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TL1 NRSA F award application workshop and How to Prepare Complete Application

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Portions of this workshop on "Preparing an F-award at the Pre-doctoral Level" was presented at the ACTS meeting in Washington DC on April 20, 2017 at 1 pm in the Washington Marriott Wardman Park Hotel. This presentation has been updated to include the release of instructions 24March 2017, Adobes Forms D and new F-award funding opportunity releases.

The important components of the training plan and research strategy sections were described.

29 April 2017 the file was updated.

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TL1 NRSA F award application workshop and How to Prepare Complete Application

  1. 1. The First (F) award? No, F does not mean first but Fellowship TL1 Subcommittee on Funding Opportunities PJ Simpson-Haidaris, PhD Association for Clinical & Translational Science April 20, 2017 1 Session: Preparing an F-Award at the Pre-Doctoral Level (same information works for the F32 postdoc NRSA too) Extended Version for SlideShare distribution and update Updated and uploaded to SlideShare April 29, 2017
  2. 2. Disclosures PJ Simpson-Haidaris, PhD Director, Translational Biomedical Science PhD Program Clinical and Translational Science Institute University of Rochester, NY pj_simpsonhaidaris@urmc.rochester.edu PJ has no actual or potential conflict of interest in relation to this program or presentation. 2
  3. 3. Table of Contents (1) Topic Slide number Speaker’s Credentials and Disclosures 1,2, 9, 10 Table of Contents 3 - 7 What is a Grant? And How do you get one? 8 Outline describing how presentation organized 11 Four Critical Take Home Messages About F-awards 12, 101 Four Critical Take Home Messages About Peer Review 13, 115 How Ruth L. Kirschstein NRSA F-award program started 14 NIH structure and NIH Path to a Successful F-award 15-17 Getting Started: F Kiosk is your Friend, Types of F-awards 18, 19 Reading and Understanding the Funding Opportunity Announcement 20-28, 31 PJ’s recommended F-award Checklist per SF424 attachments 29, 30 Craft a Robust Title 32-33 Training Specific Sections of F-award 34 Other grant sections to include depending on Research Conducted 35 Sections needed for Research Grant 36 PI is the Trainee (Applicant); Need eRA Commons ID as Trainee and PI 37 3
  4. 4. Table of Contents (2) Topic Slide number First Critical Take Home Message: Prepare Proper NIH Fellowship Biosketch 38 - 50 Interim Reports, what they are and how to cite them in grant and Biosketch 51-54 NIH example of Fellowship Biosketch 55-58 University Representative Submits Grant on Your Behalf 59 Cover Letter Requirements and Suggested Format (Example Provided) 60 Second Critical F-award Take Home Message: Build an Exceptional Research and Career Development Mentoring TEAM 61-73 Back to the SF424 instructions and attachments 74 PD/PI and Key Personnel information required 75-76 Sponsors and Co-Sponsors Information ($$, former trainees, Mentoring Plan) 77-80 Third Critical F-award Take Home Message: Recruit outside Referees who can write the STRONGEST possible letters attesting to your potential to launch an independent research career 81-83 Fourth Critical F-award Take Home Message: Prepare a Research and Career Individual Development Plan (IDP) to define gaps in training, and design activities and metrics to meet career goals 84-91 4
  5. 5. Table of Contents (3) Topic Slide number Applicant’s Background and Goals for Fellowship Training (in 3 parts) 86 A) Doctoral Dissertation and Research Experience 87 B) Goals and Objectives 88 C) Activities Planned Under This Award (and Examples) 89-91 Respective Contributions (Example) 92, (93) Selection of Sponsor and Institution 94 Responsible Conduct of Research (Example) 95, (96) Training in Data Rigor and Reproducibility 97 Other Research Training Plan Information 98 Resource Sharing Plan (Example) 99 Authentication of Key Biological and/or Chemical Resources 100 Research Grant and Other Important Sections on SF424 102, 103 Project Summary/Abstract 104 Project Narrative/Public Health Relevance 105 Bibliography & References Cited 106 5
  6. 6. Table of Contents (4) Topic Slide number Facilities & Other Resources (include intellectual resources) and example 107, 108 Equipment 109 Institutional Environment and Commitment to Training (new section in 2016) 110-113 Certification of Eligibility for Diversity Award (F31 Diversity only FOA) 114 Four Critical Take Home Messages About Peer Review 115 SF424 attachments Specific Aims Research Strategy 116 Peer Review Message 5. They are not called “Vague Aims but “Specific Aims;” Specific Aims Page Importance, Format and Language 117-121 Peer Review Message 6. Reviewers have limited time to review YOUR grant 122 Research Strategy: Significance and Innovation 123 Purpose of Significance Section (Scientific Premise) 124 Research Strategy: Approach 125-126 Peer Review Message 7. Demonstrate (on paper) Enthusiasm and Passion for Research and Prepare Visually Splendid Figures 127 Figures and Tables “Dos and Don’ts” 128 Diagrams and Drawings 129 Grant Schematics Dos and Don’ts 130-133 6
  7. 7. Table of Contents (5) Topic Slide number Some Sections Depend on Type of Research Conducted 134 Human Subjects Protection Sections 135 Vertebrate Animal Care and Use Section 136 Peer Review Message 8. 15 Minutes of Fame (aka Peer Review) 137 The NIH Grant Process: What Reviewers Are Looking For 138 Criteria for Reviewing F-awards 139-143 What will immediately cause an application to go un-reviewed (because you did NOT READ the FOA) 144 Where FOA specific instructions Found? 145 What does it take to write an F-award application? (refusal to take “No” for an answer) 146-147 Timeline for how long it takes to write a grant 148 Acknowledgements 149 Source Material 150-151 Helpful NIH Websites and Videos (links) 153 Disclaimer 153 7
  8. 8. What is a grant? noun 1. a sum of money given by an organization, especially a government, for a particular purpose. = gr + ant? How do you get one? 8
  9. 9. Seek formal instruction in Grant Writing to increase success rate Funding success rates of individual predoctoral grant recipients at the University of Rochester who attended a semester-long grant writing class (Dr. PJ’s) 9
  10. 10. • Mentored >80 MS, PhD & MD-PhD students as primary, co-mentor or thesis committee member. • Served on 80+ peer-review grant panels for NIH, DoD, AHA, Komen Foundation, US Army, Air Force & Combat Casualty Care & others. • Awarded many grants (over 20 million dollars direct costs) as PI, Co- Investigator or Institutional Training Program Director! • Written many grants not awarded; some triaged. • Knows what NOT to do to get grants. • What to do RIGHT is the hardest part of successful grant getting! Dr. PJ’s mentoring and grant reviewing & getting experience 10
  11. 11. Outline • The presentation is organized around “Critical Take Home Messages” about F-awards and Peer Review. • Brief introduction to NIH and reading the Funding Opportunity Announcement • Detailed tips and examples of F-award grant sections you need to get to next career stage – Career Development and Skills acquisition — the training sections – Research Strategy—the science • NIH Peer Review—what reviewers are looking for in an F-award application. • Resource Materials and Useful Links 11
  12. 12. Critical take home messages about F awards 1. Prepare a proper NIH Fellowship Biosketch. 2. Build an exceptional Research and Career Development Mentoring TEAM. 3. Recruit outside Referees who can write the STRONGEST possible letters attesting to your potential to launch an independent career. 4. Prepare a Research and Career Individual Development Plan (IDP) to define gaps in training, and design activities and metrics to meet career goals. 12
  13. 13. Critical take home messages about Peer Review 5. They are not called “Vague Aims”… they are called “Specific Aims” 6. Reviewers are assigned 8-10 grants so they have limited time to review YOUR grant. 7. Demonstrate your enthusiasm and passion for research and attaining career goals with Clear, Concise and Compelling writing and prepare Visually Splendid Figures. 8. You get 15 minutes of Fame at Peer Review – (if you are lucky to have your grant discussed). 13
  14. 14. Ruth L. Kirschstein, MD NRSA Individual Fellowship Funding Opportunity Announcements (FOA) • Role in development of safe and effective polio vaccine • First woman director of major institute at the NIH (NIGMS) • Champion of basic biomedical research and training programs for all talented students, and particularly underrepresented minorities. http://www.nih.gov/about/kirschstein/ 14
  15. 15. By now, you know what NIH is, but maybe you don’t know how it works 15 • The good news is, there are lots of resources to help you understand how NIH works. • The bad news is, there are so many its hard to know where to start.
