[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]
[[Page 28155]]
_______________________________________________________________________
Part IV
Department of Education
_______________________________________________________________________
34 CFR Part 97
Protection of Human Subjects; Proposed Rule
Federal Register / Vol. 62, No. 99 / Thursday, May 22, 1997 /
Proposed Rules
[[Page 28156]]
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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__Subjects@ed.gov).
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
[[Page 28157]]
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
[[Page 28159]]
(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
