Preparation for a Grant Application
Training Opportunities
Research Grants
Human Subjects Research
Submission and Review Process
Funded Investigators

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Preparation for a Grant Application

What is GrantsInfo (previously ASKNIH)?
GrantsInfo is a public service that provides information about NIH extramural research and research training programs and standard application and review procedures. It also offers assistance with obtaining information from the NIH system of websites and refers inquiries to appropriate NIH offices when necessary. GrantsInfo staff is available by telephone from 8:30 a.m. to 5:00 p.m. EST Monday through Friday except on Federal holidays. Inquiries may also be processed via voicemail, e-mail, or fax.

For convenience and economy, NIH strongly encourages applicants to obtain application materials locally from the office of sponsored programs or research office at their institutions or from the NIH grants website. Any individual unable to obtain application kits and forms from their institution or the NIH website may request them from GrantsInfo at GrantsInfo@nih.gov.

After October 2007, all applications will be electronic and no paper copies will be available. See http://grants.nih.gov/grants/ElectronicReceipt/index.htm for grant mechanisms that have transitioned to electronic status. Electronic submissions may not be mailed as paper copies and may not be obtained in paper form from NIH.

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Some of the commonly used terms for NIH applications have changed. What are they?
New terms used for different types of applications are as follows:

  • “Competing Continuation” is now termed “Renewal”
  • “Revision” or “Amendment” is now termed “Resubmission”
  • “Competing Supplement” is now termed “Revision”
  • Funding Opportunity (FO) is the generic term for both RFAs and PAs.

A renewal (formerly competing continuation) is a grant that is a logical extension of a current or recent grant. A renewal advances and extends the science of the initial grant. The goal is to time the application so that there is no disruption in funding from one grant to the next. If you wish to review abstracts of other renewal grants, the grant number in the RePORT Expenditures and Results (RePORTER) database will identify which are renewals. The grant number will be the same number as the original grant with one difference. Instead of the number 1 R01 NR001234-05, it will be 2 R01 NR001234-06. The number ‘2’ refers to a type 2 or renewal application. The number following the hyphen is always the year of the grant activity. Below are some common types of applications:

Type 1 - New
Type 2 - Renewal (formerly “competing continuation”)
Type 3 - Application for additional (supplemental) support
Type 5 - Noncompeting continuation

See the NIH Glossary of Terms for other types of applications and this document (PDF) from the NIH Glossary to learn more about all grant designations.

One resubmission (formerly amendment) is allowed when the first submission is not funded. The resubmission number is signified by an A1 after the application number assigned by CSR. For more information on resubmissions, see http://grants.nih.gov/grants/policy/resubmission_q&a.htm.

A revision (formerly competing supplement) is an application that goes through the usual review process and is intended to add a component to an ongoing study. It may be that the review panel recommended an addition to the study or the principal investigator learns something early in the project that indicates a new measure, an addition to an aim, or a new aim would add significantly to the scientific value of the study. A revision component must be completed within the same time frame as the original funded study, that is, it cannot extend beyond the duration of the previously funded study. The application, therefore, must be submitted in time to accommodate the review process and for the period required for funding decisions. In NIH terms, this is called a type 3 application.

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What's the difference between a request for applications (RFA) and a program announcement (PA)?
NIH publishes two types of funding opportunities to stimulate submission of applications in areas of high priority or special interest. Each FO includes information about the funding mechanism supported and which forms to use to apply. NIH publishes announcements with additional information and instructions for each FO in the NIH Guide.

Requests for applications (RFAs) invite grant proposals in well-defined areas of research to accomplish a scientific program purpose at a specified funding level. RFAs have a one-time receipt date. They may be sponsored individually by one NIH Institute or Center or, frequently, by several Institutes and Centers that share a particular research interest. Applications submitted in response to RFAs are reviewed by specially convened review groups and compete with each other for the specified set-aside of funds.

Program announcements (PAs) describe new, continuing, or expanded program interests of the NIH Institutes and Centers or announce the availability of a new mechanism of support and approximate level of funding. They usually remain in effect for a minimum of three years, at which time they are either inactivated or renewed. Applications submitted in response to PAs compete for funding through the regular peer review process. Applicants should NOT insert PA numbers or titles that are no longer active in their application. The expiration date is listed on the first page of each FO.

Note that not all science areas of interest to NINR are represented in . Most of the research funded by NINR results from investigator-initiated proposals. You are encouraged to contact the appropriate NINR Program Director regarding your research ideas. Click here for a list of areas of research supported by NINR. In general, NIH and NINR are focusing on program announcements and investigator-initiated research, and fewer RFAs are being issued.

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What are NINR’s research priorities?
The primary areas of research funded by NINR are health promotion/disease prevention, eliminating health disparities, caregiving, symptom management, and self-management. NINR is the lead Institute at NIH on research on care at the end of life—an important emerging field. The NINR Mission and Strategic Plan help to direct funding decisions. Expert panels and research working groups help NINR to identify gaps in current knowledge that require research. In addition, NINR considers guidance from the National Advisory Council for Nursing Research and from Congressional mandates.

