Contents 1. Learning Objectives 5. Grant Proposal Submission 2. Grant Application Preparation 6. NIH Review Process 3. Writing a Research Proposal 7. Resources 4. Budget Preparation

Learning Objectives Individuals completing this tutorial will be able to: Outline plans for preparing and submitting grant proposals Complete required registrations for electronic grant submission Recognize elements of successful research proposals Create a comprehensive budget Describe grants review process

Grant Application Preparation Do your homework Make sure appropriate registrations are in place. Take the time to understand the application and submission process. Decide who will be responsible for completing the different forms within the application. Consider how the application file will be shared between the contributors (email attachment, placed on shared drive, copied to portable media, etc.). Determine when forms must be completed to allow time for submission. Develop a submission plan; institution administrators and PIs should work together to develop the plan.

Grant Application Preparation Create a timeline Plan backward from the due date for proposal submission. Remember that 75% to 80% of the grant development process is planning (only 20% to 25% is writing): Make sure all registrations are completed. Identify stakeholders early. Secure collaborators/key personnel. Understand your institution’s grant submission system. Get buy-in from leadership at your organization.

Grant Application Preparation Seek mentors and finalize goals Choose two or three senior colleagues as a mock “grant review committee.” Discuss goals, aims, and ideas with the committee before you start writing. Draft three to five specific aims to discuss with the committee and get advice. Finalize your aims before drafting the abstract and research strategy. Finish a reasonable draft in time to get a mock review.

Grant Application Preparation Steps to register to apply for grants Step 1: Obtain a NATO Commercial and Government Entity (NCAGE) code The NCAGE code is a five-character code used to identify a given facility at a specific location. Foreign organizations must obtain an NCAGE code for System for Award Management (SAM) registration. Step 2: Obtain a DUNS (Data Universal Number System) number A DUNS number is a free unique nine-character identification number provided by Dun & Bradstreet. Foreign organizations can request and register for a number online. Step 3: Register with System for Award Management (SAM) This replaces Central Contractor Registration (CCR); you will need to create a SAM account if you were previously registered in CCR Your email address will link your new SAM account to your old CCR info SAM must be renewed annually

Grant Application Preparation Steps to register to apply for grants Step 4: Get a Grants.gov username and password Complete multiple Authorized Organization Representative (AOR) profiles. You can track your status at any time with any AOR’s username and password. Step 5: For NIH grants, register in eRA Commons Principal investigators (PIs) and applicant institution must apply. PIs have one account that follows them from project to project. PIs may be affiliated with multiple organizations. Signing officials/AORs who also serve as PIs should have separate eRA commons account for each role. Start the registration process at least four weeks before the grant application submission deadline. Information current as of September 2013. Please see websites for updates on policies and procedures.

What Is a Research Proposal? Research proposals are written descriptions of how you plan to carry out your research. Your proposal should describe clearly and in detail: Knowledge or information you seek to obtain (specific aims/objectives) How you plan to obtain it (methodology) How much it will cost (budget) How long it will take (timeline) How to share findings (dissemination)

Writing a Research Proposal Tips for writing successful proposals Understand the game: Limited funding + Lots of proposals = Only the most competitive proposals receive grant funding. Learn about the donor agency (visit websites, read brochures, call, visit) before writing the proposal. Read and follow all instructions (date of submission, length of application, font, supporting documents, etc.). Think through the idea (project) before writing. Start writing early and allow time to revise and edit before submission. Write to communicate and not to impress; clarity is key.

Writing a Research Proposal Tips for writing successful proposals Be specific about what you plan to do. Use the language of the field. Be persuasive to convince the donor that the match between you and the agency is a perfect one. Within your organization/institution: Find sponsored basic proposal-writing workshops. Ask for editorial services and assistance. Ask for proposal templates and examples of successful past proposals. Have a mentor help coordinate the final packaging of the proposal.

Internal Review Format and presentation Your proposal should be: Detailed and clear; avoid vague statements Easy to read: avoid jargon, define your terms, write in plain English In a regular format; free of extravagant packaging Include a cover letter that: Briefly describes the proposal content Is signed by an individual in high authority at your institution

Writing a Research Proposal Review your criteria Your research proposal should address all the following criteria: Significance/Background: Does the proposal address an important problem or critical barrier to progress in the field? Innovation: Does the application challenge and seek to shift current research or clinical practice standards by utilizing novel concepts, approaches, or methodology, etc.? Approach: Are the overall strategy, methodology, and analyses well reasoned and appropriate to accomplish specific aims? Investigator(s): Are project directors/investigators, collaborators, and other researchers well suited to the project? Environment: Will the scientific environment in which work will be done contribute to the probability of success?

