Instructions for U.S. Department of Education 

Supplemental Information for the SF-424

1. Project Director. Name, address, telephone and fax numbers, and e-mail address of the person to be contacted on matters involving this 

application. Items marked with an asterisk (*) are mandatory.

2. Novice Applicant. Check “Yes” if you meet the definition for novice applicants specified in the regulations in 34 CFR 75.225 and included 

on the attached page entitled “Definitions for U.S. Department of Education Supplemental Information for the SF-424”). By checking “Yes” 

the applicant certifies that it meets these novice applicant requirements. Check “No” if you do not meet the definition for novice applicants.

This novice applicant information will be used by ED to: 1) determine the amount and type of technical assistance that a novice might need, if 

funded, and 2) determine novice applicant eligibility in discretionary grant competitions that give special consideration to novice applications. 

Certain ED discretionary grant programs give special consideration to novice applications, either by establishing a special competition for 

novice applicants or by giving competitive preference to novice applicants under the procedures in 34 CFR 75.105(c)(2). If special 

consideration is being given to novice applications under a particular discretionary grant competition, the application notice for the competition 

published in the Federal Register will specify this information

3. Human Subjects Research. (See I. A. “Definitions” in attached page entitled “Definitions for U.S. Department of Education Supplemental 

Information for the SF-424.”)

3a. If Not Human Subjects Research. Check “No” if research activities involving human subjects are not planned at any time during the 

proposed project period. The remaining parts of Item 3 are then not applicable.

3a. If Human Subjects Research. Check “Yes” if research activities involving human subjects are planned at any time during the proposed 

project period, either at the applicant organization or at any other performance site or collaborating institution. Check “Yes” even if the 

research is exempt from the regulations for the protection of human subjects. (See I. B. “Exemptions” in attached page entitled “Definitions for 

U.S. Department of Education Supplemental Information for SF-424.”) 

3b. If Human Subjects Research is Exempt from the Human Subjects Regulations. Check “Yes” if all the research activities proposed are 

designated to be exempt from the regulations. Check the exemption number(s) corresponding to one or more of the six exemption categories 

listed in I. B. “Exemptions.” In addition, follow the instructions in II. A. “Exempt Research Narrative” in the attached page entitled 

“Definitions for U.S. Department of Education Supplemental Information for the SF-424.” 

3b. If Human Subjects Research is Not Exempt from Human Subjects Regulations. Check “No” if some or all of the planned research 

activities are covered (not exempt). In addition, follow the instructions in II. B. “Nonexempt Research Narrative” in the attached page entitled 

“Definitions for U.S. Department of Education Supplemental Information for the SF-424.”

3b. Human Subjects Assurance Number. If the applicant has an approved Federal Wide Assurance (FWA) on file with the Office for 

Human Research Protections (OHRP), U.S. Department of Health and Human Services, that covers the specific activity, insert the number in 

the space provided. (A list of current FWAs is available at: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc) If the applicant does not 

have an approved assurance on file with OHRP, enter “None.” In this case, the applicant, by signature on the SF-424, is declaring that it will 

comply with 34 CFR 97 and proceed to obtain the human subjects assurance upon request by the designated ED official. If the application is 

recommended/selected for funding, the designated ED official will request that the applicant obtain the assurance within 30 days after the 

specific formal request.

3c. If applicable, please attach your “Exempt Research” or “Nonexempt Research” narrative to your submission of the U.S Department of 

Education Supplemental Information for the SF-424 form as instructed in item II, “Instructions for Exempt and Nonexempt Human Subjects 

Research Narratives” in the attached page entitled “Definitions for U.S. Department of Education Supplemental Information for the SF-424.” 

Note about Institutional Review Board Approval. ED does not require certification of Institutional Review Board approval with the 

application. However, if an application that involves non-exempt human subjects research is recommended/selected for funding, the designated 

ED official will request that the applicant obtain and send the certification to ED within 30 days after the formal request.

No covered human subjects research can be conducted until the study has ED clearance for protection of human 

subjects in research.

Public Burden Statement:

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless such collection 

displays a valid OMB control number. Public reporting burden for this collection of information is estimated to average 20 minutes per 

response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing 

and reviewing the collection of information. The obligation to respond to this collection is required to obtain or retain benefit (20 USC 3474 

General Education Provisions Act). Send comments regarding the burden estimate or any other aspect of this collection of information, 

including suggestions for reducing this burden, to the U.S. Department of Education, 400 Maryland Ave., SW, Washington, DC 20210-4537 or 

email ICDocketMgr@ed.gov and reference the OMB Control Number 1894-0007. Note: Please do not return the completed ED SF 424 

Supplemental Form to this address.
Definitions for U.S. Department of Education 

Supplemental Information for the SF-424

Definitions:

Novice Applicant (See 34 CFR 75.225)

For discretionary grant programs, novice applicant means any 

applicant for a grant from ED that—

 Has never received a grant or subgrant under the 

program from which it seeks funding;

 Has never been a member of a group application, 

submitted in accordance with 34 CFR 75.127-75.129, 

that received a grant under the program from which it 

seeks funding; and

 Has not had an active discretionary grant from the 

Federal government in the five years before the 

deadline date for applications under the program. For 

the purposes of this requirement, a grant is active until 

the end of the grant’s project or funding period, 

including any extensions of those periods that extend 

the grantee’s authority to obligate funds.