Applicants should discuss their research ideas with a Program Director who has expertise in their particular area of science interest. Applicants may also review the Areas of Research Opportunity described in concept papers [hyperlink] that indicate NINR’s interest in receiving applications in particular areas. Listed research opportunities do not always result in a Funding Opportunity (FO, can be a RFA or PA), however, investigators may submit applications relating to NINR research interests whether or not there is a FO. Funding decisions for any application are related to its scientific merit, its relevance to program priorities, and the availability of funds.

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What research grants are currently funded by NINR?
Research grants and traineeships that are currently funded by NINR and by other NIH components may be found in RePORTER. You may search by several criteria including science topic, principal investigator, institute (such as NINR), type of grant, fiscal year(s) and so on.

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How do I get application forms?
Currently there are two kinds of research application forms: form PHS 398 (for printed submissions) and form SF 424 (for electronic submissions). Form PHS 416-1 is for individual pre and postdoctoral National Research Service Award applications. For convenience and economy, NIH strongly encourages applicants to obtain application materials locally from the office of sponsored programs, or research office, at their institutions or from the NIH grants website. See this site for all NIH forms and applications.

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Is it possible to obtain a copy of an application submitted by another investigator?
The Freedom of Information Act ("FOIA"), 5 U.S.C. 552, provides individuals with a right to access to records in the possession of the federal government. These rights are subject to certain exceptions described on the NIH FOIA site. Read carefully the requirements for submitting a request and follow the instructions for the information requested in order to facilitate your request. You may also consider asking the principal investigator directly for a copy of the application of interest.

Each of the NIH Institutes and Centers has its own FOIA Coordinator though coordinators may work with several institutes/centers.

The NINR FOIA Coordinator is:
Suzanne Freeman
6705 Rockledge Dr., Room 6070
Bethesda, MD 20817
Phone: 301-496-9737
Fax 301-402-3604.

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How can I find out whether NINR is interested in the kind of research I'm proposing?
Program staffs of NIH's various institutes and centers are always available to speak with investigators, and, in fact, such contacts are encouraged during the preparation of an application. In addition to information about the application process and strategies to consider in preparing an application, program staff can provide feedback on the relative "fit" between the proposed research and the program interests of the Institute or Center.

NINR welcomes innovative proposals for clinical and basic studies across a broad continuum of health-related issues. The NINR mission statement and Strategic Plan can be viewed here. NINR’s ongoing science areas of interest may be viewed here. See also specific areas of research opportunity for the current fiscal year and current program announcements and requests for applications. As a potential applicant for an NINR grant, you are strongly urged to contact NINR's Office of Extramural Programs at (301) 594-6906 to discuss your research ideas with the Program Director in your area of interest. You may also email or fax a two-page concept paper to the Program Director in your area of interest.

If you are unsure about the appropriate contact, send your concept to Dr. Nara Gavini, Chief, Office of Extramural Programs, who will forward it to the appropriate NINR Program Director or to another NIH Institute or Center where the proposed research ideas would best fit. Dr. Gavini's email address is nara.gavini@nih.gov and fax number is (301) 480-8260. For concepts related to end-of-life and palliative care research, please contact Dr. Jeri Miller, Chief, Office of End-of-Life and Palliative Care Research, at jeri.miller@nih.gov.

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How do I know which mechanism to use in response to a specific Funding Opportunity (FO) or for investigator-initiated applications?
There are several strategies to use in deciding which research or training mechanism to use. First, here are some useful definitions and background information. The mechanism, or activity code designates a particular type of grant. For example, the R03 mechanism is a small grant for two years of pilot work that is not renewable. The R01 mechanism is the standard NIH grant for larger research projects that are based on pilot studies that yielded significant and published results. In addition to these two mechanisms, others include the R15, R21, F31, F32, K01, K23, R43 (small business), and so on. Note that there are many funding mechanisms at NIH but each Institute supports its own subset of mechanisms. See the IC (Institute or Center) website for specific mechanisms supported. In addition, there are NIH Roadmap initiatives supported by all ICs.

Here are strategies to use in deciding the appropriate mechanism for an application.

  1. Consult with an experienced investigator at your institution.
  2. Review the FO (RFA or PA) for the mechanism requirements if you intend to respond to a particular FO.
  3. Review the mechanism summary information about each mechanism supported by NINR and then read the funding opportunities for the mechanisms of interest.
  4. Discuss the mechanism options with a Program Director at NINR. Send your biosketch and a concept paper about your research project by email prior to your discussion to the Program contact whose science area most closely matches your science interests. Do NOT send the same materials to more than one program contact as your first contact will forward your material to the correct person if you err in your selection. It helps to be prepared to describe your personal research or training goals and the aims, population, and methods for the research problem of interest.

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When should I talk with or email my NIH Institute program official?
NINR Program Directors (synonyms: program officials/project officers) serve as a point of contact and a resource for research and research training applicants. They also monitor research progress through annual reports and through other communications with investigators. Program Directors are appropriate points of contact for individuals during application preparation, after the review process, during resubmissions if necessary, and throughout the duration of a grant. During the application phase the Program Director may assist with identifying the science area fit with NINR’s mission and assist in deciding what is the appropriate funding mechanism. After review, the Program Director should be contacted with any questions or to discuss the summary statement resulting from the review. During a grant funding period, the investigator should apprise the Program Director of any problems in conducting the research or any untoward events. In addition, the investigator may wish to discuss the application for the next phase of research with the Program Director.