  16. 16. NIH Path to a Successful F-Award, in a Nutshell • When choosing the institute for your grant oversight, consider whether your research project fits the Funding Mission of the Institute. – Seek advice from mentors and contact NIH officials listed on FOA • Choose the Study Section that best fits your research topic. – http://www.crs.nih.gov 16 8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant URL in Source Materials slide
  17. 17. 27 Institutes and Centers (IC) at NIH 17 http://www/nih.gov/icd
  18. 18. Getting Started with FOA: “F Kiosk” is your Friend 18 Always check for most recent Funding Opportunity Announcement Although no longer called the “F Kiosk, if you Google “F Kiosk”, the NIH Individual Fellowship page of NIH’s Research Training (Fs) and Career Development (Ks) Funding Opportunity Announcements is one the top links
  19. 19. 19 Types of F-awards • Predoc • F30 dual degree • F31 (not diversity) • F31 diversity • Postdoc • F32 • Predoc to Postdoc • F99/K00 transition • Sr. Fellow • F33
  20. 20. Funding Opportunity Announcement (FOA) PA-16-308 20 The grant sections (grant body parts) described in this workshop are almost the same for F30 and F31 funding mechanisms. PA-16-308 used as model. Make sure the most recent version of FOA
  21. 21. Hard Part is Over • Almost. • Your know what kind of grant you will write (F-award). – Saves time navigating the landscape of all possible funding agencies and different rules and types of grants to write, i.e., finding the correct Funding Opportunity Announcement • You know what NIH Institute or Center (IC) will most likely want to fund your research – Because your advisor is already an expert in the field and had been a successful “grant getter” with funding from that institute 21
  22. 22. Must Check Which Institutes and Centers (IC) Participate Must determine IC specific rules and opportunities for each F-award mechanism 22 Understand how to read the FOA
  23. 23. PA-16-308 Diversity F31 IC-specific info and contacts https://grants.nih.gov/grants/guide/contacts/ parent_F31_diversity.html 23 Scroll down web page to see info specific to your IC
  24. 24. Before submitting grant, discuss Specific Aims and Impact of Research with PO to make sure fits IC funding mission • Program Official (PO) – Programmatic, scientific and technical aspects of grant – Pre- and post-award contact for guidance • Scientific Review Officer (SRO) – Contact during Peer Review – Assigns grants to reviewers – Oversight for fair and unbiased review of grants – Provides evaluation summary of review technical and scientific merit • Grants Management Officer – Negotiates awards – Evaluates administrative content and compliance with policy – Post-award mostly 24 https://www.youtube.com/watch?v=rNwsg_PR90w
  25. 25. How do you obtain the electronic application? 25 Look for the “Apply Online Using ASSIST” button in program announcement and click on it OR click on Grants.gov in FOA and download the SF 424 Adobe FORMS-D package
  26. 26. Grants.gov gives you two options 26 The SF424 Make sure you have the correct form for grant you will be submitting and that the FOA has not expired.
  27. 27. Make sure to download the Fellowship Instruction Guide 27 • Look for new and updated instructions in section F.120 – Significant Changes
  28. 28. PJ uses SF424 Form upload fields as the Checklist by attaching most recent completed documents Note: all fields highlighted in yellow are required BUT Not all fields required are highlighted! 28 PJ also created a word document as a checklist downloadable from SlideShare (Google “Simpson-Haidaris SlideShare”)
  29. 29. PJ’s F-award Checklist per SF424 instructions page 1 29
  30. 30. PJ’s F-award Checklist per SF424 instructions page 2 30
  31. 31. FOA PA-16-308 Diversity F31 (Parent) specific SF424 FORMS-D 31 If using human subjects, select optional forms too. Create name for application—include Institute, your last name and brief subject identifiers
  32. 32. Craft a Robust Title— Title Wins Over Grant Reviewers • Create a title that stands out from others and virtually compels reviewers to read your application. • The significant piece of information must be a unique, relevant and intriguing description of your research plan — all packed into about 80 to 200 characters (including spaces and punctuation). 32
  33. 33. • Limit in title length for NIH 200 characters and spaces 1 • Can use Greek and special symbol characters 2 • Reviewers will ding you for a lousy title3 NIH Grant Titles—Key Points https://principalinvestigators.org/no-126-how-to-craft-a-winning- title-for-your-research-proposal/ 33 TIP Be sure the title you create when starting your project remains accurate to reflect all revisions and changes in Specific Aims of submitted project! Highly recommended link
  34. 34. Knee joint connected to the leg bone…Training-Specific Sections 34 Institutional Environment and Commitment to Training (2-page limit) Applicant's Background and Goals for Fellowship Training (6-page limit) Respective Contributions (1-page limit) Selection of Sponsor & Institution (1-page limit) Sponsors Training Plan, Mentoring History and Resources ($$) (6-page limit) Responsible Conduct of Research (1-page limit) Diversity Eligibility Letter If this section is missing from F31 diversity application, it will NOT get reviewed.
