CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE PART 46--PROTECTION OF HUMAN SUBJECTS

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• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00789R003000020002-5
• Release Decision: RIFPUB
• Original Classification: U
• Document Page Count: 18
• Document Creation Date: November 4, 2016
• Document Release Date: June 17, 2003
• Sequence Number: 2
• Publication Date: March 8, 1983
• Content Type: REGULATION

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CODE OF FEDE F AFL REGULATIONS
T!T1 rfir
PUBLIC WELFARE
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
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Page 4 45 CFR 46
PART 4~--
HUMAN
SUBJECTS
6ubpart A-Basic HITS 1'oiicy for
4`rotectlon of Human _Research
subjects r
Se,.
46 101 To what do these regulations apply?
46.102 Definitions,
46.103 Assurances
46 104 Section reserved
46.105 Section reserved,
46.106 Section reserved.
46 107 IRB membership.
46.108 IRB functions and operations.
46.109 IRB review of research.
46.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
46 111 Criteria for IRB approval of
research.
46. 112 Review by institution.
46. 113 Suspension or termination of IRB
approval of research.
46.114 Cooperative research.
46.115 IRB records.
46 116 General requirements for informed
consent.
46. 1 17 Documentation of informed
consent.
46. 118 Applications and proposals lacking
definite plans for involvement of human
subjects.
46.119 Research undertaken without the
intention of involving human subjects.
46.120 Evaluation and disposition of
applications and proposals.
46.121 Investigational new drug or device
30-day delay requirement.
46.122 Use of federal funds.
46.123 Early termination of research
funding; evaluation of subsequent
applications and proposals.
46 124 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.
46.202 Purpose.,
46.203 Definitions.
46.204 Ethical Advisory Boards.
46 205 Additional duties of the Institutional
Revicw Boards in connection with
c.1 .. it', ,, L. r
wun,cri, ur bur an in vet.: lcri~i~,ai;ur..
46.201: General lrrritaiiur:s
Jo.:u ! i.ilSiiics tiireCtec in-aro p:rgr m
women as subjects.
-it).,: VO Activities directed toward tctuscs iii
uteri) as subjects.
46.209 Activities directed toward fetuses ex
uteri:, including nonviable louses. a;
subn:cts,
46.210 Activities involving the dead fetus,
fetal material, or the placenta.
46.211 Modification or waiver of specific
requirements.
Subpart C-Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisoners as Subjects
"C'. .
46.301 Applicability.
46.302 Purpose.
46.303 Definitions.
46.304 Composition of Institutional Review
Boards where prisoners are involved.
46.305 Additional duties of the Institutional
Review Boards where prisoners are
involved.
46.306 Permitted activities involving
prisoners.
Subpart D-Additional Protections
for Children Involved as Subjects In
Research
Sec.
46.401 To what do these regulations apply?
46.402 Definitions. _
46.403 IRB duties.
46.404 RescArch not involving greater than
minimal risk.
46.405 Research involving greater than
minimal 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
benefit to individual subjects, but likely to
yield generalizable knowledge about the
subject's disorder or condition.
46.407 Research not otherwise approvable
which presents an opportunity to
understand, prevent, or alleviate a serious
problem affecting the health or welfare of
children.
46.408 Requircinenss for permission by
parents or guardians and for assent by
children.
46.409 Wards.
Authority: S US C 30!, sec. 474(al, 88
F,tat. 1 5~2 (42 U,S.C. 2891-3(511.
lei;:viii A --L;sic IllS folic) for
P'toicction of Human Research
irttrir' -fc
_n 46 FR 6386, January 26, 1981, 48 Ff.
9265, March 4, 1981.
146. 101 To what do these
te;;taiations 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 each Principal Operating
Component head may adopt such
nonsubstantive. procedural
modifications as may be appropriate
from art 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 (e) 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'ategories are exempt from
these regulations unless the research
is covered by other subparts of this
part:
(I) Research conducted in
established or commonly accepted
educational settings. involving
normal 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,
dta,nostic, aptitude. achievement), if
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' 45 (:FR 46
m ti ,, tak:. t;,r.:L.
is recorded in such a manner that
suh-Iects cannot he identified, directly
or-through it'entific?rs linked to it',
subjects.
