1. 9/15/2015LSUHSC-NO ORS Training Series 1 LSU School of Medicine-New Orleans (LSUSOM-NO) is the provider of Continuing Medical Education for this activity. The planning and presentation of all LSUSOM-NO activities ensure balance, independence, objectivity and scientific rigor. The LSU School of Medicine-New Orleans designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

2. 9/15/2015LSUHSC-NO ORS Training Series 2 Disclosure I do not have any relationship(s) with commercial interests. A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

3. NIH Grant Application Forms

4. 9/15/2015LSUHSC-NO ORS Training Series 4 Welcome –Presenter: Nicole G. Hammill, MBA Coordinator of Grants and Development Office of Research Services –Nbarro@lsuhsc.eduNbarro@lsuhsc.edu –(504) 568-4970 tel –(504) 568-8808 fax –http://www.lsuhsc.edu/administratio n/academic/ors/grants_contracts_pr ocessing.aspxhttp://www.lsuhsc.edu/administratio n/academic/ors/grants_contracts_pr ocessing.aspx

5. 9/15/2015LSUHSC-NO ORS Training Series 5 Director: Dr. Kenneth E. Kratz Staff: Nicole G. Hammill – Pre-award (Grants and Contracts) Rose Castay – IACUC and IBC Dyan Melson – IRB Lynn Arnold – IRB Amy Tassin – IRB Anissa McDougle – Conflicts of Interest Responsibilities: Pre-award, sponsored project activity; this includes evaluation and routing for signatures all grant applications, research agreements, and clinical trial agreements. Conflict of Interest Program based upon Chancellor’s Memorandum #35 “Individual and Institutional COI in Sponsored Projects”. The AAHRPP “Fully Accredited” Human Research Protection Program and Institutional Review Board (IRB) which provides oversight for the protection of human subjects participating in research. The Institutional Animal Care and Use Committee (IACUC) which provides oversight for the welfare of animals used in research. The Institutional Bio-safety Committee (IBC) which in collaboration with the Office of Environmental Health and Safety provides oversight of bio-safety issues and recombinant DNA research. Office of Research Services

6. Helpful Administrative Information Most of the numbers, dates, names, and titles commonly needed for the completion of grant applications can be found here: http://www.lsuhsc.edu/administra tion/academic/ors/docs/Helpful_ Administrative_%20Information.p df 9/15/2015LSUHSC-NO ORS Training Series 6

7. 9/15/2015LSUHSC-NO ORS Training Series 7 Agenda  Purpose of Presentation and NIH’s Goals  Overview of Application Changes since 2010 overhaul  Tour of a “Typical” Application Package  Resources  Questions and Answers

8. 9/15/2015LSUHSC-NO ORS Training Series 8 Purpose of Presentation Since January 25, 2010, all NIH grant applications have required the use of “new” forms and instructions. Major changes include: –Restructured forms to align with review criteria –Significantly shorter page limits

9. 9/15/2015LSUHSC-NO ORS Training Series 9 NIH’s Goals Of Restructured Applications: –Align the structure and content of the forms with review criteria To focus the applicants and reviewers on the same elements To help ensure a more efficient and transparent review process Of Shortened Page Limits: –Reduce burden –Focus on the essentials of the science –Avoid information overload

10. 9/15/2015LSUHSC-NO ORS Training Series 10 Overview of the Application Changes Application forms have been revised in three sections: –Research Plan –Biographical Sketch –Resources and Facilities

11. 9/15/2015LSUHSC-NO ORS Training Series 11 Major Changes to the Research Plan Specific Aims should include new language about the impact of the proposed research. Research Strategy has been created as a “new” section and will include 3 of the “old” sections –Background and Significance –Preliminary Studies/Progress Report –Research Design and Methods

12. 9/15/2015LSUHSC-NO ORS Training Series 12 “New” Research Plan Components Introduction Specific Aims Background and Significance Preliminary Studies/Progress Report Research Design and Methods Inclusion Enrollment Report Bibliography and References Cited Human Subjects Sections…. protections, women/minorities, enrollment, children Other Research Plan Sections…. animals, select agents, multi PD/PI, consortium, support, resource sharing Appendix Research Strategy

