I. PREPARING YOUR APPLICATION

A. INTRODUCTION

These instructions pertain to applications for research project grants. Use the additional instructions and sample pages included in sections IV, V, or VI of this document when applying for Research Career Awards, Institutional National Research Service Awards or Small Business Innovation Research (SBIR) or Small Business Technology Transfer Research (STTR) Awards.

When applying for other specialized grants or cooperative agreements, request additional instructions from the appropriate PHS awarding component. Phone numbers for contacting these awarding components are listed in Section II-C, "Interactions Before Submission". For further assistance, contact:

GrantsInfo
National Institutes of Health (NIH)
E-mail: GrantsInfo@nih.gov
Phone: (301) 435-0714.

Requests for Applications/Program Announcements

If you are responding to a specific request for applications (RFA) or program announcement (PA) published in the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/index.html), the Federal Register (http://www.access.gpo.gov/nara/index.html), or other public media, then it is important that you contact the issuing PHS component for additional instructions. The instructions in the RFA or PA may differ from the general instructions, and they supersede the general instructions. Many RFAs incorporate On-Time (Just-in-Time) procedures. Thus, it is important for applicants planning to respond to RFAs to review the instructions in the announcements carefully. Each RFA and PA contains contact information under INQUIRIES in addition to information specific to the RFA or PA.

Authorization

The PHS requests the information described in these instructions pursuant to its statutory authorities for awarding grants, contained in Sections 301 (a) and 487 of the PHS Act, as amended (42 USC 241a and 42 USC 288). Therefore, such information must be submitted if an application is to receive due consideration for an award. Lack of sufficient information may hinder the PHS' ability to review an application and to monitor the grantee's performance.

B. GENERAL INSTRUCTIONS

Read and follow the instructions carefully to avoid delays, misunderstandings and possible return of applications. Prepare the application single-sided and single-spaced, using the PHS 398 RTF or PDF form/format pages as provided. The print must be clear and legible. Use standard size, black letters that can be clearly copied.

The PHS 398 and PHS 2590 Rich Text File (RTF) and Portable Document File (PDF) Form pages as provided are acceptable by NIH. All other sections of the application (e.g., Biographical Sketch, Introduction, if necessary, and the Research Plan) must conform to the specifications described in the next section .  Deviations from the font size specifications and page limitations will be grounds for the PHS to reject and return the entire application without peer review.

You may substitute computer-generated facsimiles for government-provided forms; however, they must maintain the exact wording and format of the government forms, including all captions and spacing.

The PHS 398 includes Form Pages and Format Pages. The format pages are intended to assist you in the development of specific sections of the application. Format Pages have been left "unprotected" to allow you to format text, insert graphics, diagrams, or tables. Alternatively, you may create a page similar to the format provided and inclusive of requisite information.

Format Specifications

Observe type size and format specifications, or the application will be returned without review. See frequently asked questions FAQs (http://www.format.nih.gov/FAQ/FAQ.htm) for additional information related to format requirements. The application must be clear, readily legible, and conform to the following four requirements:

1. The height of the letters must not be smaller than 10 point; Helvetica or Arial 12-point is the NIH-suggested font.

2. Type density, including characters and spaces, must be no more than 15 characters per inch (cpi). For proportional spacing, the average for any representative section of text must not exceed 15 cpi; 

3. No more  than 6 lines of type within a vertical inch;

4. Margins, in all directions, must be at least ˝ inch. 

Applicants should check the type size using a standard device for measuring type size, rather than relying on the font selected for a particular word processing/printer combination. Figures, charts, tables, figure legends, and footnotes may be smaller in size but must be readily legible. The type size used must conform to all four requirements. Small type size makes it difficult for reviewers to read the application; consequently, the use of small type will be grounds for the PHS to return the application without peer review. Adherence to type size and line spacing requirements is also necessary so that no applicant will have an unfair advantage, by using small type, or providing more text in their applications.

Do not use photo reduction. Prepare all graphs, diagrams, tables, and charts in black ink. The application must contain only material that reproduces well when photocopied in black and white. Glossy photographs or other  materials that cannot be photocopied must be submitted in five collated sets as appendices (see Section I-9, Appendix.)

Some fields on the PDF Form Pages are pre-set to auto calculate.  In these cases, a zero will appear until actual data are entered.

Page Limitations and Content Requirements

All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in NIH solicitations, internet Web site addresses (URLs) may not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Moreover, reviewers are cautioned that they should not directly access an Internet site as it could compromise their anonymity.

Observe the page number limitations given in Table 1. Only in cases involving interdependent multiple subprojects (e.g., Program Projects and Multi-Center Clinical Trials) will the PHS accept applications that exceed the page number limitations. However, specific page number limits may apply to each subproject. For information pertaining to page number limits for such projects, contact the awarding component to which the application may be assigned. (See Section II-C, "Interactions Before Submission".) The page number limitations may also be different for other specialized grant applications. For information regarding page number limitations, request and follow the additional instructions for those applications.

Note:  Failure to comply with the formatting and page specifications will be grounds for the PHS to reject and return the entire application without peer review.

The Division of Receipt and Referral has the responsibility to make the final determination of legibility and authority to return applications. Questions should be directed to the Division of Receipt and Referral, Center for Scientific Review, (301) 435-0715.

Table 1. Page Limitations and Content Requirements

C. SPECIFIC INSTRUCTIONS

1. Face Page (MS Word or PDF)

Item 1. Title of Project

Do not exceed 56 characters, including the spaces between words and punctuation. Choose a title that is specifically descriptive, rather than general. A new application must have a different title from any other PHS project with the same principal investigator/program director. A competing continuation or revised application should ordinarily have the same title as the previous grant or application. If the specific aims of the project have significantly changed, choose a new title. A supplemental application must have the same title as the currently funded grant.

Item 2.  Response to Specific Request for Applications (RFA) or Program Announcement (PA)

Check "Yes" if the application is submitted in response to an RFA or a PA, and identify the number of the RFA or the number and title of the PA. For RFAs only, attach the RFA label or a facsimile, including the RFA number, to the bottom (MS Word or PDF) of the face page of the original application. The RFA label is under the general mailing label, following the checklist and personal data pages. In addition, identify grant applications such as for the Research Career Award, Academic Research Enhancement Award (AREA), Institutional National Research  Service Award, and AIDS research. Any special instructions in the RFA must be followed when preparing the application.

Item 3. Principal Investigator/Program Director

New Investigator. Check "Yes" in the "New Investigator" box only if the principal investigator has not previously served as such on any PHS-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research career (K01, K08,  K22, and K23). If the Principal Investigator/Program Director is not a new investigator, check "No." Current or past recipients of Independent Scientist and other non-mentored career awards (K02 and K04) are not considered new investigators.

Item 3a. Name of Principal Investigator/Program Director

Name the one person responsible to the applicant organization for the scientific and technical direction of the  project. A supplemental application must have the same principal investigator/program director as the currently funded grant. PHS staff conduct official business only with principal investigators and institutional officials.

Item 3b. Degree(s)

Indicate up to three academic and professional degrees or other credentials, such as licenses (e.g., R.N.) 

Item 3c. Position Title

Provide the academic or professional title of the principal investigator/ program director. If more than one title, indicate the one most relevant to the proposed project, such as Professor of Biochemistry, Chief of Surgical Service, or Group Leader.