Writing a Research Proposal Research proposal structure: Title and abstract Title Should be specific, not vague Gives the application an identity Must be creative, be brief, and cover: The essence of the project The study population The setting in which research takes place Abstract Determines your study section/funding institute’s assignments Includes objectives, rationale, and design Sets the stage for your study section

Writing a Research Proposal Research proposal structure: Specific aims Concisely state the goals of the proposed research. Summarize the expected outcomes. Describe the impact that the proposed research results will have. List the specific aims/objectives (what will be achieved during research). State the significance of the planned study: Does it address an important problem? How will it improve scientific knowledge? Limit it to one page. Draw from the literature review. Make the proposal realistic. Use active verbs.

Writing a Research Proposal Research proposal structure: Research strategy 1. Significance/Background Set the stage, frame your questions, and state the impact clearly. Explain the importance of the problem or critical barrier to progress. Make sure it is not a review article. Use literature that frames and rationalizes the issues you will approach in your study. Include underlined statements of gaps in the current knowledge. Explain how the proposed project will improve scientific knowledge, technical capacity, and clinical practice.

Writing a Research Proposal Research proposal structure: Research strategy 2. Innovation Explain how the application challenges and seeks to shift current research or practice standards. Describe any novel concepts, approaches, interventions, etc., to be used and any advantage over current practice. Explain any refinements, improvements, or new applications of concepts, approaches, etc.

Writing a Research Proposal Research proposal structure: Strategy 3. Approach Present your: Framework. Design (how research is organized or structured to answer questions and/or hypothesis). Methodology (what you plan to do, how you will do it, why you are doing it this way, who will carry out the plan, and when and where it will be done). Analysis plans (how data will be collected and resources shared, etc.). Include preliminary studies/progress reports (emphasize your and your collaborators’ expertise). Ensure your approach is well developed, well integrated, and appropriate to the aims.

Writing a Research Proposal Self-assessment question Which of the following items should be included in a research proposal? A: _____ Description of any novel concepts B: _____ Specific aims/objectives C: _____ Relevant preliminary studies D: _____ Explanation of the importance of the problem E: _____ Analysis plan F: _____ All of the above

Writing a Research Proposal Self-assessment answer F. All of the above.

Budget Preparation Purpose of a budget: To present all expenses required to achieve the project’s aims and objectives Think about: How much it will cost to accomplish what is being proposed How it can be requested F&A (facilities and administrative) costs Whether there are restrictions on what can be requested What form should be used How the budget should be submitted How much will it cost to accomplish what is being proposed

Budget Preparation Terms to know Funding Opportunity Announcement (FOA): A publicly available document stating an intention to award grants, usually as a result of competition for funds Budget information is included in FOAs under Award Information Allowable expenses: Costs incurred by the recipient that are: Reasonable for performance of award Allocable to the grant Allowable; in conformance with limitations or exclusions Consistent with regulations, policies, and procedures

Budget Preparation Terms to know Approved budget: The financial plan for the grant-supported activity or project Project period: Total time for which the approved project is supported Budget period: Time intervals (usually 12 months) into which the project is divided

Budget Preparation Terms to know Direct cost: Any cost that can be specifically identified with or directly benefit a particular project, program, or activity. Direct costs include: Salaries and benefits Travel Supplies Consultants Publications Facilities and Administrative (F&A) Cost: A flat eight percent rate (exclusive of equipment) is allowed in order to help foreign institutions defray the cost of compliance with NIH policies.

