[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Rules and Regulations]
[Pages 63220-63222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31020]
[[Page 63219]]
_______________________________________________________________________
Part II
Department of Education
_______________________________________________________________________
34 CFR Part 97
Protection of Human Subjects; Final Rule
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 /
Rules and Regulations
[[Page 63220]]
DEPARTMENT OF EDUCATION
34 CFR Part 97
RIN 1880-AA75
Protection of Human Subjects
AGENCY: Department of Education.
ACTION: Final regulations.
-----------------------------------------------------------------------
SUMMARY: The Secretary amends the Department's regulations governing
the protection of human research subjects to add special protections
for children who are involved as subjects of research. These amendments
to the Department's regulations are needed to secure additional
protections for children who are involved as subjects of research. The
regulations will, for research involving children as subjects, remove
exemptions for certain kinds of research, modify the informed consent
provisions, and further limit the risks to which children may be made
vulnerable. These amendments will make the Department's policy
regarding the protection of children as research subjects consistent
with the regulations of the Department of Health and Human Services and
the Federal Policy for the Protection of Children as practiced by other
research agencies of the Federal government.
EFFECTIVE DATE: These regulations take effect December 26, 1997.
FOR FURTHER INFORMATION CONTACT: Kent H. Hannaman, U.S. Department of
Education, 600 Independence Avenue, SW., Room 5624, Regional Office
Building 3, Washington, D.C. 20202-4651. Telephone: (202) 708-5207.
Individuals who use a telecommunications device for the deaf (TDD) may
call the Federal Information Relay Service (FIRS) at 1-800-877-8339,
between 8 a.m. and 8 p.m., Eastern time, Monday through Friday.
Individuals with disabilities may obtain this document in an
alternate format (e.g., Braille, large print, audiotape, or computer
diskette) on request to the contact person listed in the preceding
paragraph.
SUPPLEMENTARY INFORMATION: The Secretary adopts for the Department of
Education regulations that are already in effect for research supported
or conducted by the Department of Health and Human Services (DHHS),
Subpart D--Additional DHHS Protections for Children Involved as
Subjects in Research (Subpart D). These regulations contain provisions
specifically designed to protect children who are involved in research
as subjects. Children are involved as subjects of important research
that will benefit the Nation's children. Balancing the importance of
this research with the needs of children, the Secretary is adding these
protections because the research activities supported by the Department
often include children, and the Department has a particular interest in
protecting the welfare of children.
The Common Rule, in which the Department of Education is a
participant, currently only includes Subpart A of the DHHS rule. To
ensure that the protections in Subpart D apply to research subjects who
are children, the Secretary adopts Subpart D, applying it to research
programs of the Department.
On May 22, 1997, the Secretary proposed to add Subpart D through a
notice of proposed rulemaking (NPRM) published in the Federal Register
(62 FR 28156-28159). In the preamble to that NPRM, the Secretary
discussed the current government-wide and Department of Education
policy, the additional protections provided by these regulations, the
additional costs and administrative burdens, alternative policy
mechanisms, and additional protections for children as education
research subjects other than the protections in these regulations.
There are no differences between the proposed regulations and these
final regulations.
Analysis of Public Comment
In response to the Secretary's invitation in the NPRM, three
parties submitted comments on the proposed regulations. Two commenters
were from associations representing affected communities, and one
commenter was an individual at an institution of higher education. Two
of the commenters expressed support for the protections and the
consistency of these protections with policies of other Federal
agencies. An analysis of the other comments follow.
Comment: One commenter expressed concern over whether the
regulations were sufficiently clear about the need to provide potential
research subjects with specific information about their involvement in
proposed research activities.
Discussion: The Secretary agrees that potential research subjects
must have appropriate information about a specific research activity in
order to give informed consent to participate. Subpart A of the
existing regulations protecting human research subjects requires, as
part of the provisions concerning informed consent, that potential
research subjects be given information including the purpose of the
particular research activity, the specific procedures to be followed,
and the risks and benefits to the subject. Because existing regulations
cover this subject, Subpart D, as proposed in the NPRM, has not been
changed.
Changes: None.
Comment: One commenter recommended that the regulations include
guidance stating that research project descriptions include information
about what safeguards will be put into place in order to respond to
anticipated risks that actually occur.
Discussion: Information about safeguards for anticipated risks in
research is important both for the review and approval of research
activities and for the informed consent of potential research subjects.
Subpart A of the existing regulations for the protection of human
research subjects calls for information about available medical
treatment in cases of injury as part of the informed consent process
for research involving more than minimal risks. This information should
be made available to any potential human research subject, not just
children who are potential research subjects. Because existing
regulations cover this subject, Subpart D, as proposed in the NPRM, has
not been changed.
Changes: None.
Paperwork Reduction Act of 1995
These final regulations have been examined under the Paperwork
Reduction Act of 1995 and have been found to contain no additional
information collection requirements.
Assessment of Educational Impact
In the NPRM the Secretary requested comments on whether the
proposed regulations would require transmission of information that is
being gathered by or is available from any other agency or authority of
the United States.
Based on the response to the NPRM and on its own review, the
Department has determined that the regulations in this document do not
require transmission of information that is being gathered by or is
available from any other agency or authority of the United States.
Electronic Access to This Document
Anyone may view this document, as well as all other Department of
Education documents published in the Federal Register, in text or
portable document format (pdf) on the World Wide Web at either of the
following sites:
http://gcs.ed.gov/fedreg.htm
http://www.ed.gov/news.html
To use the pdf you must have the Adobe Acrobat Reader Program with
Search,
[[Page 63221]]
which is available free at either of the previous sites. If you have
questions about using the pdf, call the U.S. Government Printing Office
toll free at 1-888-293-6498.
Anyone may also view these document in text copy only on an
electronic bulletin board of the Department. Telephone: (202) 219-1511
or, toll free, 1-800-222-4922. The documents are located under Option
G--Files/Announcements, Bulletins and Press Releases.
Note: The official version of this document is the document
published in the Federal Register.
List of Subjects in 34 CFR Part 97
Human subjects, Reporting and recordkeeping requirements, Research.
(Catalog of Federal Domestic Assistance Number does not apply)
Dated: November 18, 1997.
Richard W. Riley,
Secretary of Education.
The Secretary amends Part 97 of Title 34 of the Code of Federal
Regulations as follows:
PART 97--PROTECTION OF HUMAN SUBJECTS
1. The authority citation for Part 97 is revised to read as
follows:
Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C.
300v-1(b).
2. Sections 97.101 through 97.124 are designated as Subpart A--
Federal Policy for the Protection of Human Subjects (Basic ED Policy
for Protection of Human Research Subjects) and Subparts B and C are
reserved.
* * * * *
3. Sections 97.101, 97.102, 97.103, and 97.107 through 97.124 are
amended by adding authority citations to read as follows:
(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C.
300v-1(b))
4. A new Subpart D containing Secs. 97.401 through 97.409 is added
to read as follows:
Subpart D--Additional ED Protections for Children Who are Subjects in
Research
97.401 To what do these regulations apply?
97.402 Definitions.
97.403 IRB duties.
97.404 Research not involving greater than minimal risk.
97.405 Research involving greater than minimal risk but presenting
the prospect of direct benefit to the individual subjects.
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.
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.
97.408 Requirements for permission by parents or guardians and for
assent by children.
97.409 Wards.
Subpart D--Additional ED Protections for Children Who Are Subjects
in Research
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
[[Page 63222]]
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 Secs. 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))
[FR Doc. 97-31020 Filed 11-25-97; 8:45 am]
BILLING CODE 4000-01-P