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How do I know if I am a new investigator by NIH criteria?
Applicants are considered new investigators if they have not previously served as the principal investigator on any PHS-supported research project, including an R01. Exceptions to this include the small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or certain research career awards directed to individuals at the beginning of their research careers (K01, K08, K12s, K22, K23, K25, or K30). Current or past recipients of independent scientist and other non-mentored career awards (K02s and K04s) are not considered new investigators. In addition, new investigators should be in the early stages of their research careers, generally within five years of their postdoctoral experience or its equivalent.
Additional resources for new investigators are available at these NIH web sites: Resources for New Investigators and NIAID's Advice for New Investigators.

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How do I know how much budget I can request? 
Budget requests must be science driven. The mechanism table provides information about budget limits when they apply. The only grant mechanism supported by NINR for which there is no stated limit is the R01. Although there is no stated limit on funding levels for these grants, R01 applications assigned to NINR that request $350,000 or more in direct costs are brought to NINR's National Advisory Council for special consideration of their requested budget before they can be funded. Because of the proposed large investment of NINR's resources in these applications, the Council is asked to consider the relevancy of the research to the Institute's mission and to determine whether, from a policy perspective, the expenditure is warranted in relation to the research to be accomplished. In addition, any application requesting $500,000 or more in direct costs for any year must have NINR (or other Institute) approval before the application can be submitted and will not be accepted without prior approval.The request must be submitted to the Program Director at least six weeks before the submission date. 

Applications:  See the NIH Guide, March 20, 1998, and a subsequent Notice for details about this requirement.
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Where can I get help with grantsmanship?
Investigators at your institution who have received NIH funding can serve as sources of information and consultation regarding grant preparation. In addition, the offices of sponsored research at many institutions offer assistance and/or workshops on the preparation of NIH grant applications. Applicants are encouraged to take advantage of such services before they begin to develop their research proposals. Review carefully the application instructions and the links within the instructions for application process details.
There are a number of grant writing resources on the NIH website. Several institute tutorials, tip sheets, and review resources are available here. The website is http://grants.nih.gov/grants/grant_tips.htm.

Reminder: Check grant application information obtained from other Institutes/Centers with your NINR program officer to verify its application to NINR.

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When can I submit my application to NIH?
Each mechanism has a designated submission date. Applications for any given cycle may be submitted earlier than the final date but not after that date. On occasion, unusual circumstances (hurricanes, etc.) may warrant a late submission date. Detailed information about submissions, including late applications, and the assignment process may be found here. As noted on that page, “as NIH moves to shorten the receipt to award timeframe, the ability to accept late applications likely will be diminished.” Review this page for important updated information before each submission.
For all standard submission dates, see here.

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What funding opportunities are available for applicants from foreign countries?
Non-USA citizens and organizations may apply for NIH grants. There are some limitations on types and amounts of grants. Foreign investigators would, for example, need to indicate how the proposed research would be relevant to the public health of the people of the U.S.A. A Kirschstein-NRSA individual fellowship award is made only to a U.S. citizen or a non-citizen national. More information about “foreign grants” can be found at NIH Grants Policy Statement. Scroll to the header: Grants to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components.

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Training Opportunities

If I have nearly completed or recently completed my doctorate, what are the next steps in the research career path? There is no one "right way" to build a research career since individuals follow different paths to their doctorates and need to consider different priorities and explore different opportunities in planning their futures. While each individual must determine their own best research training and grants path, a full progression to a research program, for a beginner, could include the following sequence: predoctoral traineeship --> postdoctoral traineeship --> career development (K) award --> research (R) awards. This is the expected sequence in many disciplines, however, in nursing where the doctorate is sometimes delayed, individuals sometimes choose to select the postdoc or the K award rather than both.

For all new doctoral program graduates, the first step is to publish dissertation findings in a peer reviewed journal. Disseminating the findings demonstrates a commitment to the full research process. Research training beyond the doctorate is strongly recommended. NIH offers a number of research training and career development options that provide a continuum of opportunities for beginning investigators. The characteristics of these mechanisms are described below. If you have questions about your eligibility or about which training mechanism may be best for you, contact Dr. David Banks. You may also, before writing an application, write a brief concept paper and send it, along with a biosketch, to the NINR program director most relevant to your science interests.

Postdoctoral Training Mechanisms
Institutional Training Awards (T32s) . These grants are awarded to eligible institutions in support of predoctoral and postdoctoral research training to prepare scientists for careers in behavioral and biomedical research. Graduate students and postdoctoral trainees are appointed to positions on training grants by the training institutions. Individuals appointed to postdoctoral positions are expected to engage in at least two years of research or research training beginning at the time of appointment. Check the NINR website for a list of institutions with NINR-funded T32s. If you have questions about NINR's T-32 Institutional Training Programs, please contact Dr. Lois Tully. See also the question “What is the difference between an individual fellowship and an institutional research training grant?”