Budget Preparation Terms to know Total project costs Total allowable costs to carry out a grant-supported project or activity If matching funds or cost-sharing requirement is included in the RFA/PA, include costs charged to the grant and costs borne to grantee to satisfy this requirement Full-time equivalent (FTE) Indicates the workload of an employed person or student Is used to measure a worker’s involvement in the project: FTE of 1.0 means a person is equivalent to a full-time worker; FTE of 0.5 means a worker is only half- time

Budget Preparation Budget categories Cost-sharing and fringe benefits Consultants and subcontracts Equipment and supplies Travel Patient care costs Tuition and budget justification Other expenses

Budget Preparation Budget categories: Cost-sharing and fringe benefits Cost-sharing, matching, in-kind Should only be included when required by RFA/PA, or if institution wants to commit to provide these resources Portion of total project costs not borne by the sponsor Must be verifiable through documentation Fringe benefits Calculated using the rate applicable to the actual total annual salary earned by an individual

Budget Preparation Budget categories: Consultants and subcontracts Consultant costs Describe the consultants’ role in the research plan and budget justification. Note that consultants’ role must be advisory, professional, and short-term or intermittent. Include a biographical sketch and letter of participation for each. List all external consultants, even those not charging fees. Note that only under special circumstances can consultants be from the same institution. Include consultant fee(s). Subcontract and consortium costs Include names and costs of all services provided by an organization outside of the grantee’s institution.

Budget Preparation Budget categories: Equipment and supplies Equipment Include items that are $5,000 or more per unit, are expected to last longer than 1 year, and can be tagged by the grantee. Provide vendor quotations if possible. Supplies Include lab/clinical supplies, chemicals, animals, etc., required for research. Estimates should be supported by description of supplies to be used. Provide basis for computing estimates (e.g., 100 assay kits x $25/kit = $2,500).

Budget Preparation Budget categories: Travel Travel Explain the purpose of trips Ensure that transportation and per diem rates comply with sponsor/institution policies Include number of people traveling, number of trips, and length of travel Include separate lists for estimated costs for travel and lodging

Budget Preparation Budget categories: Patient care costs Include allowable costs, such as routine and ancillary services provided by the hospital or clinic to individuals participating in research programs, including patients and volunteers. Include patient travel and parking, professional physician fees, and supplies such as syringes in the “Supplies” or “Other Expenses” categories.

Budget Preparation Budget categories: Tuition and budget justification For sponsored projects: Some students may be reimbursed for tuition and fees, if they are working under grants and/or contracts. For training projects: Tuition may be budgeted unless otherwise specified in the program guidelines. Tuition remission for graduate students on research grants may be paid in lieu of wages if that is the institution’s practice. Budget justification Include it, whether it is required or not. Make it clear and focused. Take the opportunity to explain budgetary requests that may not be obvious to the reviewer.

Budget Preparation Budget categories: Other expenses Other expenses List expenses that do not fit into any of the other categories: printing/publication costs, equipment maintenance costs and service contracts, insurance, telephone service, postage costs. Break down all costs.

Budget Preparation Budget narrative A budget narrative is the written justification for those items and amounts included in the budget. Make it clear and focused. Budget justification requires description of personnel participating in research, but not their salaries; no budget breakdown is necessary.

Budget Preparation Review Complete a final check of all the numbers to ensure that no discrepancies exist between the budget narrative and the budget form. You may also need to have an internal review and approval from your institution.

Budget Preparation Resources For help, contact: Administrative: Grants Management Specialist Scientific/Programmatic: Program Official Application and electronic submission information: Modular Budget Sample: Same Modules Modular Budget Sample: Variable Modules Read more about developing budgets for grant proposals.

Grant Proposal Submission Timely submissions Submission dates: The FOA provides discrete application deadlines or will refer to NIH’s standard due dates. Late applications: NIH expects applications to be submitted on time. The NIH Policy on Late Submission of Grant Applications applies to both paper and electronically submitted grant applications.

Grant Proposal Submission Types of submissions Paper submissions require use of the PHS 398 application form. Note that paper submissions being phased out Electronic submissions require the SF424 (R&R) application.  FOA lists forms needed in application package Instructions included in forms; NIH-specific instruction denoted with HHS logo

Grant Proposal Submission Submission methods Different ways to submit an electronic application: Downloadable forms are the most common. System-to-system data streams are usually used by institutions with lots of NIH grant funding. Commercial service providers are commercial companies that, for a fee, assist applicants in submitting grant applications electronically to NIH and other federal agencies.

Grant Proposal Submission Grants.gov: Submit, track, and view Error-free applications must be accepted with time stamp before 5 p.m. local time on the due date. NIH recommends submitting several days early to allow time for correcting errors. All registration must be completed before the due date. When the application is ready for submission, the AOR should log in to Grants.gov to electronically sign and submit the application.