  35. 35. Some Sections Depend on Type of Research Conducted 35 Risks Benefits Human Subjects? Enrollment Women Children Minorities DSMP/DSMB Vertebrate Animal Research? Vertebrate Animal Section • Description of Procedures • Justify Species Used • Minimization of Pain and Distress • Euthanasia Select Agents? Resource Sharing Plan Stem Cell Research/Bio- hazards? Facilities & Other Resources; Equipment (required, but include only facilities related to YOUR research) Data Sharing Plan
  36. 36. Don’t Forget the Research Grant! Summary/ Abstract (30 lines max) Narrative/ Public Health Significance (2-3 sentences) Introduction, if resubmission (1-page limit) Specific Aims (1-page limit) Research Strategy (6- page limit) Bibliography (no page limit) Cover Letter (required) PHS assignment request form (optional) Biosketches • PD/PI (You!) • Sponsor • Co-sponsor • Advisory Committee Members • Consultants 3 Outside (Referees) Letters of Recommendation Letters of Support Consultants/Collaborators (6-page limit) 36
  37. 37. Key Personnel: PD/PI is automatically populated PD/PI must include eRA Commons ID 37 You must be listed in your eRA Commons account as a trainee AND as a PI
  38. 38. First critical take home message about F awards 1. Prepare proper NIH Fellowship Biosketch. • Use NIH legal font typeface and size • Arial • Garamond • Georgia • Helvetica • Palatino Linotype • Times New Roman • Verdana • Black font color; 11 points or larger • Smaller font sizes can be used in figure legends and tables, but no smaller then 8 pt; Color font can be used in figures and graphs in Research Strategy • No figures or graphs can be included on the Biosketch! • Arial 11 pt most frequently used font – Limit of 15 characters (letters & spaces) on average per inch (horizontal) – Max of 6 lines per inch vertical line spacing (set to exactly 12 point) – BUT exact 12 point is TOO DENSE; set at single or EXACT 13 point for line spacing 38
  39. 39. 39 NIH Biosketch Format has a 5-page limit https://grants.nih.gov/grants/forms/biosketch.htm
  40. 40. Sections of NIH Biosketch for a Fellowship (F), Mentored Career Development (K) or Researcher-initiated (R) Grant • Education and Training in Table Format A. Personal Statement (can include 4 citations) B. Positions and Honors (Fs-list grant support in honors) C. Contributions to Science (5 contributions with up to 4 citations for each contribution) D. Scholastic Performance (F-grants) or Research Support (K- and R-grants) 40
  41. 41. NIH Fellowship Biosketch eRA Commons User Name Tip: Be sure to get your Commons ID and have you listed in Commons as PD/PI Education/Training Format same for all NIH Biosketches for R, K and F awards 41
  42. 42. A. Personal Statement SF424 Instructions - Overview • Describe collaborators or scientific environment; past performance in this or related fields Ø May identify up to 4 peer-reviewed publications or work products including preprints that specifically highlight your experience and qualifications for this project. Ø The citations may be different or also listed in Section C. • May explain impediments to your past productivity by describing factors such as family care responsibilities, illness, disability, and active duty military service. • Describe why well-suited to receive the award for which you are applying (relevant previous training, experimental work and technical expertise). 42
  43. 43. A. Personal Statement must be specific for current application! – Start Personal Statement with Proposal Goal and your role on project – Predocs with few publications may describe research experiences demonstrating expertise for this proposal – Sponsors (R-Bios) include leadership and mentoring history qualifications – F- and K-Bios include Training Potential to take you to next career stage, which include brief mention of skills to be gained from training components 43
  44. 44. Tip: Well-written personal statements really help reviewers write their critiques for review criteria of applicant, sponsors, and training potential. In Personal Statement, describe Training Potential (F-predoc) or Launch to Independence (F-postdoc and Ks) § Describe how new training plan will provide you with the skills to launch next career stage. § Outline (briefly!) set of career development activities, didactic coursework, workshops, seminar series, etc. that will enhance your abilities to become an independent investigator. § Explain how your primary mentor/sponsor and mentoring team members will foster your career goals and why your institution is perfect place for training. § Spell out the names of mentors and collaborators so reviewer does not have to go back to other section to look up 44
  45. 45. NIH Fellowship Predoc Personal Statement Example Highlight Diversity Status Highlight manuscripts Briefly Describe WHY sponsor (mentor) and project is best choice for YOU 45
  46. 46. NIH Example of Personal Statement for R-award, or Sponsor on F-award Be careful that you do not dig a hole to fall into because reviewers want to see innovative research with high impact to address NIH mission—remember F-awards do not have innovation sections because the science falls thematically under Mentor’s established and productive research program Best to tell what that expertise is. Statements with no specifics do not help reviewers assess your ability to carry out research Your Sponsors, Co-sponsors and Collaborators Biosketches must include their history of mentoring trainees and their specific role on YOUR grant 46
  47. 47. Personal Issues in Personal Statement • NIH recognizes that personal factors affect career advancement and productivity. – Taking care of a terminally ill relative – A complicated pregnancy requiring bed-rest – A natural disaster that wiped out a valuable resource – Death of a mentor (PJ has reviewed grants when this has happened after submission of the grant) • Optional, but best to explain if big gaps in training, job history or publications occur! Source—Modification of the Biographical Sketch in NIH Grant Application Forms. Notice Number: NOT-OD-11-045 47
  48. 48. B. Positions and Honors Remember to List Oldest First 48 Put grant support received in Honors: e.g., T32, pilot funding, foundation award, travel award
  49. 49. C. Contributions to Science Instructions (1) § Considering your level of experience, briefly describe up to 5 of your most significant contributions to science (e.g., research papers, abstracts, book chapters, reviews, as well as non- publication research products, such as materials, methods, models, or protocols). § Graduate students and post-docs encouraged to consider high- lighting 2 or 3 research experiences considered most significant. § For each contribution, indicate historical background that frames the scientific problem; the central finding(s); relevance of the finding(s) to science, technology, or public health; and your specific role in the described work. § For each contribution, you may reference up to 4 peer-reviewed publications or other non-publication research products—no more than 4 per ”Contribution”! 49
  50. 50. C. Contribution to Science Instructions (2) § Can list audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware that are relevant to the described contribution. § Description of each contribution no more than ½ page including citations (Figures, tables, graphs no longer allowed per NOT-OD-16-004). § Provide a URL to full list of your published work found in a publicly available digital database such as SciENcv or My Bibliography, which are maintained by the US National Library of Medicine. § Manuscripts listed as “pending publication” or “in preparation” should be included and identified as such (Fellowship Bios only). § Indicate if you previously used another name that is reflected in any of the citations. URL for My Bibliography—can only use Government based URL (.gov) No Google Scholar 50
  51. 51. Interim Reports: what are they and why should I care? 51
  52. 52. What are Interim Research Products? • Interim Research Products are complete, public research products that are not final. – Preprint, a complete and public draft of a scientific document • Preprints are typically not reviewed manuscripts written in the style of a peer-reviewed journal article. • Preprints issued to speed dissemination, establish priority, obtain feedback, and offset publication bias. • Preprints must be electronically archived to be cited – Preregistered protocol • Publicly declare key elements of your research protocol in advance. • Helps enhance the rigor of your work. 52 NOT-OD-17-050 — Reporting Preprints and Other Interim Research Products https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html
  53. 53. Interim Reports: Why should I do it? Will it affect publication in peer-reviewed journals later? 53 http://biorxiv.org • bioRxiv (pronounced "bio- archive") is a free online archive and distribution service for unpublished preprints in the life sciences. • Operated by Cold Spring Harbor Laboratory, a not-for-profit research and educational institution. • By posting preprints on bioRxiv, authors are able to make their findings immediately available to the scientific community and receive feedback on draft manuscripts before they are submitted to journals. Concerns about “prior publication.” List of academic journals by preprint policy: https://en.wikipedia.org/wiki/List_of_academic_jo urnals_by_preprint_policy
  54. 54. How to Cite Interim Research Products • To cite the product, must include the Digital Object Identifier (doi) and the Object type (e.g. preprint, protocol) in the citation. • List any information about the document version (e.g. most recent date modified), and if relevant, the date the product was cited. – Example: Bar DZ, Atkatsh K, Tavarez U, Erdos MR, Gruenbaum Y, Collins FS. Biotinylation by antibody recognition- A novel method for proximity labeling. BioRxiv 069187 [Preprint]. August 11, 2016 [cited 2017 Jan 12]. Available from: https://doi.org/10.1101/069187. • Proper citing of preprints helps reviewers understand that the product is public, interim, and identifies the specific version that is being referenced. 54
  55. 55. Can highlight in prep or submitted manuscripts in personal statement on K or R Bio Mention of High School Research at University Level is not typical unless really sophisticated research OK to list abstracts and in prep manuscripts on Fellowship Bio but abstracts only on K or R Bio NIH Fellowship Biosketch Example Although no longer required, PJ recommends including all authors names and PMCID numbers 55 Why does PJ recommend including all authors names? As a reviewer of 100s of training/career development grants, I want to see who you have published with!
