Dr. Kathleen Jett, Research Consultant Pam Selby, Editor Chris Anthony, Grants Specialist Angela Gifford, Senior Accountant Beth Auten, Reference and Liaison Librarian NIH Proposal Writing Right on Target for 2011 2 Working with Your Editor: Avoid Confusing Versions Around grant deadlines, you all know it can get pretty intense. To avoid confusion from multiple “versions” of the same grant, please consider the following: Although the “Details” view of files will show the date and time, I have learned that including these in the actual title of the document can be a big help, particularly the closer you are to your deadline. 1. Early in revision process, include the date and your initials on every version (e.g., Yoon_Aims_5-8-10_sy). Once having relinquished your draft to the editor, allow “wait time” to get it back. The editor will send it back with the date she finished editing it and her initials (Yoon_Aims_5-9-10_ps). 2. If you want the editor to work on a particular section only, let her know. That way, you can continue to work on other sections. This gets tricky around deadlines, so save doc with specific info: section worked on/date/time/initials (e.g., Human Subjects and References_8-7-10_215pm_ps). 3. For FINAL documents, include “FINAL” in title: (e.g., FINAL Specific Aims_5-1310_4pm_sy and ps). Once FINAL version is ready, send to Grants Specialist to convert Word docs to pdf and enter into appropriate section in application. 4. *It makes everyone’s job easier if you send the Grants Specialist ONLY the FINAL edited version of each grant section. 3 Page Limits Specific Aims 1 page maximum in any proposal requiring Specific Aims (does NOT count toward overall page length—separate doc). Research Strategy 6 pages for activity codes R03, R13/U13, R21, R36, R41, R43, Fellowships (F), SC2, SC3, and X01. 12 pages for activity codes R01, single project U01, R10, R15, R18, U18, R24, R33, R34, U34, R42, R44, DP3, G08, G11, UH2, UH3, and SC1. For more info on activity codes and proposal types, see: http://grants.nih.gov/grants/funding/funding_program.htm NOTE: Even for SBIR proposals that include 12 pages for research strategy and 12 pages for the business plan, RESUBMISSIONS are only allowed 1 page for introduction (response to reviewers). Biosketch 4 pages, 15 or less clearly relevant citations. K-Codes For individual Career Development (K) proposals, the Research Strategy does not include the Candidate Information section. The combined page limit for the Research Strategy and items 2-5 of the Career Development (K) Award Supplemental Form will be 12 pages. Items 2-5 are: •Candidate’s Background •Career Goals & Objectives •Career Development/Training Activities During Award Period •Training in the Responsible Conduct of Research 4 Section Lengths, Organization, and Formatting 1. Lettering and numbering sections Depending on the length of your application and its complexity, You may want to letter and number subsections under the Research Strategy. Introductions (resubmissions) and Specific Aims page are submitted as separate pdf documents. Note: Although NIH format changes do not specify a Preliminary Studies section, if you are applying for an R01, reviewers may look for this section. In addition, lettering and numbering the Approach subsections may make it easier for reviewers to find information. 2. Project Narrative is restricted to a maximum of 3 easy-to-read sentences. 3. Abstract is 30 lines maximum. 4. Title of proposal is still 81 characters, including spaces. Title should distill ESSENCE of proposed work. 5. 6. 7. 8. Facilities and Other Resources section not limited in page length, but include only what is relevant to proposal (Workbook, p. 159.) Appendices - There is no page length restriction for the Appendices; you are allowed 3 separate ones. Include items the PI considers vital and, as the guidelines say, be brief! Font size and styles: As it says in the instructions, “Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface, a black font color, and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies.)” In Tables and Figures, font may be smaller if easy to read. Use color sparingly—make sure colors enhance, not detract, from the table/figure, and print out in grayscale to see. For more information refer to the Forms and Applications. Margins and spacing: Not only do some consultants assert that using 1-inch margins looks better, they urge the writer to use as much white space between sections as possible, NOT to write short little paragraphs in sections, and to justify margins with hyphenation (Russell & Morrison, 2009). 5 Biosketches To streamline process of collecting biosketches from key personnel, a template of your own biosketch should be sent to each member of the team to ask if they would be willing to cut and paste information into it (big timesaver and uniform look throughout proposal). In addition: Ask your team members to PLEASE include Pubmed Central reference numbers or NIH manuscript reference numbers for each reference. Tell them it is a requirement (see Slide 26 for detailed info). Your editor or the part-time ORS program asst. may not have enough time to get this info. I. Maximum of 4 pages and 15 references—ALL should be highly relevant to proposal. II. The Personal Statement, a new feature, should reflect why the person described has been included on the research team: • • • • • • Relevance of expertise? Relevance of experience? Role in developing preliminary data? Provides access to resources/technology? Prior record of working with research team? Proximity to other members of the team? • Tailored to research aims/objectives, not just routine biographical info. For template and sample of 2010 NIH biosketch see: http://research.unl.edu/docs/NIHbiosketchexample.pdf 6 Titles According to experts, the proposal title should emphasize the “payoff” or product resulting from the research proposed (Russell & Morrison, 2009, pp. 177-179). You have a total of exactly 81 characters, including spaces and punctuation to create a compelling title—the FIRST thing reviewers see. Think of it like a book or even a documentary title. (1) Create a title that clearly defines your research purpose/goal(s). (2) Key terms should be easily understood—use acronyms ONLY if necessary and readily understood by reader (e.g., ICU, HIV) (3) Avoid ambiguity (see “poor” title in second example ). (4) Get rid of unneeded words (see “best” title in first example). Poor: Describing the Experience of Self Managing Close Calls for Old Homebound Women (78) Better: Describing the Experience of Self Managed Close Calls for Elderly Homebound Women (81) Best: Experiences of Elderly Homebound Women in Managing Potentially Serious Incidents (80) Poor: Caring for Both Ends of the Leash: Effect of Owners Visiting Their Dogs While Hospitalized (91) Better: Caring for Both Ends of the Leash: Effect on Patients Visited by Their Dogs in the Hospital (86) Best: Caring for Both Ends of the Leash: Effect of Dog Visits on Hospitalized Owners (78) *For more info about titles, see CON share drive: Everyone>Faculty Resources>NIH and HRSA Grants>Project Titles 7 Project Narrative The following suggestions from Russell and Morrison can be found in The Grant Application Writer’s Workbook, 2009, pp. 180-182. The Project Narrative is the two to three-sentence (max) explanation of how your project is relevant to public health. It is submitted as a separate pdf document. Accordingly, you may want to begin the first or second sentence with something like “The proposed project is relevant to public health because… .” Sample (2 sentences) Infectious disease is a major global cause of death and disability. The proposed study is relevant to public health because it will allow us to collect preliminary data on ___ as a means of fighting infection and reducing personal, social, financial and health burden costs. 8 Project Summary/Abstract The following suggestions from Russell and Morrison can be found in The Grant Application Writer’s Workbook, 2009, pp. 180-182. • Maximum of 30 lines. • Possibly the most important section during review, because it will be read by all reviewers, not just those assigned. • Must be interpretable by laypersons. • Avoid writing in the first person. • Write it last, but not at the last minute. • Do not use to summarize past accomplishments or to review background material. • Should be stand-alone section that makes it crystal clear to reviewers what problem/gap you are addressing, its relevance to public health, how it fits with funding agency’s mission/priority, why it has a good chance of succeeding, benefits to public health, and how it leads to next step in research trajectory. • Since the abstract becomes part of the public domain, protect what you don’t want revealed. See more writing tips on Share drive>Everyone>Faculty Resources>NIH and HRSA Grants>How Not to Kill an Abstract 9 Former NIH Main Narrative Structure A. Specific Aims* (included in page length) B. Background and Significance Review of Relevant Literature C. Preliminary Studies D. Research Design and Methods D.1 Design D.2. Sample, etc. D.3. Measures D.4. Recruitment/enrollment D.5. Procedures for data collection D.6. Data and power analyses D.7. Timeline *Many proposals included a conceptual model after Aims or in Design section. 2010 NIH Main Narrative Structure Specific Aims (one separate page) Research Strategy (main heading, centered, 12 pages R01/R15: 6 pages R21/R03) Significance Innovation Approach Design Sample, etc. Measures Recruitment/enrollment Procedures for data collection Data and power analyses Potential Problems and Alternative Strategies Future directions Timeline *An alternate outline is available from Russell & Morrison, who are experts in career development awards, recommend organizing the Approach section by Aim (Russell, S.W. & Morrison, D.C. , 2009). The Grant Application Writer’s Workbook, National Institutes of Health, Grant Writers’ Seminars and Workshops, LLC., pp. 84-99). For direct queries about this workbook, contact: [email protected] 10 Specific Aims To develop a compelling flow of logic that leads clearly and reasonably to your aims and expected outcomes, an outline can help you see links between ideas and help you avoid wordy or repetitious detail. The following outline, extracted from pp. 62-68 of Russell & Morris’s Workbook, may prove helpful.* Introduction Paragraph I. In the opening paragraph, the first sentence should immediately establish the relevance of your proposal research to human health (Russell & Morrison, 2009). II. What gap/need exists? (Is it gap in knowledge, a critical need, or both?) III. What is current status quo: Knowledge? Standard of care? Approach? IV. Why is it a problem? Second Paragraph I. Purpose: What do you seek to accomplish by the end of the proposed research (must link to either the gap or the need from paragraph 1). II. As someone who has carefully reviewed and researched all possibilities, how do you plan to test the objective? Justify approach—prelim studies, literature, etc. III. Rationale: What will become possible as a result of you accomplishing your purpose/objective(s)? IV. Long-term goal(s)? Aims Paragraph I. Make sure each aim clearly links with your purpose/objectives. (See Russell and Morrison, p. 66, to avoid setting yourself up by writing an Aim that leaves you vulnerable to invalid results.) Payoff Paragraph I. At least one important outcome as a result of accomplishing each aim. II. In general, how will this fill the gap, address the need, advance the field, contribute to NIH mission? *Pages 25-29 in Russell & Morrison provide important detail about section headings and writing strategies. 11 Specific Aims Linkage, achieved by outlining, is a sound strategy for constructing the Aims page. I. Introductory Paragraph Opening sentence What is known Unknown or need Unknown/need as a problem II. What, Why, Who Paragraph Long-term goal Overall purpose/objective of application Rationale/justification for proposed work III. Specific Aims Paragraph Specific aims Working hypothesis for each aim IV. “Payoff” Paragraph Expected outcomes General positive impact Congruent w/NIH mission/priority Again, these are suggestions by Russell and Morrison for writing the Specific Aims page. 12 Alternate Intro/Aims Strategy I. Introduction (first paragraph) A. Introduce the problem (could use brief, general but relevant statistics) B. NIH mission/priority (that fits with your proposal purposes/objectives) C. What your proposed research is about (how it fits with NIH mission/priorities) D. Results (what is known) from previous funded grants that make this proposal the next logical and