Laws & Guidance GRANTS & CONTRACTS
Instructions and Checklists for Preparing the U.S. Department of Education Single Project Assurance and the Independent Investigator Agreement
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(Revised February 2006)

I. Instructions and Checklist for Single Project Assurance

A. Instructions for Preparing the Single Project Assurance

The Assurance document must be on institutional letterhead and must include original signatures.

The parts of the Assurance should be prepared as follows:

Parts Instructions
Page 1, Top of Page Enter the legal name of the institution filing the Assurance.
Part 2, I, A. Enter (1) the name of the research project to which this Assurance applies; (2) the PR/Award or RFP number assigned by ED; (3) the name of the project investigator responsible for the research to be accomplished at the institution, or the overall project director, if any, who may be located at another site for multi-site projects; and (4) the full name of each separate research activity this institution will conduct or sponsor under this research project.
Part 2, I, B. Enter (1) the name of the Institution Providing the Assurance; and (2) the name of the Institution Providing the Institutional Review Board, if other than the Institution Providing the Assurance.
Part 3, Certification Enter (1) the name of the research project to which this Assurance applies; (2) the PR/Award or RFP number assigned by ED; (3) the name of the project investigator responsible for the research to be accomplished at the institution, or the overall project director, if any, who may be located at another site for multi-site projects; and (4) the name of each separate research activity this institution will conduct or sponsor under this research project.
Part 3, Dates of IRB Approval Enter the date of review by the IRB of record, and the projected date for the IRB’s next review for the research project/each research activity this institution will conduct or sponsor under this research project. The date of IRB review and approval must be within the last 12 months and must be the same date or precede the dates that correspond to signatures for the institutional offical and IRB chair.
Part 3, I. Obtain the signature and enter the name, title, address, etc., of the administrator (e.g., CEO) who is authorized to commit the Institution Providing the Assurance to legal agreements and is an employee of this institution. (This is not the investigator.) The signature must be an original signature.
Part 3, II. Disregard this section if the Institution Providing the Assurance has its own IRB. If this institution borrows the IRB of another institution, enter the name, title, address, etc., of the authorized official for the Institution Providing the IRB and obtain an original signature of the authorized official.
Part 3, III. Obtain the signature and enter the name, address, etc., of the IRB Chair. If the institution with the IRB has a Federal Wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), enter the OHRP assigned number of the assurance on the IRB roster, V.
Part 3, IV. Be sure to have the Project Investigator or Director sign in this section.
Part 3, V. IRB Membership Roster The research investigator(s) for the research project/activity(ies) for which this Assurance is provided may not be shown as (a) voting member(s) on the designated IRB for the research activity(ies). 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 for in the regulations [34 CFR 97.107(e)].

Be sure to fill in all required fields of information. The roster is an integral part of the SPA, and revisions must be forwarded to ED with each change in membership.

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

B. Checklist for the Single Project Assurance

1. Letterhead and Original Signatures. Make sure page 1 is on institutional letterhead, and that the signatures on the signature lines are original.

2. IRB Membership. Make sure the membership of the designated Institutional Review Board (IRB) complies with the requirements of 34 CFR  97.107 and, if applicable, 34 CFR  350.4 (c) and 34 CFR  356.3(c).

34 CFR Part 97.107: Check for the following:

a. At least 5 members with varying backgrounds to promote complete and adequate review of research activities;
b. Experience and expertise, diversity of backgrounds, sensitivity to community attitudes to promote respect;
c. Professional competence necessary to review specific research activities;
d. Knowledge of institutional commitments and regulations, applicable law, and standards of professional conduct and practice;
e. Knowledge about and experience in working with vulnerable subjects, e.g., children, persons with disabilities;
f. Both genders if possible;
g. More than one profession represented;
h. At least one person whose primary concerns are in scientific areas;
i. At least one person whose primary concerns are in nonscientific areas;
j. At least one voting member who is not affiliated with the institution and not part of the immediate family of a person affiliated with the institution.

34 CFR 350.4(c) and 34 CFR 356.3(c), if applicable, check for:

a. At least one person primarily concerned with the welfare of children with disabilities or persons with mental disabilities if these vulnerable populations are purposefully selected as research subjects in certain projects funded by the National Institute on Disability and Rehabilitation Research.

3. Use of another institution’s IRB. If you do not have your own IRB, you may be able to "borrow" the IRB of an institution that has one.

a. Check the web site for the Office for Human Research Protections, Department of Health and Human Services, for the list of institutions in your state that have an existing Federal Wide Assurance (FWA) [http://ohrp.cit.nih.gov/search/asearch.asp]. If there is one, contact them and ask them if they would be willing to serve as the institution with the IRB for your project.

