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NATIONAL INSTITUTES OF HEALTH
Office of Extramural Research |
Abstracts are allowed in the appendix of an application. Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, and other printed materials directly relevant to the project may be included.
Each page in the appendix may be double-sided.
The appendix will be distributed to the primary and the secondary reviewers of the application assigned within the study section. One copy of the appendix is forwarded to the assigned NIH institute's program administrator, and one copy remains with the Scientific Review Administrator (SRA) until the review is complete.
Civil Rights - Before a grant award can be made, a domestic applicant organization must certify that it has filed with the DHHS Office for Civil Rights and Assurance of Compliance (Form HHS 690) pertaining to four non-discrimination requirements. This form is required to be submitted only once by an institution; it may be obtained from grantsinfo@nih.gov or by telephone at 301/435-0714.
As a condition of receiving NIH Support, an applicant organization must certify compliance with a number of assurances. Most assurances and certifications are incorporated by reference in the PHS 398 application kit (see pp.27-36). For those assurances, the signature on the application face page of the duly authorized representative of the applicant institution certifies that the applicant organization will comply. The inclusion of human subjects or animals in research requires special certifications as described below.
Human Subjects - The Federal Policy (Common Rule) for the protection of human subjects at Section 103(a) requires that each institution "engaged" in Federally-supported human subject research file an "Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions. For additional information and guidance, please visit the Office for Human Research Protections (OHRP) web site at: http://www.hhs.gov/ohrp/.Animal Welfare - Research involving human and/or animal subjects must comply with the HHS regulations for the Protection of Human Subjects (45 CFR 46) and/or the PHS Policy on Humane Care and Use of Laboratory Animals. Institutions without an applicable Assurance of Compliance on file with the Office of Laboratory Animal Welfare (OLAW) must provide an appropriate Assurance prior to funding. For additional information and guidance, please visit the OLAW web site at: http://grants.nih.gov/grants/olaw/olaw.htm.
NIH award data is accessible on the NIH web site at: http://grants/nih.gov/grants/award/award.htm. This site provides provides reports, charts and graphs, extramural trends, listings of awards arranged geographically by state, city, and grantee organization within the city and other award-related information.
The Center for Scientific Review (CSR) is the new organizational name of the former Division of Research Grants (DRG). CSR is the central NIH organization that receives grant applications; creates a new computer record for each; assigns applications to initial review groups as well as to potential funding units of NIH and other cooperating health research agencies; and conducts peer review of grant applications. For more detailed information, please see the website http://www.csr.nih.gov and the section on peer review. At that site there is also an excellent overview of the NIH peer review and award process.
Citations may not be scattered throughout the Research Plan of an application. They should be put in Section G, Literature Cited.
A co-investigator (collaborator) is an individual involved with the principal investigator in the scientific development or execution of the project. These individuals would typically devote a specific percent of effort to the project and would be identified as key personnel. The individual(s) may be employed by, or affiliated with, either the grantee organization or an organization participating in the project under a consortium or contractual agreement.
Submission of more than one application within the same review cycle is permissable for some, but not all, award mechanisms:
For a NRSA Fellowship (F series), only one application may be submitted in the same review cycle.
For an investigator-initiated grant (R01), small grant (R03), career development award (K-Series, excepting K08), small business innovation research grant (SBIR), small business technology transfer grant (STTR), or a conference grant (R13), more than one application in the same review cycle may be submitted, if each application describes a different research topic.
An application for an investigator-initiated grant (R01) for support of the same research proposed as a subproject within an application for a program project grant (P01), or as a subproject within an application for other P-series grants, such as P30 or P50, may be submitted in the same cycle.
A consultant is an individual who provides professional advice or services on the basis of a written agreement for a fee. These individuals are not normally employees of the organization receiving the services.
NOTE: A biographical sketch (Form FF) is required for all key personnel. Consultants should be included only when their level of involvement on the grant meets the key personnel definition and each biographical sketch must be no more than four pages.
Photocopies of blank application forms may be used as original forms for grant preparation.
Instructions for the number of copies of research grant applications and appended materials to be submitted at the regular application receipt dates are detailed on page 21 of the PHS 398 instructions. There may be additional instructions for submission of responses to Requests for Applications (RFAs) in the NIH Guide announcements of RFAs.
All applications and other deliveries to the Center for Scientific Review must either come via courier delivery or the USPS. Applications delivered by individuals to the Center for Scientific Review will no longer be accepted.
For additional information, see the NIH Guide Notice (Nov. 13, 2001) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
In general, any organization is eligible to apply for regular NIH research grants, such as R01 grants and other grant mechanisms. The applicant is the research organization, although a principal investigator (PI) writes the research proposal; and if a grant is awarded, the grantee is the organization that submitted the application. For some specific programs there may be special eligibility requirements, and those requirements are detailed in the Program Announcement (PA) or Request for Applications (RFA) published in the NIH Guide. (See next item for access to the NIH Guide.)