Item 3d. Mailing Address

Provide complete information (including room number, building, and street address) necessary for postal delivery. All written communications with the principal investigator will use this address. For electronic mail, enter the appropriate e-mail address.

Item 3e. Department, Service, Laboratory, or Equivalent

Indicate your organizational affiliation, such as department of medicine, materials research laboratory, or social sciences institute.

Item 3f. Major Subdivision

Indicate your school, college, or other major subdivision, such as medical, dental, engineering, graduate, nursing, or public health. If there is no such subdivision, enter "None."

Item 3g. Telephone and Fax Numbers

Provide a daytime telephone number and, if available, a fax number.

Item 4. Human Subjects

(See Section III-A, "DEFINITIONS")

No Human Subjects

Check "No" if activities involving human subjects are not planned at any time during the proposed project period. The remaining parts of Item 4 are then not applicable.

Human Subjects Involved

Check "'Yes" if 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. "Yes" should be  checked even if the research is exempt from regulations for the protection of human subjects (See Exemption Categories).

Item 4a. Exemptions from Human Subjects Regulations

Check "Yes" if the 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 Section I, 8.E under "Exempt Human Subjects Research." If the proposed research corresponds to one or more of the exempt categories then the remaining parts of Item 4 of the Face Page are not applicable.

Note:

Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research may result in delays in the review of an application or the return of the application without review. The PHS will make a final determination as to whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the Research Plan. In doubtful cases, consult with the Office for Human Research Protections (OHRP) Department of Health and Human Services by accessing their website http://www.hhs.gov/ohrp/ for guidance and further information.

Human Subjects Activities Not Exempt from Regulations

Check "No" if the planned activities involving human subjects are not exempt, and complete the remaining parts of Item 4.

Item 4b. Human Subjects Assurance Number

If the applicant organization has an approved Federal Wide Assurance (FWA), Multiple Project Assurance (MPA), Single Project Assurance (SPA) Number or Cooperative Project Assurance Number on file with the OHRP (http://www.hhs.gov/ohrp/) that covers the specific activity, insert the number in the space provided.

Insert "None" in Item 4b if the applicant organization does not have an approved assurance on file with OHRP. Do not insert the human subjects assurance number of any collaborating institution in the space provided. In this case, the applicant organization, by the signature on the face page, is declaring that it will comply with 45 CFR 46 and proceed to obtain a human subjects assurance (see http://www.hhs.gov/ohrp/.)

Following NIH peer review, applicants and their institutions will be notified of the need for review and certification for the proposed research by an OHRP-Registered Institutional Review Board (IRB). See http://www.hhs.gov/ohrp/ to register an IRB. The certification of IRB approval from an official signing for the  applicant organization must then be sent to and received by the Grants Management Office identified in the  notice requesting IRB certification. This IRB certification must include: the PHS application number, title of the  project, name of the principal investigator/program director, date of IRB approval, and appropriate signatures.  You may also use optional Form 310, "Protection of Human Subjects" to provide IRB certification (see http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf.)

Any modifications in the Research Plan section of the application, required by the IRB, must be submitted with the follow-up certification. It is the responsibility of the principal investigator/program director and the applicant organization to submit the follow-up certification. When a year will have elapsed between the initial IRB review date and the anticipated award date, awarding unit staff shall require re-review by the IRB and certification prior to award.

Item 4c. NIH-Defined Phase III Clinical Trial

Check "Yes" or "No" to indicate whether the project is an NIH-Defined Phase III clinical trial. See Section III-A, "DEFINITIONS" for definitions of clinical research and NIH-defined Phase III clinical trial.

Item 5. Vertebrate Animals

Check "No" if activities involving vertebrate animals are not planned at any time during the proposed project period. The remaining parts of Item 5 are then not applicable. Check "Yes" if activities involving vertebrate animals are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution,

Item 5a. IACUC Certification

NIH policy requires the submission of Institutional Animal Care and Use Committee (IACUC) approval when  animal studies are involved.

Enter the date of approval by the IACUC in the space provided, if the applicant organization has an Animal Welfare Assurance.

If the IACUC review is unavoidably delayed beyond the submission of the application, enter "Pending" in the box requesting IACUC approval date. A follow-up certification of IACUC approval from an official signing for the applicant organization must then be sent to and received by the Scientific Review Administrator of the scientific review group (SRG). The name and address of the Scientific Review Administrator of the SRG will be sent to the principal investigator/program director and applicant organization as soon as possible after the receipt date, usually within 6 weeks. To avoid delays in review, send the follow-up information directly to the Scientific Review Administrator.

The follow-up certification must include: the PHS application number, title of project, name of principal investigator/program director, institution, Animal Welfare Assurance number, date of IACUC approval, and appropriate signatures.

Any modifications of the Research Plan section of the application, required by the IACUC, must be submitted with the follow-up certification. It is the responsibility of the principal investigator/program director and the applicant organization to submit the follow-up certification.

Item 5b. Animal Welfare Assurance

Enter the Assurance number of the applicant organization in Item 5b if the applicant organization has an approved Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW). See http://grants.nih.gov/grants/olaw/olaw.htm. 

Insert "None" in Item 5b if the applicant organization does not have an approved Animal Welfare Assurance on file with OLAW. Do not insert the Animal Welfare Assurance of any collaborating institution in the space provided. By inserting "None" and, by the signing on the face page, the applicant organization is declaring that it will comply with PHS policy regarding the care and use of animals by establishing an IACUC and submitting an Animal Welfare Assurance and certification of IACUC approval when requested to do so by OLAW.

Item 6. Dates of Proposed Period of Support

Request no more than 5 years of support. To select an appropriate beginning date for a new application, consult the review and award schedule in Table 2, Receipt, Review, and Award Cycles. For a competing continuation application, choose a beginning date immediately following the termination date of the current period of support. Submit a supplemental application only for a period within the current period of support. (A supplement may not extend beyond the parent award period.) Make the ending date of the supplement's first budget period coincide with the ending date of the budget period that is to be supplemented, regardless of the supplement's beginning date. If requesting supplemental funds for the future years of a currently funded grant, make the future years' budget periods coincide with those of the currently funded grant. 

Item 7. Costs Requested for Initial Budget Period

Be sure to read the instructions for Modular Grant Applications to determine if the application should be submitted in this format. All amounts requested in Items 7 and 8 and on the budget pages must be in U.S. dollars.

Item 7a. Direct Costs Requested for Initial Budget Period

Enter the direct costs from Form Page 4 or the "Modular Budget Format Page." For budget requests of $500,000 direct costs or more for any year, see specific instructions in Section I-4.

Item 7b. Total Costs Requested for Initial Budget Period

Enter the sum of the total direct costs from Form Page 4 or the "Modular Budget Format Page" and the Facilities and Administrative costs for the initial budget period, as calculated on the Checklist Form Page.

Item 8. Costs Requested for Proposed Period of Support

Item 8a. Direct Costs Requested for Proposed Period of Support.

Enter the direct costs from Form Page 5 or the "Modular Budget Format Page."

Item 8b. Total Costs Requested for Proposed Period of Support

Enter the sum of the total direct costs from Form Page 5 or the "Modular Budget Format Page" and the Facilities and Administrative costs for the proposed period of support, as calculated on the Checklist Form  Page.

Item 9. Applicant Organization

Name the one organization that will be legally and financially responsible for the conduct of activities supported  by the award. If the NIH-assigned Institutional Profile File (IPF) number is known, insert it in Item 9; otherwise, leave it blank.

