Instructions for "Supplemental Information for the SF-424 Application for Federal Assistance"

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Instructions for U.S. Department of Education
Supplemental Information for the SF-424 Application for Federal Assistance
1. Project Director. Name, address, telephone and fax numbers, and e-mail and alternate email addresses of the Project Director to be
contacted on matters involving this application. Enter Project Director’s level of effort (the percentage of time devoted to the grant). Items
marked with an asterisk (*) are mandatory.
2. New Potential Grantee or Novice Applicant. If applicable, for (a), check “Yes” if you meet the definition for new potential grantees or
novice applicants specified in the program competition’s notice inviting applications (NIA) 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 the new potential grantee or novice applicant requirements. Check “No” if you do not meet the definition for new potential grantees or
novice applicants. For (b), if the program competition NIA is giving competitive preference points for new potential grantees or novice
applicants, indicate how many points you are claiming for your application. The NIA will indicate how many are available depending on the
design of the competition. Some competitions may provide more than one category of new potential grantees with differing levels of points.
3. Qualified Opportunity Zones. If applicable, provide the Qualified Opportunity Zones (QOZ) census tract number(s) if the NIA includes a
QOZ Priority in which you propose to either provide services in QOZ(s) or are located in a QOZ.
4. Human Subjects Research. (See I. A. “Definitions” in attached page entitled “Definitions for U.S. Department of Education Supplemental
Information for the SF-424 form.”)
4a. 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.
4a. 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 the SF-424 Application for Federal Assistance.”)
4b. 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 eight exemption categories
(Regulation revised in 2018 and became effective in 2019) 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
Application for Federal Assistance.”
4b. 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 Application for Federal Assistance.”
4b. 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 part 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.
4c. 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
Application for Federal Assistance.”
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.
Instructions for U.S. Department of Education
Supplemental Information for the SF-424 Application for Federal Assistance
1. Project Director. Name, address, telephone and fax numbers, and e-mail and alternate email addresses of the Project Director to be
contacted on matters involving this application. Enter Project Director’s level of effort (the percentage of time devoted to the grant). Items
marked with an asterisk (*) are mandatory.
2. New Potential Grantee or Novice Applicant. If applicable, for (a), check “Yes” if you meet the definition for new potential grantees or
novice applicants specified in the program competition’s notice inviting applications (NIA) 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 the new potential grantee or novice applicant requirements. Check “No” if you do not meet the definition for new potential grantees or
novice applicants. For (b), if the program competition NIA is giving competitive preference points for new potential grantees or novice
applicants, indicate how many points you are claiming for your application. The NIA will indicate how many are available depending on the
design of the competition. Some competitions may provide more than one category of new potential grantees with differing levels of points.
3. Qualified Opportunity Zones. If applicable, provide the Qualified Opportunity Zones (QOZ) census tract number(s) if the NIA includes a
QOZ Priority in which you propose to either provide services in QOZ(s) or are located in a QOZ.
4. Human Subjects Research. (See I. A. “Definitions” in attached page entitled “Definitions for U.S. Department of Education Supplemental
Information for the SF-424 form.”)
4a. 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.
4a. 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 the SF-424 Application for Federal Assistance.”)
4b. 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 eight exemption categories
(Regulation revised in 2018 and became effective in 2019) 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
Application for Federal Assistance.”
4b. 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 Application for Federal Assistance.”
4b. 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 part 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.
4c. 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
Application for Federal Assistance.”
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 Application for Federal Assistance
Definitions:
A research activity involves human subjects if the activity is
research, as defined in the Department’s regulations, and the
NEW POTENTIAL GRANTEE OR NOVICE APPLICANT
research activity will involve use of human subjects, as defined
in the regulations.
New Potential Grantee: The definition of New Potential Grantee
—Research
is set in the program competition’s Notice Inviting Applications
(NIA). The New Potential Grantee priority is from the
The ED Regulations for the Protection of Human Subjects, Title
Department’s Administrative Priorities for Discretionary Grant
34, Code of Federal Regulations, Part 97, define research as “a
Programs published in the Federal Register March 9, 2020
(85
systematic investigation, including research development,
FR
13640).
testing and evaluation, designed to develop or contribute to
generalizable knowledge. Activities which meet this definition
Novice Applicant: For discretionary grant programs, novice
constitute research whether or not they are conducted or
applicant means any applicant for a grant from ED that—
supported under a program that is considered research for other
purposes. For example, some demonstration and service
Has never received a grant or subgrant under the program
programs may include research activities.”
