[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Proposed Rules]
[Pages 28156-28159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13317]



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Part IV





Department of Education





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34 CFR Part 97



Protection of Human Subjects; Proposed Rule

  Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 / 
Proposed Rules  

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DEPARTMENT OF EDUCATION

34 CFR Part 97

RIN 1880-AA75


Protection of Human Subjects

AGENCY: Department of Education.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Secretary proposes to amend 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 proposed regulations would, 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.

DATES: Comments must be received on or before July 21, 1997.

ADDRESSES: All comments concerning these proposed regulations should be 
addressed to Kent H. Hannaman, Attention: Protection of Human Subjects 
in Research, U.S. Department of Education, Seventh and D Streets, S.W., 
Room 5624, Regional Office Building 3, Washington, D.C. 20202-4651. 
Comments may also be sent through the Internet to 
(Human__S[email protected]).

FOR FURTHER INFORMATION CONTACT: Ivor Pritchard, U.S. Department of 
Education, 555 New Jersey Avenue, N.W., Washington, D.C. 20208-5573. 
Telephone: (202) 219-2231. 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.

SUPPLEMENTARY INFORMATION: The Secretary proposes to adopt 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 
believes that these protections should be added because the research 
activities supported by the Department often include children, and the 
Department has a particular interest in protecting the welfare of 
children.

Current Government-Wide and ED Policy

    The Federal Policy requires institutions receiving support from 
Federal agencies or offices for research activities involving human 
subjects to assure that covered research activities will be reviewed by 
an Institutional Review Board (IRB). The purpose of the IRB review is 
to ensure that persons not involved in carrying out the research 
activities determine that adequate provisions have been made to protect 
the research subjects involved in the proposed activities. The adequacy 
of the protections is judged by the IRB, which consists of qualified 
individuals at the institutions where the research takes place, and by 
other individuals in the local community who are familiar with the 
research population and with local community standards.

Additional Protections Afforded by Subpart D

    The amendments regarding children substantially modify the Federal 
Policy in three ways. First, they remove an exemption from IRB review 
of research involving surveys, interviews, or observation of public 
behavior if the research investigators interact with subjects who are 
children. Second, they modify the procedures for obtaining informed 
consent from research subjects who are children, by including 
procedures for proxy consent by the parent or guardian, and assent by 
the children themselves. Third, they limit the kind of risks to which 
children may be made vulnerable during the research activity, if the 
child's participation in the research contains no prospects of benefits 
to the individual child. IRBs are charged with the responsibility of 
ensuring that these modifications are included in research activities 
taking place at their institutions, or sponsored by their institutions, 
whenever children are involved as subjects.
    The Secretary believes that adopting Subpart D protections through 
rulemaking is an important part of meeting the Department's obligation 
to fully implement the Federal Policy. Children are a primary focus of 
the Department's mission and activities, and protections designed 
specifically for children serving as research subjects are appropriate. 
With the Subpart D protections, children involved as research subjects 
would have more protections than they would have if Subpart D is not 
adopted, and the Secretary believes that there is good reason to 
protect children in this manner. In addition, the adoption of the 
Subpart D protections would make the Department's policy more 
consistent with that of DHHS and certain other Federal agencies and 
offices, which was the original intent of the Common Rule.
    The Secretary considered but rejected implementing Subpart D on a 
case-by-case basis as a matter of policy without formal rulemaking. The 
effect of the case-by-case approach would be to make Subpart D 
application a matter of negotiation between the Department and some 
institutions receiving support for relevant research activities. It 
would be more costly, burdensome, and confusing for researchers and 
institutions requesting Department support and for the Department's own 
administration of the Federal Policy. It would also increase the 
possibility that sponsored research projects would not be fully 
reviewed for appropriate protections.
    The Secretary recognizes that this action will produce some 
additional costs and administrative burdens. More resources will be 
expended inside and outside the Government to ensure that children who 
are research subjects are protected. More research protocols will be 
reviewed by Institutional Review Boards, the protocols will have to 
meet higher standards for approval with respect to the potential 
benefits to the individual subjects where the research poses more than 
minimal risk, and parental consent and a child's assent will be 
required when it otherwise would not be. It is not possible to provide 
an accurate estimate of the additional costs. The Secretary, however, 
believes that the important benefits of providing consistent 
protections for children as research subjects outweigh the burden of 
additional administrative costs.
    The Secretary also recognizes that some additional protections for 
children as education research subjects exist even if Subpart D is not 
adopted. The applicability of DHHS multiple project assurances 
1 at some three hundred

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institutions means that education research supported by those 
institutions is already regulated by Subpart D. The Protection of Pupil 
Rights Amendment (PPRA) (20 U.S.C. 1232h) and the Family Educational 
Rights and Privacy Act (FERPA) (20 U.S.C. 1232g) both provide some 
protections. However, the safeguards provided by the PPRA and the FERPA 
are enforced retrospectively, after infractions have occurred. In 
contrast, these regulations assure compliance before research is 
initiated. Therefore, the Secretary believes that adoption of Subpart D 
is important to ensure the highest degree of protection for children as 
human research subjects.
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    \1\ DHHS issues multiple project assurances to some 
institutions. A multiple project assurance is an agreement between 
DHHS and an institution that sets forth the institution's commitment 
to employ the basic ethical principles of ``The Ethical Principles 
and Guidelines for the Protection of Human Subjects of Research'', 
known as the Belmont Report, and to comply with DHHS regulations for 
the protection of human subjects. The assurances are issued for a 
five-year period and are approved for Federal-wide use. Institutions 
with DHHS-approved multiple project assurances must abide by the 
provisions of Title 45 CFR Part 46 Subpart D.
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Executive Order 12866

