**GRANTS & CONTRACTS**\
**U.S. Department of Education Sample Single Project Assurance**

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**(Revised September 2008)**

*This is a sample Single Project Assurance (SPA) for an institution that
currently does not have a Federal Wide Assurance (FWA) on file with the
U.S. Department of Health and Human Services, Office for Human Research
Protections (OHRP).*

*Using this Sample, type on Institutional Letterhead supplying, where
indicated, information specific to the proposed research
project/activity and your Institution. Include the required
certification(s) on the endorsement page(s) in Part 3.*

\*\* *Prepare submission using the MS Word version [(Link to MS Word
version)](http://www.ed.gov/policy/fund/guid/humansub/sample.doc).* \*\*

**\"Name of Institution\"**

**Assurance of Compliance with U.S. Department of Education Regulations
for the Protection of Human Research Subjects**

Name of Institution\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_,
hereinafter known as the \"institution,\" hereby gives assurance that it
will comply with the Department of Education (ED) regulations for the
protection of human subjects (34 CFR Part 97) and, if applicable, with
34 CFR Part 350 and Part 356, as specified below.

**Part 1**

**Ethical Principles and Institutional Policies Governing Research
Involving Human Subjects**

**I. Applicability**

**A.1.** Part 1 of this Assurance applies to all research involving
human subjects and all other activities which even in part involve such
research, regardless of whether the research is otherwise subject to
Federal regulation, unless the research is:

i.  exempted under the Department of Education regulations 34 CFR
    97.101(b);

ii. if children are research subjects, exempted under 34 CFR 97.101(b)
    as amended by 34 CFR 97.401(b); or

iii. waived under 34 CFR 97.101(i).

**A.2.** Research is subject to Part 1 of this Assurance if:

i.  the research is sponsored by this institution, **or**

ii. the research is conducted by or under the direction of any employee
    or agent of this institution in connection with institutional
    responsibilities, **or**

iii. the research is conducted by or under the direction of any employee
     or agent of this institution using any property or facility of this
     institution, **or**

iv. the research involves the use of this institution\'s nonpublic
    information to identify or contact human research subjects or
    prospective subjects.

**II. Ethical Principles Governing Human Subjects Research**

This institution is guided by the ethical principles regarding all
research involving humans as subjects as set forth in the report of the
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research entitled, [Ethical Principles and Guidelines for
the Protection of Human Subjects of Research]{.underline} (the \"Belmont
Report\") and as specified below.

**A.** This institution recognizes the principles of respect for
persons, beneficence (including minimization of risks and maximization
of benefits), and justice as stated in the Belmont Report, and will
apply these principles in all research covered by this Assurance.

**B.** This institution acknowledges and accepts its responsibilities
for protecting the rights and welfare of human research subjects.

**III.** **Policies**

**A.** This institution acknowledges that it and its investigators bear
full responsibility for the performance of all research covered by this
Assurance, including full responsibility for complying with Federal,
state, and local laws as they may relate to such research.

**B.** This institution assures that before human subjects are involved
in research, proper consideration will be given to:

1.  the risks to the subjects;

2.  the anticipated benefits to the subjects and others;

3.  the importance of the knowledge that may reasonably be expected to
    result;

4.  the informed consent process to be employed;

5.  the provisions to protect the privacy of subjects;

6.  the additional safeguards for vulnerable populations; and,

7.  compensation due to subjects in the case of harms they suffer as a
    result of the research.

**C.** This institution recognizes the need for appropriate additional
safeguards in research involving subjects who are likely to be
vulnerable to coercion or undue influence, such as children, children
with disabilities or individuals with mental disabilities, or
economically or educationally disadvantaged persons, and shall ensure
that appropriate safeguards exist to protect vulnerable subjects.

**D.** This institution encourages and promotes constructive
communication among the institutional officials, research
administrators, department heads, research investigators, clinical care
staff, human subjects, and other relevant parties as a means of
maintaining a high level of awareness regarding the safeguarding of the
rights and welfare of the subjects.

**E.** This institution will exercise appropriate administrative
overview carried out at least annually to assure that its practices and
procedures designed for the protection of the rights and welfare of
human subjects are being effectively applied.

