63220 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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

§§ 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

§ 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

§ 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 § 97.101(b)(1) and

(b)(3) through (b)(6) are applicable to

this subpart. The exemption in

§ 97.101(b)(2) regarding educational

tests is also applicable to this subpart.

The exemption in § 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

§ 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)).

§ 97.402 Definitions.

The definitions in § 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)).

§ 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)).

§ 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 § 97.408.

(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,

3474; and 42 U.S.C. 300v–1(b))

§ 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 §97.408.

(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,

3474; and 42 U.S.C. 300v–1(b))

§ 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
63222 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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 § 97.408.

(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,

3474; and 42 U.S.C. 300v–1(b))

§ 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 § 97.404, § 97.405, or

§ 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 § 97.404, § 97.405, or

§ 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 § 97.408.

(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e–3,

3474; and 42 U.S.C. 300v–1(b))

§ 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 § 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 § 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 § 97.404 or § 97.405. If

research is covered by §§ 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 § 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 § 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))

§ 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 § 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. 97–31020 Filed 11–25–97; 8:45 am]

BILLING CODE 4000–01–P