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Grants and Funding: Extramural Programs (EP)

FAQ Pages - Applying For a Grant

Q: I know my impact score, how can I tell if my application will be funded?
A: Generally speaking, applications receiving impact scores between 10 and 30 will be the first to be considered for funding. Depending on availability of funds, their relevance to NLM priorities, New/early stage status of the investigator, and the balance of NLM's grant portfolio, some applications with scores in the 31-35 may be funded.  NLM grant funding plan for the current fiscal year is available at http://www.nlm.nih.gov/ep/Payplan.html.

Q: When will I know if I'm going to be funded?
A: The time from an application deadline to a funding decision is at least 9 months. For example, an application submitted February 1 will receive first level review in mid June. At that time, you will know your impact score. About 3 months later, in September, the second level of review will be completed. Final funding decisions are made 1-2 months after the 2nd level review.

Q: Can I send additional materials after the deadline?
A: Every effort should be made to submit a complete, intact application, including letters of support. Applicants have an obligation to check the submitted version of their grant applications to ensure completeness and correctness, and are provided a two business day application reviewing window to check the assembled application image in the NIH eRA Commons. During the initial peer review phase, acceptance of additional materials is at the discretion of the NLM Scientific Review Officer (SRO). Applicants should contact the SRO if they wish to submit additional materials before peer review. NIH policy on Submission of Additional Grant Application Materials can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-082.html.

Q: Where can I get a sample of a successful grant?
A: You should start by searching NIH RePORTER at http://projectreporter.nih.gov/reporter.cfm, which will provide the abstract for the application, and other information. If you require more information, you may request a copy of a successful grant application under the Freedom of Information Act (FOIA). Contact NLM grants management staff to initiate a FOIA request. NIH requires that personal salary information and other proprietary information be removed from any grant application provided in response to a FOIA request.

Q: How do I cite my grant in a publication or website?
A: The citation should include the grant number and the awarding Institute or Center, followed by a disclaimer. Some examples:

  • This publication [or web site] was partially supported by Grant Number R01 LM1234 from the National Library of Medicine, NIH.
  • The project described was supported by Grant Number GO8 LM1234 from the National Library of Medicine, National Institutes of Health.

A standard disclaimer should follow, such as:

  • The contents of this report [or web site] are solely the responsibility of the authors and do not necessarily represent the official views of the National Library of Medicine or NIH, DHHS.

Q: What kinds of grants does NLM fund?
A: NLM awards grants for research, resource development, training, career development and small business research and development . All NLM grants focus on use of computers and information sciences to improve the access, storage, retrieval, management, dissemination and use of biomedical information.

Q: Who can apply for an NLM grant?
A: Eligibility requirements for each grant program are spelled out in its program description, available on NLM's Extramural Programs web site at http://www.nlm.nih.gov/ep/.

Q: Will you accept an application from foreign (non-US) institutions?
A: Generally speaking, NLM research grants are available to foreign institutions. However, a pplicants whose grant proposals are from foreign institutions or contain a significant foreign component are encouraged to contact NLM p rogram staff (http://www.nlm.nih.gov/ep/Staff.html) responsible for the grant program before applying.

Q: Can a for-profit institution apply for a grant?
A: For-profit institutions can apply for SBIR/STTR grants and most NIH research grants. See the eligibility criteria in each funding opportunity announcement for further information. For resource grants, for-profit institutions can be involved as consultants and sub-contractors.

Q: What application form do I use to apply for an NLM grant?
A: See Section IV of a Funding Opportunity Announcement for the form and the instructions. Forms and instructions for completing them are available for download at http://grants.nih.gov/grants/forms.htm.

Q: Will NLM review a draft of my project plan?
A: Time permitting, an NLM grant program officer will review an abstract, outline or concept paper to help assess the responsiveness of a proposed project to the mission of NLM, and give general advice about features of a successful application. Such review should be requested well in advance of the grant deadline. Each grant program description provides contact information for the program officer who can answer your questions.

Q: Can I use grant money to reimburse purchases made before the grant was awarded if they are grant-related?
A: Grant funds can be used to cover grant-related expenditures made up to 90 days before an award was issued. However, if your grant is not awarded, you are responsible for these expenditures. Questions about financial aspects of your application should be directed to your sponsored business official or NLM Grants Management staff.