  56. 56. 56 D. Scholastic Achievement for Fellowship F-award Biosketches Indicate whether 4.0 grading scale or other scale used and describe University specific grading definitions
  57. 57. § STICK to one format of your name for publication. § If you have a middle name use initial, especially if your name is common and there are dozens of you in PubMed! § Don’t do what I did—Published under 3 versions of name: v PJ Simpson, PJ Haidaris, and PJ Simpson-Haidaris—eek § On my Biosketch, I used to include: The following search string will retrieve the PI’s citations in PubMed: v ("simpson-haidaris pj"[AU] OR "haidaris pj"[AU] OR “haidaris p” OR "simpson pj"[AU] AND Rochester[AD]) OR ("simpson pj"[AU] AND "Gene"[Journal]) OR ("simpson-haidaris pj"[AU] AND "Thromb Res"[Journal]) OR ("simpson-haidaris pj"[AU] AND "J Thromb Haemost"[Journal]) OR (“haidaris p”[AU] AND “Thromb Haemost”[Journal]) § Now I include: v My NCBI | My Bibliography: http://www.ncbi.nlm.nih.gov/sites/myncbi/pj.simpson- haidaris.1/bibliography/40100400/public/?sort=date&direction=ascending NIH Biosketch Pointer 57
  58. 58. NIH Biosketch Review • List positions/jobs, education, honors, experiences, memberships, AND publications from oldest to newest (i.e., chronological order unlike in CV where list newest first). • Include Post-doc, Residency and Fellowship training in Education table (include in Positions section as well). • PJ recommends you include all authors names and publication PMCID numbers NIH Public Access Policy. Ø https://publicaccess.nih.gov Ø Can include PMID numbers if no PMCID assigned • Use NIH legal fonts and type size 58
  59. 59. University Authorized Representative submits grant on your behalf 59
  60. 60. Example Format for Cover Letter Indicate Institute for Review and Names of Outside Referees 60 Communicate with Program Officer before submitting grant to make sure grant focus matches expectations of Institute’s Fellowship Training Mission. You should use the optional PHS “NIH Institute and Study Section Assignment Request Form” in SF424 to request this— cover letter still required to list names of outside referees.
  61. 61. Second critical take home message about F awards 2. Build an exceptional Research and Career Development Mentoring TEAM (Key Personnel). • Chose sponsors with complementary expertise in scientific disciplines who will serve as role models for career advancement and leadership skills. • Add consultants and research content mentors for training in highly unique skills. • Pick mentors (sponsors) with substantial research support ($$) and experience mentoring. – If primary mentor/sponsor has expertise but “in between” NIH grants, recruit a co-mentor with substantial funding who commits to support research. 61 TIP
  62. 62. Who are Key Personnel? • Principal Investigator/Program Director (PD/PI) (Trainee is PI of F-award) • Multiple PIs (MPIs)-not allowed for Fs or Ks • Mentors/Sponsor • Co-Mentors/Co-Sponsors • Co-Investigators • Consultants/Collaborators 62
  63. 63. Mentor or Supervisor? • A “mentor for life” or a “pair of hands” to advance the mentor’s career? • A great mentor vs great supervisor focuses on helping build the trainee’s career 63 • A mentor for life o is inspirational o shares networking o provides opportunities o maximizes trainee’s abilities and learning style o is part of extended family Lee et al, Nature 2007
  64. 64. An Inspirational Mentor is… • Enthusiastic and Passionate • Sensitive • Appreciative of Individual Differences • Respectful • Unselfish • Supportive of other trainees (not just his/her own) • A good communicator/teacher • Available 64 Lee et al, Nature 2007
  65. 65. Enthusiasm and Passion • Years of research has not diminished mentor’s drive to discover new ideas and to pass that passion on to students 65 Lee et al, Nature 2007 • Can find the “teaching moment” in a bad result • Unexpected observations may provide novel insight • Provides a big picture view
  66. 66. One Size Does Not Fit All • Trainees are not like Money where – “One Size Fits All” and – “Is the Perfect Color” 66 Lee et al, Nature 2007 • Great mentor appreciates individual differences o Different learning styles o Work ethics o Cultural diversity o Personalities http://www.cyh.com/HealthTopics/library/diversity1.jpg
  67. 67. One Size Does Not Fit All (mentoring style) (trainees) 67 Lee et al, Nature 2007 http://live-language.com/wp- content/uploads/2013/10/adult-learning- styles.jpg Mentor’s management style and Trainee’s work style need to be compatible http://www.buzzle.com/img/article Images/310162-38716-51.jpg
  68. 68. Respectful 68 Lee et al, Nature 2007 • Inspires confidence in trainees as collaborators • Team Builder • Treats colleagues and trainees with same high regard • Gives positive and constructive assessment of trainee’s progress http://monkeypantz.net/wp-content/uploads/2013/02/the- cycle-of-Respect.gif
  69. 69. Unselfish 69 Lee et al, Nature 2007 • Allows trainees to have experiences to build career, network and be recognized for contributions • Shares own ideas— lets trainees take mentor’s ideas and run with them • Lacks defensive manner http://www.isikplastik.com/wp-content/uploads/2013/10/career.jpg • Delights in seeing younger scientists succeed
  70. 70. Picking a Mentor (1) 70 • Mentor needs to commit to the length of time needed to accomplish your training o Sufficient lab space, equipment and resources o Financial resources from grants, start-up funds, industry collaborations o Does the professor plan to stay at the university? • Mentor’s research is broadly aligned with your research interests o Is a recognized expert in the field o Able to provide networking opportunities o Publishes in a timely and regular manner o Commits to trainee’s career development, hopefully lifelong adapted from: http://www.cc.gatech.edu/faculty/ashwin/wisdom/how-to-choosean-advisor.html
  71. 71. Picking a Mentor (2) 71adapted from: http://www.cc.gatech.edu/faculty/ashwin/wisdom/how-to-choosean-advisor.html • Are more advanced trainees happy with the mentoring interaction? o Check with 3rd or 4th year graduate students currently in the lab o Are postdocs doing most of the mentoring? o Is the lab environment congenial? • Is the mentor’s lab in a department associated with your training program? • Are research projects identified such that a “no” answer is still publishable? o How are research projects assigned? (individually or several people working on very similar projects?)—project “ownership”
  72. 72. Picking Mentoring Team 72 • Identify needed expertise to carry out research project. • Choose a co-mentor who complements the primary mentor’s expertise. o e.g., basic science researcher, clinician-scientist, or population/public health researcher • Advisory or thesis committee mentors who are content mentors. o Provide short-term training or expertise in special skills not available in primary mentor’s lab o Grant advisory committee members agree to meet 2-4 times/yr; Thesis committees usually meet 1-2 times/yr
  73. 73. Consultants & Collaborators 73 • Usually provide a very specialized reagent, method or data analysis skill lacking on your mentoring team • Are often located at outside Universities • Can be Advisory Committee Members and also collaborators • Must define their working relationship with you (PI) o Provide reagents only o Provide intellectual input, career guidance and authorship of publications o Consultants and collaborators provide letters of support agreeing to their contributions o Sometimes Consultants/Collaborators are also Key personnel, which means must include their NIH Biosketch
  74. 74. Back to the SF424 form • Now that you know who belongs on your mentoring team and in what capacity, • Solicit NIH Biosketches (for all listed as Key Personnel) and • Request Letters of Support from consultants and collaborators – altogether these letters cannot exceed 6 pages 74
  75. 75. PD/PI field populated from front page information Asterisks denote required information, including eRA Commons ID 75 Make sure you are listed in eCommons as both Trainee and PI; Consult the person who has authority to submit NIH grants on behalf of your University
  76. 76. After PD/PI, enter Sponsor and Co-sponsor, then rest of mentors alphabetically Attach Biosketches as pdf files 76 Other Support only for some K-awards
  77. 77. Sponsor’s and Co-sponsor’s Research Support available to trainee (PD/PI) (6-page limit) 77 Included in Sponsors & Co-sponsors Statements: Training Plan, Mentoring History and Resources ($)
  78. 78. 78 Sponsors’ Track Records of Mentored Training • Reviewers want to see that your mentors are experienced and passionate about training predocs. • If Primary Mentor has little experience, enlist co-mentor with successful mentoring history.
