EDGAR Part 97 Subpart D (Additional ED Protections for Children Who are Subjects in Research)
Subpart D_Additional ED Protections for Children Who Are Subjects in
Research
Source: 62 FR 63221, Nov. 26, 1997, unless otherwise noted.
Sec. 97.401 To what do these regulations apply?
(a) This subpart applies to all research involving children as
subjects conducted or supported by the Department of Education.
(1) This subpart applies to research conducted by Department
employees.
(2) This subpart applies to research conducted or supported by the
Department of Education outside the United States, but in appropriate
circumstances the Secretary may, under Sec. 97.101(i), waive the
applicability of some or all of the requirements of the regulations in
this subpart for that research.
(b) Exemptions in Sec. 97.101(b)(1) and (b)(3) through (b)(6) are
applicable to this subpart. The exemption in Sec. 97.101(b)(2)
regarding educational tests is also applicable to this subpart. The
exemption in Sec. 97.101(b)(2) for research involving survey or
interview procedures or observations of public behavior does not apply
to research covered by this subpart, except for research involving
observation of public behavior when the investigator or investigators do
not participate in the activities being observed.
(c) The exceptions, additions, and provisions for waiver as they
appear in Sec. 97.101(c) through (i) are applicable to this subpart.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b)).
Sec. 97.402 Definitions.
The definitions in Sec. 97.102 apply to this subpart. In addition,
the following definitions also apply to this subpart:
(a) Children are 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.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b)).
Sec. 97.403 IRB 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 that satisfies the conditions of all applicable sections
of this subpart.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b)).
Sec. 97.404 Research not involving greater than minimal risk.
ED conducts or funds 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 Sec.
97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b))
Sec. 97.405 Research involving greater than minimal risk but
presenting the prospect of direct benefit to the individual
subjects.
ED conducts or funds research in which the IRB finds that more than
minimal risk to children is presented by an intervention or procedure
that holds out the prospect of direct benefit for the individual
subject, or by a monitoring procedure that is likely to contribute to
the subject's well-being, only if the IRB finds that--
(a) The risk is justified by the anticipated benefit to the
subjects;
(b) The relation of the anticipated benefit to the risk is at least
as favorable to the subjects as that presented by available alternative
approaches; and
(c) Adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians, as set forth in
Sec. 97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b))
Sec. 97.406 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.
ED conducts or funds research in which the IRB finds that more than
minimal risk to children is presented by an intervention or procedure
that does not hold out the prospect of direct benefit for the individual
subject, or by a monitoring procedure which is not likely to contribute
to the well-being of the subject, only if the 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 that 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 Sec. 97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b))
Sec. 97.407 Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children.
ED conducts or funds research that the IRB does not believe meets
the requirements of Sec. 97.404, Sec. 97.405, or Sec. 97.406 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 that--
(1) The research in fact satisfies the conditions of Sec. 97.404,
Sec. 97.405, or Sec. 97.406, as applicable; or
(2)(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; and
(iii) Adequate provisions are made for soliciting the assent of
children and the permission of their parents or guardians, as set forth
in Sec. 97.408.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b))
Sec. 97.408 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 IRB shall determine that
adequate provisions are made for soliciting the assent of the children,
if in the judgment of the IRB the children are capable of providing
assent. In determining whether children are capable of assenting, the
IRB shall take into account the ages, maturity, and psychological state
of the children involved. This judgment may be made for all children to
be involved in research under a particular protocol, or for each child,
as the IRB deems appropriate. If the IRB determines that the capability
of some or all of the children is so limited that they cannot reasonably
be consulted or that the intervention or procedure involved in the
research holds out a prospect of direct benefit that is important to the
health or well-being of the children and is available only in the
context of the research, the assent of the children is not a necessary
condition for proceeding with the research. Even if the IRB determines
that the subjects are capable of assenting, the IRB may still waive the
assent requirement under circumstances in which consent may be waived in
accord with Sec. 97.116.
(b) In addition to the determinations required under other
applicable sections of this subpart, the IRB shall determine, in
accordance with and to the extent that consent is required by Sec.
97.116, that adequate provisions are made for soliciting the permission
of each child's parent(s) or guardian(s). If parental permission is to
be obtained, the IRB may find that the permission of one parent is
sufficient for research to be conducted under Sec. 97.404 or Sec.
97.405. If research is covered by Sec. Sec. 97.406 and 97.407 and
permission is to be obtained from parents, both parents must give their
permission unless one parent is deceased, unknown, incompetent, or not
reasonably available, or if only one parent has legal responsibility for
the care and custody of the child.
(c) In addition to the provisions for waiver contained in Sec.
97.116, if the IRB determines that a research protocol is designed for
conditions or for a subject population for which parental or guardian
permission is not a reasonable requirement to protect the subjects (for
example, neglected or abused children), it may waive the consent
requirements in subpart A of this part and paragraph (b) of this
section, provided an appropriate mechanism for protecting the children
who will participate as subjects in the research is substituted, and
provided further that the waiver is not inconsistent with Federal,
State, or local law. The choice of an appropriate mechanism depends upon
the nature and purpose of the activities described in the protocol,
the risk and anticipated benefit to the research subjects, and their
age, maturity, status, and condition.
(d) Permission by parents or guardians must be documented in
accordance with and to the extent required by Sec. 97.117.
(e) If the IRB determines that assent is required, it shall also
determine whether and how assent must be documented.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b))
Sec. 97.409 Wards.
(a) Children who are wards of the State or any other agency,
institution, or entity may be included in research approved under Sec.
97.406 or Sec. 97.407 only if that research is--
(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or similar
settings in which the majority of children involved as subjects are not
wards.
(b) If research is approved under paragraph (a) of this section, the
IRB shall require appointment of an advocate for each child who is a
ward, in addition to any other individual acting on behalf of the child
as guardian or in loco parentis. One individual may serve as advocate
for more than one child. The advocate 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 research and who is not associated in any way (except in the role as
advocate or member of the IRB) with the research, the investigator or
investigators, or the guardian organization.
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b))
EDGAR version June 23, 2005