Item 10. Type of Organization

Check the appropriate box. See Section III-A, "DEFINITIONS."

Item 11. Entity Identification Number, Duns Number, Congressional District

Enter the number assigned to the applicant organization by the Department of Health and Human Services for payment and accounting purposes. If a number has not yet been assigned, enter either (1) the organization's Internal Revenue Service employer identification number (nine digits). or (2) the words "Applied for" to indicate that the organization does not have an EIN but has applied to the local office of the IRS for one. An individual's social security number is not appropriate for this item.

(Note: Text shown in purple below was updated on August 14, 2003.)
A Dun and Bradstreet (D&B;) Data Universal Numbering System (DUNS) number must be entered. The DUNS number is a nine-digit identification code assigned by Dun & Bradstreet. For additional information on this requirement see NIH Guide Notice OD-03-055. Also, enter the number of the Congressional District.

Item 12. Administrative Official to be Notified if Award is Made

Name the applicant organization administrative official to be notified if an award is made. Provide a complete address for postal delivery and the telephone, fax, and e-mail address for the administrative official.

Item 13. Official Signing for Applicant Organization

Name an individual authorized to act for the applicant organization and to assume the obligations imposed by the Federal laws, requirements, and conditions for a grant or grant application, including the applicable Federal regulations. For electronic mail, enter the appropriate e-mail address.

Item 14. Principal Investigator/Program Director Assurance

An original signature, in ink, is required. "Per" signatures are not acceptable. Date of signature must be included.

Item 15. Applicant Organization Certification and Acceptance

An original signature, in ink, is required. "Per" or "For" signatures are not acceptable. Date of signature must be included. In signing the application face page, the duly authorized representative of the applicant organization certifies that the applicant organization will comply with all applicable assurances and certifications referenced in the application. The applicant organization is responsible for verifying the accuracy, validity, and conformity with the most current institutional guidelines of all the administrative, fiscal, and scientific information in the application, including the Facilities and Administrative rate. Deliberate withholding, falsification, or misrepresentation of information could result in administrative actions, such as withdrawal of an application, suspension and/or termination of an award, debarment of individuals, as well as  possible criminal penalties. The signer further certifies that the applicant organization will be accountable both for the appropriate use of any funds awarded and for the performance of the grant supported project or activities resulting from this application. The grantee institution may be liable for the reimbursement of funds associated with any inappropriate or fraudulent conduct of the project activity.

Assurances/Certifications

Each application to the PHS requires that the following assurances and certifications be verified by the signature of the Official Signing for Applicant Organization on the Face Page of the application. Definitions are provided in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm) and in Section III. G. Assurances and Certifications of these instructions.

Human Subjects
Research on Transplantation of Human
Fetal Tissue
Women and Minority Inclusion Policy
Inclusion of Children Policy
Research Using Human Embryonic Stem Cells
Vertebrate Animals
Debarment and Suspension
Drug-Free Workplace
Lobbying
Non-Delinquency on Federal Debt
Research Misconduct
Civil Rights
Handicapped Individuals
Sex Discrimination
Age Discrimination
Recombinant DNA and Human Gene Transfer Research
Financial Conflict of Interest (except Phase I SBIR/STTR)
Certification of Research Institution Participation (STTR only)

Notice of Proprietary Information

When the application contains information that constitutes trade secrets; or information that is commercial or financial; or information that is confidential or privileged, the information must be identified by asterisks (*) and page number in the Research Plan. The information is furnished to the Government in confidence with the understanding that it shall be used or disclosed only for evaluation of this application; provided that, if a grant is awarded as a result of, or in connection with, the submission of this application, the Government shall have the right to use or disclose the information to the extent authorized by law. This restriction does not limit the Government's right to use the information if it is obtained without restriction from another source.

2. Description, Performance Sites and Key Personnel

FORM PAGE 2 (MS Word or PDF)

Note:

Do not insert additional pages between Form Page 1 and Form Page 2.

Description

Instructions for this section are on Form Page 2.

Performance Site(s)

Indicate where the work described in the Research Plan will be conducted. If there is more than one performance site, list all the sites, including V.A. facilities and foreign sites, and provide an explanation on the Resources Format page of the application. One of the sites indicated must be the applicant organization or be identified as off-site in accordance with the conditions of the applicant organization's negotiated Facilities and Administrative (F&A) agreement. This information must agree with the F&A information on the Checklist Form Page of the application. State if a consortium/contractual arrangement is involved with one or more collaborating organizations for the conduct of a portion of the work described in the Research Plan. If a performance site is participating in research using human subjects, it is the responsibility of the applicant organization to assure that the performance site complies with the regulations in 45 CFR Part 46.

Key Personnel

Key personnel are defined as all individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested. Typically, these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level should be included if their involvement meets the definition of key personnel. Consultants should also be included if they meet the definition of "key personnel."

Start with the principal investigator. List the PI's last name first.  All other key personnel should be listed in alphabetical order, last name first. For each individual provide: name, organization (their institutional affiliation), and role on the project. Under role on the project, indicate how the individual will function with regard to the proposed project. Use additional pages as necessary.

3. Research Grant Table of Contents

FORM PAGE 3 (MS Word or PDF)

Provide the page number for each category listed on the Table of Contents. Consecutively number pages throughout the application. Place page numbers at the bottom of each page. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b.

BUDGET INSTRUCTIONS

Modular Format

• Used for grant applications requesting $250,000 or less per year in direct costs  (http://grants.nih.gov/grants/guide/notice-files/not98-178.html)

• Applicable only to R01, R03, R15, and R21 applications.

• Do not use Form Pages 4 and 5

• Use only the Modular Budget Format Page (MS Word or PDF)

If an application requesting $250,000 or less per year in direct costs contains Form Page 4 and/or Form Page 5, the application will be returned to the applicant organization without peer review.

Applicants must request total direct costs in modules of $25,000, reflecting appropriate support for the project. There will be no future year escalations. A typical modular grant application will request the same number of modules in each year.

There is no form page for the budget of modular grant applications. Follow the format on the “Modular Budget Format Page.” At the top of the Budget Justification Page for Modular Research Grant Applications, enter (a) the total direct costs requested for each year and (b) the total direct cost requested for the entire project period.

Personnel. List all personnel, including names, percent of effort and roles on the project. No individual salary information should be provided.  Since the modules should be a reasonable estimate of costs allowable, allocable, and reasonable for the proposed project, applicants must use the current salary cap when estimating the number of modules. With the significant flexibility to rebudget and the ability to carry forward unobligated balances, funds generally should be available to cover any modest increase in the legislatively imposed salary cap.

Consortium/contractual costs. Provide an estimate of total costs (direct plus facilities and administrative) for each year, rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made. List all personnel, including percent of effort and roles on the project. No individual salary information should be provided. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the number of modules requested.

NIH may request (prior to award) additional budget justification in exceptional circumstances. For further information, see http://grants.nih.gov/grants/funding/modular/modular.htm and http://grants.nih.gov/grants/funding/modular/modular_review.htm.

Non-Modular Format

• Used for research grant applications requesting more than $250,000 direct costs per year.

• Use Form Page 4 and Form Page 5

Note:

If the proposed budget is $250,000 or less per year, skip items 4 and 5 that follow, use the 'Modular Budget Format Page' only and follow the specific Budget Instructions for Modular Grant Applications (p.13).

