Sample Single Project Assurance

U.S. Department of Education

Sample Single Project Assurance (Revised February 2006)

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.

“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).

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 (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 .

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:

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