APPLYING FOR AN NIH GRANT BY LEORA LAWTON, EXECUTIVE DIRECTOR

APPLYING FOR AN NIH GRANT BY LEORA LAWTON, EXECUTIVE DIRECTOR llawton@berkeley.edu First: there are basic links on the Popcenter website for learning about NIH grants, so you don t have to click around the NIH site in frustration. www.popcenter.berkeley.edu/grants/nih_grants.html. Second: read Section I at the very beginning of this process, and skim through Section II just to get a sense of it. Read Section II when you are ready to sit down and start pulling it together, or contact me: I m here to help. I. Getting Started A. NIH Grant Basics Responding to a specific program announcement or opportunity is one way to submit a grant application. However, unsolicited proposals are the most common. Both solicited and unsolicited proposals have detailed instructions in terms of the proposal requirements. There are also different kinds of grant programs (grant types), of which R01 is one kind. The most common types for our faculty research are: R01: Large multi year (up to 5, renewal possible) primary research projects, typically involving data collection or database creation. R03: Smaller 1 2 year projects, often with existing data. Direct costs are limited to $100,000 direct costs over the R03 2 year period, with no more than $50,000 in direct costs allowed in a single year. R21: Larger budgets allowed than for an R03, smaller than R01, R21 s are for exploratory, innovative research projects, often collecting data, but limited to 1 2 year durations. Direct costs are limited to $275,000 over an R21 two year period, with no more than $200,000 in direct costs allowed in any single year. For explanations and links to the announcements for unsolicited proposals for each mechanism, go to: http://grants.nih.gov/grants/funding/funding_program.htm. The NIH is organized into institutes and centers (IC). The ICs support research through the grant programs BUT not all ICs utilize all grant programs. For example, while NICHD (Eunice Kennedy Shriver National Institute of Child Health and Human Development) and NIA (National Institute on Aging) use the R03, the National Center on Minority Health and Health Disparities (NCMHD) does not. B. Finding the right IC for your research 1. Define the scope and nature of your project and whether it s suitable for an R01, R03, R21 or whatever, then read the Parent Announcement instructions carefully, that is, the document specific for your particular grant. For example, an unsolicited R01 Announcement is PA 13 302, found at http://grants.nih.gov/grants/guide/pa files/pa 13 302.html. Note which IC s participate in the Announcement, as listed in the Components of Participating Organizations. Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 1

2. Visit the IC website and locate the research areas of interest to the IC. Then find the program officer who heads that area. A summary of NICHD program areas is on the Popcenter website: http://www.popcenter.berkeley.edu/grants/nichd_grants.html. 3. Before you apply, write to the program officer with a 1 page description of your project (Program Announcement title/number; research question, hypotheses, data collection/acquisition, methods, timeline). Your draft Specific Aims is a good thing to send. Write to several if you aren t sure which is best and let them know which ones you are considering, or cc them on the same email so they know who you are talking to. Don t be shy: their job is to talk to you. 4. Contact me or RES to begin the process. Read this document which is step by step instructions in considerably fewer pages than what the NIH provides. You don t have to master this information if you wish to rely on my help. That s what I m here for. 5. NIH forms are complicated and unclear. Your job: write the research plan, tell us whether the project includes working with anyone outside of Cal, and give us a rough budget. Our job: fill out the forms and make sure that all the required documentation and information is in place. Some NIH ICs have tutorials and advice for how to apply for grants and interpret funding decisions: http://grants.nih.gov/grants/grants_process.htm NIH s overview http://www.niaid.nih.gov/researchfunding/grant/strategy/pages/default.aspx National Institute of Allergies & Infectious Diseases http://deainfo.nci.nih.gov/extra/extdocs/grantrevprocess.htm National Cancer Institute II. SF424 (R&R) attachment instructions and examples A. The Application Forms General Issues This section is meant to be used as you go through the various parts of the form. I can get everything started for you. I have examples of most documents in a zip file that I can send you. Read this section when you are really ready to start putting it together, no later than about 3 weeks (and better if earlier) before its NIH due date. It s due to SPO FIVE business days before the NIH date, and I like to see it at least one week before that, even if the research plan is not finalized. There is a link on the parent announcement (PA) to download the SF424(R&R) application specific for the PA, but grant programs use a generic application form. [Note: you need Adobe version 8 or 9 to utilize this application form.] As there are items that are not obvious, you will need help. For electronic applications and not all are, as specified in the announcement SF424(R&R) is the form one fills out, and attaches a series of.pdf documents that comprise different parts of the application, e.g., the biosketch, research plan and the budget. There are instructions for the SF424: this document is 260 pages long, as is the companion instructions for PHS 398, which is what used to be used; some of the PHS 398 forms are still part of the SF424 process. I ve read these instructions and that s why I created this much condensed version. Within the SF424, not all documents that could be attached are always required, depending on the announcement, the kind of grant, or the stage of grant. Sometimes they will be grayed out in the Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 2