In the case of a group application submitted in accordance with 

34 CFR 75.127-75.129, a group includes only parties that meet 

the requirements listed above.

PROTECTION OF HUMAN SUBJECTS IN RESEARCH

I. Definitions and Exemptions

A. Definitions.

A research activity involves human subjects if the activity is 

research, as defined in the Department’s regulations, and the 

research activity will involve use of human subjects, as defined 

in the regulations.

—Research

The ED Regulations for the Protection of Human Subjects, Title 

34, Code of Federal Regulations, Part 97, define research as “a 

systematic investigation, including research development, 

testing and evaluation, designed to develop or contribute to 

generalizable knowledge. Activities which meet this definition 

constitute research whether or not they are conducted or 

supported under a program that is considered research for other 

purposes. For example, some demonstration and service 

programs may include research activities.

—Human Subject

The regulations define human subject as “a living individual 

about whom an investigator (whether professional or student) 

conducting research obtains (1) data through intervention or 

interaction with the individual, or (2) identifiable private 

information.” (1) If an activity involves obtaining information 

about a living person by manipulating that person or that 

person’s environment, as might occur when a new instructional 

technique is tested, or by communicating or interacting with the 

individual, as occurs with surveys and interviews, the definition 

of human subject is met. (2) If an activity involves obtaining 

private information about a living person in such a way that the 

information can be directly or indirectly linked to that 

individual), the definition of human subject is met [Private 

information includes information about behavior that occurs in a 

context in which an individual can reasonably expect that no 

observation or recording is taking place, and information which 

has been provided for specific purposes by an individual and 

which the individual can reasonably expect will not be made 

public (for example, a school health record).]

B. Exemptions.

Research activities in which the only involvement of human 

subjects will be in one or more of the following six categories of 

exemptions are not covered by the regulations:

(1) Research conducted in established or commonly accepted 

educational settings, involving normal educational practices, 

such as (a) research on regular and special education 

instructional strategies, or (b) research on the effectiveness of or 

the comparison among instructional techniques, curricula, or 

classroom management methods. If an educational practice is 

being introduced to the site and is not widely used for similar 

populations, it is not covered by this exemption.

(2) Research involving the use of educational tests (cognitive, 

diagnostic, aptitude, achievement), survey procedures, interview

procedures or observation of public behavior, unless: (a) 

information obtained is recorded in such a manner that human 

subjects can be identified, directly or through identifiers linked 

to the subjects; and (b) any disclosure of the human subjects’ 

responses outside the research could reasonably place the 

subjects at risk of criminal or civil liability or be damaging to 

the subjects’ financial standing, employability, or reputation. If 

the subjects are children, exemption 2 applies only to research 

involving educational tests and observations of public behavior 

when the investigator(s) do not participate in the activities 

being observed. 

Exemption 2 does not apply if children are surveyed or 

interviewed or if the research involves observation of public 

behavior and the investigator(s) participate in the activities 

being observed. [Children are defined as persons who have not 

attained the legal age for consent to treatments or procedures 
involved in the research, under the applicable law or jurisdiction 

in which the research will be conducted.]

(3) Research involving the use of educational tests (cognitive, 

diagnostic, aptitude, achievement), survey procedures, interview

procedures or observation of public behavior that is not exempt 

under section (2) above, if the human subjects are elected or 

appointed public officials or candidates for public office; or 

federal statute(s) require(s) without exception that the 

confidentiality of the personally identifiable information will be 

maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, 

documents, records, pathological specimens, or diagnostic 

specimens, if these sources are publicly available or if the 

information is recorded by the investigator in a manner that 

subjects cannot be identified, directly or through identifiers 

linked to the subjects. [This exemption applies only to 

retrospective studies using data collected before the initiation 

of the research.]

(5) Research and demonstration projects which are conducted 

by or subject to the approval of department or agency heads, and 

which are designed to study, evaluate, or otherwise examine: 

(a) public benefit or service programs; (b) procedures for 

obtaining benefits or services under those programs; (c) possible 

changes in or alternatives to those programs or procedures; or 

(d) possible changes in methods or levels of payment for 

benefits or services under those programs. [The standards of 

this exemption are rarely met because it was designed to apply 

only to specific research conducted by the Social Security 

Administration and some Federal welfare benefits programs.]