Current and past issues of the NIH Guide may be accessed from the NIH website under the
category of Funding Opportunities at http://grants.nih.gov/grants/oer.htm
or a Table of Contents Email version of the NIH Guide may be obtained by subscription to the
NIH Listserv. To subscribe to the Table of Contents, send an Email message to
listserv@list.nih.gov in which the text of the mail
should read ONLY:
SUBSCRIBE NIHTOC-L Firstname Lastname
(e.g. SUBSCRIBE NIHTOC-L Bill Jones)
The message must originate from the same address where you would like the weekly Table of Contents to be received and read, circulated or filed.
Reimbursement for indirect costs (also called facilities and administration costs, or F&A;) is allowed on most types of NIH awards. Typically, indirect cost reimbursement is calculated using the institution's indirect cost rate as negotiated with HHS. The applicant institution's office of sponsored research or business office can provide this information. If an organization does not already have an HHS-negotiated indirect cost rate, refer to the PHS Grants Policy Statement, appendix 8, for the appropriate HHS Division of Cost Allocation office (for educational and other non-profit organizations) or PHS agency (for-profit organizations).
Required only on REVISED and SUPPLEMENTAL applications, the "Introduction" section of the application is not counted towards the Research Plan 25-page limit. It is separate from the Research Plan.
The term, Investigator-Initiated Application, means that the applicant has proposed research for funding by NIH that is not responding to any solicitation by NIH in anouncements such as a Program Announcement (PA) or a Request for Applications (RFA). The research proposed by the applicant mostly likely would be related to the stated program interests of one or more of the Institutes of NIH in descriptions of their programs, but the scientist has proposed a research project that is independent of any particular solicitation by an Institute. The mechanisms of support for such applications most frequently used are the "R" series of grants, notably the R01 research project grant.
According the Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications IRB approval is not required prior to NIH peer review of an application. However, no grant award can be made without IRB approval. Following NIH peer review and notification of priority score/percentile, institutions should proceed with IRB review for those applications that have not yet received IRB approval and that appear to be in a fundable range. The term "fundable range" does not signify a certainty of funding. For more information, please visit the following web site: http://grants.nih.gov/grants/irb_review_pol.htm.
Institutional Animal Care and Use Committee (IACUC) approval is required when animal studies are involved. Beginning with applications submitted for the October 1, 2002, receipt date (and any other receipt dates that result in applications being reviewed for May/June 2003 Councils), IACUC "just-in-time" will be in effect. That is, institutions will be permitted flexibility in the timing of IACUC review relative to submission of an application. The full NIH Guide Notice is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-064.html.
The definition of key personnel in the PHS 398 kit is " individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested."
The modular grant application concept establishes a size (in dollars) of module in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. In addition, an applicant will need to submit certain information only when it is highly likely that NIH will make an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 05/01) is to be used with the instructions for the modular grant application.
Modular Grant applications request direct costs in $25,000 modules, and may request up to $250,000 (10 modules) for direct costs per year. Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.
The NIH Modular Research Grant Application web page http://grants.nih.gov/grants/funding/modular/modular.htm can guide you to detailed information about the application process, including samples of relevant pages from an application.
The snap-out mailer is the only official notification from the NIH that an application has been received by the Center for Scientific Review (CSR) Referral Office. It acknowledges receipt of the application, indicates the Initial Review Group (IRG), NIH Institute assignment, and provides the Scientific Review Administrator's (SRA) name and telephone number. The snap-out mailer is sent 6 to 8 weeks after the receipt date to the addresses provided on the application face page.
If additional proof that an application has been received is desired, the application may be hand delivered to the Rockledge Center before 5:00 p.m., Monday thru Friday, and the messenger can obtain a signature of receipt.
If information has been inadvertently omitted from a submitted application package that is critical to the receipt and assignment of the application, e.g., the face page or reference letters, the applicant should call the Center for Scientific Review (CSR) Referral Office at (301) 435-0715. Otherwise, the applicant should wait for receipt of the snap-out mailer (about 6-8 weeks after the receipt date), and then contact the Scientific Review Administrator (SRA) identified on the mailer.
According to the PHS 398 Instructions, "Other support information is required for all applications that are to receive grant awards; however, NIH will request complete and up to date "other support" information from applicants at an appropriate time after peer review. The institute's scientific program and grants management staff will review this information prior to award."
The pages must be numbered with consecutive integers. If a continuation page is necessary for one of the pre-numbered forms pages, the requirement for consecutive integer numbering of the whole application takes precedence.