from which it seeks funding;
—Human Subject
Has never been a member of a group application, submitted
in accordance with 34 CFR 75.127-75.129, that received a
The regulations define human subject as “a living individual
grant under the program from which it seeks funding; and
about whom an investigator (whether professional or student)
conducting research obtains (i) information or biospecimens
Has not had an active discretionary grant from the Federal
through intervention or interaction with the individual and uses,
government in the five years before the deadline date for
studies, or analyzes the information or biospecimens, or (ii )
applications under the program. For the purposes of this
obtains, uses, studies, analyzes, or generate identifiable private
requirement, a grant is active until the end of the grant’s
information or identifiable biospecimens.”
project or funding period, including any extensions of those
periods that extend the grantee’s authority to obligate funds.
If an activity involves obtaining information about a living
person by manipulating that person or that person’s
In the case of a group application submitted in accordance with
environment, as might occur when a new instructional technique
34 CFR 75.127-75.129, a group includes only parties that meet
is tested, or by communicating or interacting with the
the requirements listed above. The Novice Applicant priority is
individual, as occurs with surveys and interviews, the definition
from 34 CFR 75.225, and it must be included in the program
of human subject is met. If an activity involves obtaining private
competition NIA to be claimed on the form.
information about a living person in such a way that the
information can be directly or indirectly linked to that
QUALIFIED OPPORTUNITY ZONES
individual, the definition of human subject is met.
Definition: From 26 USC section 1400Z–1 of the Internal
Private information includes information about behavior that
Revenue Code, which, in relevant part, defines “qualified
occurs in a context in which an individual can reasonably expect
opportunity zone” as “a population census tract that is a low-
that no observation or recording is taking place, and information
income community that is designated as a qualified opportunity
which has been provided for specific purposes by an individual
zone.”
and which the individual can reasonably expect will not be
made public (for example, a school health record).
The Qualified Opportunity Zones priority is from the
Department’s Final Priority for Discretionary Grant Programs
B. Exemptions.
published in the Federal Register November 27, 2019
(84 FR
65300).
Research activities in which the only involvement of human
subjects will be in one or more of the following eight categories
Note: The Treasury Department has created a website of
of exemptions are not covered by the regulations:
Opportunity Zones Resources that includes a searchable map:
https://www.cdfifund.gov/Pages/Opportunity-Zones.aspx.
(1) Research conducted in established or commonly accepted
educational settings, that specifically involves normal
PROTECTION OF HUMAN SUBJECTS IN RESEARCH
educational practices that are not likely to adversely impact
students’ opportunity to learn required educational content or
I. Definitions and Exemptions
the assessment of educators who provide instruction. This
includes most research on regular and special education
A. Definitions.
instructional strategies, and research on the effectiveness of or
the comparison among instructional techniques, curricula, or
classroom management methods. If an educational practice is
such benign behavioral interventions would include having the
being introduced to the site and is not widely used for similar
subject play an online game, having them solve puzzles under
populations, it is not covered by this exemption.
various noise conditions, or having them decide how to allocate
a nominal amount of received cash between themselves and
(2) Research that only includes interactions involving
someone else.
educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of
If the research involves deceiving the subjects regarding the
public behavior (including visual or auditory recordings) if at
nature or purposes of the research, this exemption is not
least one of the following criteria is met: (i) the information
applicable unless the subject authorizes the deception through a
obtained is recorded by the investigator in such a manner that
prospective agreement to participate in research in
the identity of the human subjects cannot readily be ascertained,
circumstances in which the subject is informed that he or she
directly or through identifiers linked to the subjects; (ii) Any
will be unaware of or misled regarding the nature or purposes of
disclosure of the human subjects’ responses outside the research
the research.
would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects’ financial standing,
(4) Secondary Research for which Consent is not required.
employability, educational advancement or reputation; or (iii)
Secondary research uses of identifiable private information or
the information obtained is recorded by the investigator in such
identifiable biospecimens, if at least one of the following criteria
a manner that the identity of the human subjects can readily be
is men: (i) The identifiable private information or identifiable
ascertained, directly or through identifiers linked to the subjects,
biospecimens are publicly available; (ii) Information, which
and an Institutional Review Board (IRB) conducts a “limited
may include information about biospecimens, is recorded by the
IRB review” to make the determinations required by 34 CFR
investigator in such a manner that the identity of the human
97.111(a)(7).
