# INSTRUCTIONS FOR

# DEPARTMENT OF EDUCATION SUPPLEMENTAL INFORMATION FOR 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.

**2. Novice Applicant.** Check **"Yes"** or "**No**" only if assistance
is being requested under a program that gives special consideration to
novice applicants. Otherwise, **leave blank.**

Check "**Yes"** if you meet the requirements for novice applicants
specified in the regulations in 34 CFR 75.225 and included on the
attached page entitled "Definitions for Department of Education
Supplemental Information for SF 424." By checking "Yes" the applicant
certifies that it meets these novice applicant requirements. Check
"**No**" if you do not meet the requirements for novice applicants**.**

**3. Human Subjects Research.** (See I. A. "Definitions" in attached
page entitled "Definitions for Department of Education Supplemental
Information For SF 424.")

**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.

**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 Department of Education Supplemental Information For SF 424.")

**3a. 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. Insert 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 Department of Education Supplemental Information For SF
424."

**3a. 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 page
entitled "Definitions for Department of Education Supplemental
Information For SF 424

**3a. Human Subjects Assurance Number.** If the applicant has an
approved Federal Wide (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.
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.

**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.

***Paperwork 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.
The valid OMB control number for this information collection is
1894-0007. The time required to complete this information collection is
estimated to average between 15 and 45 minutes per response, including
the time to review instructions, search existing data resources, gather
the data needed, and complete and review the information collection. If
you have any comments concerning the accuracy of the estimate(s) or
suggestions for improving this form, please write to: U.S. Department of
Education, 400 Maryland Avenue, S.W., Washington, D.C. 20202-4537. If
you have comments or concerns regarding the status of your individual
submission of this form write directly to: Application Control Center,
U.S. Department of Education, Potomac Center Plaza, 550 12^th^ Street,
S.W. Room 7076, Washington, D.C. 20202-4260*.

**DEFINITIONS FOR**

# DEPARTMENT OF EDUCATION SUPPLEMENTAL INFORMATION FOR SF 424

# (Attachment to Instructions for Supplemental Information for SF 424)

**Definitions:**

**Novice Applicant (See 34 CFR 75.225**). For discretionary grant
programs under which the Secretary gives special consideration to novice
applications, a 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." *If an
activity follows a deliberate plan whose purpose is to develop or
contribute to generalizable knowledge it is research.* 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 linked to that individual (the identity of the
subject is or may be readily determined by the investigator or
associated with the information), 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]{.underline}** 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.

\(2\) 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.

\(5\) 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.

\(6\) 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 of Department of Education
Supplemental Information for SF 424, the applicant must provide a human
subjects "exempt research" or "nonexempt research" narrative. Insert the
narrative(s) in the space provided. 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 a. and designated exemption numbers(s),
provide the "exempt research" narrative. 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 a. you must provide the "nonexempt
research" narrative. 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 U.S. Department of Education, Protection of Human Subjects
Coordinator, Office of the Chief Financial Officer, LBJ Building, 400
Maryland Avenue, SW, Washington, D.C. 20202-4250, telephone: (202)
260-3353, 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 OMB Standard 424 in the upper right
corner of the form (if applicable).