(3) Research involving survey or
interview procedures, except where
all of the following conditions extsr: fir en lr~ ?tn'j iti,? or ~...~:.... t, rF.
it responses are recorded in such it approval of the Department of
manner that the human subjects can Health and Human Services, and
be identified, directly or through which are designed to study.
identifiers linked to the subjects, (ii) evaluate, or otherwise examine: (i)
the subject's responses, if they programs under the Social Security
hc',.ame known outside the research. Act, or other public benefit or
could reasonably place the subject at service programs; (ii) procedures for
i
k
s
r
of criminal or civil liability or be obtaining benefits or services under
damaging to the subject's financial
standing or employability, and (iii)
the research deals with sensitive
aspects of the subject's own behavior,
such as illegal conduct, drug use,
sexual behavior, or we of alcohol.
All research involving survey or
interview procedures is exempt,
without exception, when the
respondents are elected or appointed
public officials or candidates for
public office.
(4) Research involving the
observation (including observation
participants) of public behavior.
except where all of the following
by
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 or civil liability or be
damaging to the subject's financial
standing or employability, and (iii)
the research deals with sensitive
aspects of the subject's own behavior
such as illegal conduct, drug use.
sexual behavior, or use of alcohol.
(5) Research involving the
collection or study of existing data,
documents, records, pathological
specimens, or diagnostic specimens,
it these sources are publicly available
or if the information is recorded by
the investigator in such a manner that
or through Identifiers linkeu to tht'
sU3jeels.
(6) Uniess specifically required by
statute (t.rt? 4 ,,_ .; to the extent
specified in paragraph (i)), research
and demonstration projects which
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.
(c) The Secretary has final
authority to determine whether a
particular activity is covered by these
regulations.
(d) The Secretary may require that
specific research activities or classes
of research activities conducted or
funded by the Department, but not
otherwise covered by these
regulations, comply with some or all
of these regulations.
Page 5
sUL,;; Ft of these
rcr t itions caniainc a separate
;', ?h,r:t, to v:hat the su,pari
JP11110. Research which is covered
by nil!--` than one subpart shall
ct}ir ~iy wtt)i all applicable subparts.
(i) if, following review of
.r;1nr1 ST (Certification is required when
the research is funded by the
Department and not otherwise exempt
in accordance with ? 46.101(b)).
4::.i; I nneez.
(a) Loch In !i:i i r, er;r'a, . to
shall provide written assurance
crlli%t" 'tars' h, t!'.t Sc,,: Ct:.'` ;}.St tt
will comply with the reyuireinents tint
furilt tit ("ies, regulations.
(b) The Department will conduct or
fund research covered by these
?Irt:.,.... .
c)nrr.; if tut iiraiitiliruai IM,
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 1RB. This
assurance shall at a minimum include:
(1) A statement of principles
governing the institution in the
discharge of its responsibilities for
protecting the rights and welfare of
human subjects of research conducted
at or sponsored by the institution,
regardless of source of funding. This
may include an appropriate existing
code, declaration, or statement of
ethical principles, or a statement
formulated by the institution itself.
This requirement does not preempt
provisions of these regulations
applicable to Department-funded
research and is not applicable to any
research in an exempt category listed
in ? 46.101.
(2) Designation of one or more
iRBs established in accordance with
the requirements of this subpart, and
for which provisions are made for
meeting space and sufficient staff to
support the IRB's review and
recordkeeping duties.