Do not include "subpages" to the form pages in the kit
(i.e., do not number
the pages as 4, 4a, 4b, 5).
Glossy photographs or color images that are represented in the Research Plan may be included in the appendix with the original application. DO NOT paste photographs in application.
Graphs, diagrams, tables, and charts not needed in a glossy format to show detail must be included with the Research Plan and may NOT be included in the appendix.
Do NOT use the appendix to circumvent the page limitations of the Research Plan.
Beginning January 10, 2002, applicants are required to use the revised (05/01 forms). The revised PHS 398 and PHS 2590 instructions are only available online at http://grants.nih.gov/grants/forms.htm. Applicants are encouraged to access the instructions and forms via the Internet because they provide valuable links to current policy documents and allow easy navigation of the instructions.
PHS 398 application kits cannot be faxed to applicants.
The revised Ruth L. Kirschstein Individual National Research Service Award Application (PHS 416-1) and Progress Report for Continuation Support (PHS 416-9) are available online in a fillable format at: http://grants.nih.gov/grants/forms.htm. NOTE: For the April 2003 application receipt date and beyond, use of the new version (Rev. 6/02) is required.
For general information about NIH research and research training programs, interested parties may contact grantsinfo@nih.gov.
Information about the programs of a specific NIH institute can be found on the NIH website: http://www.nih.gov. Click on Institutes and Offices. Also the NIH Extramural Programs describes the programs of the NIH and includes contacts for additional information at the website: http://grants.nih.gov/grants/funding/funding.htm.
Each Program Announcement (PA) and Request for Applications (RFA) in the NIH Guide for Grants and Contracts includes contact information for the grants management officer and program administrator for additional information about that PA or RFA.
To obtain a specific program announcement, consult the NIH Guide for Grants and Contracts on the OER website, http://grants.nih.gov/grants/oer.htm or contact the Institute that issued the program announcement. The NIH Guide has a numerical list of the program announcements.
Each of the NIH institutes that use P01s publishes its own guidelines for program project (P01) applications. For answers to questions regarding program project grants, applicants are encouraged to contact the NIH institute most likely to fund their project. Occasionally, an Institute's solicitation published in the NIH Guide will specify that a program project is the funding mechanism appropriate for a grant application in response to the announcement.
The PHS application documents (i. e., PHS 398, PHS 416-1) contain the receipt dates that apply to grant applications unless special receipt dates have been specified in either a program announcement (PA), request for application (RFA), or program guidelines published in the NIH Guide for Grants and Contracts. A list of receipt dates is available from GrantsInfo (301-435-0714) by choosing Option 3 on the menu. Receipt date schedules are also posted on the NIH website: http://grants.nih.gov/grants/funding/funding.htm under the category of Receipt Dates.
WHENEVER A RECEIPT DATE FALLS ON A WEEKEND OR HOLIDAY, THE APPLICATION IS DUE ON THE FOLLOWING BUSINESS DAY. This applies to postmark dates as well.
Unsolicited Applications. An unsolicited application is considered on time if it is:
Proof of mailing may be either a dated receipt from a commercial carrier or the US Postal Service, or a legible US Postal Service postmark. (Private meter postmarks are not acceptable.) This policy also applies to unsolicited AIDS-related applications and to Academic Research Enhancement Award (AREA) applications. Unsolicited applications, with the exceptions of SBIR and STTR, are those submitted on the standard receipt dates stated in the grant application forms instruction books and in the table of receipt dates posted on the NIH website above.
Solicited Applications. A solicited application or proposal must be received by the date specified in the request for applications (RFA) or program announcements with special receipt dates (PAR). However, an application received after the deadline may be acceptable if it carries a legible proof-of-mailing date assigned by the carrier that is AT LEAST ONE WEEK prior to the deadline date. Solicited applications include those submitted in response to RFAs; program announcements with special receipt dates (PARs); or solicitations for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applications.
In an application for a Fellowship Award (F32), or for selected Research Career Development Awards (see instructions for the K series of awards), three sealed, reference letters must be submitted with the application. If fewer than three letters are submitted with the application, the application will be returned to the applicant.
The sealed envelopes should clearly indicate the application to which they belong, in case they are inadvertently separated from the application. It is not necessary to designate a person to receive them.
The sealed letters must be attached to the front of the original application and included in the package with the original application and the copies.
See Revised/Amended Applications.
For peer review and award schedules of grants, refer to the application instruction books, (PHS 398, PHS 416-1), program announcements (PAs), requests for applications (RFAs), and program guidelines. Schedules depend upon the type of application submitted. Review and award cycle schedules are also posted on the NIH website: http://grants.nih.gov/grants/funding/funding.htm and click on Receipt Dates.