critically important step. (Note: this strategy may work best with proposals with strong preliminary results.) E. What is unknown (research questions). F. Purpose of proposed study. II. Long-term Goals A. Can repeat problem briefly, now that reviewer understands , and zero in on your specific area that leads logically to long-term goal to address problem. B. Knowledge gained is expected to: How does it fulfill NIH mission/priorities? How is it critically relevant to public health? How does it advance the field? Why is it a crucial next step? III. Specific Aims A. Aims and hypotheses 13 Definitions of Significance and Innovation According to expert NIH reviewers, a common problem grant writers encounter in these two sections is repetition—repeating in Innovation what was already said in Significance (Russell & Morrison, 2009, p. 77). They also advise fitting these major sections on one page if possible, but this advice is not necessarily supported by other grant writing experts, especially if one is writing an R01. Definition of Significance: the positive effect/impact that successful completion of your proposed research will have on (1) filling a critical gap or (2) addressing a critical need related to NIH mission or priority (concrete benefits expected as a result of completing the study). Definition of Innovation: novel or substantially different way of considering, approaching, or addressing an important public health problem that results in departure from the status quo, thereby vertically advancing the field and/or enabling new directions pertinent to NIH mission or priority. 14 Outline for Significance The Significance section needs to convey the positive impact your research contribution is likely to have on something relevant to the targeted agency. Most important of the core criteria. Avoid small paragraphs. Make linkage between ideas evident. The following parts may constitute one or two paragraphs (suggested ½ 1 ½ pages, depending on your mechanism—R03/R21 vs. R01/R15). • Part 1: Substantiate/explain in more detail the gap/critical problem or need/barrier to progress in the field that your study will address (Can use both literature and preliminary findings.) • Part 2: Italicized statement of significance. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. • Part 3: List of benefits that can credibly be expected to add new knowledge and/or address critical public health need, and furnish essential data for next step in research trajectory. In other words, describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be enhanced/changed if the proposed aims are achieved. 15 Alternate Outline for Significance (This outline may work best with proposals built on strong preliminary results.) I. Although the section is now headed Significance, write it as you used to write Background and Significance. Keep opening paragraph brief and get to major findings from literature. Organize lit review so at the end of each section, you can write in how the proposed study will significantly contribute to/fill a gap in what has been found before. (Note: The UMBRELLA heading for this section is RESEARCH STRATEGY, centered on page.) 16 Outline for Innovation (Suggested length 1/2 - 3/4 page) for R03/R21; 1-1 ½ pp. for R01 I. Explain how the application challenges and seeks to shift current research or clinical practice paradigms. II. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions. III. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions. 17 REVIEW NIH Main Narrative Structure Specific Aims (one separate page) Research Strategy (12 pages R01: 6 pages R21/R03) Significance Innovation Approach* Research Strategy (main heading, centered, 12 pages R01/R15: 6 pages R21/R03) Significance Innovation Approach Design Sample, etc. Measures Recruitment/enrollment Procedures for data collection Data and power analyses Potential Problems and Alternative Strategies (suggested by Russell and Morrison) Future directions (suggested by Russell and Morrison) Timeline NOTE: You may want to consult with our expert, Dr. Jett, about organizing this section. 18 Approach Strategy 1 Retrieved verbatim on 7-30-2010: http://research.unl.edu/stories/story.php?ID=390 • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted, and any resource sharing plans as appropriate, unless addressed separately in Item 15 (Resource Sharing Plan). • Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. You also may wish to include a discussion of future directions for your research, as well as a project timeline, in this section. • If project is in early stages of development, describe any strategy to establish feasibility, and address management of any high risk aspects of the proposed work. • Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised (can be detailed later in section). • Preliminary Studies for New Applications: For new applications, include information on Preliminary Studies as part of the Approach section. Discuss the PD/PI’s preliminary studies, data, and or experience pertinent to this application. Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data (however, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary data in application from Early Stage Investigators than on the preliminary data in applications from more established investigators). • Progress Report for Renewal and Revision Applications. For renewal/revision applications, provide a Progress Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last competitive review. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes to the specific aims and any new directions including changes resulting from significant budget reductions. A list of publications, patents, and other printed materials should be included in Item 5 (Progress Report Publication List); do not include that information here. 19 Approach Outline 2 The following outline employs organizational strategies suggested by expert NIH reviewers (Russell & Morrison, 2009). This is only one possible way to organize your Approach section. I. Introduction (suggested length is 1/4 to 1/3 page) Begin with sentence that justifies why work under this aim needs to be done, including overall problem to be addressed. Next, write objective (put word in italics) and tell reviewer how you will attain it—by testing this particular aim’s working hypothesis—this should repeat VERBATIM what was said on Aims page. EX: To attain the objective of this aim, we will test the working hypothesis that… . (If aim is driven by need, substitute that here.) Follow this with sentence or two about overall strategy/approach used to test working hypothesis. EX: “We will test working hypothesis by using the approach of … . Next, sentence provides rationale—why you want to undertake this research. EX: The rationale for this aim is that successful completion will contribute… . Acquisition of this knowledge is critical to … . Last, summarize overall expected positive impact of this aim. EX: Findings are expected to yield…this would be of importance because… . II. Justification and Feasibility (no page length suggested—approx. 