  79. 79. Additional Sections of Sponsors’ Information Sponsor’s training plan must mesh with PI’s goals and activities planned to accomplish goals. Activities Planned Goals IDP Dissertation Research and Prior Research Experience Respective Contributions Research Approach 79 Section E is equivalent to the Sponsors Letter of Recommendation
  80. 80. Consultants and Collaborators Letters of Support (6-page limit in one pdf attachment) • Consultant and Collaborator letters of support (LOS) are NOT the same as the Reference letters provided from 3 Outside Referees. • Form an advisory committee of key collaborators, consultants, or advisors who make substantive contributions to the applicants planned project • Contents of letter include their anticipated role and contributions to the research training and/or career development of the applicant. 80
  81. 81. Third critical take home message about F awards 3. Recruit outside Referees who can write the STRONGEST possible letters attesting to your potential to launch an independent research career. Three Letters of Recommendation Submitted Separately from Application Link to format for outside referees to follow when submitting letters: https://public.era.nih.gov/commons/public/refe rence/submitReferenceLetter.do?mode=new 81 • Outside Referees are individuals not directly involved in the application. • May need to consider whether a collaborator is really better suited to be an outside Referee.
  82. 82. Information PI provides to outside referees • PI (Fellowship applicant) Commons user name • PI first and last name as they appear on the PI’s Commons account • Funding Opportunity Announcement (FOA) under which the applicant is applying (in our example, PA-16-308) 82
  83. 83. Outside Referees should comment on PI’s: • Research ability and potential to become an independent researcher • Adequacy of scientific and technical background • Written and verbal communication skills including ability to organize scientific data • Quality of research experiences and/or publications • Perseverance in pursuing goals • Evidence of originality • Need for further research experience and training • Familiarity with research literature 83
  84. 84. Fourth critical take home message about F awards 4. Prepare a Research and Career Individual Development Plan (IDP) to define gaps in training, and design activities and metrics to meet career goals and launch to next career stage. 84 Selection of Sponsor & Institution A. Doctoral Dissertation and Research Experience C. Activities Planned (from IDP) B. Goals (from IDP) Respective Contributions Advisory (thesis) committee members Responsible Conduct of Research Applicant’s Background and Goals for Fellowship Training An IDP is designed to be a blueprint for your success.
  85. 85. Research and Career Individual Development Plan • PI works with Sponsor to develop a research and career individual development plan (IDP). • All training grant mechanisms for NIH require that IDPs be used and described in annual reporting to agency. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-113.html • IDP is a “living document” where you define goals, describe activities to meet goals, define benchmarks and timelines to complete goals, define mentoring team meetings to monitor progress in achieving goals and plans to remedy situation if goals change. – Goals, Respective Contributions, Selection of Sponsors, and Activities Planned Under this Award are derived from IDP! 85
  86. 86. Applicant’s Background and Goals for Fellowship Training • This section is “new” in F-award FOAs released June 2016. • Increased to 6-page limit (from 4 pages) • Combines three sections (as defined in past FOAs) into one attachment (and presented in this order): A. Doctoral Dissertation and Research Experiences B. Training Goals and Objectives C. Activities Planned Under Award 86
  87. 87. A. Doctoral Dissertation and Research Experience • Summarize research experiences, including undergrad experiences and lab rotations in chronological order. • Describe your contribution to the research and how it addressed the “big picture” of research question — did your contribution help move the field forward? • Include narrative of doctoral dissertation (may be preliminary); Do not list academic courses. • Postdoctoral applicants should specify which areas of research were part of thesis and which, if any, were part of a previous postdoctoral project. PJ Recommends limit to 2 of 6 pages in section. 87
  88. 88. B. Goals and Objectives • Describe your overall training goals for the duration of the fellowship and how the proposed fellowship will enable the attainment of these goals. • Identify the skills, theories, conceptual approaches, etc. to be learned or enhanced during the award. • Discuss how proposed research and career development training plans facilitate transition to next career stage and future career goals. PJ Recommends limit to 2 of 6 page in section. 88
  89. 89. C. Activities Planned Under This Award • Perform Gap Analysis of what skills you have and what are missing to achieve goals (This comes from your IDP). • Define activities to fill those gaps. • Remember to mention training activities to enhance research skills in the Research Strategy 89 Example table taken from F31 in which the review criteria of “Training Potential” scored 1 (Exceptional)
  90. 90. C. Activities Planned Under This Award • PJ recommends three areas of Activities Planned: 1. Didactic Coursework and Seminars 2. Mentored Research Activities 3. Career Development Activities • Describe, by year, the activities (research, coursework, professional development, clinical activities, etc.) you will be involved in during the proposed award. • Estimate the %-time devoted to each activity; should = 100% each year • Describe the planned, non-research activities (e.g. those related to professional development and clinical activities) that you plan to engage in during the award period. 90 Develop table with %-effort devoted to training activity, timeline of completion, and benchmarks to measure success!
  91. 91. C. Example of Activities Planned Under This Award 3 first-authored papers high impact journals Career skills workshop How to Negotiate Present at National Meetings Teach Class or Two in Research Discipline Research techniques to be learned; how learn and mentors involved Short Course on Specialized Techniques Biostatistics/Advanced Programing Grant Writing Seminar Series in Discipline of Science Student Seminars Discipline-specific courses to fill gaps Travel to Collaborators Lab for Specialized Techniques Lab Meetings, Research in Progress Write and Defend PhD Thesis Submit Grant Application Secure Postdoc Position and others…specific to YOU Suggest start section with three paragraphs corresponding to 3 major areas of Research and Career Development: 1. Didactic Coursework and Seminars. 2. Mentored Research Activities. 3. Career Development Activities. Briefly explain where you are to date in training activities in each category and describe new activities to meet your goals. Include specifics on didactic course work (# credit hours, course ID and Name and how this will accomplish you training objective). Indicate time needed to accomplish and percent of time on each major area. 91 TIP: Include Benchmarks to document success Reviewers like this!
  92. 92. Respective Contributions This item is limited to one page. • Describe the collaborative process between you and your sponsor/co-sponsor in the development, review, and editing of this research training plan. • Discuss the respective roles in accomplishing the proposed research. • Include respective roles of Advisory Committee members and consultants/collaborators. 92
  93. 93. Example Template for Respective Contributions Section for F31 93 TIP: Include Milestones and Benchmarks to document accomplishments— Reviewers like this!