Grant Proposal Submission Grants.gov email notices After submitting the proposal, the PI will receive three email notices from Grants.gov: First notice: Application received and being validated If errors are found, the PI must resubmit. Warnings do not require any action by the applicant. Second notice: Application validated and being prepared for grantor review Third notice: Application received by grantor agency For NIH grants, PIs can log into eRA Commons to see any errors/warnings that may have been triggered.

Grant Proposal Submission Tips for proper submission Do a final check of the following: Guidelines for submission: margins, font size, page limits, budget formats, biosketch formats, how to submit (on paper or electronically) Accuracy of budget Application of indirect rates and cost rates PIs and level of effort Space commitments Cost-sharing commitments Subcontractor commitments

Grant Proposal Submission NIH submission tips Applicants should: Study the range of expertise in the study group likely to review the application Include a cover letter to influence the process Compose a clear and informative title Compose a clear and informative abstract Tip: Despite popular myth, proposing a cost- sharing (matching) arrangement where you only request that NIH support some of the funding while your organization funds the remainder does not normally impact the evaluation of your proposal. Only a few select programs require cost-sharing, and these programs will address cost-sharing in the FOA.

(1/4) Review Staff Program Staff Grants Management NIH Review Process NIH extramural team assigned to your application Review Staff (1/4) Program Staff Grants Management

NIH Review Process NIH contacts: A matter of timing Before applying, contact Program Officers about: Whether your research ideas meet the current program priorities The best funding mechanism to use for your application After submitting, contact Scientific Review Officers to ask questions related to the review of your application. After the review, contact Program Officers to discuss summary statement and plans for resubmission. After award, contact Grants Officers/Specialists about financial matters and contact Program Officers about scientific matters.

NIH Review Process Assignment of your application Within 7 to 10 days of applying, you should find your initial assignments in eRA Commons. Your application is assigned to an Integrated Review Group based on the areas of science and expertise needed. If you feel your application was not assigned to an appropriate study section, you can request a change.

NIH Review Process Levels of review First-level review is conducted by the Scientific Review Group (SRG), a group of independent outside reviewers who: Evaluate scientific merit and significance Recommend length and level of funding Second-level review is conducted by the National Advisory Council, which: Assesses the quality of the SRG’s review Makes recommendations on funding Evaluates program priorities and relevance Advises on policy

NIH Review Process Center for Scientific Review (CSR) Central receipt point for most PHS applications Assigns application to NIH Institute or Center (IC) Assigns application to peer review group CSR: Integrated Review Group/Study Section IC: Scientific Review Group/Subcommittee CSR conducts initial scientific merit review of about 80% of all NIH research applications

NIH Review Process Scientific Review Officer Responsible for NIH scientific and technical review of applications Ensures fair and unbiased evaluation of the scientific and technical merit of the proposed research Provides accurate summaries of the evaluation to aid funding recommendations made by National Advisory Councils and Institute Directors Reviews applications for completeness and conformance with application requirements Point of contact for applicants during the review process

NIH Review Process Pre-meeting activities At least 6 weeks prior to review date, The Scientific Review Officer: Has selected approximately 20 reviewers Sends all applications to each reviewer Assigns primary and secondary reviewers plus at least one reader Assigned reviewers: Read your application thoroughly and write a critique before the meeting Assign preliminary scores for each review criterion and an overall impact score

NIH Review Process First-level review meeting The Standing study section typically has 12 to 24 members. There are three face-to-face meetings each year. Meetings are conducted over 1 to 2 days. At each meeting, 60 to 100 applications are reviewed.

NIH Review Process NIH review criteria Five scored criteria (see Writing a Research Proposal for more information): Significance Investigators Innovation Approach Environment Other criteria: Human subjects inclusions and protections Animal welfare Type of application (i.e., resubmission, renewal, revision) Biohazards

NIH Review Process NIH review criteria What is not scored: Budget and period support Select agent research Applications from foreign organizations Resource sharing plans These criteria do not affect the overall impact, but reviewers must comment or provide text for an administrative note.

NIH Review Process Comments regarding foreign applications Reviewers assess whether comparable work is being done in the United States. If it is, the grant will not likely be funded. NIH awards grants to foreign applicants if either the expertise or resources are not available in the United States; for example, access to a unique study population. Applications are reviewed for relevance to IC mission.