(3) A list of the IRB members
identified by name; earned degrees;
representative capacity; indications of
.experience such as board
certifications, licenses, etc.,
sufficient to describe each member's
chief anticipated contributions to IRB
deliberations; and any employment or
other relationship between each
member and the institution; for
example: full-time employee, part-
time employee, member of governing
panel or board, stockholder, paid or
urp-;d consultant f'h_t.r,, it, litB
i tt itii+Cr'htr ~)I;'H (',t r,.?t,r... t t. rl i
(4) Wiitten procedutes which tn:
r
its
initial and continuing review of
research and for rept,i trop its findings
and actions to the investigator and the
institution: (ii) for determining which
pr.-ic:: rcy; if,, idle st r,-.Pic t,ftc,r
than annually and which projects
need verification from s..urces other
than the investigators that no material
changes have occurred since previous
IRB review; (iii) for insuring prompt
reporting 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
risks 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
obligations imposed by these
regulations, and shall be filed in such
form 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 light of the
anticipated scope of the institution's
research activities and the types of
subject populations likely to be
' Reports should be filed with the Office
for Protection from Research Risks, National
Institutes of Health. Dcparmeni vt Health
and Human Services, Be:he4da, M_rylaed
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I;;volved, 01C ahproptiatc;.
review procedures in light of the
probable risks, and the stet- an f
complexity of the institution.
(c) On the basis of this rvalua!ion,
the Secretary may approve or
disapprove the assurance, or enter
into r, e0niationc to d:?vclon an
approvahle one. The Secretary may,
limit the period during which any
particular approved assurance or class
Of approved assurances shall remain
effective or otherwise condition or
restrict approval.
(f) Within 60 days after the date of
submission to HHS of an application
or proposal, an institution with an
approved assurance covering the
proposed research shall certify that
the application or proposal has been
reviewed and approved by the IRB.
Other institutions shall certify that the
application or proposal has been
approved by the IRB within 30 days
after receipt of a request for such a
certification from the Department. If
the certification is not submitted
within these time limits, the
application or proposal may be
returned to the institution.
? 46.104 [Reserved]
? 46.105 [Reserved)
? 46.106 [Reserved)
? 46.107 IRB membership.
(a) Each IRD shall have at least
five members, with varying
backgrounds to promote complete and
adequate review of research activities
commonly conducted by the
institution. The IRB shall be
sufficiently qualified through the
experience and expertise of its
members, and the diversity of the
members' backgrounds including
consideration of the racial and
cultural backgrounds of members and
sensitivity to such issues as
community attitudes, to promote
respect for its advice and counsel in
safeguarding the rights and welfare of
human subjects. In addition to
possessinc: the prc,fession;t!
C %V
specific research activities, the IRB
shall hr- ^+!,- to -ccrt,,.;n t!%
aeveptahility of proposed research in
terms of institutional commitments
and regulations, applicable law, and
standards of professional conduct and
praCtii i:. ii1G IRB shad tliciefore
include persons knowledgeable in
these areas. If an IRB regularly
reviews research that involves a
vulnerable category of subjects,
including but not limited to subjects
covered by other subparts of this part,
the IRB shall include one or more
individuals who are primarily
concerned with the welfare of these
subjects.
(b) No IRB may consist entirely of
men or entirely of women, or entirely
of members of one profession.
(c) Each IRB shall include at lcabt
one member whose primary concerns
are in nonscientific areas; for
example: lawyers, ethicists, members
of the clergy.
(d) Each IRB shall include at least
one member who is,not otherwise
affiliated with the institution and who
is not pan of the immediate family of
a person who is affiliated with the
institution.
(e) No IRB 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 1R13.
(f) An IRB may, in its discretion,
invite individuals with competence in
special areas to assist in the review of
complex issues which require
expertise beyond or in addition to that
available on the IRB. These
individuals may not vote with the
IRB.
? 46.108 IRB functions and
operations.
In order to fulfill the requirements
of these regulations each IRB shall:
(a) Follow written procedures as
provided in ? 46.103(h)(4).
Page 7
rh) Fxccp: zi, ex),:.,.ftt-
reslcvww pr,kcdurc is used t.scc
? 46.110), review proposed research
at convened meetings at which a
maJority of the members of the 1RB
ate 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
meeting.