Q: Are there budget caps or ceilings for different kinds of grants?
A: Each NLM grant program description describes the budget restrictions that apply. This information can be found in Section II of the Funding Opportunity Announcement (FOA). If you submit an application whose budget is above the recommended guideline, there is no assurance that you will receive the amount you request. Budget requests in excess of $500,000 per year will not be accepted without prior approval by the head of NLM’s Extramural Programs Division. For details, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Q: What are requirements for Data Safety and Monitoring Plans?
A: If you seek funding from the National Library of Medicine (NLM) for a research project that involves a clinical trial, your application must include a Data Safety and Monitoring (DSM) plan. The purpose of this plan is to assure (1) safety of participants and (2) validity of the data. (See NIH Guide http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Instructions on preparing a DSM Plan are provided in section 4.1.5 of the SF424 (R&R) Supplemental Grant Application Instructions at http://grants1.nih.gov/grants/funding/424/SupplementalInstructions.pdf. Review of the DSM plan will be part of the initial merit review of your application. The DSM plan should also be part of the research protocol submitted to your local IRB. Some institutions have developed standard monitoring policies. These may be used in place of an investigator-defined plan if they fit the project's needs.

A clinical trial is a prospective study involving human subjects, which is designed to answer questions about the effects of a biomedical or behavioral intervention. This includes interventions whose goal is to initiate or change behavior in a target population (such as physicians or consumers) by introducing information resources and services. A decision tree for determining whether you need a DSM plan is available from NIAID at http://www.niaid.nih.gov/researchfunding/sci/human/decisiontrees/pages/datasafety.aspx. An observational study, or a study that does not test an intervention, is not a clinical trial and does not require a DSM plan.

The monitoring of a clinical trial should be commensurate with risks and the size and complexity of the trial. For example, in a clinical trial which involves only a small number of human subjects and low risk, close monitoring by the study investigator may be adequate, while a multi-site or large clinical trial might require a central reporting entity; for more details, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html).

The essential elements of a Data Safety and Monitoring plan are:

  • Monitoring the progress of trial and the safety of participants
  • Description of the mechanism for reporting adverse events to the IRB, FDA and NIH (that is, to the NLM program official responsible for the grant)
  • Plans for assuring data accuracy and protocol compliance.

Instructions on preparing a DSM Plan are provided in section 4.1.5 of the SF424 (R&R) Supplemental Grant Application Instructions at http://grants1.nih.gov/grants/funding/424/SupplementalInstructions.pdf.

Any investigator who plans to seek NLM funding for a clinical trial, should consult with the appropriate NLM grant program official to discuss the Data Safety and Monitoring plan and frequency of reports to NLM before the grant application is submitted.

Q: What are requirements for Human Subjects Research?
A: Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

 

Q: What happens to my application if I don't get funded?
A: If an application does not result in funding, there may be an opportunity to respond to the reviewers’ comments and resubmit the application within the appropriate timeframe. Applicants seeking advice beyond that available online may want to contact the NIH Program Officer listed at the top of the summary statement (see http://grants.nih.gov/grants/policy/amendedapps.htm for more information).

Q: If I don't get funded, can I apply again?
A: For all applications with due dates after April 16, 2014,following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-14-074). Talk to your NLM program officer about options for your application.

Q: Can I resubmit an unfunded application that was submitted to a Request for Application (RFA) to another funding opportunity announcement (FOA)?
A: Yes, but you must wait until the summary statement for the previous submission is released and you need to look carefully at the requirements of the FOA and/or activity code. Since an RFA often has special considerations of eligibility, scientific scope, and review criteria, unfunded RFA applications may be resubmitted as new applications to another FOA or activity code as long as the application is modified appropriately to fit the application requirements of the new FOA or activity code. Please note the following conditions:

  • When an application that was submitted in response to an RFA is not funded and the investigator wishes to submit an application on this topic as an investigator-initiated application, it is to be submitted as a new application, unless provision for a resubmission is clearly delineated in the RFA. In addition, if a subsequent RFA specifically solicits resubmissions of unfunded applications from a previous RFA, the instructions in the second RFA should be followed. In all other cases, an application submitted in response to an RFA and then resubmitted as an investigator-initiated application must be prepared as a new application.
  • When a previously unfunded application that was originally submitted as an investigator-initiated application is to be submitted in response to an RFA, it is to be prepared as a new application.
  • When an unfunded application that was reviewed for a particular research grant activity code is to be submitted for a different grant activity code, it is to be prepared as a new application. In such cases it is not possible to continue both application lineages and it is not possible to submit a resubmission application for the first activity code. In addition, due to the NIH policy of not allowing submission of, similar, essentially identical, or identical applications, no resubmission under the resubmission policy stated above may occur until after the peer review process is completed and a summary statement has been provided to the applicant.