4. Detailed Budget For Initial Budget Period

FORM PAGE 4 (MS Word or PDF)

Budget Requests of $500,000 Direct Costs or More for Any Year

Applicants are required to seek agreement from Institute/Center staff at least 6 weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costs for any year. If staff is contacted less than 6 weeks before submission, there may be insufficient time to make a determination about assignment prior to the intended submission date. If the requested dollars are significantly greater than $500,000, then approval should be sought even earlier. This policy does not apply to applications submitted in response to RFAs or in response to other Announcements that include specific budgetary limits. However, such applications must be responsive to any budgetary limits specified, or they will be returned to applicants without review.

Each item listed in the budget must be clearly justified on Form Page 5. All amounts must be in U.S. dollars. List only the direct costs requested in this application. Do not include any items that are treated by the applicant organization as Facilities and Administrative (F&A) costs according to a Federal rate negotiation agreement, except for those F&A costs included in consortium/contractual costs.

For a supplemental application, show only those items for which additional funds are requested. If the initial budget period of the supplemental application is less than 12 months, prorate the personnel costs and other appropriate items of the detailed budget.

Foreign Justification

For projects with a foreign component, explain and justify on Form Page 5 or, for Modular Applications, on the "Modular Budget Format Page." For a definition of a substantial foreign component, see Section III. A.

Personnel

Name. Starting with the principal investigator, list the names of all applicant organization employees who are involved on the project during the initial budget period, regardless of whether a salary is requested. Include all collaborating investigators, individuals in training, and support staff. 

Role on Project. Identify the role of each individual listed on the project. Describe their specific functions under Justification on Form Page 5. Provide budget narrative for ALL personnel by position, role, and level of effort. This includes consultants and any "to be appointed" positions.

Type of Appointment/Months. List the number of months per year reflected in an individual's contractual appointment to the applicant organization. PHS staff assume that appointments at the applicant organization are full time for each individual. If an appointment is less than full time, e.g., 50 percent time, identify with an asterisk (*) and provide a full explanation under "Justification" on Form Page 5. Individuals may have split appointments, for example for an academic period and a summer period. For each appointment, identify and enter the number of months on separate lines. In cases where no contractual appointment exists with the applicant organization and salary is requested, enter the number of months for that period.

Percent of Effort on Project. For each individual at the applicant organization, list the percent of each appointment to be spent on this project.

Institutional Base Salary. An applicant organization may choose to leave this column blank. However, PHS  staff will require this information prior to award. See Section III-A, "DEFINITIONS".

Salary Requested. Enter the dollar amounts for each position for which funds are requested. The salary requested is calculated by multiplying the individual's institutional base salary by the percent of effort on this project. Explain under "Justification" on Form Page 5 if a lesser amount is requested (e.g., endowed position or  institutional sources.)

Some PHS grant recipients are currently subject to a legislatively imposed salary limitation. Any adjustment for salary limits will be made at the time of award. For guidance on current salary limitations, see the NIH Guide for Grants and Contracts on the NIH grants Web site or contact your office of sponsored programs.

Fringe Benefits. Fringe benefits may be requested, in accordance with institutional guidelines for each position, provided the costs are treated consistently by the applicant organization as a direct cost to all sponsors.

Totals. Calculate the totals for each position and enter the subtotals in each column where indicated.

The applicant organization and its subcontractor(s) may omit salaries and fringe benefits for individuals from copies of the application that are available to non-Federal reviewers. In such cases, replace the numbers with asterisks. You must show the subtotals. Provide one copy, for use only by PHS staff, with the asterisks replaced by the salaries and fringe benefits. 

Special Instructions: Joint University and Department of Veterans Affairs Appointments

Individuals with Joint University and Department of Veterans Affairs Appointments may request the university's share of their salary in proportion to the effort devoted to the research project. The individual's salary with the university determines the base for computing that request. Signature by the institutional official on the application certifies that: (1) the individual is applying as part of a joint appointment specified by a formal Memorandum of Understanding between the university and the Department of Veterans Affairs (VA); and (2) there is no possibility of dual compensation for the same work, or of an actual or apparent conflict of interest regarding such work.

Consultant Costs

Whether or not costs are involved, provide the names and organizational affiliations of all consultants, other than those involved in consortium/contractual arrangements. Include consultant physicians in connection with patient care and persons who serve on external monitoring boards or advisory committees to the project. Describe the services to be performed on Form Page 5 under "Justification." Include the number of days of anticipated consultation, the expected rate of compensation, travel, per diem, and other related costs.

Equipment

List each item of equipment separately and justify each purchase on Form Page 5.

Supplies

Itemize supplies in separate categories, such as glassware, chemicals, radioisotopes, etc. Categories in amounts less than $1,000 do not have to be itemized. If animals are to be purchased, state the species and the number to be used.

Travel

Itemize travel requests and justify on Form Page 5. Provide the purpose and destination of each trip and the number of individuals for whom funds are requested.

Patient Care Costs

If inpatient and/or outpatient costs are requested, provide the names of any hospitals and/or clinics and the amounts requested for each on Form Page 5.

State whether each hospital or clinic has a currently effective DHHS-negotiated research patient care rate agreement and, if not, what basis is used for calculating costs. If an applicant does not have a DHHS-negotiated rate, the PHS awarding component can approve a provisional rate. Indicate, in detail, the basis for estimating costs in this category, including the number of patient days, estimated cost per day, and cost per test or treatment. If both inpatient and outpatient costs are requested, provide information for each separately. If multiple sites are to be used, provide detailed information by site.

Include information regarding projected patient accrual for the project/budget periods and relate this information to the budget request for patient care costs. If patient accrual is anticipated to be lower at the start or during the course of the project, plan budget(s) accordingly.

Provide specific information regarding anticipated sources of other support for patient care costs, e.g., third party recovery or pharmaceutical companies. Include any potential or expected utilization of General Clinical Research Centers.

Alterations and Renovations

Itemize, by category and justify on Form Page 5, the costs of essential alterations and renovations including repairs, painting, removal or installation of partitions, shielding, or air conditioning. Where applicable, provide the square footage and costs. Costs for alterations and renovations are not allowed on grants made to foreign organizations.

Other Expenses

Itemize any other expenses by category and unit cost. These might include animal maintenance (unit care costs and number of care days), patient travel, donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, service contracts, and tuition remission in lieu of salary. Justify costs on Form Page 5.

Consortium/Contractual Costs

Each participating consortium/contractual organization must submit a separate detailed budget for both the initial budget period (Form Page 4) and the entire proposed project period (Form Page 5). 

Consortium arrangements may involve personnel costs, supplies, and other allowable costs, including Facilities and Administrative (indirect) costs. Contractual costs for support services, such as the laboratory testing of biological materials, clinical services, or data processing, are occasionally sufficiently high to warrant a similar categorical breakdown of costs.

When Facilities and Administrative (F&A) costs are requested by a consortium organization, enter the F&A costs in the F&A cost category for each supplementary budget. Provide the F&A cost base and rate. Leave the direct cost category blank.

For the applicant organization budget, list the sum of all consortium/contractual costs (direct and F&A). Insert additional page(s) after Form Page 5, numbering them sequentially. (Do not use 5a, 5b, 5c, etc.) 

5. Budget for Entire Proposed Period of Support

FORM PAGE 5 (MS Word or PDF)

Enter the totals under each budget category for all additional years of support requested. Identify with an asterisk (*), and justify any significant increases or decreases from the initial year budget. Also, justify budgets  with more than a standard escalation from the initial to the future year(s) of support.