(c) 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 1RB.
? 46.109 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.
(b) An IRB shall require that
information given to subjects as part
of informed consent is in accordance
with ? 46.116. The lRB 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.
(c) An IRB shall require
documentation of informed consent or
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. the proposed research
activity, or of modifications required
to secure IRB approval of the
research activity. If the IRB decides
to disapprove a research activity, it
shall include in its written notification
' Reports should he filed with the Office
for Protcction from Research Risks. National
institutes of health, Department of Health
and Flumars Ser' tccs. Bethesda. Maryland
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 Page8
a statement of the resson? f,,r it:,
t+.CCtsron turd give t`tc imrsiig for an
ol., : n.,istt? to r 'pu:. 1 it, p crsoi or in
writing.
;c) An IRB shsl1 conduct
conLncing review of research covered
by these regulations at intervals
appropriate to the degree of risk, but
not less than once per year, and shall
lla'vt aud-loiity to obtiCiYC Ur havc 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
changes In approved research.
(a) The Secretary has established,
and published in the Federal
Register, a list of categories of
research that may be reviewed by the
1RS through an expedited review
procedure. The list will be amended.
as appropriate, through periodic
republication in the Federal
Register.
(bl An IRB may review some or all
of the research appearing on the list
through an expedited review
procedure, if the research involves no
more than minimal risk. The IRB may
also use the expedited review
procedure to review minor changes in
previously approved research during
the period for which approval is
authorized. Under an expedited
review procedure, the review may be
carried out by the IRB chairperson or
by one or more experienced reviewers
designated by the chairperson from
among members of the IRB. In
reviewing the research, the reviewers
may exercise all of the authorities of
the IRS except that the reviewers may
not disapprove the research. A
research activity may be disapproved
only after review in accordance with
the non-expedited procedure set forth
in ? 46.108(b).
(c) Each IRB which uses an
expedited review procedure shall
adopt a method for keeping all
members advised of research
proposals which have been
under U c nru cdurc
(d) 1 is 5rcretar' may
fc;tiltt,
suspend, or terminate an institution's
or 1};h''s use of the cxpe.l;ik :-4 re?.ie,k
procedure when necessary to protect
the rights or welfare of subjects.
?46.11! Criteria for IRR
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:
(I) Risks to subjects are
minimized: (i) By using procedures
which are consistent with sound
research design and which do not
unnecessarily expose subjects to risk,
and (ii) whenever appropriate, by
using procedures already being
performed on the subjects for
diagnostic or treatment purposes.
(2) Risks to subjects are reasonable
in relation to anticipated benefits. if
any, to subjects, and the importance
of the knowledge that may reasonably
be expected to result. In evaluating
risks.and benefits, the IRB should
consider only. those risks and benefits
that may result from the research (as
distinguished from risks and benefits
of therapies subjects would receive
even if not participating in the
research). The IRS should not
consider possible long-range effects
of applying knowledge gained in the
research (for example, the possible
effects of the research on public
policy) as among those research risks
that fall within the purview of its
responsibility.
(3) Selection of subjects is
equitable. In making this assessment
the IRS should take into account th
e
45 CFR 46
(5) infonned consent will be
a ..,rd:+nce wit!'., and to the extent
required by ? 46-117.
(6) Wircrc appropriate, the resca;ch
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 vulncrablt to
coercion or undue influence, such as
persons with acute or severe physical
or mental illness, or persons who arc
economically or educationally
disadvantaged. sppropriatc edditional-
safeguards have been included in the
study to protect the rights and welfare
of these subjects.
? 46.112 Review by institution.
Research covered by these
regulations that has been approved by
an IRS may be subject to further
appropriate review and approval or
disapproval by officials of the
institution. However, those officials
may not approve the research if it has
not been approved by an IRB.
f 46.1113 Suspension or
termination of IRS approval of
research.
