U.S. Department of Education

**Independent Investigator Agreement** (Revised Oct. 2008)

*This agreement is for investigators who will be conducting research
under a U.S. Department of Education (ED) sponsored or conducted project
when acting in their own name, independent of any institution.*

Name of Independent Investigator:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name of Institution with the Assurance[^1]:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

# Part A. Ethical Principles

1.  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
    (name of independent investigator), hereinafter referred to as the
    \"investigator,\" in the following ED-sponsored or conducted
    project:

    a.  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
        (Project Title)

    b.  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
        (PR/Award or RFP Number)

> is guided by the ethical principles regarding all research involving
> human 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\").

2.  Accordingly, this investigator understands and shall abide by the
    principles of respect for persons, minimization of risks,
    maximization of benefits, and fairness as stated in the Belmont
    Report, and shall apply these principles in all research covered by
    this Agreement.

**Part B. Responsibilities of the Investigator**

1.  This investigator acknowledges and accepts responsibility for
    protecting the rights and welfare of human research subjects.

2.  This investigator assures that before human subjects are involved in
    research, proper consideration will be given to:

    a.  the risks to the subjects;

    b.  the anticipated benefits to the subjects and others;

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

    d.  the informed consent process to be employed;

    e.  the provisions to protect the privacy of subjects;

    f.  the need for additional safeguards for vulnerable populations;
        and

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

3.  This investigator accepts responsibility for his/her performance in
    this research project and will protect human research subjects and
    satisfy the intent and procedures as specified in 34 CFR Part 97, as
    amended, and other Federal, state, or local laws or regulations
    which may apply.

4.  This investigator will comply with all other pertinent procedures,
    such as prior review by an appropriately designated Institutional
    Review Board (IRB) and informed consent, that are designed to ensure
    effective application of protections for the rights and welfare of
    human subjects.

5.  This investigator will abide by the reviews of the IRB designated
    below and will accept the final authority and decisions of that IRB.

6.  This investigator acknowledges and agrees to cooperate in the IRB\'s
    responsibility for initial and continuing IRB reviews,
    recordkeeping, reporting and certification. In addition, continuing
    reviews will be preceded by progress reports to include overall
    findings of this project.

7.  This investigator specifically acknowledges the need to promptly
    report the following to the designated IRB:

    a.  any proposed changes in IRB-approved protocols, and agrees not
        to initiate such changes without prior IRB review and approval
        except to eliminate apparent immediate hazards to subjects, and

    b.  any injuries to subjects or unanticipated problems involving
        risks to subjects or others.

8.  This investigator agrees not to accrue subjects on protocols for
    this project prior to approval of this Agreement and without
    certification of IRB review for each additional research activity
    that may be added to it.

9.  Continuing IRB reviews must be conducted at least annually and may
    be conducted more frequently at the discretion of the IRB (34 CFR
    109.2). Minor changes may be expedited (34 CFR 110(b)).

10. This investigator understands that he or she may not participate in
    convened discussion or voting of the IRB except by invited
    attendance to provide information to the IRB upon request (34 CFR
    97.107(e)).

11. The investigator understands and 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 (PPRA) (34 CFR Part 98), and Family Educational Rights and
    Privacy (FERPA) (34 CFR Part 99). [^2]

12. This investigator agrees not to refer subjects accrued for protocols
    approved for this project by the IRB for the purpose of other
    research without prior IRB notification.

**Part C. Responsibilities of the Designated IRB**

1.  The IRB and its host institution, which are designated below, agree
    to abide by 34 CFR Part 97, the cited Assurance, this Agreement, and
    all applicable Federal policies and guidelines, including those
    concerning confidentiality of information about subjects, Student
    Rights in Research, Experimental Programs, and Testing (PPRA) (34
    CFR Part 98), and Family Educational Rights and Privacy (FERPA) (34
    CFR Part 99).

2.  The IRB membership satisfies the compositional requirements of 34
    CFR 97.107 and, if applicable, 34 CFR 350.4 or 356.3. [^3]

3.  It is agreed that the IRB shall require receipt of progress reports
    from the independent investigator on at least an annual basis or
    more frequently depending on the degree of risk.