The following individual support mechanisms funded by NINR should be considered by post-doctorates:
The NIH Pathway to Independence Award (K99/R00) is a new opportunity for promising postdoctoral scientists to receive both mentored and independent research support from the same award. Award recipients will be expected to compete successfully for independent R01 support from the NIH during the career transition award period. This Award will provide up to five years of support consisting of two phases. The initial phase will provide 1-2 years of mentored support for highly promising, postdoctoral research scientists. This phase will be followed by up to 3 years of independent support contingent on securing an independent research position. Award recipients will be expected to compete successfully for independent R01 support from the NIH during the career transition award period. The award is limited to postdoctoral trainees who propose research relevant to the mission of one or more of the participating NIH Institutes and Centers, for example, NINR.

Individual Postdoctoral Fellowships (F32). These fellowships are awarded by NIH to qualified applicants, selected as a result of a national competition, to support full-time research training related to the missions of its constituent institutes and centers. Before submitting an application for this type of award, it is incumbent upon the applicant to arrange for appointment to an appropriate institution and acceptance by a sponsor who will supervise the training and research experience. The institution may be a private (profit or not-for-profit) or public institution, including a Federal laboratory. The candidate's sponsor should be an active investigator in the area of the proposed research activity who will personally supervise the candidate's research. The sponsor must document, in the application, the research training plan and the availability of staff, research support, and facilities to provide a suitable environment for performing high-quality research training. Applicants proposing training at their doctorate institution or at an institution where they have been training for more than a year must thoroughly document the opportunity for new training experiences that would broaden their scientific background.

Mentored Research Scientist Development Awards--Nursing (K01). These awards provide sponsored research experience for individuals to gain expertise in new research areas or in areas that would demonstrably enhance their scientific careers. Following this experience, candidates are expected to be able to pursue independent research careers. Candidates who have interrupted their careers because of illness or pressing family care commitments may apply if they can demonstrate their potential for productive independent research and the need for a mentored experience in order to achieve an effective reentry into research. Faculty members at institutions with a substantial minority enrollment who wish to enhance their research skills through supervised research experiences at other research centers may also apply if they agree to return to their parent institutions after completion of the award. Career development awards are made for three years by NINR and are nonrenewable.
Candidates must have research or health-professional doctorates or their equivalents and must have demonstrated the capacity or potential for highly productive independent research in the period after the doctorate. Candidates must identify mentors with extensive research and must spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities for the period of the award. The remaining 25 percent time should be devoted to other research-related and/or teaching or clinical pursuits consistent with the objectives of the award.

NIH Career Transition Award--Nursing (K22). This mechanism provides a period of support to provide research training experience in the NIH clinical research laboratories and to facilitate successful transition to an extramural environment as an independent researcher. The NINR Career Transition Award consists of an Intramural Support Phase and an Extramural Support Phase. The total period of combined intramural (on the NIH campus) and extramural (off campus) support is up to five years. Initially, up to three years of the research training program will be provided in the Intramural Support Phase in which the salary of the awardee will be commensurate with his/her level of experience. The final two years of the program, the Extramural Support Phase, will provide salary and funds for supplies, equipment and technical support thorough the NIH Career Transition Award.

Mentored Patient-Oriented Research Career Development Awards (K23). You may want to consider this mechanism if you are planning a career in patient-oriented research. It provides support for a period of supervised study and research for clinically trained professionals who have the potential to develop into productive clinical investigators in an area of patient-oriented research. While the development program focuses primarily on the conduct of patient-oriented research, there can be complementary appropriate laboratory research directly related to the patient-oriented research proposed in the application.

After the training phase, investigators will need to advance their program of research by applying for a research grant. Depending on the stage of the research conducted and published during training, the investigator may be ready for either a small research grant (R03, R15, R21) or a regular R01 research grant.

Research Grants

Academic Research Enhancement Awards (R15). These awards are intended to support health-related research projects conducted by faculty in institutions that are not research intensive. They enable qualified scientists to receive support for small-scale research projects. They create a research opportunity for scientists and institutions otherwise unlikely to participate extensively in NIH programs to participate in the Nation's biomedical and behavioral research effort. A list of ineligible institutions is published each fiscal year on the NIH website. If the name of a school does not appear on the list, it may be eligible to apply for AREA grants. Click here for more detailed information about the AREA program and a link to the list of ineligible schools for the current fiscal year.
In 1997, NIH made several significant changes in the AREA program. AREA grants are no longer regarded as simply stepping stones for investigators to move on to "traditional" NIH grant mechanisms. In recognition of the nonresearch-intensive environment and teaching loads under which investigators at AREA eligible schools work, AREA grants are now seen as legitimate ends in themselves for the conduct of meritorious research, albeit small-scale. Thus, the three objectives now established for the program are: (1) strengthening the research environment at institutions that are not research intensive, (2) exposing students at such institutions to research, and (3) providing support for meritorious research.

Applications for these awards are now accepted in response to ongoing program guidelines with three receipt dates each year--January 25, May 25, and September 25, except for AIDS-related research, which should be submitted on May 1, September 1, and January 2. Principal investigators may submit renewal (formerly “competing continuation”) applications to continue projects beyond the initial award period.