1/2 page?) NOTE: For ideas about how/where to cite references and save room throughout proposal, see p. 94. The authors suggest you leave this paragraph blank until you are done with other paragraphs for each aim - Chapter 11). In this paragraph, Review of Relevant Literature and Preliminary Studies are included. Authors highly suggest that you do Research Design paragraph first, to select the most relevant citations from that to use in this section. Primary literature only—exception: if one of your reviewers has pertinent review, cite. Lit Review should be critical analysis—use to point out critical gaps, etc. to justify need for proposed research. Avoid long citation strings (cite first 2 authors unless more info needed). Purpose of Feasibility section is to establish competence of PI and team to successfully accomplish proposed work. Select only the most relevant/essential preliminary work showing this. Feasibility of the aim must also be supported. Note: Early Stage PIs way less emphasis on prelim studies. According to authors, for an R03, reviewers expect small amount of prelim data, despite what NIH instructions say. For an R21, carefully selected preliminary data that supports proposed research despite risk of failure. The authors suggest that one of the most important writing essentials for this paragraph is to show reviewer exactly HOW you came to conclusions about justification and feasibility. EX. We concluded, from data presented in Figure 1, that…. This lead to ………. The authors also suggest that you “mix it up” in terms of using text and figures/tables, etc., depending on how much room each takes. 20 Outline for Approach cont’d. III. Research Design The authors suggest that you use the listed categories (p. 87) to find the most relevant info to include for the aim: 1. Approach to be used. 2. Overview of methods: They suggest asking these questions when trying to determine how much methodological detail to include: (a) Has anyone on team published using these methods? (If so, reference the publication—no need to describe); (b) Does your experience make it obvious that you can accomplish study? (c) Do any of your prelim data make it clear you can successfully use these methods? (See p. 88 for more detail). 3. Critical equipment needed 4. # of subjects needed and how derived. 5. Statistical analysis needed. 6. Controls (VERY important). 7. Detailed expectations (VERY important). 8. How results will be interpreted. 9. Major potential problems to be addressed (see pp. 89-90 for more detail). 10.Time required to complete work of aim. IV. Expected Outcomes (suggested length is 1/3-1/2 page) Note: Authors emphasize this is a critical component to include for each aim. A suggested strategy for crafting this paragraph is to first collect all expected outcomes from preceding Research Design paragraph(s) and copy/paste them into a new file. Organize the paragraph by (a) summarizing expected outcomes and (b) convey how they collectively achieve the aim’s objective, thereby advancing the field and accomplishing the application’s overall objective. Authors caution overstating expectations but emphasize the importance of adding this section with its own subheading. 21 Outline for Approach (by Aim) cont’d. V. Potential Problems and Alternative Strategies (suggested length is 1/3-1/2 page) NOTE: Authors emphasize NOT including MAJOR problems in this section—major problems should be dealt with in Research Design (see #9 above ). Authors describe this section as chance to anticipate and eliminate justified concerns of reviewers. Can organize by presenting the important/probable potential problems associated with aim and alternative strategies for overcoming them. For each identified problem, address the following using conditional language (e.g., In the unlikely event that…., we would….see bottom of p. 89 for more detail): 1. Nature of perceived problem. 2. Reasons you think it may arise. 3. Alternative approaches/strategies planned for addressing problem should it arise. 4. Reasonable expectation that you expect alternative approach to work—and qualify any potential limitations. 5. Supportive evidence that you have successfully used alternative approach in past. EX: Although our preliminary data (see Justification and Feasibility subsection) solidly supports the hypothesis for this aim and are complemented by [member of research team] work (cite), there is a remote possibility that ……. In that unlikely event, we would…. (see p. 90 for more detail about writing this section). VI. Timeline (1/4-1/3 page?) See p. 90 for more details on this. NOT for each aim. VII. Projecting Future Directions (best guess is 1/4 - 1/3 page) Final “bang-for-the-buck” subsection regarding positive impact of accomplishing the aims. Begin by briefly summarizing where you expect to be at conclusion of study and how this sets foundation for next study. 22 REVIEW 2010 Main Narrative Structure Specific Aims (one separate page) Research Strategy (12 pages R01: 6 pages R21/R03) Significance Innovation Approach* Design Sample, etc. Measures Recruitment/enrollment Procedures for data collection Data and power analyses Potential Problems and Alternative Strategies Future directions Timetable * Only a suggested outline. 23 Potential Problems and Alternative Strategies The importance of this Approach subsection cannot be underestimated, according to expert NIH reviewers (Russell & Morrison, pp. 89-90). I. Example of problem to address: the potential for an invalid hypothesis. • Identify nature of potential problem. • Reasons(s) why it is unlikely to arise. • Alternative approaches/strategies you would employ, should it happen. (If this happens, we would….) 