application form, but not always. Sometimes they are optional. READ THE ANNOUNCEMENT to be sure. When you are ready, I will send you a WinZip folder that is a collection of templates to use for those documents. Each document contains instructions, formats, and/or example text for you to use. Many of these take just minutes to do. They are saved in Word. You may send your documents to me saved as Word docs and I ll convert them to.pdfs, or you may send them as.pdfs or.txt, as you prefer. I prefer Word so I can more easily modify them, but I know not everyone has Word or uses it. NIH provides examples of forms as well, at: http://grants.nih.gov/grants/funding/424/index.htm#format For all of these attachments, use no smaller than 11 point font, and only one of the accepted fonts: Arial, Helvetica, Palatino Linotype, Georgia. Include at least ½ inch margin on all edges. Do not include Header or Footer information. This changed in 2015, see the Notice: http://grants.nih.gov/grants/guide/notice files/not OD 16 009.html. For applications submitted for due dates on or after May 25, 2016, the following new guidelines apply: Text in PDF attachments must follow these minimum requirements: Font size: must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%) Type density: must be no more than 15 characters per linear inch (including characters and spaces) Line spacing: must be no more than six lines per vertical inch Text Color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable as long as it is legible) Since some PDF converters may reduce font size, it is important to confirm that the final PDF document complies with the font requirements. The following fonts are recommended, although other fonts (both serif and non serif) are acceptable if they meet the above requirements. Arial Garamond Georgia Helvetica Palatino Linotype Times New Roman Verdana Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 3

Legibility is of paramount importance. Applications that include PDF attachments that do not conform to the minimum requirements listed above may be withdrawn from consideration. B. The Application Forms Specifics Each of the documents required in the SF424(R&R) application are discussed in this section, and examples of each are included in the WinZip folder. Not included are examples for (a) references and (b) the actual research plan. However, I will be available to read over any plan, and if desired (and I recommend it), will find someone in your field (with a successful grant record) to read and give comments as well. I can also provide you with examples of successful research plans. When saving documents use file titles of this format AttachmentName_ApplicantName.doc for example, Biosketch_Jones.pdf so that it s clear where on the application it gets attached. Do not use hyphens, spaces, or other characters in file names. (NIH recently standardized this format, so some web pages still say hyphens are okay. But they aren t; see p. I 13). Contents of the NIH folder, as organized by Section on the application. Page numbers in parentheses refer to the NIH provided instructions document: SF424 (R&R) Application Guide for NIH and Other PHS Agencies Version C Application Guide, Updated November 25, 2014 (http://grants.nih.gov/grants/funding/424/sf424_rr_guide_general_verc.pdf). Generally, let your grant support person (me, or RES, for example) fill in all of the first sections, and just worry about the attachments. C. Attachments by Section, Page and Number Note for this section: Text in Palatino is NIH language. Text in Calibri is mine. Green text indicates attachments that are always or almost always required. The document number refers to the number in the SF424(R&R) form. Be sure to check Table of Page Limits for all attachments: http://grants.nih.gov/grants/forms_page_limits.htm. Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 4