A revised/amended application is one that has been modified in response to the critique in the summary statement of an application that was previously reviewed, but not funded. ("revised" and "amended" applications are synonymous.)
A competing "renewal" is a grant for additional funds and period of award.
A revised/amended application or an application for a competing "renewal" is made on the same PHS application form used for the initial grant or fellowship.
NOTICE: The NIH has changed its practice regarding resubmissions of three categories of grant applications.
Those categories include:
1. Applications that were originally submitted in response to an RFA and then resubmitted as an investigator-initiated application.
2. Applications that were originally submitted as investigator-initiated applications and subsequently resubmitted in response to an RFA.
3. Applications that were originally submitted using one grant mechanism and subsequently resubmitted using a different grant mechanism (for example, an application that was originally an R01 and then is resubmitted as an R21).
See NIH Guide Announcement for details: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html.
Salary Cap Summary information is available at URL http://grants.nih.gov/grants/policy/salcap_summary.htm. For additional guidance, please contact the Grants Management Office of the NIH institute most likely to fund your application or the NIH Grants Policy Help e-mail address at GrantsPolicy@od.nih.gov.
Sample applications that have been funded are not available from central NIH sources. However, occasionally the NIH Guide announces regional seminars for assistance in grant preparation.
Applicants may also find it helpful to ask advice from an experienced investigator and to contact the NIH administrator of the program most likely to fund their application.
Several resources exist to determine the areas of research types, and levels of funding:
NIH Guide for Grants and Contracts issues Program Announcements (PAs) for ongoing programs as well as Requests for Applications (RFAs) in various scientific areas. The NIH Guide is published weekly on the OER web site, http://grants.nih.gov/grants/oer.htm.
Computer Retrieval of Information on Scientific Projects (CRISP) provides a brief description and the administrative data of each funded NIH research project. CRISP is updated quarterly on the OER Website. CRISP does not include amounts awarded on the grants.
NIH Extramural Programs, a publication available electronically, outlines all ongoing NIH extramural research and research training programs. This resource also describes various information clearinghouses that provide information to the public on health and disease. It is available at the NIH website, http://grants.nih.gov/grants/funding/funding.htm.
The scientific review administrator (SRA) is the designated Federal official responsible for the administration of a study section which conducts the initial peer review of applications. This individual compiles a summary statement for each application upon the completion of the initial review.
Original signatures are required on the original face page of the application, but not on the copies.
A scientific peer review group (SRG) is the generic functional term for any group engaged in scientific and technical peer review. SRGs may be individually chartered or they may be part of a larger chartered group (i.e., IRG). SRGs are commonly called study sections in CSR (formerly DRG) and are called review committees in the institutes and centers of NIH that have their own specialized peer review groups. An IRG (initial review group) is a cluster of SRGs with related scientific focus chartered as a single entity.
Applications are assigned to the most appropriate initial review group (IRG) - please see definitions of "IRG" and "SRG" under the SRG heading above - on the basis of the scientific emphasis of the application and the NIH Referral Guidelines. The assignments are made by NIH Referral Officers, senior science administrators who have had research and scientific review administrator experience. An applicant may suggest, in a cover letter, up to three study sections considered appropriate to review the application.
Members of study sections are selected by the scientific review administrators with the concurrence of their supervisors in the Center for Scientific Review (CSR). For specific information about the membership of study sections, see the website: http://www.csr.nih.gov/committees/rosterindex.asp with member listings. Study section members are chosen for their expertise in the areas of science relevant to a particular review group, and for their ability and willingness to evaluate research grant applications. After studying the applications at home, they meet together, generally three times a year, for the purpose of reviewing the group of applications received at the latest deadline. The members serve for a period of three or four years. Recommendations of the study sections are forwarded to the funding Institutes of NIH where funding decisions are made for each of the grant applications.
A Federal employee may serve as a study section member. However, most of the members of the study sections are researchers from universities and other research organizations throughout the United States. Applicants should not contact study section members directly. Contact the Scientific Review Administrator instead.
Rosters of the Center for Scientific Review (CSR) (formerly known as the Division of Research Grants - DRG) study sections are available electronically. They can be accessed from the CSR website, http://www.csr.nih.gov that also has descriptions of the scientific areas covered by each study section.
There are two types of supplements: Administrative and Competitive.
Administrative supplement: NIH awards additional funding to an existing grant to cover additional expenses within the scope of the existing award.
For example: the supplements to train a minority research student or a student with disabilities are administrative supplements. It is awarded "administratively:" the application does not require review by a study section or national advisory council, nor does an applicant compete for this funding with other applicants.
Competitive supplement: The applicant competes for additional funding to expand the scope of the existing grant, requiring additional personnel, equipment, and/or other expenses. A competitive supplement application must be peer reviewed.
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