6. Biographical Sketch

FORMAT PAGE (MS Word or PDF)

There is no form page for the biographical sketch. Follow the instructions on the "Biographical Sketch Format Page." This section must contain the biographical sketches of all KEY personnel including consultants following the order as listed on Form Page 2.

Use the sample format on the "Biographical Sketch Format Page" to prepare this section for all (modular and other) grant applications.

Note:

The Biographical Sketch may not exceed four pages. Items A and B (together) may not exceed two of the four-page limit.

Complete the educational block at the top of the format page, and complete sections A, B, and C.

A. Positions and Honors. List in chronological order previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee.

B. Selected peer-reviewed publications or manuscripts in press (in chronological order). Do not include manuscripts submitted or in preparation.

C. Research Support. List both selected ongoing and completed (during the last three years) research projects (federal or non-federal support).  Begin with the projects that are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch.  Note:  Do not include percent of effort or direct costs.

This information will be used by the reviewers in the assessment of each individual 's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team.

7. Resources

(FORMAT PAGE, PDF FORMAT)

There is no "Form Page" for resources. Follow the sample format and instructions on the "Resources Format Page" when completing information on resources available for the project. If there are multiple performance sites, then resources available at each site should be described.

8. Research Plan

There is no Form Page for the Research Plan. The Research Plan should include sufficient information needed  for evaluation of the project, independent of any other document. Be specific and informative, and avoid redundancies. Organize Items a-d of the Research Plan to answer these questions:

1. What do you intend to do?
2. Why is the work important?
3. What has already been done?
4. How are you going to do the work?

Introduction (Revised or Supplemental Applications Only)

All revised (amended) and supplemental applications must include an Introduction. Do not exceed three pages for revised applications or one page for supplemental applications.

Revised Applications

A revised application will be returned without review if it does not comply with all of these requirements.

Note:

NIH policy limits the number of amended (revised) versions of an application to two and these must be submitted within two years of the original version of the application.

Before a revised application can be submitted, the principal investigator must have received the summary statement from the previous review. There must be substantial changes in the content of the application. The application must include an Introduction of not more than three pages that summarizes the substantial additions, deletions, and changes. The Introduction must also include responses to the criticisms and issues raised in the summary statement. The changes in the Research Plan must be clearly marked by appropriate bracketing, indenting, or changing of typography, unless the changes are so extensive as to include most of the text. This exception should be explained in the Introduction. Do not underline or shade changes. The Preliminary Studies/Progress Report section should incorporate any work done since the prior version was submitted. Acceptance of a revised application automatically withdraws the prior version, since two versions of the same application cannot be simultaneously pending.

Competing Supplements

A competing supplemental application may be submitted to request support for a significant expansion of a project's scope or research protocol. Applications for competitive supplements are not appropriate when the sole purpose is to restore awards to the full SRG-recommended level if they were administratively reduced by the funding agency. A supplemental application will not be accepted until after the original application has been awarded, and may not extend beyond the term of the current grant. The introduction to the supplemental application should provide an overall description of the nature of the supplement and how it will influence the specific aims, research design, and methods of the current grant. Any budgetary changes for the remainder of the project period of the current grant should be discussed under the budget justification. The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application.

If the supplemental application relates to a specific line of investigation presented in the original application that was not recommended for approval by the SRG, then the applicant must respond to the criticisms in the prior summary statement, and substantial revisions must be clearly evident and summarized in the introduction.

Page Limitations

Do not exceed 25 pages for Items a-d. All tables, graphs, figures, diagrams, and charts must be included within the 25-page limit. Applicants are encouraged to be succinct and are reminded that there is no necessity to use all 25-pages allotted to Items a-d of the Research Plan.

SBIR/STTR applicants: See Section VI for Page Limitations

Full-sized glossy photographs of material such as electron micrographs or gels may be included in the Appendix; however, a photocopy of each must also be included within the page limitations of the Research Plan (see Section I-9. Appendix.)

All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet Web site addresses (URLs) may not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Moreover, reviewers are cautioned that they should not directly access an internet site as it could compromise  their anonymity.

Notice of Proprietary Information and Trade Secrets

Applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, if the application contains information that the applicant organization considers to be trade secrets or information that is commercial or financial; or information that is confidential or privileged, identify the pages in the application which contain this information by marking those  paragraphs or lines containing this information with an asterisk (*) in the left-hand margin and providing the page numbers before "a. Specific Aims."

When information in the application constitutes trade secrets or information that is commercial or financial, and confidential or privileged, it is furnished to the Government in confidence with the understanding that the information shall be used or disclosed only for evaluation of this application. If a grant is awarded as a result of or in connection with the submission of this application, the Government shall have the right to use or disclose the information to the extent authorized by law. This restriction does not limit the Government's right to use the  information if it is obtained without restriction from another source.

Research Plan Format and Page Distribution

The PHS recommends the following format and page distribution.

a. Specific Aims

List the broad, long-term objectives and what the specific research proposed in this application is intended to accomplish, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, or develop new technology. One page is recommended.

b. Background and Significance

Briefly sketch the background leading to the present application, critically evaluate existing knowledge, and specifically identify the gaps that the project is intended to fill. State concisely the importance and health relevance of the research described in this application by relating the specific aims to the broad, long-term objectives. Two to three pages are recommended.

c. Preliminary Studies/Progress Report

Preliminary Studies. For new applications, use this section to provide an account of the principal investigator/program director's preliminary studies pertinent to the application information that will also help to  establish the experience and competence of the investigator to pursue the proposed project. 

Peer review committees generally view preliminary data as an essential part of a research grant application. Preliminary data often aid the reviewers in assessing the likelihood of the success of the proposed project. 

Progress Report for Competing Continuation and Supplemental Applications. A progress report must be provided for Competing Continuation and Supplemental Applications. Provide the beginning and ending dates for the period covered since the project was last reviewed competitively. Summarize the previous application's specific aims and the importance of the findings. Discuss any changes in the specific aims as a result of budget reductions. Include the complete references to appropriate publications and manuscripts accepted for publication (not part of the page limitations). Five collated sets of no more than 10 such items of background material, may be submitted in the appendix, in addition to the original set of appendix material (see Section I-9.)

If the competing continuation or supplemental application involves clinical research, then you must report on the enrollment of research subjects and their distribution by ethnicity/race and sex/gender. Use the "5/01 Inclusion Enrollment Report" (MS Word or PDF) to provide this information for each relevant funded study and for each relevant study that will be continued. If the application contains more than one study, provide a separate table for each study. Also report on any subpopulations as an attachment to the table. If, during the previous project period, information on ethnicity/race and sex/gender was collected using an earlier NIH reporting format involving a single-question format to capture both ethnicity and race, then the former "4/98 Version of the Inclusion Table" (MS Word or PDF) may be used in the progress report section. Tables on inclusion will not be counted in the research plan page limitation. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html for more detailed instructions on using the 5/01 Inclusion Enrollment Report and the 4/98 Version of the Inclusion Table.

Provide a succinct account of published and unpublished results, indicating progress toward their achievement.

List the titles and complete references to all publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively. Up to 10 such publications may be included in the five collated sets of appendices.

Do not complete or submit the Personnel Report with the application. When the Personnel Report is requested by the awarding component, use the Personnel Report Form Page.