4.  The IRB shall report promptly to ED officials and institutional
    official of the IRB named in this Agreement:

    a.  any serious or continuing noncompliance by the investigator with
        the requirements of the IRB;

    b.  any suspension or termination of IRB approval;

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

    d.  any changes in the research activity (ies) for award which are
        reviewed and approved by the IRB.

**Part D. Endorsements**

1.  **Designation of the IRB of Record**

    a.  This investigator has designated and reached agreement with
        officials of an institution, named in D.2.a. below, for the
        following project:

        i.  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
            (Project Title)

        ii. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_(PR/Award
            or RFP Number

    b.  The institution is in possession of an applicable Assurance[^4]
        and will provide the IRB of Record for this Agreement:

        i.  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_(Assurance
            Number)

        ii. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_(IRB
            Number, if any)

    c.  Statement and Signature of the Independent Investigator

> I assure that I will abide by the principles and responsibilities set
> forth in Parts A. and B. of this Agreement:
>
> Signature:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Date:
> \_\_\_\_\_\_\_\_\_\_\_\_
>
> Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Telephone: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ FAX:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> E-Mail Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

2.  **Institutional Official and IRB Chair Statements and Signatures**

    a.  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

> (name of institution) is in possession of the Assurance cited in
> D.1.b. above.

b.  The IRB and institution agree to be cognizant of the contents of
    this Agreement and to act in concert with all its requirements, in
    addition to those of its Assurance.

c.  Institutional Official (Authorized Official of the Institution with
    the IRB)

> Signature:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Date:
> \_\_\_\_\_\_\_\_\_\_\_\_
>
> Name and
> Title:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Telephone: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ FAX:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> E-Mail Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> d\. IRB Chairperson
>
> Signature:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Date:
> \_\_\_\_\_\_\_\_\_\_\_\_
>
> Name:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Telephone: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ FAX:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> E-Mail Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Part E.**

**Institutional Review Board (IRB) Membership Roster** (Attachment to
Independent Investigator Agreement)

Name of Institution:

Assurance Number:

IRB Number, if applicable:

Note: The membership roster (names, etc., of IRB members) 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  | G     |
|                   | De      | Scientific or | with         | ender |
| (Last, First,     | gree(s) | Nonscientific | In           | (Ind  |
| Middle Initial)   | Earned  | Specialty     | stitution(s) | icate |
|                   |         |               | above        | **M   |
|                   |         |               | (Yes/No; If  | **ale |
|                   |         |               | yes, which   | or    |
|                   |         |               | one)         | *     |
|                   |         |               |              | *F**e |
|                   |         |               |              | male) |
+===================+=========+===============+==============+=======+
| \*                |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+
| \*\*              |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+
|                   |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+
|                   |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+
|                   |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+
|                   |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+
|                   |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+
| \*\*\*            |         |               |              |       |
+-------------------+---------+---------------+--------------+-------+

*\* 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.*[^5]

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

*The research investigator(s) for the research project/activity(ies) for
which this Agreement 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 Agreement are in compliance with the requirements of
34 CFR 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: Office of the Chief Financial Officer

U.S. Department of Education

400 Maryland Ave. SW,

Washington, D.C. 20202

Telephone: (202) 260-3353 Fax: (202) 205-0765

**ED Approving Official**

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

Director, FMO

Address: FMO, Office of the Chief Financial Officer

U.S. Department of Education

400 Maryland Ave. SW,

Washington, D.C. 20202

Telephone: (202) 260-3353 Fax: (202) 205-0765

**Agreement Number
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

[^1]: ED will accept a Federal Wide Assurance (FWA) issued by the U.S.
    Department of Health and Human Services, Office for Human Research
    Protections (OHRP), if the assurance is current and applicable to
    the project cited in this Agreement.

[^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
    parents or eligible student before releasing any information from a
    student\'s record, except to certain parties.

[^3]: 34 CFR Part 350 and 34 CFR Part 356 impose additional IRB
    membership requirements in certain 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.

[^4]: ED will accept a Federal Wide Assurance (FWA) issued by the U.S.
    Department of Health and Human Services, Office for Human Research
    Protections (OHRP), if the assurance is current and applicable to
    the project cited in this Agreement.

[^5]: 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.