24 Human Subjects Outline BIG change: Allow yourself TIME for this section. Depending on your grant, it may require more specificity than it did previously, so it’s not a “cut and paste” situation. (The following outline was taken from NIH guidelines; however, it will be necessary to TAILOR/CONDENSE this section to fit your proposal.) I. PROTECTION OF HUMAN SUBJECTS II. RISKS TO HUMAN SUBJECTS Human Subjects Involvement, Characteristics, and Design Involvement of Human Subjects Characteristics of Sample Recruitment and Retention Strategies Vulnerable Populations Random Assignment Collaborating Sites Sources of Materials Description of Data Access to Data Potential Risks Psychological Stress from Study Participation Other Potential Risk 25 Human Subjects Outline cont’d III. ADEQUACY OF PROTECTION AGAINST RISKS Recruitment and Informed Consent Recruitment Informed Consents Protections Against Risk Risk to Privacy New Data and Treatment Information for Subjects Financial Conflict of Interest IV. POTENTIAL BENEFITS OF PROPOSED RESEARCH TO HUMAN SUBJECTS AND OTHERS V. IMPORTANCE OF KNOWLEDGE TO BE GAINED VI. DATA AND SAFETY MONITORING PLAN Risk Assessment VII. See rest of sections on UF IRB Addendum N: Data Safety Monitoring Plan on share drive at: Everyone>Faculty Resources>NIH and HRSA Grants>Human Subjects>Data and Safety Monitoring Blurbs 26 Bibliography and References Cited NIH guidelines state: “The references should be limited to relevant and current literature. While there is not a page limitation, it is important to be concise and to select only those literature references pertinent to the proposed research.” Russell and Morrison (p. 102) suggest the following: • mostly primary literature, not reviews. • up-to-date, especially if you are resubmitting. • information for each reference must be complete. • consider using what these reviewers say is more “reader-friendly”—APA. • page numbers accompany appropriate citations (e.g., page in a book). • avoid using submitted manuscripts or conference proceedings. • Manuscripts in press should be submitted in their entirety as appendices. • Include the NIH manuscript reference number (e.g., NIHMS97531) or the Pubmed Central reference number (e.g., PMCID234567) when citing articles that that either fall under the Public Access Policy or were authored/co-authored by the applicant and arose from NIH support. If the PMCID is not yet available, indicate PMC Journal - in Process (see http://publicaccess.nih.gov/submit_process_journals.htm). • citations that are available in a free, online journal (and not covered by Public Access policy) may include the URL, along with the full reference. • URLs should not be used in the text. NOTE: The ORS cannot use Endnote to help anyone who has not used the Cite-While-You-Write feature of Endnote while composing the grant (not a cut and paste situation)! If you need Endnote training, contact Beth Auten at the HSC library. We MAY be able to help by manually inserting APA-style references, but we need advance warning, PLEASE. 27 Tips for Writing Facilities and Other Resources • Not routine equipment and resources. • Emphasize only those things that distinguish your environment from those elsewhere. • Key collaborative arrangements and other unique features that enhance probability of success. • Extraordinary institutional commitment. • Intellectual environment conducive to successful completion of your research. Please see detailed instructions and updated blurbs in share drive: Everyone>faculty Resources>NIH>Facilities and Other Resources Blurbs 28 Appendices/Attachments LIMITATIONS: 1. You are not technically limited on how many attachments you can add, and you could even convert as many documents as you want to one file; therefore, it is not about the number. Be judicious in what you attach and follow the guidelines about what is allowed vs. not allowed. Appendices should always be supplemental and not critical to the review (i.e. ,if you need a diagram to explain something ,the diagram should be in the research strategy, not appendix). 2. If the article is not publicly available but is highly pertinent to the research, then it should go in the appendix. However, only 3 publications may be included, so the PI needs to decide which are most pertinent. Here is notice regarding appendices http://grants.nih.gov/grants/guide/notice-files/not-od-07-018.html and http://grants.nih.gov/grants/guide/notice-files/not-od-10-077.html 3. According to SF434 guide: Manuscripts in press (chronological order) should include article in entirety. The individual may choose to include selected publications based on recency (should still be highly relevant to proposed work), importance to the field, and/or relevance to the proposed research. Copies of publicly available publications are not acceptable as appendix material). 4. Note: The important thing is that you follow the rules above (#2). You may be able to attach quite a few files, but the key is following the allowable appendices rules. Also, appendix limitations/rules may vary by program announcement or RFA. Reviewers are not obligated to review appendices. 29 Appendices cont’d Materials Allowed in the Appendix: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html (Accessed 6-25-10) Publications: Applicants may submit up to 3 of the following types of publications. Any exceptions will be noted in specific FOAs. Manuscripts and/or abstracts accepted for publication but not yet published. Published manuscripts and/or abstracts only when a free, online, publicly available journal link is not available. Patents materials directly relevant to the project. Other: •Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents may be submitted in the Appendix as necessary. •Paper PHS398 applications only may include full-sized glossy photographs of material such as electron micrographs or gels in the Appendix; however, an image of each (may be reduced in size but readily legible) must also be included within the page limitations of the Research Plan. Format of Appendix Materials •For electronic submission using the SF 424 (R&R) forms and Grants.gov, Appendix materials must be submitted in PDF format. •For paper submission using the PHS 398, Appendix materials may be submitted in paper format; five collated sets are needed. •Applicants are encouraged to send Appendix materials submitted with paper PHS 398 applications on a CD in PDF format in lieu of the five collated sets. See application instructions for details on preparing CDs. Only a single CD need be sent. •For materials that cannot be submitted electronically or materials that cannot be converted to PDF format; (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Administrator for instructions following notification of assignment of the application to a study section. If the SRA is listed in the FOA, they should be contacted in advance to address acceptability of materials . 