An IRB shall have y.uthi r ty_toll
suspend or terminate approval of
research that is not being conducted
in accordance with the IRB 's
requirements or that has been
associated with unexpected serious
harm to subjects. Any suspension or
termination of approval shall include
a statement of the reasons for the
-IRS's actiolt and shad be reported
purposes of the research and the
setting in which the research will be promptly to the investigator,
conducted. appropriate institutional officials, and
(4) Informed consent will be
sought from each prospective subject
or the subject's legally authorized
representative, in accordance with,
and to the extent required by
? 46.116.
I Reports should be filed with the office
for Protection from Research Risks, National
Institutes of Health. Department of Health
and Human Services, Bethesda, Maryland
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t, 46.114 Cooperative res.~arcft.
Cooperhtrvc research proicct'. ;rr(
:) oS(' ilii)Jeets, nOrili) Jirk poIIca
through grants, contracts, or similar
..; gcmcret:~, ''.Bich invclvc
institutions in addition to the grantee
or prime contractor (such as a
contractor with the grantee, or a
subcontractor with the prime
c4pnrraciori in such instances., the
grantee or prime contractor remains
responsible to the Department for
safeguarding the rights and welfare of
human subjects, Also, when
cooperatir.~ institutions conduct some
or all of the research involving some
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
rna~ use ioint review, reliance upon
the review of another qualified IRR,
or siniiies arrangements aimed at
avoidance of duplication of effort.
46.115 IRB records.
(a) 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
to subjects.
(2) Minutes of IRB 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.
(4) Cn ic, (Ft all cnrrr,,ponderkec
hcts+e r tl?- JRl: anJ the
in e Li LT a!or`..
(5) A list of lRB members
tcquircu by ? 4o. iu3(b)(i).
sc,t ing. informed conscat the
Page 9
provided to each subject:
(b A statement that the study
involves rescar,li, an explanation of
the purposes of the rese^reh 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;
i1 t A description of any reasonably
foreseeable risks or discomforts to the
subject;
(M A description of any benefits to
the subject or to others which may
.reasonably be expected from the
r!reseach;
4) A disclosure of appropriate
alternative procedures or courses of
treatment, if any, that might be
advantageous to the subject;
?A statement describing the
extent, if any, to which
(6) Written procedures for the IRIS
as required by ? 46,103(h)(4).
(7) Statements of significant new
findings providc(l to subjects, as
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 for inspection and copying
by authorized representatives of the
Department at reasonable times and
in a reasonable manner.
* 46.1116 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
UUMMEMCftidly e fft t r .
ative, An investigator shall
seek such consent only under
circumstances that provide the
prospective subject or the
confidentiality of records identifying
the subject will be maintained;
For research involving more
than minimal risk, an explanation as
to whether any compensation and an It)
explanation as to whether any
medical treatments are available if
injury occurs and, if so, what they
representative sufficient opportunity inf anon niay be obtained;
to consider whether or not to
An explanation of who
participate and that minimize the
possibility of coercion or undue
influence. The information that is
given to the subject or the
representative Shad be in language
understandable to_14C,.subject or the
representative,r.$odinformed consent,
whether oral or. written, may include
any exculpatory language through
which the subject or the
m to
contact for answers to pertinent
questions about the research and
.research subjects' rights, and whom
to contact in the event of a research-
related injury to the subject; and
,A statement that participation is
voluntary, refusal to participate will
involve no penalty or loss of benefits
.to which the subject is otherwise
representative is made to waive or discontinue participation at any time
appear to waive any of the subject's without penalty or loss of benefits to
legal rights, or releases or appears to ,which the subject is otherwise
release the investigator, the sponsor, entitled.
the institution or its agents from I (b) Additional elements of
liability for negligence. informed consent. When appropriate,
(a) Basic elements of informed one or more of the following elements
consent. Except as provided in of information shall also be provided
paragraph (c) or (d) of this section, in to each subject:
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 1'11'
wrr,c cr s1i of the
cc't:srrt 6r!