D. Paper Applications the PHS398 Some grants still use the paper application, known as the PHS398. In fact, many of the forms for the SF424(R&R) come from the PHS398. It too has some 250 pages of instructions, but the guidelines are very similar so to a large extent this entire instruction document still applies. E. The Attachments The rest of this section details the attachments that may be required for your grant application, and are referenced according to their section and numbering in the SF424 form. i. SF424(R&R) PG 2. 18. SFLLL or other explanatory documents (Disclosure of Lobbying Activities). Not likely to be needed. 20. Pre application. Unless specifically noted in a program announcement, the Preapplication option is not used by NIH and other PHS agencies ii. RESEARCH & RELATED Other Project Information 7. Project Summary/Abstract A one page abstract. (pp.i 76). This document is meant to serve as a succinct and accurate description of the proposed work when separated from the application. State the application s broad, long term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe concisely the research design and methods for achieving the stated goals. This section should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate reader. Avoid describing past accomplishments and the use of the first person. Finally, please make every effort to be succinct. This section must be no longer than 30 lines of text. 8. Project Narrative 2 3 sentences in layperson language about how your project meets the public health goals of NIH and the IC (institute/center, e.g., NICHD) that you are seeking funding from. (p. I 77) 9. Bibliography & References Cited Provide a bibliography of any references cited in the Research Plan. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Applicants should be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application. There may be page or number of citation limitations to this: check the announcement instructions. (p. I 77) 10. Facilities and Other Resources Where the research will be conducted, and what resources you have available at each place to do the research. Can be as little as one page, but may often hold detailed information about the resource, for example, a data collection vendor s experience and resources. Do not use this section to circumvent the page limits in Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 5

the research plan (p. I 77 to I78). This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. 11. Equipment List any major equipment already available and necessary for this project, noting the location and pertinent capabilities of each (p. I 78). This is NOT the section for equipment to be purchased; see Budget, below. Major means $5,000+. 12. Other Attachments. These are for when you need further explanation, e.g., for foreign justification, environmental impact. This is NOT the appendix. From the Instructions (p.i- 62): Attach a file to provide any other project information not provided above or in accordance with the announcement and/or agency specific instruction. iii. RESEARCH & RELATED Senior/Key Person Profile (Expanded) Attach Biographical Sketch. (p.i 88, I 89). NIH keeps changing this format, so be sure you are upto date. Each PI and key personnel submits a biosketch. The biographic sketch now has a personal statement and a contributions to science section, instead of a list of publications. It s usually a 5 page limit but check announcement. The personal statement and contributions to science are VERY important: make sure it s tailored to the specific application, not simply grabbed from another application. Recent (Oct 16, 2015) clarifications are as follows: Indicating that a URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography Allowing publications (peer reviewed and non peer reviewed) and research products to be cited in both the personal statement and the contributions to science sections Explicitly stating that graphics, figures and tables are not allowed See instructions and samples here: http://grants.nih.gov/grants/funding/424/index.htm#biosketch. Attach Current & Pending Support: No longer needed (8/27/09) except for K award mentors. (p.i 70). Unless otherwise required in a specific FOA, do not use this attachment upload for NIH and other PHS agency submissions. This information is no longer required at the time of application submission. This information may be requested later in the pre award cycle, in the Just in time requests prior to the funding decision. iv. PHS 398 RESEARCH PLAN Research Plan Attachments Three sections of the previous Research Plan (Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods) have been consolidated into a new single section within the Research Plan entitled Research Strategy. The new Research Strategy Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 6