30 For more information about professional writing, including APA style, please see Writing Resources for Nursing Faculty and Students on the CON’s website at: http://www.nursing. ufl.edu/research/res earch_resources_wri ters_students.shtm “Life’s A Beach” From Proposal to the NOA By: Chris Anthony Proposal Time Line • • • • You do not want there to be a “First Time” Allow review time of final application Signatures cause the greatest delay Timely Submission allows the College and DSR to Review for errors Intent to Submit ORS Grant Timeline Proposal Flow Chart PI Submit Final Proposal Documents to Grant Specialist • Proposal is entered into PS for Dept and Subprojects • Budget is entered into PS by Grants Specialist Attach Grants.gov application in PS, Excel Budget, and Signatures not available via PS Work List in PS created All PI’s Approved All College Deans Approve All Dept Chairs Approve AOR approval and submitted by Research Administrator at DSR to NIH Correspondence between Grants Specialist & DSR relating to Corrections or Concerns After all signatures it will appear on DSR Work Flow list Email Received from DSR and ERA Commons for NIH errors Cover Sheet every error explained unless errors corrected same day***Only before Deadline starting 1/25/2011 48 hours for correction ***Only before Deadline starting 1/25/2011 Email from DSR stating NIH acceptance NEW NIH Guidelines • Beginning January 25, 2011Correcting eRAidentified errors and warning after the deadline will no longer be an option • The Application viewing window will still be available but no corrections can be made after the deadline • NIH pleas “Please Submit Early” • Starting September 25, 2010 no post submission grant materials will be accepted by NIH unless unforeseen administrative issues, departure of a participant, natural disaster has occurred, NOT TO CORRECT OVERSIGHTS?ERRORS discovered after submission. Signatures • Each level of approval through PS depends on completion of the prior level • Any other faculty with a % of effort on your project will receive a subproject if internal and a sub award if external • All subprojects have to go through signature process of which the dept and college will have to sign for approval • To obtain approval from other dept’s budget has to be completed and project has to be entered into PS (Science is not necessary most of time) Signature Flow Chart PI Signature Approval All CO-I Signature Approval PI Dept Chair Signature Approval All CO-I Dept Chair Signature Approval PI Dean of College Signature Approval Health Science Center for Clinical Approval AOR of Institution at DSR Approval Work Flow Approval Sample Budget:Think it Through • Second most scrutinized part of the proposal so dedicate time to ensure your budget is competitive • A clear concise budget supported by a strong budget justification can increase the chances of a proposal being funded • Think through every cost of the project because the proposal budget can become the actual award budget Examine the Budget • Important each cost is Allowable, Allocable, Reasonable, and Consistently Treated • No “educated Guesses” of estimates • Only apply costs that can be explained or verified and are reality-based • NIH Streamlining only top 50% get assigned a score, where would your budget stand? Fringe Rate 2010-2011 Budget Sample Budget Sample Grants.gov Submission • No longer cut and paste sections • Attach PDF completed Documents • Very important that no symbols or spaces in the name of documents • No symbols in the title of the Project • NIH ERA Commons ID Required for PI an prefers for all other Co-I Grants.gov Submission Grants.gov Submission Proposal Mail Log UF Proposal Processing Temp Advance • Complete Temp Advance Request Memo • Obtain Signatures • Can request up to 25% of total funding guaranteed and IDC • Included needs to be correspondence from Agency stating that funding will be given by email or letter. Temp Advance Sample Memo Contact! Contact! Contact! • Contact the program officer in the early stages of planning • Find out the institute’s interest in your research area and the scientific direction • Utilize email because Program Officers are very busy and the feedback is written so you will be able to review later Utilize Your Grants Specialist • Searches can be provided with detail of grants funded in your area of research, these can be used to assess your competition and use as collaborators to improve your strength • Searches can be completed through UF Office for Research to assist with finding funds from Foundations and other access to agency’s we as departments do not have • Guidelines for Forms, Templates, and directions for proposal submission Links • Proposal Mail Log http://apps.research.ufl.edu/research/pml.cfm • Proposal Processing http://www.research.ufl.edu/research/proposal.ht ml • NIH Center for Scientific Review http://cms.csr.nih.gov/ • NIH Guidelines http://grants.nih.gov/grants/funding/424/SF424_RR _Guide_General_Adobe_VerB.pdf Chris Anthony, Grants Specialist Phone 273-6518 [email protected] Where do I begin? Salary Distributions Operating Expenses Justifications Reporting Cost Sharing (if applicable) •Payroll Versus Effort •Can not report less effort than what is being paid •CAS Violations •Grant Term Restrictions •Computer Purchases •Salary Retros •Expense Transfers •Monthly Reports •Quarterly Reports (if applicable) •For large grants, I can create a unique report that will monitor expenses/projections for the entire grant period based on the original or revised budget. •Cost Sharing Certification Form •Status Emails sent out twice a semester •Please remember that all purchases require authorization