Assessment of Costs and Benefits

    These proposed regulations have been reviewed in accordance with 
Executive Order 12866. Under the terms of the order, the Secretary has 
assessed the potential costs and benefits of this regulatory action.
    The potential costs associated with the proposed regulations are 
those resulting from statutory requirements and those determined by the 
Secretary as necessary for administering the Department's programs 
effectively and efficiently. As stated under the heading Paperwork 
Reduction Act of 1995 in this preamble, this proposed rule contains no 
paperwork burdens.
    In assessing the potential costs and benefits--both quantitative 
and qualitative--of these proposed regulations, the Secretary has 
determined that the benefits of the proposed regulations justify the 
costs.
    The Secretary has also determined that this regulatory action does 
not unduly interfere with State, local, and tribal governments in the 
exercise of their governmental functions.
    To assist the Department in complying with the specific 
requirements of Executive Order 12866, the Secretary invites comment on 
whether there may be further opportunities to reduce any potential 
costs or increase potential benefits resulting from these proposed 
regulations without impeding the effective and efficient administration 
of the program.

Summary of Potential Costs and Benefits

    The potential costs and benefits of these proposed regulations are 
discussed elsewhere in this preamble under the heading Additional 
Protections Afforded by Subpart D.

Clarity of the Regulations

    Executive Order 12866 requires each agency to write regulations 
that are easy to understand.
    The Secretary invites comments on how to make these proposed 
regulations easier to understand, including answers to questions such 
as the following: (1) Are the requirements in the proposed regulations 
clearly stated? (2) Do the regulations contain technical terms or other 
wording that interferes with their clarity? (3) Does the format of the 
regulations (grouping and order of sections, use of headings, 
paragraphing, etc.) aid or reduce their clarity? Would the regulations 
be easier to understand if they were divided into more (but shorter) 
sections? (A ``section'' is preceded by the symbol ``Sec. '' and a 
numbered heading; for example, Sec. 97.401 To what do these regulations 
apply?) (4) Is the description of the regulations in the Supplementary 
Information section of this preamble helpful in understanding the 
regulations? How could this description be more helpful in making the 
regulations easier to understand? (5) What else could the Department do 
to make the regulations easier to understand?
    A copy of any comments that concern how the Department could make 
these proposed regulations easier to understand should be sent to 
Stanley M. Cohen, Regulations Quality Officer, U.S. Department of 
Education, 600 Independence Avenue, S.W. (Room 5121, FB-10B), 
Washington, D.C. 20202-2241.

Regulatory Flexibility Act Certification

    The Secretary certifies that these proposed regulations would not 
have a significant economic impact on a substantial number of small 
entities. For the most part, these revisions are adopted to effect 
greater consistency in the protection of children as human research 
subjects. The proposed revisions would not have a significant impact on 
the entities affected. The applicability of Department of Health and 
Human Services multiple project assurances at some three hundred 
institutions means that education research supported at those 
institutions is already regulated by Subpart D. The institutions that 
do not have multiple project assurances with DHHS should find the 
consistent approach to safeguarding children as research subjects a 
workable approach to increased protections.

Paperwork Reduction Act of 1995

    These proposed regulations have been examined under the Paperwork 
Reduction Act of 1995 and have been found to contain no additional 
information collection requirements. (The recordkeeping requirements of 
Subpart A, for which DHHS has received OMB approval on behalf of 
affected agencies, encompass recordkeeping requirements of Subpart D.)

Invitation to Comment

    Interested persons are invited to submit comments and 
recommendations regarding these proposed regulations.
    All comments submitted in response to these proposed regulations 
will be available for public inspection, during and after the comment 
period, in Room 5624, Regional Office Building 3, 7th and D Streets, 
S.W., Washington, D.C., between the hours of 8:30 a.m. and 4:00 p.m., 
Monday through Friday of each week except Federal holidays.

Assessment of Educational Impact

    The Secretary particularly requests comments on whether the 
proposed regulations in this document would require transmission of 
information that is being gathered by or is available from any other 
agency or authority of the United States.

List of Subjects in 34 CFR Part 97

    Human subjects, Reporting and recordkeeping Research, requirements.

(Catalog of Federal Domestic Assistance Number does not apply.)

    Dated: February 18, 1997.
Richard W. Riley,
Secretary of Education.

    The Secretary proposes to amend 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; and 42 U.S.C. 
300v-1(b).


Secs. 97.101, 97.102, 97.103, 97.104, 97.107, 97.108, 97.109, 97.110, 
97.111, 97.112, 97.113, 97.114, 97.115, 97.116, 97.117, 97.118, 97.119, 
97.120, 97.121, 97.122, 97.123, 97.124  [Redesignated as Subpart A]

Subpart B--[Reserved]

Subpart C--[Reserved]

    2. Sections 97.101 through 97.124 are designated as ``Subpart A--
Federal

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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

Sec.
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 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

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    (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 
Secs. 97.406 or 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. 97-13317 Filed 5-21-97; 8:45 am]
BILLING CODE 4000-01-P