section will be sub divided into three parts: Significance, Innovation, and Approach, although this will now be a single upload. See I 106 to I 117. Other instructions are in the Program Announcement. It s this section where the page limits apply, for example, 12 for R01 s apply. Read the Announcement to be sure. Each section is a separate document, but the content of all comprises the allotted pages. 1. Introduction to Application: For revisions or resubmissions only, where the PI responds to the reviewers comments. See pg. I 29, I 131. 2. Specific Aims. (p.i 132). This page is perhaps the most important document in your entire application. It must be letter perfect, succinct, clear, engaging and enticing. It s not the lit review, rather, it s what you are going to do, how, and its significance and innovation, all in one page. State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. Specific Aims are limited to one page. 3. Research Strategy, pg I 133 to I 134. This is the section limited to the new page limits, 6 for R21 and R03, 12 for R01. Do read http://enhancing peerreview.nih.gov/docs/application_changes.pdf for more details on how proposals are evaluated, that is, the emphasis on Significance, Innovation and Approach; these should be sub headings of the Research Strategy. Begin the research strategy with a section on Significance, followed by one on Innovation, to total 1 2 pages of your allotted 12. Occasionally underline the text or put in italics if there s something you want to make sure the reviewers don t miss. Note that when required Preliminary Studies and Progress Reports for renewals are part of the page limits. Preliminary data is required for R01 applications. Most others have it as optional. Upon request, I can provide some successful examples. Page limits can be tough, but remember that tables and figures can be smaller as long as they are clearly legible. 4. Inclusion Enrollment Report (p.i 149, II 14). This is only for a renewal of clinical research, and so not likely to be something you will deal with. Use only if this is a renewal or revision application involving clinical research. If so you must report on the enrollment of research subjects and their distribution by ethnicity/race and sex/gender. 5. Progress Report Publication List (p.i 135). For renewal applications only. Not needed on new applications. Human Subjects Section In the section RESEARCH & RELATED Other Project Information of the application, one specifies whether the research includes Human Subjects. If you check no then for form #6, If you check the yes box for Human Subjects involved in Question 1 of RESEARCH & RELATED Other Project Information then you need to provide forms #6 9. Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 7

6. Protection of Human Subjects (p.i 135). In the section RESEARCH & RELATED Other Project Information earlier in the application, one specifies whether the research includes Human Subjects. There are far more detailed instructions in Part II of the SF424(R&R): http://grants.nih.gov/grants/funding/424/supplementalinstructions.pdf. a. If you check no then for form #6, then for this form indicate why your research does not fall into Human Subjects research, for example, you are using publicly available data that is already cleaned of identifying data. b. If you check yes then the research might be exempt from Human Subjects, in which case you need to provide the exemption number (see p. III 34). YOU SHOULD NOT MAKE THIS DETERMINATION YOURSELF: IT MUST BE DECIDED BY THE COMMITTEE ON THE PROTECTION OF HUMAN SUBJECTS (http://cphs.berkeley.edu). Just contact one of the CPHS analysts they have office hours every day to verify if your research is exempt or if it will need to undergo expedited or partial review. For further explanation, read the BPC summary document on Human Subjects requirements, http://www.popcenter.berkeley.edu/grants/humansubjects_summary.pdf, on the website. c. Or the research may be human subjects and not exempt. In this case you must indicate whether the IRB approval is pending (which is fine), or whether it s already undergone review and received approval of protocols, in which case you provide the date of approval. The HWA number for UC Berkeley is 00006252. Regardless of whether it s pending or approved, in this form you explain how you meet human subjects requirements. This information is essentially what is documented in the pending or approved protocols. Having determined whether your research requires some kind of human subjects documentation, the more detail you provide the less likely you will get dinged. Indeed, in some cases they have rejected the application outright because of this attachment. Run this document by OPHS analysts to make sure there are no red flags. 7. Inclusion of Women and Minorities (p.i 136 and II 11+ and II 19+). Document why you are or are not including both genders and minority populations in your research. 8. Targeted/Planned Enrollment (p.i 145 to I 151). Use this table http://grants.nih.gov/grants/funding/424/sf424r R_enrollment.doc for this section. See p. II 14 for more detail, but basically you need to provide a crosstab of the number of subjects by sex and race/ethnicity. 9. Inclusion of Children (p.i 136; p. II 15+ and p. II 20). Document why you are or are not including children in your research population. Research on children must be addressed specifically in your human subjects document. A child is defined as an individual under the age of 18 years (per a recent change in rules, Oct 2015) (p. II 15). Other Research Plan Sections 10. Vertebrate Animals (p I 137). We almost NEVER need this! 11. Select Agent Research (p.i 139) Also not a social science concern. 12. Multiple PI Leadership Plan (p. I 111, I 140). Management plans for more than one PI/PD. (PI is for research. PD is for programs). The role of Co PD/PI is not currently used by NIH and other PHS agencies. Human Subjects assurances must name all PIs. Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 8