  94. 94. Selection of Sponsor and Institution Predoctoral and postdoctoral fellows: • Describe the rationale/justification for the selection of the sponsor and institution to accomplish research training goals. Postdoctoral fellows only: • Training is expected to broaden a fellow's perspective, thus postdoc applicants requesting training at either their doctorate institution or at the institution where they have been training for more than a year must explain why further training at that institution would be valuable. This item is limited to one page. 94
  95. 95. Responsible Conduct of Research (RCR) This item is limited to one page. –Cover the five REQUIRED items: 1. Format with substantial face-to-face contact (all online training not acceptable) 2. Content/Subject Matter 3. Participating Faculty (name specific faculty involved) 4. Duration of training (contact hours) 5. Frequency—at least once per career stage or every four years, whichever is shorter time period 95
  96. 96. Example Template of Responsible Conduct of Research (RCR) covering format, content, faculty, duration and frequency 96 Recommend including Training in Data Reproducibility and Rigor in Science
  97. 97. Training in Data Rigor and Reproducibility Institutional Training Grants = new attachment “Plan for the Instruction in Methods for Enhancing Reproducibility.” Not required as separate attachment in FORMS-D for F-awards Based on the new online training modules in Rigor and Reproducibility, as developed and released by the National Institute for General Medical Sciences (NIGMS), the PI in discussions with Co-sponsors will examine each step of the scientific method from the standpoint of enhancing scientific rigor and reproducibility – starting with experimental design, and progressing to methodology and laboratory practices, statistical data analysis, reporting of results, data interpretation, the confirmation of bias in hypothesis testing, and the current system of scientific rewards and advancement - using specific examples and cases. Furthermore, Authentication of Key Biological and/or Chemical Resources will be carried out per NIH recommendations as well. 97 Sample Language (by PJ not NIH) for satisfying the need to address. Can include in RCR, Research Strategy Approach and/or Sponsor’s statement.
  98. 98. Other Research Training Plan Information • A select agent is a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant product • Include a “Select Agent Research” attachment if your proposed activities involve the use of select agents at any time, either at the applicant organization or at any performance site. • Your Primary Advisor/Sponsor will know if your research involves select Agents! • HOWEVER, if you use biohazardous agents, include in Research Strategy how you handle them (e.g., BL2 organisms, primary cells, human tissue samples or viral constructs, etc.) 98
  99. 99. Resource Sharing Plan: indicate how will distribute 99 • Sharing Model Organisms – include a description of a specific plan for sharing and distributing unique model organisms or state why such sharing is restricted or not possible. • Genomic Data Sharing (GDS) – Examples of large-scale genomic data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. • Other Unique Resources – If generate other resources such as new monoclonal antibodies, cell lines or other unique reagents not easily made or available, must also include resource sharing plan.
  100. 100. Authentication of Key Biological and/or Chemical Resources • Do not submit an “Authentication of Key Biological and/or Chemical Resources” attachment unless it is specifically requested in the FOA. – However, if you are using unique resources not widely available, best to include information in Research Strategy on how the reagent was validated for intended use • Check frequently for release of updated FOAs and notices (NOTs) from NIH to verify sections required! 100
  101. 101. Critical take home messages about F awards 1. Prepare a proper NIH Fellowship Biosketch. 2. Build an exceptional Research and Career Development Mentoring TEAM. 3. Recruit outside Referees who can write the STRONGEST possible letters attesting to your potential to launch an independent career. 4. Prepare a Research and Career Individual Development Plan (IDP) to define gaps in training, and design activities and metrics to meet career goals. 101
  102. 102. Don’t Forget the Research Grant! Biosketches PD/PI Sponsor Co-sponsor Advisory Committee Members Consultants + their letters Summary/ Abstract Narrative/ Public Health Significance Introduction, if resubmission Specific Aims Research Strategy Bibliography Cover Letter 102
  103. 103. Other important sections of F-award applications Bibliography Facilities & Other Resources Equipment Summary/ Abstract Narrative/ Public Health Significance Other Attachments 1) Diversity eligibility Diversity_Eligibility_Ltr.pdf Only for F31 Diversity PA-16-308 103
  104. 104. Project Summary/Abstract (Max 30 lines of text) • 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 funding agency). • Describe concisely the research training program design and methods for achieving stated goals. • Avoid describing past accomplishments and the use of the first person. • Do not include proprietary, confidential information or trade secrets. 104
  105. 105. Project Narrative Public Health Relevance • Describe the relevance of this research to public health. • Be succinct and use plain language that can be understood by a general, lay audience. • Use no more than two or three sentences. 105
  106. 106. Bibliography & References Cited • Each reference must include names of all authors, the title, Journal name, volume number, inclusive page numbers, and year of publication. • Include only bibliographic citations. • Applicants should follow scholarly practices in providing citations for source materials used in any section of application. • Provide PMCID number for PI’s articles that fall under NIH Public Access Policy. – https://publicaccess.nih.gov 106
  107. 107. Facilities & Other Resources (no page limit) • Identify only facilities used for this project and PI’s training activities (Laboratory, Animal, Computer, Office, Clinical and Other such as Core Facilities—some of this info is in Sponsors statement—make use of sections to maximize information for reviewers). • Describe how scientific & intellectual environment contributes to probability of success (e.g., institutional support, physical resources, and intellectual rapport/environment) – Any Nobel Laureates, National Academy or Institute of Medicine members, etc., with whom you interact or are invited to your institution to give seminars, lectures or workshops? Be sure to mention! • Discuss ways proposed studies will benefit from unique features of scientific environment, subject populations or collaborative, multidisciplinary arrangements. • Include resources from Clinical and Translational Science Institutes and support for Graduate Students at your University. 107
  108. 108. Describe the physical layout of research labs and PhD training program home base and how these resources aid in training the PI (F-award applicant!) 108 Facilities and Other Resources Section:
  109. 109. Equipment (no page limit) • List major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities. • List major equipment that will be used by PI in co- sponsors’ and collaborators’ labs as well. • Note, core facilities to be used by this project are usually described in Facilities & Other Resources section. 109 Identify special equipment used in collaborator’s labs. But, no need to identify every vortex stir plate in the lab…
  110. 110. Institutional Environment and Commitment to Training • Document a strong, well-established research program related to the candidate's area of interest. • Describe opportunities for intellectual interactions with other investigators, including didactic courses offered, journal clubs, seminars, and presentations. • Indicate the facilities and other resources that will be made available for both career enhancement and the research proposed in this application. • Refer to other sections: Equipment, Facilities, and Other Resources, Sponsor and Co-sponsor Statement, and Applicant’s Background and Goals for Fellowship Training. 110 New Section • These parts provided with input from Sponsors and PI (you)
  111. 111. Institutional Environment and Commitment to Training 2-page limit • Describe the dual-degree (F30) or graduate (F31) program in which the applicant is enrolled. • structure of the program, required milestones and their usual timing • number of courses, teaching commitments and qualifying exams • average time to degree over the past 10 years • the progress/status of the applicant in relation to the program’s timeline, and the frequency and method by which the program formally monitors and evaluates a student’s progress. • clinical tutorials during the graduate research years and any activities to ease transition from the graduate to the clinical years of the dual-degree program. • research-associated activities during the clinical years of the dual-degree program. 111 • This information is provided by the PhD and/or MD-PhD Program Directors. • Include names of individuals providing this information at the end of section.