Six to eight pages are recommended for the narrative portion of the Preliminary Studies/Progress Report.

d. Research Design and Methods

Describe the research design and the procedures to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted as well as the data sharing plan as appropriate. Describe any new methodology and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.

Although no specific number of pages is recommended for the Research Design and Methods section, the total for Items a-d may not exceed 25 pages, including all tables  and figures. Applicants are encouraged to be as succinct as possible and reminded that there is no requirement that all 25 pages allotted for this section be used.

e. Human Subjects Research

Applicants are encouraged to use the decision charts on OHRP's website (http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm) for guidance in determining whether the proposed research involves human subjects research as defined in part A of the human subjects regulations  (45 CFR 46) (See Section III A., "Definitions").

If you have marked "Yes" for Item 4 on the Face Page of the application, create a section heading entitled Human Subjects Research immediately following the last entry in the Research Design and Methods section. When you have completed this section, you will need to address the instructions in the sections entitled "Women and Minority Inclusion in Clinical Research" and the "Inclusion of Children" and Data and Safety Monitoring if the research involves a clinical trial. Although no specific page limitation applies to this section of the application, be succinct.

Special Populations

Investigators who conduct research involving fetuses, pregnant women, human in vitro fertilization, prisoners, or children must follow the provisions of the regulations in Subparts B, C, and D of 45 CFR 46, respectively, which describe the additional protections required for these populations. Relevant information may be obtained at the OHRP website http://www.hhs.gov/ohrp/assurances/assurances_index.html). Exemptions 1-6 below do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization (see Subparts B and C.) Also, Exemption 2 below, for research involving survey or interview procedures or observation of public behavior, does not apply to research with children (see Subpart D), except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

Human Subjects Research Section

In the Human Subjects Research section, applicants must (1) address the involvement of human subjects and protections from research risk relating to their participation in the proposed research plan (see Non Exempt  Human Subjects Research for specific requirements), or (2) provide a justification for exemption with sufficient information about the involvement of the human subjects to allow a determination by peer reviewers and NIH staff that a claimed exemption is appropriate (see Exempt Human Subjects Research for specific requirements).

The following table is intended to provide guidance on what must be addressed in the Human Subjects Research section.

Guidance for Preparing the Human Subjects Research Section

Non Exempt Human Subjects Research

Protection of Human Subjects

If you marked "Yes" for Item 4 on the Face Page of the application and did not claim any exemptions from the  regulations, create a section entitled "Protection of Human Subjects." In this section, you must provide information to address all four evaluation criteria below as they apply to the research you are proposing.

Under each criterion, indicate whether the information relates to the primary research site, or to a collaborating performance site(s), or to all sites.

1. RISKS TO THE SUBJECTS

Human Subjects Involvement and Characteristics: Describe the proposed involvement of human subjects in the work outlined in the Research Design and Methods section. 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 fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

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.

Potential Risks: Describe the potential risks to subjects (physical, psychological, social, legal, or other) and assess their likelihood and seriousness to the subjects. Where appropriate, describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures to participants in the proposed research.

2. ADEQUACY OF PROTECTION AGAINST RISKS

Recruitment and Informed Consent: Describe plans for the recruitment of subjects and the process for obtaining informed consent. Include a description of 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. The informed consent document need not be submitted to the PHS unless requested.

Protection Against Risk: Describe the planned procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. In studies that involve clinical trials (biomedical and behavioral intervention studies), describe the plan for data and safety monitoring of the research to ensure the safety of subjects.

3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS

Discuss the potential benefits of the research to the subjects and others. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.

4. 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 importance of the knowledge that reasonably may be expected to result.

Note: If a test article (investigational new drug, device, or biologic) is involved, name the test article and state whether the 30-day interval between submission of applicant certification to the Food and Drug Administration and its response has elapsed or has been waived and/or whether use of the test article has been withheld or restricted by the Food and Drug Administration.

Collaborating Site(s)

When research involving human subjects will take place at collaborating site(s) or other performance site(s), the principal investigator must provide in this section of the application a list of the collaborating sites and their OHRP assurance numbers. Further, the principal investigator must obtain in writing, and keep on file, an assurance from each site that the four previous points have been addressed adequately at a level of attention that is at least as high as that documented at the applicant organization. Site(s) added after an award is made also must adhere to the above requirements.

Exempt Human Subjects Research

If you marked "Yes" for Item 4 on the Face Page and claimed an exemption from the human subjects regulations, then identify which one or more of the exemptions identified below is claimed. Provide a justification with sufficient information about the involvement of human subjects in the proposed research to allow a determination by peer reviewers and NIH staff that the designated exemption is appropriate. 

Population Sample: 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, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

Sources: Applicants should identify the sources of research material obtained from 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.

Exemption Categories

The six categories of research that qualify for exemption from coverage by the regulations include activities in which the only involvement of human subjects will be in one or more of the following categories:

Exemption 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.

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.

Exemption 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 paragraph (2)(b) of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Exemption 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 such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Exemption 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. 

Exemption 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 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. 

Note: Some exemptions do not apply when research involves vulnerable populations as indicated in 45 CFR.

Women and Minority Inclusion in Clinical Research

If you are conducting clinical research (See definition in Section III. A., DEFINITIONS), create a section heading entitled "Inclusion of Women" and a separate section heading entitled, "Inclusion of Minorities." Place these sections immediately after the Human Subjects Research section in your application. Address each of the items identified below with respect to your plans for the "Inclusion of Women" and the "Inclusion of Minorities" as they relate to the proposed research. Although no specific page limitation applies to these sections of the application, be succinct.

NIH policy requires that women and members of minority groups and their subpopulations be included in all  NIH-supported biomedical and behavioral clinical research projects involving human subjects (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html and also definition in Section III A., "DEFINITIONS").

The inclusion must be addressed in developing a research design appropriate to the scientific objectives of the study. Inclusion is required unless a clear and compelling rationale shows that inclusion is inappropriate with respect to the health of the subjects or that inclusion is inappropriate for the purpose of the study. Exclusion under other circumstances may be made based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be excluded routinely from participation in clinical research. This policy applies to research subjects of all ages.

Information to be Provided for All Clinical Research Studies

See definition of clinical research in Section III., A., DEFINITIONS.

Provide information on the composition of the proposed study population in terms of sex/gender and racial/ethnic group and provide a rationale for selection of such subjects in terms of the scientific objectives and proposed study design. The description may include (but is not limited to) information on the population characteristics of the disease or condition under study, national and local demography, knowledge of the racial/ethnic/cultural characteristics of the population, prior experience and collaborations in recruitment and retention of the populations and subpopulations to be studied, and the plans, arrangements and letters of commitment from relevant community groups and organizations for the planned study.

This section of the research plan must include the following information:

• A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and  proposed study design.
• A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group.
• The proposed dates of enrollment (beginning and end).
• A description of proposed outreach programs for recruiting women and minorities in clinical research as subjects.
• The proposed sample composition using the "5/01 Targeted/Planned Enrollment Format Page" and/or the "5/01 Inclusion Enrollment Report Format Page."

FOR ALL STUDIES INVOLVING HUMAN SUBJECTS, USE THE FOLLOWING ETHNIC AND RACIAL CATEGORIES.