**Part 2**

**Institution, Institutional Review Board, and Investigator
Responsibilities for Compliance with 34 CFR Part 97 and, if Applicable,
34 CFR Part 350 and 34 CFR Part 356 - [(Footnote
1)](http://www.ed.gov/policy/fund/guid/humansub/#1)**

**I. Applicability**

**A.** Part 2 of this Assurance applies to the following research
project/activity(ies) conducted or sponsored by this institution and
supported or regulated by the Department of Education .

1\. Project
title:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2\. ED P/R Award or RFP Number:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

3\. Project Investigator or Director:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

4a. Research activity title, if different from Project Title (*list each
separate research activity this institution will conduct or sponsor
under this research project, adding more lines, e.g., 4a., 4b., 4c., as
necessary)*:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

4b. Research activity title, if different from Project Title:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**B.** The institutions that are a party to this Assurance are:

1\. Institution Providing the Assurance:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2\. Institution Providing the Institutional Review Board (IRB), if other
than the institution in B.1. above:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**C.** Applicability of II C

II\. C. applies to the institution with the IRB. If the Institution
Providing the Assurance borrows the IRB of another institution, II.C.
applies to the Institution Providing the IRB.

**II.** **Institutional Responsibilities**

**A.** This institution has complied and shall continue to comply with
the requirements of 34 CFR Part 97.

**B.** In accordance with the compositional requirements of 34 CFR
97.107 and the quorum requirements of 34 CFR 97.108, the IRB designated
in the Assurance and in the roster attached to the Assurance is
responsible for the initial and continuing review of the research
project/activity(ies) involving human subjects specified in Part 2 of
this Assurance.

**C.** The institution with the IRB shall provide both meeting space for
the IRB and sufficient staff to support the IRB\'s review and record
keeping duties for the research project/activity(ies) specified in Part
2 of this Assurance.

**D.** This institution attests that the IRB membership for the research
project/activities specified in Part 2 of this Assurance satisfy the
compositional requirements of 34 CFR 97.107 and, if applicable, 34 CFR
350.4 and 34 CFR 356.3.

**E.** This institution shall accept and comply with the decisions of
the IRB.

**F.** In addition to the review and approval of the IRB, this
institution has reviewed and sponsors the research project/activity(ies)
specified in Part 2 of this Assurance.

**G.** This institution shall take steps to ensure that the research
investigators involved in the research project/activity(ies) specified
in Part 2 of this Assurance have a copy of this institution\'s statement
of commitment to the ethical principles and institutional policies
governing research involving human subjects.

**III.** **IRB Responsibilities**

**A.** The IRB shall review, and has the authority to approve, require
modification in, or disapprove the research project/activity(ies)
specified in Part 2 of this Assurance, or proposed changes to it, before
human subjects may be involved.

**B.** The convened IRB reviewed and approved and/or will review (the)
project/research activity(ies) specified in Part 2 of this Assurance.

**C.** The IRB determined, in accordance with the criteria found at 34
CFR 97.111, that protections for human research subjects are adequate.
This includes, where applicable, the determination that adequate
protections are ensured for children, in accordance with 34 CFR Part 97,
Subpart D.

**D.** The IRB has the authority to suspend or terminate approval of the
research project/activity(ies) in accordance with 34 CFR 97.113 for (1)
non-compliance with 34 CFR Part 97 and any other applicable regulations
or non-compliance with the IRB\'s requirements, and (2) for elimination
of unexpected serious harm to subjects.

**E.** The IRB has determined that legally effective informed consent
will be obtained in a manner and method which meets the requirements of
34 CFR 97.116 and 97.117. If children are involved, the IRB shall ensure
that the researcher(s) obtains the assent of the children and the
permission of their parents or guardians, or, if authorized under 34 CFR
Part 97, Subpart D, permission of the parents or guardians without the
assent of the children.

**F.** Continuing reviews by the IRB shall be conducted at intervals
appropriate to the degree of risk, but not less than once per year (34
CFR 97.109(e)). The IRB may be called into an interim review session by
the Chairperson at the request of any IRB member or institutional
official \[of the institutions named in this Assurance\] to consider any
matter concerned with the rights and welfare of any subject.

**G.** The IRB shall report promptly to institutional officials \[of the
institutions named in this Assurance\] the date(s) of continuing IRB
reviews of covered research activities and the results of these reviews.

**H.** The IRB shall prepare and maintain adequate documentation of its
activities in accordance with 34 CFR 97.115.

**I.** The IRB shall report promptly to institutional officials \[of the
institutions named in this Assurance\] and the Department of Education:

1.  any serious or continuing noncompliance by investigators with the
    requirements of the IRB;

2.  any suspension or termination of IRB approval;

3.  any unanticipated problems or injuries involving risks to subjects
    or others; and

4.  any changes in this research project activity(ies) which are
    reviewed and approved by the IRB.

