00788R001500160010-9