Research Project Grants (R01s). These grants are awarded to institutions on behalf of a principal investigator to facilitate pursuit of a scientific focus or objective in the area of the investigator's interest and competence. Applications are accepted for health-related research and development in all areas within the scope of the NIH mission. Those responding to the NINR mission are referred to the Institute for potential funding. Awards are usually made for three to five years and can be competitively renewed. Although there is no stated limit on funding levels for these grants, R01 applications assigned to NINR that request $350,000 or more in indirect costs or $500,000 in total costs in any year are brought to NINR's National Advisory Council for special consideration of their requested budget before they can be funded. Because of the proposed large investment of NINR's resources in these applications, the Council is asked to consider the relevancy of the research to the Institute's mission and to determine whether, from a policy perspective, the expenditure is warranted in relation to the research to be accomplished. Any application requesting $500,000 or more in direct costs for any year must have institute approval before the application can be submitted. The request must be submitted to the Program Director at least six weeks before the submission date. See the NIH Guide, March 20, 1998, and a subsequent Notice for details about this requirement.

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What is the difference between an individual fellowship and an institutional research training grant?
An individual fellowship is awarded to an institution to support an individual predoctoral (F31) or postdoctoral (F32) student. The student applicant completes and submits an application to NIH, including a cover letter requesting assignment to NINR. The applicant should work with her/his research mentor in preparing the application to insure that the mentor has approved the project and their mentor role on the traineeship. An institutional research training grant (T32) enables schools of nursing with research programs to provide full-time predoctoral and postdoctoral research training. The institution with the training program grant selects the trainees to be appointed. See the T32 or training web page within the institution website for contact or application information. These applications are not sent to NIH but to the specific T32 program of interest.

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Where are the current NINR-supported institutional training grants located so that I can contact them about a possible fellowship?
Individuals interested in searching for an institutional training program that matches their research interests for a pre- or postdoctoral fellowship may search the NINR site for a list of such grants. Searching the individual T32 sites will help you to decide if the program has faculty mentors with expertise in your area of research interest. It is also useful to contact the program to learn about resources at the institution that may not be obvious on their website.

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Does NIH offer any special opportunities for underrepresented or disadvantaged groups, including minorities?
NINR has consistently offered opportunities to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce, specifically in nursing research investigators. Over the years, NIH has developed a number of opportunities for underrepresented or disadvantaged groups, including minorities. The NINR Mentored Research Scientist Development Award for Underrepresented or Disadvantaged Investigators (K01) is one approach to increasing diversity of nurse investigators by providing additional research career development opportunities with financial support. This Program Announcement (PA) seeks to address the lack of diversity of qualified nurse scientists in research settings by enhancing the research capabilities of underrepresented or disadvantaged nurse investigators so that these individuals may establish research laboratories and research programs in nursing science. There is abundant evidence that the research, biomedical, and health enterprise will directly benefit from this broader inclusion. Click here for the PA.

Another resource for underrepresented individuals, ranging from high school to postdoctoral faculty, is the Research Supplement . Special supplements to currently funded research grants are available to recruit and support underrepresented or disadvantaged students and investigators. The aim of these supplements is to attract and encourage individuals to enter and pursue biomedical and behavioral research careers in areas within the missions of the NIH institutes and centers. A request for a supplement may be submitted by the principal investigator at any time during their grant but there should be at least two years remaining on the grant at the time of the supplement award. You may obtain more details about this mechanism from the program announcement.

Click here for a complete list of research training and career development opportunities sponsored by NIH, including those designed to meet the special needs of underrepresented groups. In addition, all qualified nurses are eligible for all NINR supported training programs.

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What submission forms are used for training applications? 
The NIH website has detailed information for application submission. All training and fellowship applications are submitted electronically. Please be sure to check the website before beginning to develop or write an application. Each role in the submission process carries specific responsibilities. Principal Investigators (PIs) work with their institute or organization to prepare the application, and pass the completed application on to their Authorized Organization Representative (AOR). Only AORs have the ability to actually submit a grant application to NIH.  In addition, numerous instructions and information are available on the website, including e-submission FAQs. The SF424 application is required for electronic submissions and replaces the PHS 398. Important updates and alerts are also located on the webpage.

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Is part-time effort allowed for pre- or postdoctoral National Research Service Award (NRSA) fellowships?
NINR does not support either short-term or part-time pre- or postdoctoral fellowships. You must make a fulltime commitment of 40 hours and must be compensated with a stipend. In addition, a NRSA may not be held concurrently with another Federally-sponsored fellowship or similar Federal award which provides a stipend or otherwise duplicates provisions of the NRSA.

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Human Subjects Research


What steps do I have to complete prior to using human subjects in my research?
The DHHS regulations for the protection of human subjects provide a systematic means, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the DHHS. The regulations stipulate that an applicant organization, whether domestic or foreign, bears responsibility for safeguarding the rights and welfare of human subjects in DHHS-supported research activities. The regulations, 45 CFR Part 46, Protection of Human Subjects, are available from the OHRP, Department of Health and Human Services, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20854, 1-866-447-4777 or (240) 453-6900.

If your application is missing any of the required sections addressing human subjects, NIH designates it as incomplete, constituting grounds for returning it without review.

In addition to the regular review criteria for scientific merit, reviewers use four other criteria to judge human subjects research applications:

1) Risks to subjects.
2) Adequacy of protection against risks.
3) Potential benefits to the subjects and others.
4) Importance of the knowledge to be gained.