before expenditure of funds, whether those purchases are paid with P-cards, from grant or other College accounts, or with personal funds. Request to Purchase forms are the in-house method to document such authorization. •The person who must authorize the request varies depending upon the account to which the purchase will be charged. Required signatures are listed on the back (or on page 2) of the Request to Purchase form. Please remember that Joe Burley, as our Information Security Administrator, must sign all requests for computer hardware, including any portable devices, and software. Joe will not sign the request form after a purchase occurs. •If a faculty or staff member makes a purchase without prior approval, he/she will not be reimbursed for that purchase. •For purchases paid with grant funds, please verify with me first to make sure that you indeed have sufficient funding available to cover the cost and that it is allowable per CAS and your grant terms. If not allowable, you may have to use another source of funds, submit a CAS exemption form, prepare a revised budget to funding agency, or just forego the purchase. Per DSR’s Researcher’s Handbook: Consultant payments on sponsored projects must represent compensation to individuals who are independent of the university and who render independent services. Consultant payments may not be made by faculty to colleagues where an employer/employee relationship exists. Rather, in these situations colleagues should be compensated for services via the University personnel/payroll system according to percent effort of committed time; or donate their services as professional courtesy. If overload can be demonstrated for short-term teaching situations, permission must be obtained from the Division of Continuing Education (DOCE). On the whole, it is expected that consulting needs can be satisfied from resources within the University community. When outside consulting services are needed for a grant or contract, all of these conditions must be met: •There must be evidence that the services provided are essential and cannot be provided by persons receiving salary support under the sponsored project. •There must be evidence that a selection process was employed to secure the most qualified person available. •There must be evidence that the charge is appropriate considering the qualifications of the consultant, normal charges, and the nature of the services rendered. In accordance with Public Law 103-333, the “Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act of 1995,” the following provisions are applicable to this grant award: Section 507: “Purchase of American-Made Equipment and Products - It is the sense of the Congress that, to the greatest extent practicable, all equipment and products purchased with funds made available in this Act should be American-made.” Items Not Allowed To Be Charged To A Federal Grant: •Administrative and Clerical Salaries •Office Supplies •Postage •Basic Telephone(basic service, local, and cellular) •Memberships •Subscriptions •General Computer Software/Supplies If you believe that your project has special circumstances that would warrant an exemption of these costs, you must complete and submit a CAS Exemption Form to the Division of Sponsored Research (DSR) for approval. Because computers and electronic devices are generally used for many different activities (for example, instruction, research, administration, email, personal use), the default presumption is that these devices cannot meet the threshold requirements to allow the direct charging of their acquisition to a sponsored project. Just because you may have had a computer listed on your proposed budget does not necessarily make it allowable. If you feel strongly that your computer should be charged to the grant, then you can submit a justification to Contracts & Grants for approval. Justification Requirements: •Contracts & Grants require a letter in writing with the PI’s signature. •It should say something along the lines of the purchase of a computer was necessary in order to conduct the research for this grant alone. •If the computer is to be used for several grants, then the cost will need to be allocated and its use for each grant detailed. •If you have a copy of your agency approved budget that has a computer listed, that will need to be included as backup. Any retroactive salary (beyond current pay period) being charged to a federal or non-federal grant must now be justified and approved by Contracts & Grants. Any other expenses that were incorrectly or temporarily charged to another account that must be transferred to the grant must now be justified and approved by Contracts & Grants. Reasons for Change: • To help manage grants more effectively • To provide better audit trails • To manage additional documentation • To respond to recent audit recommendations In order for the grant end date to be extended, I must receive a copy of the updated IRB letter. Once received, I will forward to DSR for processing. Acceptable Online Approval Acceptable Approval Letter For NIH, Miscellaneous Donors, & Multiple Sponsor Awards: •Principal Investigators may submit their no cost extension requests directly to DSR via email. DSR does not require a Department Chair or Dean endorsement on no cost extension requests. •Extension requests should be submitted to DSR no later than 30-days prior to the grant's current expiration date. This allows plenty of time to meet our deadlines. •Upon approval of an internal extension, DSR must provide written notification to Federal Agency's Grant Officer. This notification must be received by the agency at least (10) ten days prior to the original expiration date of the award. •If this notification deadline is missed, DSR may not exercise its ability to extend the grant, without the sponsor's approval. General Guidelines DSR may extend the final budget period of a project one time for a period not to exceed (12) twelve months beyond the original expiration date, as long as there will be no change in the project's originally approved scope or objectives, and at least one of the following applies: •Additional time beyond the established expiration date is required to ensure adequate completion of the originally approved project. •Continuity of Sponsor grant support is required while a competing continuation