**J.** The IRB membership satisfies the compositional requirements of 34
CFR 97.107 and, if applicable, 34 CFR 350.4 or 34 CFR 356.3.

**K.** The IRB shall comply fully with the requirements of all
applicable Federal policies and guidelines, including those concerning
confidentiality of information about subjects, Student Rights in
Research, Experimental Programs, and Testing, also known as the
Protection of Pupil Rights Amendment (PPRA), (34 CFR Part 98), and
Family Educational Rights and Privacy (FERPA) (34 CFR Part 99) -
[(Footnote 2).](http://www.ed.gov/policy/fund/guid/humansub/#2)

**IV.** **Research Investigator Responsibilities**

**A.** The research investigators acknowledge and accept their
responsibility for protecting the rights and welfare of human research
subjects and for complying with all applicable provisions of this
Assurance and 34 CFR Part 97.

**B.** The research investigators shall report promptly to the IRB
proposed changes in this research project/activity(ies), and the changes
shall not be initiated without IRB review and approval except where
necessary to eliminate apparent immediate hazards to the subjects. The
research investigators shall report promptly to the IRB changes made
without IRB review and approval in order to eliminate apparent immediate
hazards to the subjects.

**C.** The research investigators shall report promptly to the IRB any
unanticipated problems involving risks to subjects and others.

**Part 3**

**Certification of IRB Approval and Institutional Endorsement**

1\. Project
Title:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2\. ED PR/Award RFP
Number:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

3\. Project Investigator or
Director:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Type of Review: Full \_\_\_\_ **or** Expedited \_\_\_\_ IRB review\
Date of IRB Approval: \_\_\_\_\_\_\_ Date of Next Scheduled IRB
Review:\_\_\_\_\_\_\_\_\_\_

4a. Research Activity Title, if different from Project Title *(list each
separate research activity this institution will conduct or sponsor
under this research project, adding more lines as necessary)*:\
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Type of Review: Full \_\_\_\_ **or** Expedited \_\_\_\_ IRB review\
Date of IRB Approval: \_\_\_\_\_\_\_ Date of Next Scheduled IRB
Review:\_\_\_\_\_\_\_

4b. Research Activity Title, if different from Project Title:\
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Type of Review: Full \_\_\_\_ **or** Expedited \_\_\_\_ IRB review\
Date of IRB Approval:\_\_\_\_\_\_\_\_\_ Date of Next Scheduled IRB
Review:\_\_\_\_\_\_\_\_

The officials signing below assure that the research
project/activity(ies) referenced above was (were) approved by the IRB on
the date(s) indicated and that the research project/activity(ies) will
be conducted in accordance with the Department of Education regulations
for the protection of human subjects, 34 CFR Part 97, and the Assurance
document and, if applicable, 34 CFR Parts 350 and 356.

**I. Authorized Official of the Institution Providing this Assurance**

Signature:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please type the following items:

Name and
Title:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Telephone:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
FAX:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

E-Mail Internet
Address:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**II. Authorized Official of the Institution with the IRB (Include only
if different from the institution above.)**

Signature:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please type the following items:

Name and
Title:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Telephone:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
FAX:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

E-Mail Internet
Address:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**III. IRB Chairperson**

Signature:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please type the following items:

Name and
Title:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Telephone:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
FAX:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

E-Mail Internet
Address:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**IV. Responsible Project Investigator**

I have attached copies of all IRB approved consent/assent documents to
be used in this project, *if requested by the Department of Education.*

Signature:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Please type the following items:

Name and
Title:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Telephone:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
FAX:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

E-Mail Internet
Address:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**V. Institutional Review Board (IRB) Membership Roster** (Attachment to
Single Project Assurance)

Name of Institution Submitting this
Assurance:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of Institution with the
IRB:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Assurance Number, if Applicable:\_\_\_\_\_\_\_\_\_\_ IRB Number, if
Applicable: \_\_\_\_\_\_\_\_\_\_\_

***Note: The membership roster (names of IRB members, etc.) is not
required if the IRB is registered with the Office for Human Research
Protections (OHRP), unless requested by ED, or if the research is
subject to the additional requirements in 34 CFR 350.4 or 350.6.***