The Office of Management and Budget (OMB) Directive No. 15 (http://www.whitehouse.gov/omb/fedreg/ombdir15.html) defines minimum standards for maintaining, collecting and presenting data on race and ethnicity for all Federal reporting (including NIH). The categories in this classification are social-political constructs and should not be interpreted as being anthropological in nature. The standards were revised in 1997 and now include two ethnic categories, "Hispanic or Latino" and "Not Hispanic or Latino." There are five racial categories: American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; and White. Reports of data on race and ethnicity shall use these categories. NIH is required to use these definitions to allow comparisons to other federal databases, especially the census and national health databases. The following definitions apply for the ethnic and racial categories (OMB Directive 15).

Ethnic Categories:

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, “Spanish origin,” can be used in addition to “Hispanic or Latino”. 

Not Hispanic or Latino  

Racial Categories:

American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliation or community attachment.

Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.  (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)

Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”

Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

Standards for Collecting Data.  When an investigator is planning data collection items on ethnicity and race, categories identified above should be used. The collection of greater detail is encouraged. However, more detailed items should be designed in a way that they can be aggregated into these required categories. Self-reporting or self-identification using two separate questions is the preferred method for collecting data on ethnicity and race. When ethnicity and race are collected separately, ethnicity shall be collected first.  Respondents shall be offered the option of selecting one or more racial designations.  When data on ethnicity and race are collected separately, provision shall be made to report the number of respondents in each racial category who are Hispanic or Latino.  When aggregate data are presented, the investigator shall provide the number of respondents who selected only one category, for each of the five racial categories.  If data on multiple responses are collapsed, at a minimum the total number of respondents reporting “more than one race” shall be made available. Federal agencies shall not present data on detailed categories if doing so would compromise data quality or confidentiality standards.

Additional Information to be Provided for NIH-Defined Phase III Clinical Trials

If an NIH-defined Phase III clinical trial (see "Definitions" in Section III-A) is proposed, the application must address whether the investigator expects to find clinically important sex/gender and/or race/ethnicity differences in the intervention effect. The discussion may include supporting evidence and/or data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies. The research plan also must include one of the following plans: 

• plans to conduct valid analyses to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR

• plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups. (Representation of sex/gender and racial/ethnic groups in not required as subject selection criteria, but inclusion is encouraged.), OR

• plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.

Completing the Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research

New Applications

Use the "5/01 Targeted/Planned Enrollment Table Format Page (MS Word or PDF)." Provide the study title and plans for the total number of subjects proposed for the study. Also provide the distribution by ethnic categories and by sex/gender according to the format in the 5/01 Targeted/Planned Enrollment Table. If there is more than one study, provide a separate table for each study. List any proposed racial/ethnic subpopulations below the table. If the proposed research uses existing data, then applicants must use the formats for Competing Continuations, Competing Supplements and Annual Grant Progress Reports.

Competing Continuations, Competing Supplements and Annual Grant Progress Reports

For Competing Continuations involving the collection of new/additional clinical data, use the  "5/01 Targeted/Planned Enrollment Table (MS Word or PDF)"(see Note below) to estimate the distribution of subjects proposed for the study. Provide the study title and plans for the total (cumulative) number of subjects proposed for the study (total planned enrollment). Provide the distribution of subjects by ethnic and racial categories and by sex/gender according to the format in the 5/01 Targeted/Planned Enrollment Table.  If there is more than one study, provide a separate table for each study.

For Competing Continuations that do not involve the collection of new/additional clinical data, the data on ethnicity/race and sex/gender may be presented in EITHER the 4/98 Version of the Inclusion Table (MS Word or PDF) or the 5/01 Inclusion Enrollment Report (MS Word or PDF). If data were originally collected using two questions (one about ethnicity and one about race) and subjects were given the option of selecting more than one race, then the 5/01 Inclusion Enrollment Report should be used.  Otherwise, the 4/98 Version of the Inclusion Table should be used.

For Competing Supplement Applications and Annual Grant Progress Reports investigators may choose to report ethnicity/race and sex/gender composition using EITHER the format in the 4/98 Version of the Inclusion Table (MS Word or PDF) or the 5/01 Inclusion Enrollment Report (MS Word or PDF). If data are being collected using two questions (one about ethnicity and one about race) and subjects were given the option of selecting more than one race, then the 5/01 Inclusion Enrollment Report should be used. Note: If you choose to report information with the new 5/01 Inclusion Enrollment Report, you must continue to use this format for the remaining years of the project.

For Annual Grant Progress Reports, if there are changes from the targeted/planned enrollment originally approved, a revised targeted/planned enrollment page and an inclusion enrollment report reflecting data collected to-date should be submitted.

Note on use of the "5/01 Inclusion Enrollment Table": Principal Investigators of successful competing continuation awards involving collection of new/additional clinical data will be required to use the new " 5/01 Inclusion Enrollment Report (MS Word or PDF)" in subsequent annual PHS 2590 Progress Reports (5/01). The 5/01 Inclusion Enrollment Report contains two parts: part A is for all subjects and part B is for Hispanics or Latinos. For Part A provide the distribution of subjects by ethnic and racial categories and by sex/gender according to the format in the 5/01 Enrollment Report Table. Part B should include information on the race of all Hispanics (or Latinos) enrolled in Part A.  If there is more than one study, provide a separate table for each study. List any proposed ethnic/racial subpopulations as an attachment to the table. In filling out the 5/01 Inclusion Enrollment table, the investigator should not assume or guess a subject's ethnic or racial affiliation. The investigator should collect the data using instruments that, at a minimum, allow all respondents to select their ethnic and racial affiliation separately. Under racial affiliation, subjects must be provided the option of selecting more than one race. When reporting these data to NIH, subjects who selected only one of the five racial categories should be designated in that category. Subjects who selected more than one racial category should be reported in the "More than one race" category. For previously funded studies that used an earlier NIH reporting format, the earlier reporting format is NOT directly transferable to the new format. Investigators should review the instructions and frequently asked questions about using the new format at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.

Inclusion of Children

If you have marked "Yes" for Item 4 on the Face Page of the application, create a section heading entitled "Inclusion of Children." Place it immediately following the "Women and Minority Inclusion in Clinical Research" section of the application.

NIH policy requires that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH see http://grants.nih.gov/grants/funding/children/children.htm for additional information),, unless there are clear and compelling reasons not to include them. Therefore, proposals for research involving human subjects must include a description of plans for including children. If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

In the section entitled "Inclusion of Children", the applicant should provide either a description of the plans to include children or if children will be excluded from the research, the application or proposal must present an acceptable justification (see below) for the exclusion.

If children are included, the description of the plan should include a rationale for selecting or excluding a specific age  range of children. When children are included, the plan also must include a description of the expertise of the investigative team for dealing with children at the ages included, of the appropriateness of the available facilities to accommodate the children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study.

Scientific Review Groups will assess each application as being "acceptable" or "unacceptable" with regard to the age-appropriate inclusion or exclusion of children in the research project.

Justifications for Exclusion of Children

It is expected that children will be included in all research involving human subjects unless one or more of the following exclusionary circumstances can be fully justified:

1. The research topic to be studied is not relevant to children.
2. There are laws or regulations barring the inclusion of children in the research.
3. The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be redundant. Documentation of other studies justifying the exclusions should be provided. NIH program staff can be contacted for guidance on this issue if the information is not readily available.
4. A separate, age-specific study in children is warranted and preferable. Examples include:
   1. The relative rarity of the condition in children, as compared to adults (in that extraordinary effort would be needed to include children, although in rare diseases or disorders where the applicant has made a particular effort to assemble  an adult population, the same effort would be expected to assemble a similar child population with the rare condition); or
   2. The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network; or
   3. Issues of study design preclude direct applicability of hypotheses and/or interventions to both adults and children (including different cognitive, developmental, or disease stages or different age-related metabolic processes). While this situation may represent a justification for excluding children in some instances, consideration should be given to  taking these differences into account in the study design and expanding the hypotheses tested, or the interventions, to allow children to be included rather than excluding them; or 
5. Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis; or
6. Study designs aimed at collecting additional data on pre-enrolled adult study subjects (e.g., longitudinal follow-up studies that did not include data on children); or
7. Other special cases justified by the investigator and found acceptable to the review group and the Institute Director.