application is under review. •The extension is necessary to permit an orderly phase out of a project that will not receive continued support. •The fact that funds are anticipated to remain unspent is not sufficient justification for an Extension. Awards that contains a zero funds balance will not be extended. Procedures and Required Information The Principal Investigator (PI) must transmit the request to [email protected] The email subject line should state: No Cost Extension Request for UF Project Number ########. In the body of the e-mail please provide the following information: Sponsor: Sponsor Award Number: Current Expiration Date: Length of Extension (up to 12 months): Scientific/Programmatic Justification explaining the need for the extension of time. This narrative should be written as if you were writing your Program Officer requesting an extension. In the case of Federal grants, DSR forwards this narrative section (as provide by the PI) to the awarding agency. For any internal subprojects or external subawards that require the extension, please identify and provide the necessary information and justification similar to the above. For those grants that are extended DSR will issue the eNOA extending the UF Project/s. For external subawards, DSR will authorize the extension by issuing a formal amendment to the existing subaward. Per DSR’s Researcher’s Handbook: When there is a change of PI or Co-PI, the Department chairperson in conjunction with the original PI should notify the sponsor in writing of the upcoming change. The letter should explain the situation, introduce the new PI, highlight his or her special qualifications which assure continuance of the research as originally approved, and attach their curriculum vitae. A new DSR-1 Form should be sent along with this letter to DSR. This document will be countersigned by DSR and forwarded to the agency. Depending on the project period and the date of proposed change of PI, the agency may issue a new award letter or merely confirm its agreement in writing. Per DSR’s Researcher’s Handbook: With the exception of training grants, researchers who decide to leave the University of Florida may be allowed to transfer their research grant to their new institution. Faculty should notify the agency of their relocation plans and request proper forms and instructions to effect the transfer. The documentation must be routed through DSR for endorsement. Due to the wide variation in procedures among sponsors, faculty are encouraged to check with Award Administration with regard to specific guidelines. A faculty member who accepts an appointment with another university may wish to transfer research equipment purchased with sponsored project funds. (Note: Research equipment that was purchased with state funds may not be transferred.). A list should be prepared indicating the type of equipment, property identification number, date of purchase, acquisition cost, and account number to which it was charged. This list should be submitted to the University Property Services. Property Services will check the listing against its records, and if correct, will process the transfer. Any questions will be settled by a phone call from Property Services to the researcher. Approval will be required by the department or center, University Property Services, and DSR. Indirect Funds are transferred every November to an Overhead Account based on the below breakdown: Funds in an Overhead Account can be used to purchase anything “Research” related and there is no expiration date. Email Notifications Regarding Closeout Procedures Notify Employees of Termination(if applicable) Closeout all Open PO’s and TA’s Make Sure Cost Sharing Met (if applicable) Sign Closeout Memo Prepare Final Reports Prepare Carryover Request (if applicable) DSR’s Researcher’s Handbook: http://www.research.ufl.edu/research/handbook/re searcher_handbook/index.html DSR’s Award Administration Webpage: http://www.research.ufl.edu/research/award.html DSR Award Search: http://apps.research.ufl.edu/research/search/ DSR and C&G Mail Logs (Use to check the status of an Award): http://www.research.ufl.edu/research/maillogs.html Any Questions? Beth Auten, MLIS, MA Reference and Liaison Librarian [email protected] 352-273-8410 http://guides.uflib.ufl.edu/westauten Liaison Librarian Services • Providing information consultations to assist students, faculty, and staff with literature searching and other information gathering • Developing and teaching library orientations or information-related classes based on your recommendations • Meeting with you in person, by phone or over e-mail to discuss any of your information needs, including copyright, bibliographic citations or bibliographic software (such as RefWorks and EndNote) • Presenting at department meetings or journal clubs • Creating customized online interactive tutorials for use by on- and off-campus faculty, staff, and students • Conducting literature searches for HSC faculty and staff • Taking your recommendations for expanding electronic and print resources for the HSC Libraries' collection • Collaborating with you on publications and grants Citation Management Software The UF Libraries provide access to RefWorks and EndNote Web for UF faculty, students, and staff. • Accessible though the Health Science Center library website: http://www.library.health.ufl.edu/writing/ • We provide support, including instruction to classes or other groups, for EndNote, EndNote Web, and RefWorks Information About Open Access Open Access (OA) is free, permanent, web-based access to scholarly publications. OA is the principle that research should be readily available immediately after publication and to anyone with an Internet connection. It is improving the way scholarly information is shared. UF Open Access Resources: Open Access at UF: http://www.uflib.ufl.edu/oa/ Open Access and Open Access Publishing Fund: http://guides.uflib.ufl.edu/OpenAccess Information About Copyright Copyright FAQs and Helpful Information: Copyright Policies, Practices and Resources http://www.uflib.ufl.edu/admin/Copyright/Smathers_Libraries _Policies_and_Procedures.html Legal FAQs – UF General Counsel http://www.generalcounsel.ufl.edu/faq/ For specific, in-depth questions, it is recommended that you consult the Office of the Vice President and General Counsel.