### 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 i n volving this application. Items marked w ith 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 Educat i on S upplemental Information for the SF

- 424”). By checking “Yes” the applicant certifies t h at 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 disc retionary 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 specia l consideration is being given to novice applications under a particular discretionary grant competition, the application notic e for the competition published in the Federal Register will specify this information **3. Hum an Subjects Research.**  (See I. A. “ Definitions” in attached page ent i tled “Definitions for U.S. Department of Education Supplemental Information for the SF

- 424.”) **3a. If Not Hum an Subjects Research.**  Check “ **No** ” if research activities invol v ing human subjects are not planned at any time during the proposed project period. The r e maining parts of Item 3 are then not applicable. **3a. If Hum an Subjects Research.**  Check “ **Yes** ” if research activities involving human subjects are planned at any time dur ing 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 regul a tions for the protection of human subjects. (See I. B. “Exemptions” in attached page entitled “Definitions f or U.S. Department of Education Supplemental Information for SF

- 424.”) **3b. If Hum an Subjects Research is Exempt from the Human Subjects Regulations.**  Check “ **Yes** ” if all the research activ i ties proposed are designated to be exempt from the regul a tions. Check the exem ption 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 Narr a tive” in the attached page entitled “Definitions for U.S. Departm ent of Education Supplemental Information for the SF

- 424.” **3b. If Hum an Subjects Research is Not Exempt from H**  **u man Subjects Regulations.**  Check “ **No** ” if some or all of the planned research activities are covered (not exempt). In addition, follow the ins tructions in II. B. “Nonexempt Research Narr a tive” in the attached page entitled “Definitions for U.S. Department of Education Supplemental Information for the SF

- 424 .” **3b. Hum**  **an Subjects Assurance Number.** If the applicant has an approved Federal Wide A ssurance (FWA) on file with the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Serv ices, 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 d eclaring 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 de s ignated ED official will request that the applicant o btain 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 Departmen t of Education Supplemental Information for the SF

- 424 form as instructed in item II , “ Instructions for Exempt and Nonexempt Human Subjects R e search Narratives ” in the attached page entitled “Definitions for U.S. Department of Education Supplemental Information for the SF

- 424.” **Note about Institutional Revie w Board Approval.**  ED does not require certification of Institutional Review Board approval w ith the application. How ever, if an application that involves non

- exem pt human subjects research is recommended/selected for funding, the designated ED official w ill request that the applicant obtain and send the certification to ED within 30 days after the formal r e quest


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

### . **Public Burde n Statem**  **ent:** According to the Paperw ork Reduction Act of 1995, no persons are required to respond to a collection of information unless su ch collection displays a valid OMB control number. Public reporting burden for this collection of information is esti mated to average 20 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data need ed, 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 info rm ation, including suggestions for reducing this burden, to the U.S . Department of Education, 400 Maryland Ave., SW, Washington, DC 20210

- 4537 or em ail ICDocketMgr@ed.gov and reference the OMB Control Number 1894

- 0007. Note: Please do not return the completed ED SF 424 Supplement al 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 fro m ED that

—

 Has never received a grant or subgrant under the pr o gram from which it seeks funding;

 Has never been a member of a group application, submi tted in accordance with 34 CFR 75.127

- 75.129, that r e ceived a grant under the program from which it seek s fun d ing; and

 Has not had an active discretionary grant from the Fe d eral government in the five years before the deadline date for applications under the program. For the purposes of this requirement, a grant is a c tive until the end of the grant’s proje ct or funding period, including any exte n sions of those periods that extend the grantee’s authority to obl i gate 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 requir e me nts listed above.

**PROTECTION OF HUMAN SUBJECTS IN R E**  **SEARCH**
**I. Definitions and Exe mptions**  **A. Definitions.** A research activity involves human subjects if the activity is research, as defined in the Department’s regulations, and the r e search activit y will involve use of human subjects, as defined in the regul a tions.

—**Research** The ED Regulations for the Protection of Human Su b jects, Title 34, Code of Federal Regulations, Part 97, define research as “a systematic investigation, including research dev elopm ent, tes t ing and evaluation, designed to develop or contribute to generali z able knowledge

. Activities which meet this definition constitute research whether or not they are conducted or su p ported under a program that is considered research for other p urposes. For example, some demonstration and service pr o grams 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 inform a tion.” (1) If an activity involves obtaining information about a living person by manipulating that person or that person’s env i ronment, as might occur when a new instructional technique is tested, or by comm u nicating or interacting with the individual, as occurs with surveys and interviews, the definition of human su b

ject is met. (2) If an activity involves obtaining private inform a tion about a liv ing person in such a way that the information can be **directly or indirectly** linked to that individual), the defin i tion of human subject is met [Private information includes info r mation about behavior that occurs in a context in which an individual can re a sonably expect that no observation or recording is taking place, and information which has been provided for sp e cific purposes by an individual and which the individual can re a sonably expect will not be made public (for example, a school health re c ord).] **B. Exemptions.** Research activities in which the **only** involvement of human su b jects will be in one or more of the following six categories of **e x**  **em ptions**  are not covered by the regulations: (1) Research conducted in established or commonly accepted edu cat ional settings, involving normal educational practices, such as (a) research on regular and special education instru c tional strategies, or (b) research on the effectiveness of or the compar i son among instructional techniques, curricula, or classroom manage ment met h ods. **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, d i agnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) inform a tion obtained is recorded in such a manner that human su b jects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the r e search could reasonably place the subjects at risk of criminal or civil liability or be damaging to the su b jects’ financial standing, employability, or reputation. **If the subjects are chi** 