+---------+-----------+---------------+------------------+------------+
| Name    | Highest   | Primary       | Affiliation with | Gender     |
|         | Degree(s) | Scientific or | Institution(s)   | (Indicate  |
| (Last,  | Earned    | Nonscientific | above (Yes/No;   | **M**ale   |
| First,  |           | Specialty     | If yes, which    | or         |
| Middle  |           |               | one)             | *          |
| I       |           |               |                  | *F**emale) |
| nitial) |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
| \*      |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
| \*\*    |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
|         |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
|         |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
|         |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
|         |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
|         |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+
| \*\*\*  |           |               |                  |            |
+---------+-----------+---------------+------------------+------------+

*\* Denotes chairperson.*

*\*\* Denotes the person(s) meant to comply with the requirements in
Title 34, Code of Federal Regulations, Parts 350 and 356, if applicable*
[(Footnote 3).](http://www.ed.gov/policy/fund/guid/humansub/#3)

\*\*\**Denotes non-voting members, if any.*

*The research investigator(s) for the research project/activity(ies) for
which this Assurance is provided may not be shown as voting members on
the designated IRB. If their names appear on the roster, a footnote is
required that states that they are to be absent from reviews in which
they have a vested interest except as provided in the regulations.*

 

 

**-SPACE BELOW FOR ED-**

 

All parts of this Assurance are in compliance with the requirements of
34, Code of Federal Regulations, Part 97 and, if applicable, Parts 350
and 356.

In addition to Part 97, this activity is also governed by:

\_\_\_\_\_\_\_\_\_ Part 350

\_\_\_\_\_\_\_\_\_ Part 356

**ED Recommending Official**

Signature: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
\_\_\_\_\_\_\_\_\_\_\_\_

>  

Protection of Human Subjects Coordinator

Address: Financial Management Operations

Office of the Chief Financial Officer

U.S. Department of Education

400 Maryland Ave. SW

Washington, D.C. 20202-4331

Telephone: (202) 260-3353

Fax: (202) 205-0765

**ED Approving Official**

Signature: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
\_\_\_\_\_\_\_\_\_\_\_\_

Finance Management Operations

Address: Finance Management Operations

Office of the Chief Financial Officer

U.S. Department of Education

400 Maryland Ave. SW #4C112

Washington, D.C. 20202-4331

Telephone: (202) 260-3353

FAX: (202) 205-0765

**SINGLE PROJECT ASSURANCE NUMBER:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

 

**Footnote 1:**\
34 CFR Part 350 and 34 CFR Part 356 impose additional Institutional
Review Board (IRB) membership requirements in research projects
sponsored by the National Institute on Disability and Rehabilitation
Research. When an IRB reviews research that purposefully requires
inclusion of children with disabilities or individuals with mental
disabilities as research subjects, the IRB must include at least one
person primarily concerned with the welfare of these research subjects.

**Footnote 2:**\
34 CFR Part 98, the Protection of Pupil Rights Amendment (PPRA), is
intended to protect the rights of parents and students in programs that
receive funding from the Department of Education. It seeks to ensure
that schools and contractors make instructional materials available for
inspection by parents if used in connection with a Department of
Education-funded survey, analysis, or evaluation in which their children
participate, and it seeks to ensure that schools and contractors obtain
written parental consent before minor students are required to
participate in a Department of Education-funded survey, analysis, or
evaluation that reveals certain personal information.

34 CFR Part 99, the Family Educational Rights and Privacy Act (FERPA),
is designed to protect the privacy of a student\'s education records at
all public elementary and secondary schools and virtually all public and
private postsecondary institutions. It affords parents or eligible
students the right to inspect and review all of the student\'s education
records maintained by the school, gives parents and eligible students
the right to request that a school correct records believed to be
inaccurate or misleading, and generally requires a school to have
written permission from the parent or eligible student before releasing
any information from a student\'s record, except to certain parties.

**Footnote 3:**\
34 CFR Part 350 and 34 CFR Part 356 impose additional Institutional
Review Board (IRB) membership requirements in research projects
sponsored by the National Institute on Disability and Rehabilitation
Research. When an IRB reviews research that purposefully requires
inclusion of children with disabilities or individuals with mental
disabilities as research subjects, the IRB must include at least one
person primarily concerned with the welfare of these research subjects.

[Protection of Human Subjects in Research
page](http://www.ed.gov/about/offices/list/ocfo/humansub.html)