subjects cannot readily be ascertained directly or through
identifiers linked to the subjects, the investigator does not
If the subjects are children, exemption 2 applies only to
contact the subjects, and the investigator will not re-identify
research involving educational tests and observations of public
subjects; (iii) the research involves only information collection
behavior when the investigator(s) do not participate in the
and analysis involving the investigators’ use of identifiable
activities being observed.
health information when that use is regulated under 45 CFR
parts 160 and 164, subparts A and E, for the purposes of “health
Exemption 2 does not apply if children are surveyed or
care operations” or “research” as those terms are defined at 45
interviewed or if the research involves observation of public
CFR 164.501 or for “public health activities and purposes” as
behavior and the investigator(s) participate in the activities
described under 45 CFR 164.512 (b); or (iv) The research is
being observed. Children are defined as persons who have not
conducted by, or on behalf of, a Federal department or agency
attained the legal age for consent to treatments or procedures
using government-generated or government-collected
involved in the research, under the applicable law or jurisdiction
information obtained for nonresearch activities, if the research
in which the research will be conducted.
generates identifiable private information that is or will be
maintained on information technology that is subject to and in
(3) Research involving benign behavioral interventions in
compliance with section 208(b) of the E-Government Act of
conjunction with the collection of information from an adult
2002, 44 USC 3501 note, if all of the identifiable private
subject through verbal or written responses (including data
information collected, used or generated as part of the activity
entry) or audiovisual recording if the subject prospectively
will be maintained in systems of records subject to the Privacy
agrees to the intervention and information collection and at least
Act of 1974, 5 USC 552a, and, if applicable, the information
one of the following criteria is met: (A) The information
used in the research was collected subject to the Paperwork
obtained is recorded by the investigator in such a manner that
Reduction Act of 1995, 44 USC 3501 et seq.
the identity of the human subjects cannot readily be ascertained
directly or through identifiers linked to the subjects; (B) Any
(5) Research and demonstration projects that are conducted or
disclosure of the human subjects’ responses outside the research
supported by a Federal department or agency, or otherwise
would not reasonably place the subjects at risk of criminal or
subject to the approval of department or agency heads (or the
civil liability or be damaging to the subject’ financial standing,
approval of the heads of bureaus or other subordinate agencies
employability, educational advancement or reputation; or (C)
that have been delegated authority to conduct the research and
The information obtained is recorded by the investigator in such
demonstration projects), and that are designed to study,
a manner that the identity of the human subjects can readily be
evaluate, improve, or otherwise examine public benefit or
ascertained, directly or through identifiers linked to the subjects,
service programs, including procedures for obtaining benefits or
and an IRB conducts a limited IRB review to make the
services under those programs, possible changes in or
determination required by 34 CFR 97.111(a)(7).
alternative to those programs or procedures, or possible changes
in methods or levels of payment for benefits or services under
For the purpose of this provision, benign behavioral
those programs. Such projects include, but are not limited to,
interventions are brief in duration, harmless, painless, not
internal studies by Federal employees, and studies under
physically invasive, not likely to have a significant adverse
contracts or consulting arrangements, cooperative agreements,
lasting impact on the subjects, and the investigator has no reason
or grants. Exempt projects also include waivers of otherwise
to think the subjects will find the interventions offensive or
mandatory requirements using authorities such as sections 1115
embarrassing. Provided all such criteria are met, examples of
and 1115A of the Social Security Act as amended.
Each Federal department or agency conducting or supporting
about the involvement of human subjects in the proposed
the research and demonstration projects must establish, on a
research to allow a determination by ED that the designated
publicly accessible Federal website or in such other manner as
exemption(s) are appropriate. The narrative must be succinct.
the department or agency head may determine, a list of the
research and demonstration projects that the Federal department
B. Nonexempt Research Narrative.
or agency conducts or supports under this provision. The
If you marked “No” for item 3.b. you must attach the
research or demonstration project must be published on this list
“nonexempt research” narrative to the U.S. Department of
prior to commencing the research involving human subjects.
Education Supplemental Information for the SF-424 form. The
narrative must address the following seven points. Although no
(6) Taste and food quality evaluation and consumer acceptance
specific page limitation applies to this section of the application,
studies, (a) if wholesome foods without additives are consumed
be succinct.