General information about the inclusion of human subjects in NIH-supported research protocols is provided in the grant application instructions, along with requirements for detailed documentation regarding descriptions of (1) the proposed involvement of human subjects in the study, (2) the sources of research material obtained from individually identifiable human subjects, (3) plans for subject recruitment and consent procedures, (4) potential risks, (5) procedures for protecting against or minimizing risks, and (6) how benefits outweigh risks. You also need to provide scientific justifications for inclusion or exclusion of populations (gender, minorities, and children). All three populations must be addressed and a plan for recruitment and retention must be included. The following resources provide details about preparing the human subjects component of the research plan.

Decision trees for human subjects: http://www.niaid.nih.gov/researchfunding/sci/human/decisiontrees/pages/default.aspx

How to write a human subjects application: http://www.niaid.nih.gov/researchfunding/sci/human/pages/hshandbook.aspx#E1

Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan (PHS 398): http://grants.nih.gov/grants/funding/phs398/phs398.html

Application Guide SF424 (R&R) (for electronic submissions): http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc

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How do I know when to use a Data and Safety Monitoring Plan versus a Data and Safety Monitoring Board?
The simple answer to this question is that data and safety monitoring plans (DSMP) are usually appropriate for phase I and II clinical trials whereas a data and safety monitoring board (DSMB) is required for a phase III trial. Certain phase I or II clinical trials may use research strategies or involve vulnerable populations that require a DSMB. See the following guides and decision trees to aid in making this decision. In addition, local institutional review boards often have criteria that must also be considered.

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What are the requirements for including women and minority subjects in NIH-funded studies?
NIH policy requires the inclusion of women and members of minority groups and their subpopulations in all NIH-supported biomedical and behavioral research projects involving human subjects unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant institute or center director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an institute or center director based on a compelling rationale and justification. This policy applies to research subjects of all ages. 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 routinely excluded from participation in clinical research. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. NIH funding components will not award any grant, cooperative agreement, or contract or support any intramural project that does not comply with this policy.
The grant application instructions contain information that must be submitted. Specific factors to be considered in making determinations about the inclusion of women and minorities in clinical trials are described in the amendment to NIH Guidelines on the Inclusion of Women and Minorities as Subjects,issued in the NIH Guide, October, 2001.A decision tree is available for women (PDF) and for minorities. (PDF)

Other resources include and overview page and a list of additional policy implementation resources: http://grants2.nih.gov/grants/policy/emprograms/overview/women-and-mi.htm
http://grants.nih.gov/grants/funding/women_min/women_min.htm

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Submission and Review Process


An excellent resource about the entire review process is available in a videotape and in documents for online review or downloading.

When should I submit my application?
NIH follows an established receipt, review, and award schedule. Special receipt dates may be specified in program announcements, requests for applications, and program guidelines. You can obtain a list of upcoming receipt dates here. Note that AIDS-related applications have different submission schedules; therefore, it is important to check the heading for the mechanisms of interest. See also the dates for transition to electronic submission for each set of mechanisms. Scroll below the submission schedule for policies regarding various submission topics.
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How does NIH make decisions about the assignment of applications to institutes and centers?
After your application arrives at NIH, it is examined by the NIH Center for Scientific Review (CSR) for completeness and relevance to the NIH mission. If the application is relevant and complete, CSR determines how it "fits" within the programs of the various institutes and centers, and an assignment is made to one or more institutes or centers for funding consideration. When your application is submitted in response to a request for applications (RFA), it is examined for relevance by the sponsoring institute or center.

Decisions about the primary assignment of applications in areas of overlapping research interests have been carefully negotiated among the NIH institutes and centers. When your application is assigned to two or more institutes or centers, the "primary" institute or center becomes your point of contact for following the progress of review and funding decisions. The "secondary" institutes or centers, which are potential alternative or collaborative sources of funding, also track the application.

To assist CSR in its assignments, you are permitted, and even encouraged, to send a cover letter with your application suggesting assignment to a specific institute or center and explaining how the research addresses its mission. NIH program staff members, if they know of your interest, can also notify CSR that they are "awaiting receipt of an application" (known as an ARA notice).
In the same cover letter, you may request assignment to a specific study section, which is also handled by CSR. For more information about this process, see the answer to the question, How does NIH make decisions about the assignment of applications to study sections?

CSR takes these suggestions very seriously. However, the final decisions regarding application referral and assignment are made by CSR.

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How does NIH make decisions about the assignment of applications to study sections?
Upon receipt of an application, the NIH Center for Scientific Review (CSR) assigns it to the appropriate study section according to the scientific emphasis of the proposed research and guidelines that delineate the scientific expertise of each study section. Assignments are made by senior science administrators who have had research and scientific review administrator experience. Applicants may include a cover letter requesting assignment of their applications to specific study sections, as well as referral to specific institutes or centers, but final decisions regarding assignment and referral rest with CSR. Reviews of applications for certain funding mechanisms, such as Individual Fellowships (F31s and F32s) and Institutional Research Training Grants (T32s), as well as responses to requests for applications (RFAs), are conducted by review committees convened by the institutes and centers to which the applications have been assigned. Certain institutes’ and centers’ training grants are reviewed by CSR review committees.