(6) Taste and food quality evaluation and consumer acceptance 

studies, (a) if wholesome foods without additives are consumed 

or (b) if a food is consumed that contains a food ingredient at or 

below the level and for a use found to be safe, or agricultural 

chemical or environmental contaminant at or below the level 

found to be safe, by the Food and Drug Administration or 

approved by the Environmental Protection Agency or the Food 

Safety and Inspection Service of the U.S. Department of 

Agriculture.

II. Instructions for Exempt and Nonexempt Human 

Subjects Research Narratives

If the applicant marked “Yes” for Item 3.b. of the U.S. 

Department of Education Supplemental Information for the SF 

424, the applicant must attach a human subjects “exempt 

research” or “nonexempt research” narrative to the U.S. 

Department of Education Supplemental Information for the SF424 form. If you have multiple projects and need to provide 

more than one narrative, be sure to label each set of responses as 

to the project they address.

A. Exempt Research Narrative.

If you marked “Yes” for item 3.b. and designated exemption 

numbers(s), attach the “exempt research” narrative to the U.S.

Department of Education Supplemental Information for the SF424. The narrative must contain sufficient information about the 

involvement of human subjects in the proposed research to 

allow a determination by ED that the designated exemption(s) 

are appropriate. The narrative must be succinct.

B. Nonexempt Research Narrative.

If you marked “No” for item 3.b. you must attach the 

“nonexempt research” narrative to the U.S. Department of 

Education Supplemental Information for the SF-424. The 

narrative must address the following seven points. Although no 

specific page limitation applies to this section of the application, 

be succinct.

(1) Human Subjects Involvement and Characteristics: 

Provide a detailed description of the proposed involvement of 

human subjects. Describe the characteristics of the subject 

population, including their anticipated number, age range, and 

health status. Identify the criteria for inclusion or exclusion of 

any subpopulation. Explain the rationale for the involvement of 

special classes of subjects, such as children, children with 

disabilities, adults with disabilities, persons with mental 

disabilities, pregnant women, prisoners, institutionalized 

individuals, or others who are likely to be vulnerable

(2) Sources of Materials: Identify the sources of research 

material obtained from individually identifiable living human 

subjects in the form of specimens, records, or data. Indicate 

whether the material or data will be obtained specifically for 

research purposes or whether use will be made of existing 

specimens, records, or data.

(3) Recruitment and Informed Consent: Describe plans for 

the recruitment of subjects and the consent procedures to be 

followed. Include the circumstances under which consent will 

be sought and obtained, who will seek it, the nature of the 

information to be provided to prospective subjects, and the 

method of documenting consent. State if the Institutional 

Review Board (IRB) has authorized a modification or waiver of 

the elements of consent or the requirement for documentation of 

consent.

(4) Potential Risks: Describe potential risks (physical, 

psychological, social, legal, or other) and assess their likelihood 

and seriousness. Where appropriate, describe alternative 

treatments and procedures that might be advantageous to the 

subjects.

(5) Protection Against Risk: Describe the procedures for 

protecting against or minimizing potential risks, including risks 

to confidentiality, and assess their likely effectiveness. Where 

appropriate, discuss provisions for ensuring necessary medical 

or professional intervention in the event of adverse effects to the 

subjects. Also, where appropriate, describe the provisions for 

monitoring the data collected to ensure the safety of the 

subjects.

(6) Importance of the Knowledge to be Gained: Discuss the 

importance of the knowledge gained or to be gained as a result 
of the proposed research. Discuss why the risks to subjects are 

reasonable in relation to the anticipated benefits to subjects and 

in relation to the importance of the knowledge that may 

reasonably be expected to result.

(7) Collaborating Site(s): If research involving human subjects 

will take place at collaborating site(s) or other performance 

site(s), name the sites and briefly describe their involvement or 

role in the research.

Copies of the Department of Education’s Regulations for the 

Protection of Human Subjects, 34 CFR Part 97 and other 

pertinent materials on the protection of human subjects in 

research are available from the Office of the Chief Financial 

Officer, U.S. Department of Education, Washington, D.C. 

20202-4331, telephone: (202) 245-8090, and on the U.S.

Department of Education’s Protection of Human Subjects in 

Research Web Site: 

http://www.ed.gov/about/offices/list/ocfo/humansub.html

NOTE: The State Applicant Identifier on the SF-424 is for 

State Use only. Please complete it on the SF-424 in the upper 

right corner of the form (if applicable).