4. IRB Roster. Check the IRB roster to be sure that all the columns of the IRB table are completed.

5. Signatures.

a. Obtain the signature of the Principal Project Investigator or co-Project Investigator at the institution for which the SPA is being prepared.
b. Present the informed consent documents and assent scripts/documents, the protocol summary, and the SPA to the designated IRB for review, approval, and signature of the IRB chairperson.
c. Obtain the signature of the IRB chairperson.
d. Obtain the signature of the administrator (CEO) of your institution who is authorized to commit the institution to binding legal agreements; this individual signs as the ‘Authorized Official of the Institution Providing this Assurance.’
e. If you use the Institutional Review Board of another institution, obtain the signature of the authorized official for that institution as well; this individual will sign the Assurance as the ‘Authorized Official of the Institution with the Institutional Review Board.’

6. Project Identifier. Include the ED assigned PR/Award or RFP number in the Assurance and in all correspondence with ED about the Assurance.

7. Mailing the SPA. Mail the SPA to the Department of Education official designated to receive the Assurance. The submitted SPA document must bear original signatures. Attach copies of IRB-approved consent/assent documents to be used in this project only if requested by the Department of Education.

(Adapted from Office for Protection from Research Risks, Department of Health and Human Services, Detailed Guidance for Preparation of a Single Project Assurance, June 1996.)

II. Instructions and Checklist for Independent Investigator Agreement

A. Instructions for Preparing the Independent Investigator Agreement

The agreement should be prepared as follows:

Parts Instructions
Part A Enter the name of the independent investigator responsible for the research to be accomplished, the title of the research project to which this Agreement applies, and the PR/Award or RFP number assigned by ED.
Part D, 1a. Enter the title of the research project to which this Agreement applies and the PR/Award or RFP number assigned by ED.
Part D, 1b. Enter the Assurance number and the Institutional Review Board (IRB) number, if any, of the institution providing the IRB review for this project.
Part D, 1c. Sign your name and enter your title, address, telephone, etc.
Part D, 2a. Enter the name of the institution signing the Agreement and providing the IRB review.
Part D, 2c. Obtain the original signature of the authorized official of the institution with the IRB. (The authorized official is not the IRB Chairperson.) Enter the official's name, title, address, etc.
Part D, 2d. Obtain the original signature of the IRB Chairperson. Enter the IRB Chairperson's name, address, etc.
Part E, Institutional Review Board Membership Roster The research investigator(s) for the research project/activity(ies) for which this Agreement is provided may not be shown as (a) voting member(s) on the designated IRB for the research activity(ies). 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 for in the regulations [34 CFR 97.107(e)].

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

B. Checklist for Preparing the Independent Investigator Agreement

1. Original Signatures. Make sure the signatures on the signature line are original.

2. IRB. Since you are an independent investigator, you need to reach agreement with officials of an institution that has an Assurance and designate that institution's IRB as the IRB of record for your research project. The Assurance can be an ED-approved Single Project Assurance or a Federal Wide Assurance (FWA).

a. Check the web site for the Office for Human Research Protections, Department of Health and Human Services, for the list of institutions in your state that have an existing FWA [http://ohrp.cit.nih.gov/search/asearch.asp]. If there is one, contact them and ask them if they would be willing to serve as the institution with the IRB for your project.

3. IRB Membership. Make sure that the membership of the designated Institutional Review Board (IRB) complies with the requirements of 34 CFR 97.107 and, if applicable, 34 CFR 350.4 (c) and 34 CFR 356.3 (c).

34 CFR 97.107: Check for the following:

a. At least 5 members with varying backgrounds to promote complete and adequate review of research activities;
b. Experience and expertise, diversity of backgrounds, sensitivity to community attitudes to promote respect;
c. Professional competence necessary to review specific research activities;
d. Knowledge of institutional commitments and regulations, applicable law, and standards of professional conduct and practice;
e. Knowledge about and experience in working with vulnerable subjects, e.g., children, persons with disabilities;
f. Both genders if possible;
g. More than one profession represented;
h. At least one person whose primary concerns are in scientific areas;
i. At least one person whose primary concerns are in nonscientific areas;
j. At least one voting member who is not affiliated with the institution and not part of the immediate family of a person affiliated with the institution.

34 CFR 350.4 (c) and 34 CFR356.3 (c), if applicable, check for:

a. At least one person primarily concerned with the welfare of children with disabilities or persons with mental disabilities if these vulnerable populations are purposefully selected as research subjects in certain projects funded by the National Institute on Disability and Rehabilitation Research.

4. IRB Roster. Check the IRB roster to be sure that all the columns of the IRB table are completed.

5. Signatures.

a. Sign your name in D.1.c., the space reserved for the signature of the Independent Investigator.
b. Obtain the signature of the administrator (CEO) of the institution that is entering into the agreement and providing the IRB of record. The person must be authorized to commit the institution to binding legal agreements. This individual signs as the "Authorized Official of the Institution with the IRB" in D.2.c.
c. Obtain the signature of the IRB Chairperson in D.2.d.

6. Project Identifier. Include the ED assigned PR/Award or RFP number in the Agreement and in all correspondence with ED about the Agreement.

7. Mailing the IIA. Mail the IIA to the Department of Education official designated to receive the Agreement. The submitted IIA document must bear original signatures. Attach copies of the IRB-approved consent/assent documents to be used in this project only if requested by the Department of Education.

Link to Protection of Human Subjects page


 
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Last Modified: 02/28/2006