**l dren, exemption 2**  **applies only to research involving educ**  **a tional tests and observations of public behavior**  **when the investig a**  **tor(s) do not participate in the activities being observed.**  **Exemption 2 does not apply if children are su r** **veyed or interviewed or if the research**  **involves observation of public behavior and the investigator(s) participate in the activ**  **i ties**  **being observed.** [C hildren are d e fined as persons who have not attained the legal age for consent to treatments or proceduresinvolved in the r e search, under the applicable law or jurisdiction in which the research will be co n ducted.] (3) Research involving the use of educational tests (cognitive, d i agnostic, aptitude, achievement), survey procedures, interview proc e dures or observation of public behavior that is not exempt under section (2) above, if the human subjects are elected or ap pointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information wil l be maintained throughout the r e search 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 su b jects 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 obtai n ing bene fits or services under those programs; (c) possible changes in or altern a tives to those programs or procedures; or (d) possible changes in methods or levels of payment for ben e fits or services under those programs. **[ The standards of**  **this exemption are rare ly 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 w ithout additives are consumed or (b) if a food is consumed that contains a food ingredient at or b e low the level and for a use found to be safe, or agricultural chem i cal or environmental contaminant at or below the level found to be safe, by the Food and D rug Administration or ap proved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agricu l ture. **II. Instructions for Exe mpt and Nonexempt Human**  **Subjects R e**  **search Narratives** If the applicant marked “ Yes” for Item 3.b. of the U.S. Department of Education Supplemental Information for the SF 424, the ap plicant must attach a human subjects “exempt research” or “nonexempt research” narrative to the U.S. Department of Education Supplemental Information for the SF

424 form. If you have multiple projects and need to provide mo re 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 SF

424. The narr ative must contain sufficient information about the involvement of human subjects in the proposed research to allow a de term i nation 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 “none x em

pt research” narrative to the U.S. Department of Education Supplemental Information for the SF

- 424 . The narrative must address the follo w ing seven points. Although no specific page limitation ap plies to this section of the application, be succinct. (1) **Hum an Subjects Involvement and Characteristics**  : Pr o vide a d etailed description of the proposed involvement of human su b jects. Describe the characteristics of the subject population, including their anticipated nu m ber, age range, and health status. Identify the criteria for inclusion or exclusion of any subpopula tion. Explain the ratio n ale for the involvement of special classes of subjects, such as children, children with di s abilities, adults with disabilities, persons with mental disabilities, pregnant women, prisoners, institutiona l ized individuals, or others who are likely to be vulne r able (2) **Sources of Materials** : Identify the sources of research material obtained from individually identifiable living human su b jects in the form of specimens, records, or data. Indicate whether the material or data will be obt ained specifically for research pur

poses or whether use will be made of existing specimens, re c ords, or data. (3) **Recruitm ent and Informed Consent**  : Describe plans for the recruitment of subjects and the consent procedures to be followed. I n clude the cir cumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be pr o vided to prospective subjects, and the method of documenting consent. State if the Institutional Revie w Board (IRB) has autho r ized a modif ication or w aiver of the elements of consent or the requirement for document ation of consent. (4) **Potential Risks** : Describe potential risks (physical, psy ch o logical, social, legal, or other) and assess their likelihood and seriou s ness. Where appropriate, describe alternative treatments and procedures that might be advant a geous to the subjects. (5) **Protection Against Risk** : Describe the procedures for protec t ing against or minimizing potential risks, including risks to conf i dentiality, and assess their lik ely effectiveness. Where appropr i ate, discuss provisions for ensuring necessary medical or profe s sional intervention in the event of adverse effects to the subjects. Also, where appropriate, d e scribe the provisions for mo nitoring the data collected to en sure the safety of the su b jects. (6) **Im portance of the Knowledge to be Gained**  : Discuss the i m portance of the knowledge gained or to be gained as a resultof the proposed research. Discuss why the risks to subjects are re a sonable in relation to the antici pated benefits to subjects and in relation to the importance of the knowledge that may re a sonably be expected to result. (7) **Collaborating Site(s)** : If research involving human su b jects will take place at collaborating site(s) or other perfo r mance site(s), name the sites and briefly describe their involv e ment 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 r** **e search are available from**  **the Office of the Chief Financial Officer, U.S. Department of Education, Washington, D.C.**  **20202**
**- 4331, tel** 

**e phone: (202)**  **245**
**- 8090** 

**, and on the U.S. Department of Education’s Protection of Human Su**  **b jects 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).