  112. 112. • Example information included in “Institutional Environment and Commitment to Training” section. • Received Criterion Score of “1” from all six reviewers on two F31 applications funded in 2017. 112
  113. 113. • Make sure information in this section agrees with information provided in other sections of grant. • Important for applicant to provide PhD program director and Sponsors with drafts of ALL training sections of the grant AND all Biosketches, including Applicant, Sponsors and Advisory Committee Members. • Why is this important? Shows the Reviewers that the applicant TALKS to all faculty needed to prepare the: • BEST APPLICATION POSSIBLE. 113
  114. 114. Certification of Eligibility for Diversity Award Provided by Dean of Graduate Studies Office (e.g., Registrar or Dean) 114 Only needed for Diversity F31 PA-16-308
  115. 115. Critical take home messages about Peer Review 5. They are not called “Vague Aims”… they are called “Specific Aims” 6. Reviewers are assigned 8-10 grants so they have limited time to review YOUR grant. 7. Demonstrate your enthusiasm and passion for research and attaining career goals with Clear, Concise and Compelling writing and prepare Visually Splendid Figures. 8. You get 15 minutes of Fame at Peer Review – (if you are lucky to have your grant discussed). 115
  116. 116. Specific Aims and Research Strategy Specific Aims Research Strategy 116
  117. 117. • Only 3 of 20 or so reviewers on study section panel read entire grant. • Rest of panel members have equal vote. • Specific Aims page may be only part of grant they read. • Needs to clearly convey entire grant to 17 other reviewers. 117 NIH Peer Review Process Revealed: https://www.youtube.com/watch?v=lzBhKeR6VIE 5. They are not called “Vague Aims”… they are called “Specific Aims” for a reason!
  118. 118. Specific Aims Language There is no innovation section in F-awards, although they can still be “innovative” but not risky! 118
  119. 119. Save space on specific aims page to briefly describe training plan and how it will launch you to next career stage This last sentence is more appropriate for K award than F award, but describe specific details of your training plan. 119
  120. 120. A good format for a Specific Aims Section is a Sandwich 120 Specific Aims: objectives (working hypotheses) and description—state how things will change (increase/decrease; better/worse)—BE SPECIFIC theWhat andHow Impact and Outcomes: how findings will move field forward and fulfill NIH mission; how findings will have broader implications for other public health problems theSo What Define Gap in Field and NEED for YOU to solve: pertinent background to establish rationale, goals, objectives, and central hypothesis—BE SPECIFIC and FOCUSED the Problem andWhy Consider use of visual models (schematics) to communicate a complex subject and how aims relate to central hypothesis
  121. 121. TIP: Your aims must be written in such a way that, no matter how the hypothesis tests – yes/no, up/down, left/right – you will accomplish the aim’s objective. Russell SW, Morrison DC. The Grant Application Writer’s Workbook for NIH. 2015. http://www.grantcentral.com/ 121 We emphasize again that the importance of your specific aims cannot be exaggerated. Therefore, before proceeding, we recommend that you review what you have just writ- ten one more time with the following important questions in mind: i. Are any of your aims descriptive, i.e., do any propose ‘look-to-see’ research, i.e., an unfocused fishing expedition? ii. Are your aims directly linked to parts of your central hypothesis? iii. Are any of your aims superfluous to testing a part of your central hypothesis? iv. Is each aim driven by a working hypothesis that serves to focus the research that is proposed under that aim? v. Does your ability to pursue later aims depend in any critical way upon an expected outcome of an earlier one? If your answer is ‘Yes’ to question i, iii or v, or ‘No’ to either question ii or iv, you need to reformulate your specific aims before proceeding.
  122. 122. Mail room 1 6. Reviewers are assigned 8-10 grants so have limited time to review YOUR grant.
  123. 123. Research Strategy Limited to 6 pages 1. Significance • Explain the importance of the problem or critical barrier to progress that project addresses. • Explain how project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. 2. Innovation • Fellowship applicants should not include an Innovation section except in the unusual circumstance where it is specified in the FOA. 123 Innovation section is currently NOT included in F31 http://grants.nih.gov/grants/forms_page_limits.htm
  124. 124. Purpose of Significance Section 1) Justify the need for research you propose to do. 2) Establish the scientific premise (rationale) for your application. Ø Discuss the strengths and weaknesses of the published literature cited in support of your research project that leads to defining the gap in the field and hypothesis to be tested Ø Discuss the strengths and weaknesses of your preliminary data presented in grant demonstrating feasibility of your project Ø Your data should provide support of your hypothesis and demonstrate “doable” methods of approach 3) Inform reviewers as to why your research contribution is expected to be significant. 124
  125. 125. Research Strategy Limited to 6 pages 3. Approach • Describe overall strategy, methodology, and analyses to accomplish specific aims; how data will be collected, analyzed, interpreted and how data or resources created are shared (include Resource Sharing Plan as appropriate). • Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. • Provide preliminary data or strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. • Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised. 125 http://grants.nih.gov/grants/forms_page_limits.htm
  126. 126. Research Strategy • Remember to include discussion of potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. • Discuss robustness of methods, soundness of published literature and your preliminary results used to establish project rationale (scientific premise) and define “Gap in Field” your research is intended to answer. • Provide a Gantt chart timeline for Research project. 126
  127. 127. Tell a good story and make is easy to read 7. Demonstrate (on paper) your enthusiasm and passion for research and attaining career goals with Clear, Concise and Compelling writing – Sorry, you have to get your help with writing from other sources such as: – ”The Nuts and Bolts of Scientific Writing” http://www.academicpeds.org/espauthoring/page_21.htm • and prepare Visually Splendid Figures. 127
  128. 128. Figures and Tables “Dos and Don’ts” • Figures and tables should stand on their own— the legend should be informative and legible. • Decide whether to present data in table, graph, figure or in the text. • Use the fewest figures and tables needed to tell a story. • Design figures, tables and graphs to have strong visual impact. 128 Tip: place preliminary data near the text (narrative) that FIRST describes the results. Don’t make the reviewer have to flip back and forth from one page to another and back again.
  129. 129. Diagrams and Drawings • Schematic (cartoon) representation of basic principles, signaling pathways or summary of results may be appropriate. • This is a way to control amount of detail needed to understand concepts or conclusions. • Often schematics are overly complicated—more is not always better. …or, how not to get a grant… 129 Tip: Include ONLY data to support your proposed research. If this means making a new figure to simplify what you present—MAKE the New Figure!
  130. 130. Grant Schematic Don’t: Fibrin(ogen)-mediated Mechanisms of Wound Repair 130 How not to get a grant in 2001
  131. 131. Larson, G. The Complete Far Side. 2003. 131 The KISS principle to making figures. Keep IT Simple, Stupid.
  132. 132. Loss of Function Schematic— from funded grant! 132 Grant Schematic “Do”
  133. 133. Gain of Function Schematic— from funded grant! 133 Grant Schematic “Do”
  134. 134. Some Sections Depend on Type of Research Conducted 134 Risks Benefits Human Subjects? Enrollment Women Children Minorities DSMP/DSMB Vertebrate Animal Research? Vertebrate Animal Section • Description of Procedures • Justify Species Used • Minimization of Pain and Distress • Euthanasia Select Agents? Resource Sharing Plan Stem Cell Research/Bio- hazards? Facilities & Other Resources; Equipment (required, but include only facilities related to YOUR research) Data Sharing Plan
  135. 135. Human Subjects Sections http://grants.nih.gov/grants/funding/424/Supplemental Instructions.pdf#4_1_protection_of_human_subject 135 Risks Benefits Human Subjects? Enrollment Women Children Minorities DSMP/DSMB NIH now considers individuals age 18 and older as adults (i.e., 18, 19 and 20 yr olds no longer children for NIH)
  136. 136. Vertebrate Animal Use Office of Laboratory Animal Welfare https://grants.nih.gov/grants/olaw/vertebrate_animal_section.htm Worksheet for Applications Involving Animals https://grants.nih.gov/grants/olaw/VASchecklist.pdf Vertebrate Animal Research? Vertebrate Animal Section • Description of Procedures • Justifications of Species • Minimization of Pain and Distress • Euthanasia Method 136Vertebrate Animal Section updated per NOT-OD-16-006
  137. 137. 8. 15 Minutes of Fame aka Peer Review • Three reviewers are assigned to your grant – Primary and Secondary Reviewers read; tertiary reviewer usually reads very quickly – Primary Reviewer BREIFLY describes proposal goals and training plan; describes strengths and weaknesses of proposal per 5 review criteria – Secondary and tertiary reviewers concur or add strengths and weakness that are different based on their perspective • In 15 minutes, the rest of reviewers on the study section panel will receive all the information they will get to score your grant • How can 20+ people decide how to score your grant in 15 minutes? 137 Video on NIH Mock Study Section https://www.youtube.com/watch?v=lzBhKeR6VIE Watch this video to understand your 15 min (or less) of fame!