a-.rvr " or waive the
.plc nts to obtain informed
piovideii the IRB t.inds and
.-nix that:
r' tic research involves no more
"iininlal risk to the subjects;
'I he waiver or alteration will
+-~ecly ailed the rights and
:c u1 the subjects;
f'ht: research could not
.t 111ly be carried out without the
Of alteration; and
Whenever appropriate, the
-t: will be provided with
ca~;ti pertinent information after
._ipulion.
t hr informed consent
:cements in these regulations are
r r :tended to preempt any
cable federal, state, or local laws
t require additional information
di%closed in order for informed
Ott to be legally effective.
Nothing in these regulations is
ded to limit the authority of a
-clan to provide emergency
s t,J .gal Care, to the extent the
trtr'? ician is permitted to do so under
till/ '-cable federal, state, or local law.
17 Documentation of
wd consent.
?.t Except as provided in
graph (c) of this section,
li t ruicd consent shall be
lttr atfentcd by the use of a written
ent form approved by the lRB
igned by the subject or the
ec-'s legally authorized
'' t nentative.
t Me
1 1.1't`
.Except -as provided in
raph (c) of this section, the
qtt,,! y'~~~
!'r'1 ,`cpt form may be either of the
t:ttt winlt:
li~lf t f A written consent document
t`Intktics the elements of
t!'aa lpcd consent required by
"ti}' , 116, This form may be read to
I It ; object or the subject's legally
rlt riz.ed representative, but in any
"'&
t. the investigator shall give
the ,object or the representative
adequate opp,:trtur.ity to read it before
it i d: car
(2) A','short form" written
consent document stating that the
elements of informed consent
required by $ 46,116 have beer
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 ?"fmmary, and the
person actually ootatning 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
for "
3-ants.1RB may waive tie'
jlNWj1jffii"r- tote investigatorio
Igtteconse' arm Tire to
(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
subj ct's wishes will govern; or
( - ~. ~ ~~rsscgts ~o
requirement is waived, the IRS may
require the investigator to provide
subjects with a written statement
regarding the research.
4 46.118 Applications and
proposals lacking definite plans for
Involvement of human subjects.
Certain types of applications for
grants, cooperative agreements. or
contracts are submitted to the
Department with the knowledge that
subjects may be involved within the
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 45, f_I R Ott Atiaroved For Release 2003/09/10 CIA-RDP96-00789R003000020002-5
i C1 duii0 but dcclinjte plans the Suhlt;is and otiierc:, and the
w;;t ;1. Jt.On or proposal. These
Page 1 t
res!Lvatrons, incluclinr ,ti cut
regulations, hzvc h-cn satis;;ca.
46.123 Early termination of
research funding; evaluation of
subsequent applications and
proposals.
include activities such as institutional
,; LXcalse* ao Subject* tn;
Research.
1146.401 To what do these
reg=ddations apply?
(a) This subpart applim to all
research involving children as
sub; cts, conducted or supported by
the Department of Health and
Human Services.
(I - This includes research
conducted by Department.
C. ::oyees, except that each (?cad of
an Operating Divininn 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 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.
(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 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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 l'irgc 16 . Approved For Release 2003/09/10 : CIA-RDP96-00789R003000020002-5
"Cl ildceii"src' IR:r_:..lns A h
consent to treatments of procedures
involved in the research, under the
ap ricah!c law Of the ju,asdiction in
which the rest?srrh wif h;
conducted.
(b) "Assent" means a child's
affirmative agrccn,ciit to narticinatr
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) "Gupian".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 IRD 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 of all applicable sections
of this subpart.
? 46.404 Research. not. tivolviag
greater than minimal risk,
HHS 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.
?46.405 Research involving greater
than minimal risk bit preaeating 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
muwto u,}, prtu:edurc that is likely to
only if the 1R1 finds that.
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
? 46.40f8.
? 46.406 Research ip,;olving greater
than minimal 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 its 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 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;
(c) 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 i s