NIH Review Process Overall impact of research applications The Overall Impact Score is based on the likelihood of a project to exert a sustained, powerful influence on research fields involved. It evaluates: The five criteria: significance, investigators, innovation, approach, and environment (weighted based on reviewer’s judgment) Other influences: human subjects, animal welfare, inclusion plans, and biohazards Overall Impact Score rating (scale of 1 to 9) High (Score 1, 2, 3): Applications are addressing a problem of high importance/interest in the field. May have some or no weaknesses. Medium (Score 4, 5, 6): Applications may be addressing a problem of high importance in the field, but weaknesses in the criteria bring down the overall impact to medium. Applications may be addressing a problem of moderate importance in the field, with some or no weaknesses. Low (Score 7, 8, 9): Applications may be addressing a problem of moderate/high importance in the field, but weaknesses in the criteria bring down the overall impact to low. Applications may be addressing a problem of low or no importance in the field, with some or no weaknesses. http://public.csr.nih.gov/ReviewerResources/GeneralReviewGuidelines/Documents/chart_overall_impact_scores.pdf

NIH Review Process Scoring of NIH grant applications Impact Score is not merely a mean/average of the Criterion Scores. Only assigned reviewers provide Criterion Scores; Range 1 to 9. All reviewers (not in conflict) provide Impact Scores; Range 1 to 9. Application’s Impact Score is the mean of all non-conflict reviewers’ scores x 10; Range 10 to 90.

NIH Review Process After first-level review meeting Impact/Priority Scores are recorded within 48 hours in eRA Commons. Summary statements (essentially unedited critiques) are viewable in eRA Commons 4 to 6 weeks after the review meeting and include the following: “Resume and Summary of Discussion” section that briefly highlights the main points discussed during the review meeting, including major strengths and weaknesses Criterion Scores given by assigned reviewers Overall Impact/Priority Score and percentile ranking Budget recommendations Administrative notes Sample summary statement

NIH Review Process After first-level review, Contact Your Program Officer As soon as you receive your summary statement, contact your Program Officer. Find his or her name in the Commons and at the top of your summary statement. Ask your Program Officer About the probability of funding Whether he or she (or a representative) attended the review meeting as an observer and can give you additional insight into the discussion

NIH Review Process Not Discussed (ND) applications About half of the applications are ND. Review meeting focuses discussions on the most competitive applications, based on preliminary scores. If any reviewer disagrees with a decision not to discuss an application, the group will review that application. ND applications: Do not receive an Overall Impact Score or a “Resume and Summary of Discussion” summary. Do receive a summary statement with Criterion Scores and critiques from assigned reviewers.

NIH Review Process Second-level review meeting Conducted by the National Advisory Council or Board for the assigned Institute/Center Review meeting focuses on discussions on the most competitive applications, based on preliminary scores. Activities open to the public: Approval of new program initiatives and concept clearances Consideration of policy issues Activities closed to the public: Assessment of the quality of first-level review Concurrence with or modification of Integrated Review Group action Designation of application as “High” or “Low” program priority

NIH Review Process Appeals Formal letter submitted by the Authorized Organization Representative (AOR) (or have concurrence documented) Letter that disputes the outcome of initial review and is based on allowable grounds for an appeal Appeals that fail to meet criteria, or lack the AOR endorsement, are treated as grievances All formal appeals (including Fellowships) must be taken to National Advisory Council, unless officially withdrawn or deferred for re-review prior to Council. Council or IC staff may decide which appeals require formal discussion by Council.

NIH Review Process Basis of an appeal Appeals: Apply to grant review, not contract review Do not apply to funding decisions Do not include difference of scientific opinion Allowable grounds for appeal: Bias Conflict of interest Reviewer lacks appropriate expertise Substantial and significant factual error(s) that could have substantially altered review outcome

NIH Review Process Appeal outcomes National Advisory Council will either: Agree to a re-review of the original application (without any updates/changes) Let original review outcome stand The recommendation of Council is final and will not be considered again by the NIH through this or another process Notice: Appeals of NIH Initial Peer Review

Resources Helpful websites NIH grants and how to apply Applying electronically Grant writing tips Award information Sample applications Center for Scientific Review: Applicant resources NIH grants and funding: Information for foreign applicants and grantees NIH scoring system