You may have multiple PIs or PDs, for example in a consortium relationship. From the instructions (p. I 140): For applications designating multiple PD/PIs, a leadership plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Grant Award. 13. Consortium/Contractual Arrangements (p.i 141). If you are going to have key personnel at another institution, then you will have a consortium arrangement. This means you will need a consortium budget, which requires several forms. See the end of this document, and talk to me if you need this. 14. Letters of Support (p.i 141). Basically, get a letter, on letterhead or even email, that indicates anyone named as key personnel s intention to participate in your research in the required capacity or contribution of expertise. Save the individual letters as.pdf files and merge them together as one document. Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services. 15. Resource Sharing Plans (p.i 142). Detail here how you are going to share the results of your research, for example, making data publicly available, websites, workshops at conferences, presenting results in conferences, in peer reviewed articles or layperson white papers, as input for policy makers, etc. 16. Appendix. See p. I 144 for details and also the Announcement. See also: http://grants.nih.gov/grants/guide/notice files/not OD 10 077.html. The appendix is used for items such as draft questionnaires, and very few other purposes. DO NOT use it to circumvent the page limits. Mandatory Cover Letter: p.i 91+ Note that this cover letter is written by the PI, but there are some kinds of applications where the letter follows a specific format, and is signed only by SPO. This letter is specified in the announcement. Both the mouse over and the instructions are fairly selfexplanatory. It used to be, until the announcement of October 2015 (for May 2016 applications) that the cover letter s purposes was to let the officer at the Center for Scientific Review know whose best qualified to review your proposal. This task will instead be provided in the PHS Assignment Request Form. Suggest a review group (e.g., SPPS) and the kinds of expertise substantive and methodological sought in the review (e.g., labor force participation, disablement, event history analysis), and which kinds of expertise are not appropriate. Do NOT mention names. If there is someone on the review panel that is a competitor or otherwise likely to be biased against you, contact the Scientific Review Officer (I recommend by phone). After you ve submitted the proposal Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 9

and the review group is assigned. You may still submit a letter to advise CSR of anything else that you might want to let them know about (e.g., which Program Officials with whom you ve been in communication. (http://grants1.nih.gov/grants/peer_review_process.htm). Required UC Documents: You also need to provide federal conflict of interest forms required by UC Berkeley s Sponsored Projects Office (SPO). The PRF (aka perf ) is no longer needed as is now subsumed within Phoebe, Cal s online submission platform. I am trying to get this changed, but right now FCOI s must be submitted at application and then resubmitted at the award. They can be downloaded from here: Conflict of Interest Checklist: http://researchcoi.berkeley.edu/phs.html. All forms and instructions: http://www.spo.berkeley.edu/forms/ucforms.html Obtaining the Letters of Support, Consortium Budget and other documents from others: If you are going to have a subcontract with a PI or key personnel at another institution where that person will be paid directly by NIH but the amount is rolled into the total costs for your grant application, you will need to tell me so that I can get documents for the other institution to fill out. 1. The first document is called the Subrecipient Commitment Form, http://www.spo.berkeley.edu/forms/subaward/ucbsubrecipient.pdf. This can take time (weeks) so get this as early as possible. You don t need to do this for a vendor (e.g., data collection company) but you do for key personnel, that is, someone who is contributing to the research itself, not ancillary to its being carried out. RES will be able to help out with this detail. 2. The second document is the budget, which is retrievable from the SF424 (R&R) form. 3. You will need biosketches for all key personnel (new format as of 2015!!) 4. And you will need letters of cooperation from these key personnel. Resubmissions The current policy (http://grants.nih.gov/grants/guide/notice files/not OD 14 074.html) For application 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 due date. The NIH and AHRQ will not assess the similarity of the science in the new (A0) application to any previously reviewed submission when accepting an application for review. Although a new (A0) application does not allow an introduction or responses to the previous reviews, the NIH and AHRQ encourage applicants to refine and strengthen all application submissions. See more at: http://grants.nih.gov/grants/guide/notice files/not OD 14 074.html#sthash.QMHbRvfD.dpuf. I have detailed instructions on how to handle a resubmission, so contact me if this is what you are going to do. Note: Text in Palatino is NIH language. Text in Calibri is mine. Green font indicates required documents. 10