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[Code of Federal Regulations] |
[Title 21, Volume 1] |
[Revised as of April 1, 2004] |
[CITE: 21CFR50] |
TITLE 21--FOOD AND DRUGS
SUBCHAPTER A - GENERAL
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PART 50 | PROTECTION OF HUMAN SUBJECTS |
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Subpart D -- Additional Safeguards for Children in Clinical
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In addition to other responsibilities assigned to IRBs under this part and
part 56 of this chapter, each IRB must review clinical investigations involving
children as subjects covered by this subpart D and approve only those clinical
investigations that satisfy the criteria described in § 50.51,
§ 50.52, or § 50.53 and the conditions of all other
applicable sections of this subpart D.
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Sec. 50.51 Clinical investigations not involving greater than minimal risk.
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Any clinical investigation within the scope described in
§§ 50.1 and 56.101 of this chapter in which no greater than
minimal risk to children is presented may involve children as subjects only if
the IRB finds and documents that adequate provisions are made for soliciting the
assent of the children and the permission of their parents or guardians as set
forth in § 50.55.
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Sec. 50.52 Clinical investigations involving greater than minimal risk but
presenting the prospect of direct benefit to individual subjects.
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Any clinical investigation within the scope described in
§§ 50.1 and 56.101 of this chapter in which more than minimal
risk to children is presented by an intervention or procedure that holds out the
prospect of direct benefit for the individual subject, or by a monitoring
procedure that is likely to contribute to the subject`s well-being, may involve
children as subjects only if the IRB finds and documents that:
(a) The risk is justified by the anticipated benefit to the subjects;
(b) The relation of the anticipated benefit to the risk is at least as
favorable to the subjects as that presented by available alternative approaches;
and
(c) Adequate provisions are made for soliciting the assent of the children
and permission of their parents or guardians as set forth in § 50.55.
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Sec. 50.53 Clinical investigations involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subjects` disorder or condition.
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prospect of direct benefit to individual subjects, but likely to yield
Any clinical investigation within the scope described in
§§ 50.1 and 56.101 of this chapter in which 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 that is not likely to contribute to the well-being of the
subject, may involve children as subjects only if the IRB finds and documents
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 that is of vital importance for the
understanding or amelioration of the subjects` disorder or condition; and
(d) Adequate provisions are made for soliciting the assent of the children
and permission of their parents or guardians as set forth in § 50.55.
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Sec. 50.54 Clinical investigations not otherwise approvable that present an
opportunity to understand, prevent, or alleviate a serious problem affecting the
health or welfare of children.
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opportunity to understand, prevent, or alleviate a serious problem affecting the
If an IRB does not believe that a clinical investigation within the scope
described in §§ 50.1 and 56.101 of this chapter and involving
children as subjects meets the requirements of § 50.51,
§ 50.52, or § 50.53, the clinical investigation may
proceed only if:
(a) The IRB finds and documents that the clinical investigation 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 Commissioner of Food and Drugs, 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, determines
either:
(1) That the clinical investigation in fact satisfies the conditions of
§ 50.51, § 50.52, or § 50.53, as applicable, or
(2) That the following conditions are met:
(i) The clinical investigation presents a reasonable opportunity to further
the understanding, prevention, or alleviation of a serious problem affecting the
health or welfare of children;
(ii) The clinical investigation will be conducted in accordance with sound
ethical principles; and
(iii) Adequate provisions are made for soliciting the assent of children and
the permission of their parents or guardians as set forth in § 50.55.
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Sec. 50.55 Requirements for permission by parents or guardians and for assent by
children.
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(a) In addition to the determinations required under other applicable
sections of this subpart D, the IRB must 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.
(b) In determining whether children are capable of providing assent, the IRB
must take into account the ages, maturity, and psychological state of the
children involved. This judgment may be made for all children to be involved in
clinical investigations under a particular protocol, or for each child, as the
IRB deems appropriate.
(c) The assent of the children is not a necessary condition for proceeding
with the clinical investigation if the IRB determines:
(1) That the capability of some or all of the children is so limited that
they cannot reasonably be consulted, or
(2) That the intervention or procedure involved in the clinical investigation
holds out a prospect of direct benefit that is important to the health or well-
being of the children and is available only in the context of the clinical
investigation.
(d) Even where the IRB determines that the subjects are capable of assenting,
the IRB may still waive the assent requirement if it finds and documents that:
(1) The clinical investigation involves no more than minimal risk to the
subjects;
(2) The waiver will not adversely affect the rights and welfare of the
subjects;
(3) The clinical investigation could not practicably be carried out without
the waiver; and
(4) Whenever appropriate, the subjects will be provided with additional
pertinent information after participation.
(e) In addition to the determinations required under other applicable
sections of this subpart D, the IRB must determine that the permission of each
child`s parents or guardian is granted.
(1) Where parental permission is to be obtained, the IRB may find that the
permission of one parent is sufficient, if consistent with State law, for
clinical investigations to be conducted under § 50.51 or
§ 50.52.
(2) Where clinical investigations are covered by § 50.53 or
§ 50.54 and permission is to be obtained from parents, both parents
must give their permission unless one parent is deceased, unknown, incompetent,
or not reasonably available, or when only one parent has legal responsibility
for the care and custody of the child if consistent with State law.
(f) Permission by parents or guardians must be documented in accordance with
and to the extent required by § 50.27.
(g) When the IRB determines that assent is required, it must also determine
whether and how assent must be documented.
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(a) Children who are wards of the State or any other agency, institution, or
entity can be included in clinical investigations approved under
§ 50.53 or § 50.54 only if such clinical investigations
are:
(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or similar settings
in which the majority of children involved as subjects are not wards.
(b) If the clinical investigation is approved under paragraph (a) of this
section, the IRB must require appointment of an advocate for each child who is a
ward.
(1) The advocate will serve in addition to any other individual acting on
behalf of the child as guardian or in loco parentis.
(2) One individual may serve as advocate for more than one child.
(3) The advocate must be an individual who has the background and experience
to act in, and agrees to act in, the best interest of the child for the duration
of the child`s participation in the clinical investigation.
(4) The advocate must not be associated in any way (except in the role as
advocate or member of the IRB) with the clinical investigation, the
investigator(s), or the guardian organization.
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Authority: 21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353,
355, 360, 360c–360f, 360h–360j, 371, 379e, 381; 42 U.S.C. 216, 241,
262, 263b–263n.
Source: 45 FR 36390, May 30, 1980, unless otherwise noted.
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