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How does the NIH application review process work?
The grants peer review system used by NIH--often referred to as the "dual review system"--is based on two sequential levels of review for each application.

The initial or first level of review is conducted by panels of experts drawn from the national pool of scientists actively engaged in research. These panels render impartial reviews and evaluations of each grant application. They consider not only the scientific merit of the proposal, but also the background and experience of the principal investigator, the research facilities available for the project, and the appropriateness of the direct costs requested.

The NIH Center for Scientific Review (CSR) routinely handles the first level of review for investigator-initiated applications for Research Project Grants (R01s), Academic Research Enhancement Awards (R15s), Exploratory/Developmental Research Awards (R21), Small Grant Research Awards (R03), Small Business Technology Transfer Grants (R41s and R42s), Small Business Innovation Research Grants (R43s and R44s), and other mechanisms according to prior arrangements made with each of the institutes and centers. These reviews are conducted by scientific review groups (SRGs), combined organizationally into scientifically related areas within Initial Review Groups (IRGs). In addition, applications may be reviewed by special emphasis panels (SEPs), which are convened by CSR under certain circumstances, for example, when special expertise is required. Click here for the specific steps carried out in the first level of review.

For other funding mechanisms, such as Individual Fellowships (F31s and F32s) and Institutional Research Training Grants (T32s), as well as responses to requests for applications, the first level of review is conducted by panels of experts convened by the institutes and centers to which the applications have been assigned. These panels, referred to as review committees, follow procedures similar to those of the SRGs in their evaluation of applications. CSR reviews of training applications follow the same initial review procedure as listed above for the research grant applications.

The second level of review is performed by a national advisory board or council (hereinafter referred to as "council"), composed of scientific and lay members appointed by the Secretary of Health and Human Services for each research institute and center. They are charged with advising the Secretary and the Institute/Center Directors on matters related to the activities carried out by the institutes and centers and the policies regarding such activities. In their capacity as second-level reviewers of grant applications, council members base their recommendations not only on considerations of scientific merit as judged in the first level of review, but also on the relevance of a proposed project to the programs and priorities of the institute or center. In most cases, councils concur with the recommendation of the SRG or institute/center review committee.

Applications are eligible for funding only if they receive both a favorable recommendation by an SRG or institute/center review committee and concurrence by the advisory council for the funding institute or center. Final decisions regarding the funding of specific applications are based on their relative merit compared to other eligible applications, availability of funds, relevance to institute/center programs, and considerations addressed in the advisory council discussions.

By separating the scientific assessment of proposed projects from policy decisions about scientific areas to be supported and the level of resources to be allocated, the NIH dual review system permits a more objective evaluation than would result from a single level of review.

NIH has developed a report entitled "Setting Research Priorities at the National Institutes of Health," which describes the process followed by NIH and its constituent institutes and centers to establish broad research objectives.
Members of the extramural community may wish to read Peer Review Notes, a publication issued by the NIH Center for Scientific Review each February, June, and October. This publication contains brief articles on the most recent changes in peer review policies and procedures and a column by the CSR Director. Current and back copies are only available electronically on the CSR website at http://www.drg.nih.gov/prnotes/prnotes.htm.

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What criteria do members of scientific review groups use to evaluate grant applications?
Scientific review groups evaluate the scientific merit of each grant application according to specific criteria. For renewal and revision applications, reviewers must also consider progress to date. In the case of resubmitted applications, reviewers must evaluate applicants' revisions of earlier proposals made in response to previous reviews. See these recent changes in terms:

  • “Competing Continuation” is now termed “Renewal”
  • “Revision” or “Amendment” is now termed “Resubmission”
  • “Competing Supplement” is now termed “Revision”

NIH uses five explicitly-stated review criteria, published in the NIH Guide Notice NOT-OD-05-002, published October 12, 2004, for all unsolicited research applications. Applications solicited through RFAs will use the review criteria in the announcement.

Fellowship (F) application review criteria are listed in the announcements.

Review criteria are the same for both paper and electronic submissions.

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Where can I get a list of all of the study sections that review applications submitted to NIH?
It is useful to review study section purposes (in description) and rosters (click on the acronym) to determine the best match for your application. The Center for Scientific Review attempts to honor applicant requests for assignment to a study section, however, CSR makes the final decision based on a number of factors.

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Is there a direct link to the nursing science study sections?
Applications submitted for primary assignment to NINR may be assigned to any appropriate NIH study section; however, if your application is assigned to either of the nursing science study sections, the names and sites are as follows.

Nursing Science: Adults and Older Adults Study Section [NSAA] http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/HOPIRG/NSAA.htm

Nursing Science: Children and Families Study Section [NSCF] http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/HOPIRG/NSCF.htm
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Where can I get a list of the members of the study sections that will review my grant?
See response to this question: Where can I get a list of all of the study sections that review applications submitted to NIH?

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What can I do if I do not agree with the review of my application?
NIH has an established appeals process for applicants who think that some aspect of the handling or initial review of their grant applications has been inappropriate. Applicants may dispute the results of an initial peer review based on an error in the review process, such as reviewer bias, factual error, or reviewer conflict of interest, but not a difference of scientific opinion.