For additional information see NOT-OD-14-074.

Q: Is there a benefit to submitting a resubmission rather than a new application?
A: It depends on the nature of the specific weaknesses or problems in your application. Some "flaws" are fairly straightforward and simple to identify and correct; others are less so. When reviewers assess an amended application, they look to see how shortcomings identified in the summary statement are addressed, but will also review the entire application, as a whole, for strengths and weaknesses. Sometimes, fixing one set of problems reveals another set. Thus, your priority score could actually worsen for a revised application. Additionally, a resubmission allows you to provide a one page introduction and to mark changes in the text, to tell reviewers directly how you have addressed their critiques. Alternatively, the introduction allows you to explain why you did not address one or more critique(s). 

Q: What do I have to do to submit a revised application?
A: Your amended application must contain all the parts of the original application, plus an Introduction and be submitted within 37 months after the date of receipt of the original application. The Introduction to the revised application should summarize additions, deletions, revisions, and your responses to criticisms in the summary statement. All changes in the body of the research plan should be highlighted typographically, e.g., by bracketing, bolding, or italicizing. If the changes are so extensive as to include most of the text, this exception should be explained in the Introduction. If nothing has changed in the budget, resources section, or biosketches, you may use what was submitted with the original application. You should incorporate an updated description of any relevant work performed since the original submission, and updated letters of support. See http://www.nlm.nih.gov/ep/Deadlines.html for receipt dates for resubmissions.

Q: Do I have to make every change the reviewers suggested?
A: You don't have to make all the changes suggested by the reviewers. In the Introduction to the revised application, you should respond to all reviewer concerns and explain your rationale for making or not making recommended changes.

Q: What happens to my original application when I submit a revised application?
A: The revised application will reside in a record distinct from the original application in the NIH administrative data system. The NIH administrative data system has been upgraded to handle multiple versions of an application.

Q: How do I submit an appeal of the peer review of my application?
A: The National Institutes of Health (NIH) policy concerning appeals of the initial peer review process is set-out in the NIH Guide Notice, NOT-OD-11-064.
An appeal is a written communication from a Program Director/Principal Investigator (PD/PI) and/or applicant institution that meets the following four criteria: 1) is received after issuance of the summary statement and up to 30 calendar days after the second level of peer review, 2) describes a flaw or perceived flaw in the review process for a particular application, 3) is based on one or more of four allowable issues (described below), and 4) displays concurrence from the Authorized Organization Representative (AOR).

An applicant who is concerned about procedural aspects related to the completed initial peer review of his or her application should consider the comments in the summary statement, and then should contact the appropriate NIH Program Official (PO) (see contact information in the upper left-hand corner of the first page of the summary statement).  The PO can answer questions about the summary statement and review outcome, and provide advice to the applicant.  For example, the PO may recommend modifying the application according to NIH policies for resubmission applications (NOT-OD-10-080) and the issues that were raised in the review and communicated in the summary statement, or may recommend reconsidering the basic intent of the project and submitting a new application that has substantial differences in aims and approach (NOT-OD-10-080).  At no time should the PD/PI or an official of the applicant organization attempt to contact individual members of the Scientific Review Group (SRG) to discuss the review of an application, as doing so could jeopardize the confidentiality of the review process. 

Following discussion of concerns with the PO, if the PD/PI and/or an official of the applicant organization wishes to appeal the outcome of the initial peer review process, an appeal letter must be submitted, either in hard copy or electronically, to the PO.  The appeal letter must display concurrence from the AOR of the applicant organization for the application. Although the content of the appeal letter may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or an organizational official(s) (not necessarily the AOR), the AOR must send the letter directly to the PO, or must send his/her concurrence to the PD/PI who will forward the materials and AOR concurrence to the PO.  A communication from the PD/PI or official of the applicant organization (other than the AOR) only or with a “cc” to the AOR will not be accepted.  The PO will send the PD/PI and/or institutional official, and AOR, an acknowledgement letter within 10 days of receipt of the appeal letter. 