Definition of a Child

For the purpose of implementing these guidelines, a child is defined as an individual under the age of 21 years.

The definition of child described above will pertain to these guidelines (notwithstanding the FDA definition of a child  as an individual from infancy to 16 years of age, and varying definitions employed by some states). Generally, State  laws define what constitutes a "child," and such definitions dictate whether or not a person can legally consent to participate in a research study. However, State laws vary, and many do not address when a child can consent to participate in research. Federal Regulations (45 CFR 46, subpart D, Sec.401-409) address DHHS protections for children who participate in research, and rely on State definitions of "child" for consent purposes. Consequently, the children included in this policy (persons under the age of 21) may differ in the age at which their own consent is required and sufficient to participate in research under State law. For example, some states consider a person age  18 to be an adult and therefore one who can provide consent without parental permission.

Data and Safety Monitoring Plan

If you have marked "Yes" for Item 4 on the Face Page of the application, and your proposed research includes a clinical trial create a section heading entitled "Data and Safety Monitoring Plan." Place it immediately following the "Inclusion of Children" section.

NIH policy requires that investigators submit a general description of the Data and Safety Monitoring Plan for clinical trials (biomedical and behavioral intervention studies) as part of the research application. In developing your Data and Safety Monitoring Plan, you should refer to the NIH Policy For Data and Safety Monitoring (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. See also (http://grants.nih.gov/grants/guide/notice-files/not98-084.html ).

A general description of a monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for monitoring, and how Adverse Events (AEs) will be reported to the Institutional Review Board (IRB), the NIH Office of Biotechnology Activities (OBA), and the Food and Drug Administration (FDA) in accordance with IND or IDE regulations. Although no specific page limitation applies to this section of the application, be succinct.

The frequency of monitoring will depend on potential risks, complexity, and the nature of the trial; therefore, a number of options for monitoring trials are available. These can include, but are not limited to, monitoring by a: 

• Principal Investigator (required)
• Independent individual/Safety Officer
• Designated medical monitor
• Internal Committee or Board with explicit guidelines
• Data and Safety Monitoring Board (DSMB - required for multi-site trials)
• Institutional Review Board (IRB - required)

NIH specifically requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multisite clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials. Although Phase I and Phase II clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.

A detailed Data and Safety Monitoring Plan must be submitted to the applicant's IRB and subsequently to the funding IC for approval prior to the accrual of human subjects (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html).

f. Vertebrate Animals.

If you have marked Item 5 on the Face Page of the application "Yes," create a section heading entitled "Vertebrate Animals." Place it immediately following the "Research Design and Methods" section of the application (or after Item e, if applicable.)

Under the Vertebrate Animals heading address the following five points. In addition, when research involving vertebrate animals will take place at collaborating site(s) or other performance site(s), provide this information before discussing the five points. Although no specific page limitation applies to this section of the application, be succinct.

1. Provide a detailed description of the proposed use of the animals in the work outlined in the Research Design and Methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.

2. Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.

3. Provide information on the veterinary care of the animals involved.

4. Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.

5. Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.

g. Literature Cited

List all references. The list may include, but may not replace, the list of publications required in the Progress Report for competing continuation applications.

Each reference must include the title, names of all authors, book or journal, volume number, page numbers, and year of publication. The reference should be limited to relevant and current literature. While there is not a page limitation, it is important to be concise and to select only those literature references pertinent to the proposed research.

h. Consortium/Contractual Arrangements

Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee.

The signature of the authorized organizational official on the face page signifies that the applicant and all proposed consortium participants understand and agree to the following statement: The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the NIH consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy.

i. Consultants

Attach appropriate letters here from all individuals confirming their roles in the project. Do not place these letters in the Appendix.

9. Appendix

Include five collated sets of all appendix material, in the same package with the application, following all copies of the application. Identify each item with the name of the principal investigator. Do not intermingle appendix materials with the application. 

New, Revised, Competing Continuation and Supplemental applications may include the following materials in the appendix:

• Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. These may be stapled as sets. Manuscripts submitted for publication should not be included.
• Surveys, questionnaires, data collection instruments, and clinical protocols. These may be stapled as sets.
• Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 25-page limit of Items a-d of the research plan. No photographs or color images may be included in the appendix that are not also represented within the Research Plan.

The appendix will not be duplicated with the application and will be sent only to certain members of the SRG who will serve as the primary reviewers of the application.

10. Checklist

CHECKLIST FORM PAGE (MS Word or PDF)

Type of Application

Check all that apply:

Inventions and Patents (Competing Continuation Applications Only)

If no inventions were conceived or reduced to practice during the course of work under this project, check "No." The remaining parts of the item are then not applicable.

If any inventions were conceived or reduced to practice during the previous period of support, check "Yes."  Also indicate whether this information has been previously reported to the PHS or to the applicant organization official responsible for patent matters.

NIH has developed an optional on-line Extramural Invention Information Management System, known as "Edison," to facilitate grantee compliance with the disclosure and reporting requirements of 37 CFR 401.14(h). The Internet address for this system is HTTP://iedison.gov. Information from these reports is not made publicly available.

Program Income

If no program income is anticipated during the period(s) for which grant support is requested, no other action is necessary.

If program income is anticipated, use the format provided. If the application is funded, the Notice of Grant Award will provide specific instructions regarding the use of such income.

Assurances/Certifications

Each application to the PHS requires that the assurances and certifications listed on the Checklist be verified by the signature of the official signing for the applicant organization on the Face Page of the application.

Facilities and Administrative (F&A) Costs

Indicate the applicant organization's most recent F&A cost rate established with the appropriate DHHS Regional Office, or, in the case of for-profit organizations, the rate established with the appropriate PHS agency cost advisory office. If the applicant organization is in the process of initially developing or renegotiating a rate, or has established a rate with another Federal agency, it should, immediately upon notification that an award will be made, develop a tentative F&A cost rate proposal. This is to be based on its most recently completed fiscal year in accordance with the principles set forth in the pertinent DHHS Guide for Establishing Indirect Cost Rates, and submitted to the appropriate DHHS Regional Office or PHS agency cost advisory office. F&A costs will NOT be paid on construction grants, grants to Federal organizations, grants to individuals, and conference grants. Follow any additional instructions provided for Research Career Awards, Institutional National Research Service Awards, Small Business Innovation Research/Small Business Technology Transfer Grants, foreign grants, and specialized grant applications.

Special Instructions for Modular Applications

Applicant institutions should calculate the F&A costs using the current negotiated F&A rate, less exclusions, for the initial budget period and all future budget periods. It is not necessary to list the exclusions on the Checklist or anywhere in the application.

Smoke-Free Workplace

Follow instructions on the Checklist. Response to the question has no impact on the review or funding of this application.

11. Personal Data

FORM PAGE (MS Word or PDF)

Self Explanatory.

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