[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]


      

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Part II





Department of Education





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34 CFR Part 97



Protection of Human Subjects; Final Rule

  Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / 
Rules and Regulations  

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DEPARTMENT OF EDUCATION

34 CFR Part 97

RIN 1880-AA75


Protection of Human Subjects

AGENCY: Department of Education.

ACTION: Final regulations.

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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,

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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

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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