The ICs may establish deadlines by which appeal letters must be received in order to be made available at the Council meeting.  However, in no circumstance will an appeal letter be accepted before the summary statement has been transmitted to the PD/PI or later than 30 calendar days after the relevant Council meeting. 

An appeal letter will be accepted only if the letter 1) describes the flaws in the review process for the application in question, 2) explains the reasons for the appeal, and 3) is based on one or more of the following issues related to the process of the initial peer review:

  • Evidence of bias on the part of one or more peer reviewers.
  • Conflict of interest, as specified in regulation at 42 CFR 52h.5. “Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects”, on the part of one or more peer reviewers.
  • Lack of appropriate expertise within the SRG.
  • Factual error(s) made by one or more reviewers that could have altered the outcome of review substantially.

Appeal letters based solely on differences of scientific opinion will not be accepted.  A letter that does not meet these criteria and/or does not include the concurrence of the AOR will not be considered an appeal letter, but rather a grievance.  The IC will handle grievances according to IC- specific procedures.  Appeals involving potential conflict of interests or violation of ethical conduct rules on the part of an NIH staff member or other federal employee will be referred to the appropriate Deputy Ethics Counselor for consideration and resolution before any further review of, or action on, the appeal is taken.

NIH staff will consider the basis for the appeal letter, and evaluate the merit of the appeal.  If both review staff and program staff support an appeal, then the original application, without additional materials or modifications, will be re-reviewed by the same or a different SRG.  In this case, only the results of the re-review, and not the first review, are made available to Council, and information about the appeal is not made available to Council.

If review staff and program staff do not support the appeal, or do not agree on its merit, the PD/PI and/or an institutional official (not necessarily the AOR) may elect to withdraw the appeal letter.  The request to withdraw an appeal letter must be submitted either in hard copy or electronically to the PO, and must display concurrence from the AOR of the applicant organization for the application. Although the content of the request may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or an organizational official(s) (not necessarily the AOR), the AOR must send the request directly to the PO, or must send his/her concurrence to the PD/PI who will forward the materials and his/her concurrence to the PO.  A communication from the PD/PI or institutional official (other than the AOR) only or with a “cc” to the AOR will not be accepted. 

If review staff and program staff do not support the appeal, or do not agree on its merit, and the appeal letter is not withdrawn, the appeal letter will be made available to Council. The IC may not deny the PD/PI or applicant organization the opportunity to have an appeal letter made available to Council. 

Only two outcomes are possible following consideration of an appeal letter by Council:

  • The Council may concur with the appeal, and recommend that the application be re-reviewed. 
  • The Council may concur with the SRG's recommendation and deny the appeal.  Although factual errors or other issues may be evident, the Council may determine that these factors were unlikely to alter the final outcome of the SRG and deny the appeal.  No action by the Council is equivalent to concurrence with the SRG’s recommendation and denial of the appeal.

The recommendation of Council concerning resolution of an appeal is final and will not be considered again by the NIH through this or another process.  At no time should the PD/PI or an official of the applicant organization attempt to contact individual members of the Council to discuss their consideration of an application or appeal, as doing so could jeopardize the confidentiality of the review process.
The PO will communicate the Council recommendation concerning an appeal to the PD/PI, AOR, and NIH staff with a need to know.  If the appeal letter was received by the IC deadline, the PD/PI and AOR will receive a written explanation of the resolution no later than 30 calendar days after the Council meeting.  If the appeal letter was received after the IC deadline, the PO will provide, no more than 30 calendar days after the date when the appeal letter was received, a written explanation of the IC’s plan for making the appeal available to Council. 

If the Council recommended that the application be re-reviewed, the original application will be re-reviewed without additional materials or modifications.  The application may be re-reviewed by the same or a different SRG, depending on the flaws in the original review process that led to the appeal.  In most cases, the re-review will entail re-assignment to a subsequent review round and delay in the final funding decision.  The outcome of the re-review is final and cannot be appealed again.

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