  138. 138. The NIH Grant Process: The Big Picture 138 https://www.youtube.com/watch?v=rNwsg_PR90w 8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant https://www.youtube.com/watch?v=_Gr-D68NawQ&t
  139. 139. Criteria for review of F-series NRSA Individual Fellowship Awards (1) -Overall Impact Score and Statement Overall impact score reflects reviewer’s assessment of likelihood that the fellowship will enhance the PI’s potential for, and commitment to, a productive independent scientific research career in health-related field. 1. Fellowship Applicant – Sections of grant that provide this information • PI Biosketch • Sponsor’s Statement • Outside Letters of Support • Applicant’s Background and Goals for Fellowship Training • Enthusiasm and Passion must resonate throughout the entire application 139
  140. 140. Criteria for review of F-series NRSA Individual Fellowship Awards (2) 2. Sponsors, Collaborators and Consultants – Sections of grant that provide this information • Sponsors, Consultants and Collaborators Biosketches • Sponsors Statement • Consultants and Collaborators Letters of Support • May be found in Outside Letters of Support if referees know your sponsors really well 140
  141. 141. Criteria for review of F-series NRSA Individual Fellowship Awards (3) 3. Research Training Plan Sections of grant that provide this information – Specific Aims page – Research Strategy – PI Biosketch – Vertebrate Animals and Human Subjects sections – Institutional Environment and Commitment to Training – Applicant’s Background and Goals for Fellowship Training • Gantt Charts/Tables included in Research Strategy and Activities Planned 141
  142. 142. Criteria for review of F-series NRSA Individual Fellowship Awards (4) 4. Training Potential Sections of grant that provide this information – Sponsors, Consultants and Collaborators Biosketches – Sponsors’ Statement – Specific Aims page – Research Strategy (Gantt Chart/Table included in Research Strategy) – Applicant’s Background and Goals for Fellowship Training • Gantt Chart/Table included in Activities Planned (section C) – Institutional Environment & Commitment to Training 142
  143. 143. Criteria for review of F-series NRSA Individual Fellowship Awards (5) 5. Institutional Environment & Commitment to Training Sections of grant that provide this information – Institutional Environment & Commitment to Training – Facilities and Other Resources – Equipment – Sponsors Statement (including intellectual environment) – Consultant and Collaborators Letters and Biosketches – Sponsors Biosketches (demonstrating grant support history) 143
  144. 144. What will immediately cause an application to go un-reviewed (because you did NOT READ the FOA) • Not following Appendix Requirements • Missing information required for F awards – Diversity_Eligibility_Ltr.pdf, which certifies eligibility for the F31 Diversity Award • Not following instructions found in NRSA parent FOAs • PA-16-309 – F31, Predoc (Parent) • PA-16-308 – F31, Diversity Predoc (Parent) • PA-16-305 – F30, MD-PhD Predoc (Parent) for institutions with NIH funded dual degree programs (e.g., MSTP) • PA-16-306 – F30, MD-PhD Predoc (Parent) for institutions without NIH funded dual degree programs • PA-16-307 – F32, Postdoctoral (Parent) 144
  145. 145. FOA-specific I Instructions and Found in Section IV! Required Application Instructions It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide [URL below] EXCEPT where instructed to do otherwise (this FOA or a Notice [NOT] from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV [of F-award parent FOA]. When the program-specific instructions [i.e., NRSA F-fellowship program] deviate from those in the Application Guide, follow the program-specific [in FOA] instructions. Applications that do not comply with these instructions may be delayed or NOT accepted for review. Verbatim instructions from PA-16-308 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/fellowship-forms-d.pdf 145
  146. 146. What does it take to write an F-award application? (refusal to take “No” for an answer) [1] • Allow plenty of time to complete all sections. – make sure when editing sections, such as goals you also edit activities planned to accommodate changes in goals. – same goes for specific aims and research strategy—if you add or delete an aim, make sure the experimental design matches! • Recommend you have at least 1 first-author publication for F31/F30 (at least submitted) and two-three for F32. 146
  147. 147. What does it take to write an F-award application? (refusal to take “No” for an answer) [2] • Enlist mentors and outside referees early and discuss project and goals so they can commit to participate and write supportive letters because they KNOW you. • Work with sponsor and university representative to complete all aspects of project. • Read ALL instructions and Pay Attention to detail; let others read, & edit, edit, edit. • Oh, and edit some more after putting it aside for awhile. 147
  148. 148. How long it really takes to write a fundable grant 148Inouye & Fiellin Ann Intern Med. 2005;142:274-282.
  149. 149. Acknowledgements • Heartfelt thanks to PJ’s students in the Translational Biomedical Science PhD program at the University of Rochester who have graciously agreed to share their experiences in writing successful F-awards. • Supported by the University of Rochester CTSA award number UL1 TR000042, TL1 TR000096 and TL1 TR002000 from the National Center for Advancing Translational Sciences of the National Institutes of Health. • The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 149
  150. 150. Source Material • PA-16-308: Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31 – Diversity) • oppPA-16-308-cidFORMS-D.pdf (SF424 form) • Fellowship Instructions for NIH and Other PHS Agencies SF424 (R&R) Application Packages (Updated 24 March 2017). • Fellowship Applicant Biosketch samples from NIH • NIH websites as screen shots • Section Templates constructed by PJ and students 150
  151. 151. Source Material • “Nuts and Bolts of Scientific Writing” – http://www.academicpeds.org/espauthoring/page_21. htm • “Clear, Concise and Compelling” – http://www.georgia4hfoundation.org/documents%20fo r%20grants%20page/Grant%20Writing%20Getting%2 0Specific%2009.pdf (retrieved 4-4-2017). 151
  152. 152. Helpful NIH Websites and Videos • NIH Peer Review Revealed – https://www.youtube.com/watch?v=fBDxI6l4dOA&feature=youtu.be • 8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant – https://nexus.od.nih.gov/all/2017/02/03/new-peer-review-videos-for- applicants-and- reviewers/?utm_source=nexus&utm_medium=email&utm_content=nihu pdate&utm_campaign=jan17 • NIH Grants Process: The Big Picture (video) – https://www.youtube.com/watch?v=rNwsg_PR90w • Getting Started: Learn the Basics – https://grants.nih.gov/grants/grant_basics.htm • Grants Process Overview – https://grants.nih.gov/grants/grants_process.htm 152
  153. 153. Disclaimer • This presentation includes recommendations from successful F-award applications of trainees, details of instructions extracted from the Fellowship Instructions for NIH and Other PHS Agencies (Updated March 24, 2017), PA-16-308 and NIH websites. • Because NIH grant instructions change periodically, we recommend that all information be verified as the most recent by frequently checking for updated NIH instructions, notices (NOTs), and funding opportunity announcements (FOAs). • Finally, specific content to include in trainee and research sections is the direct responsibility of the PI and his/her mentoring team members—information provided here is for guidance only and should not be used verbatim. 153

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