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
(1) Human Subjects Involvement and Characteristics:
chemical or environmental contaminant at or below the level
Provide a detailed description of the proposed involvement of
found to be safe, by the Food and Drug Administration or
human subjects. Describe the characteristics of the subject
approved by the Environmental Protection Agency or the Food
population, including their anticipated number, age range, and
Safety and Inspection Service of the U.S. Department of
health status. Identify the criteria for inclusion or exclusion of
Agriculture.
any subpopulation. Explain the rationale for the involvement of
special classes of subjects, such as children, children with
(7) Storage or Maintenance for Secondary Research for which
disabilities, adults with disabilities, persons with mental
Broad Consent is required. Storage or maintenance of
disabilities, pregnant women, prisoners, institutionalized
identifiable private information or identifiable biospecimens for
individuals, or others who are likely to be vulnerable
potential secondary research use if an IRB conducts a limited
IRB review and makes the determinations requires by 34 CFR
(2) Sources of Materials: Identify the sources of research
97.111(a)(8).
material obtained from individually identifiable living human
subjects in the form of specimens, records, or data. Indicate
(8) Secondary Research for which Broad Consent is Required.
whether the material or data will be obtained specifically for
Research involving the use of identifiable private information or
research purposes or whether use will be made of existing
identifiable biospecimens for secondary research use if the
specimens, records, or data.
following criteria are met: (i) Broad Consent for the storage,
maintenance and secondary research use of the identifiable
(3) Recruitment and Informed Consent: Describe plans for
private information or identifiable biospecimens was obtained in
the recruitment of subjects and the consent procedures to be
accordance with 34 CFR 97.116(a) (1)-(4), (a) (6) and (d); (ii)
followed. Include the circumstances under which consent will
Documentation of informed consent or waiver of documentation
be sought and obtained, who will seek it, the nature of the
of consent was obtained in accordance with 34 CFR 97.117.
information to be provided to prospective subjects, and the
(iii) an IRB conducts a limited IRB review and makes the
method of documenting consent. State if the IRB has authorized
determination that the research to be conducted is within the
a modification or waiver of the elements of consent or the
scope of the broad consent referenced in paragraph (d)(8)(i) of
requirement for documentation of consent.
this section; and (iv) The investigator does not prevent an
investigator from abiding by any legal requirements to return
(4) Potential Risks: Describe potential risks (physical,
individual research results.
psychological, social, legal, or other) and assess their likelihood
and seriousness. Where appropriate, describe alternative
II. Instructions for Exempt and Nonexempt Human
treatments and procedures that might be advantageous to the
Subjects Research Narratives
subjects.
If the applicant marked “Yes” for Item 3.b. of the U.S.
(5) Protection Against Risk: Describe the procedures for
Department of Education Supplemental Information for the SF-
protecting against or minimizing potential risks, including risks
424 form, the applicant must attach a human subjects “exempt
to confidentiality, and assess their likely effectiveness. Where
research” or “nonexempt research” narrative to the U.S.
appropriate, discuss provisions for ensuring necessary medical
Department of Education Supplemental Information for the SF-
or professional intervention in the event of adverse effects to the
424 form. If you have multiple projects, include information
subjects. Also, where appropriate, describe the provisions for
about each, labeling the responses as to the project they address.
monitoring the data collected to ensure the safety of the
For applications that include multiple research projects this can
subjects.
be done in a single narrative or in more than one narrative as
appropriate.
(6) Importance of the Knowledge to be Gained: Discuss the
importance of the knowledge gained or to be gained as a result
A. Exempt Research Narrative.
of the proposed research. Discuss why the risks to subjects are
If you marked “Yes” for item 3.b. and designated exemption
reasonable in relation to the anticipated benefits to subjects and
numbers(s), attach the “exempt research” narrative to the U.S.
in relation to the importance of the knowledge that may
Department of Education Supplemental Information for the SF-
reasonably be expected to result.
424 form. The narrative must contain sufficient information
(7) Collaborating Site(s): If research involving human subjects
Officer, U.S. Department of Education, Washington, D.C.
will take place at collaborating site(s) or other performance
20202-4331, telephone: (202) 245-8090, and on the U.S.
site(s), name the sites and briefly describe their involvement or
Department of Education’s Protection of Human Subjects in
role in the research.
Research Web Site:
https://www2.ed.gov/about/offices/list/ocfo/humansub.html
Copies of the Department of Education’s Regulations for the
NOTE: The State Applicant Identifier on the SF-424 form is
Protection of Human Subjects, 34 CFR part 97 and other
for State Use only. Please complete it on the SF-424 form in the
pertinent materials on the protection of human subjects in
research are available from the Office of the Chief Financial
upper right corner of the form (if applicable).
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