Applicants who have concerns about the review of their submission should first discuss the issues with the Institute program director assigned to the project. The issues of concern are almost always differences of scientific opinion and the investigator’s time may be more productively spent in revising and resubmitting the application.

Program Directors, either alone or with Scientific Review Administrators (SRAs), usually resolve issues with applicants. The Institute’s Advisory Council reviews cases that cannot be resolved, but rarely overturns initial peer review results. In most cases, Council recommends that applicants revise and resubmit their application. The appeals process is triggered when an applicant submits a letter detailing specific concerns about the review of the application to the institute/center program director. Detailed information regarding this process, including grounds for review, can be found in the NIH Guide, November 21, 1997.

It should be noted that differences of scientific opinion that may occur between investigators and reviewers may not be contested through these procedures. In addition, communications from investigators consisting of additional information that was not available to the reviewers are not considered to be appeals. Finally, appeals of receipt and referral issues regarding applications not yet reviewed should be directed to the Referral Office in the Center for Scientific Review.

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What are my chances of being funded by the National Institute of Nursing Research?
NINR funds about one out of four or five R01 applications it receives, an average comparable to that for the rest of NIH. In preparing an application for submission to any of the NIH institutes or centers, your primary challenge is to stimulate the enthusiasm of the study section that evaluates the scientific merit of the proposal. Competition for research funding is intense, and it is not unusual for an application not to be funded on its first submission. As with most creative endeavors, biomedical research requires not only good ideas but also perseverance. An application that is not submitted, however, will have zero chance of funding.

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What should I do if my application is not funded? 
On April 15, 2010, NIH issued a clarification on the resubmission policy, NOT-OD-080. Applications are allowed only one resubmission (A1). The resubmission policy applies to all types of applications, every activity code, and applications submitted in response to Program Announcements (PA, PAR, PAS) or Requests for Applications (RFA).

If your application is not funded, you should carefully consider the reviewers' suggestions contained in the summary statement. You are encouraged to make a phone appointment to discuss the review concerns with your Program Director. You may then want to revise the proposal accordingly and resubmit it. Directions for preparing resubmitted applications are contained in the application instructions.

A new application following a total of two reviews is expected to be substantially different in content and scope with more significant differences than are normally encountered in a resubmitted application. Simply rewording the title and Specific Aims or incorporating minor changes in response to comments in the previous Summary Statement does not constitute a substantial change in scope or content. Changes to the Research Plan should produce a significant change in direction and approach for the research project. Thus, a new application would include substantial changes in all sections of the Research Plan, particularly the Specific Aims and the Research Design and Methods sections.

Funded Investigators

What is the meaning of the term Just-in-time and how does it relate to my application?
See the NIH grants policy statement about the pre-award process and just-in-time requirements. NIH uses just-in-time procedures for certain programs and award mechanisms. These procedures call for limited information (e.g., a budget justification and a biographical sketch) to be submitted with investigator-initiated applications and allow for a possible NIH request for additional information, including information concerning other support, when the application is under consideration for funding. Just-in-time procedures also allow an applicant to defer certification of IRB approval of the project’s proposed use of human subjects, verification of IACUC approval of the project’s proposed use of live vertebrate animals, and evidence of compliance with the education in the protection of human research participants requirement until after completion of the peer review and just prior to funding. Applications in response to RFAs also may be subject to these procedures. The RFA will specify the timing and nature of required submissions.

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How do I obtain a no-cost extension?
A no-cost extension can be used to extend your grant's project period one time up to 12 months without additional funds by simply informing your grants management specialist of your plans through your office of sponsored projects. See this NIAID site for details.
 

What is required for a second no-cost extension request?
For second no-cost extension requests, a letter, signed by the Principal Investigator and an authorized institutional official, must be received by the appropriate Grants Management Specialist, Grants Management Branch, no later than 30 calendar days prior to the grants Project Period End Date. The correspondence must explain what has been accomplished during the first no-cost extension (NCE), the need for an additional NCE, document the activities to be completed, specify the amount of remaining grant funds, and include a detailed description of the proposed use of unexpended funds (either a detailed budget or narrative description). All required certifications, including human subjects and animal welfare, must be updated. Also, if the Financial Conflict of Interest (FCOI) policy applies to the current award, an Annual Report must be submitted via the eRA Commons according to the regulations. The request for the second no-cost extension must be evaluated and approved by the Division of Extramural Science Programs and, when granted, is for purposes other than completion of manuscripts. The request may be submitted via email from an authorized institutional business official. Additional no-cost extension beyond the 2nd will not be considered.


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What is a competing continuation?
A competing continuation is now called a renewal . A renewal application extends a project period that would otherwise expire for one or more grant budget periods; these grant applications are peer reviewed in a regular review cycle and compete with others for funds. A renewal is a continuation of the original study but adds significantly to the science by extension and advancement of the original aims. New populations can be added, along with additional aims that extend the study but not to replace the original aims.

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What should I do when my grant ends?
There are two websites that have essential information about grant management, including grant closure. The first site contains questions and answers about grant management and includes NIH websites related to grants policies: Managing NINR Funded Grants
The second site is an NIH Grants Policy site that includes discussion of grant closure issues and other potential activities occurring at the end of a grant. http://grants.nih.gov/grants/policy/nihgps/index.htm

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