13. 9/15/2015LSUHSC-NO ORS Training Series 13 “Old” v. “New” Old HeadingNew Heading Instructions from SF424 Application Guide Specific Aims State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. Background and Significance Significance Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed 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. N/AInnovation Explain how the application challenges and seeks to shift current research or clinical practice paradigms. 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. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

14. 9/15/2015LSUHSC-NO ORS Training Series 14 “Old” v. “New” Old HeadingNew Heading Instructions from SF424 Application Guide Research Design and Methods Approach Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 15 (Resource Sharing Plan), include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. Point any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of Select Agents should appear in Item 11, below. Preliminary Studies Approach 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).

15. 9/15/2015LSUHSC-NO ORS Training Series 15 “Old” v. “New” Old HeadingNew HeadingInstructions from SF424 Application Guide Preliminary Studies/Progress Report Approach 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.

16. 9/15/2015LSUHSC-NO ORS Training Series 16 New! Changes to Biographical Sketch New Biographical Sketch Format Required for Applications Submitted for Due Dates on or After May 25, 2015 Type of biosketch format to be used depends on type of applicant: –Individual fellowships, R36 dissertation grants, and diversity supplements should use the Fellowship Application Biographical Sketch Format –Research grant applications, career development, training grant, and all other application types should use the general Biographical Sketch Format

17. 9/15/2015LSUHSC-NO ORS Training Series 17 New! Changes to Biographical Sketch The new biosketch format: –Extends the page limit from four to five pages; –Allows researchers to describe up to five of their most significant contributions to science, along with the historical background that framed their research; –Allows investigators to outline the central findings of prior work and the influence of those findings on the investigator’s field; –Provides investigators involved in Team Science an opportunity to describe their specific role(s) in the work.

18. Each description can be accompanied by a listing of up to four relevant peer- reviewed publications or other non- publication research products, including 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. In addition to the descriptions of specific contributions and documentation, researchers will be allowed to include a link to a full list of their published work as found in a publicly available digital database such as MyBibliography or SciENcv.MyBibliography SciENcv 9/15/2015LSUHSC-NO ORS Training Series 18 New! Changes to Biographical Sketch

19. The Science Experts Network Curriculum Vitae (SciENcv), which serves as an interagency system designed to create biosketches for multiple federal agencies, pulls information from available resources making it easy to develop a repository of information that can be readily updated and modified to prepare future biosketches.Science Experts Network Curriculum Vitae This YouTube video provides instructions for using SciENcv: https://www.youtube.com/watch?v=PRWy- 3GXhtU&feature=youtu.behttps://www.youtube.com/watch?v=PRWy- 3GXhtU&feature=youtu.be 9/15/2015LSUHSC-NO ORS Training Series 19 New! Changes to Biographical Sketch

20. 9/15/2015LSUHSC-NO ORS Training Series 20 Changes to Resources and Facilities Instructions added to Resources: –Provide a description of how the scientific environment will contribute to the probability of success of the project –For Early Stage Investigators (ESIs), describe the institutional investment in the success of the investigator Definition of ESI: A Program Director/Principal Investigator who qualifies as a New Investigator is considered an ESI if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).

21. 9/15/2015LSUHSC-NO ORS Training Series 21 Application Alignment with Review Criteria: Major Examples CriteriaApplication SignificanceResearch Strategy a. Significance Investigator(s)Biosketch InnovationResearch Strategy b. Innovation ApproachResearch Strategy c. Approach EnvironmentResources There will be additional sections in some applications that align with review criteria. For example, in multi PD/PI applications, the Multiple PD/PI Leadership Plan is also aligned with the Investigator(s) review criterion. Another example would be applications in which select agents are used, the Select Agent Research section of the Research Plan aligns with the Environment review criterion.

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28. 9/15/2015LSUHSC-NO ORS Training Series 28 What Has Not Changed Need to have a good idea about how to answer an important question Reviewers need to be able to understand WHAT you want to do, WHY it is important, and can YOU do it? Need to align YOUR goals with the funding agency goals.

29. Tour of a “Typical” Application Package

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43. 9/15/2015LSUHSC-NO ORS Training Series 43 Modular Budget Spreadsheet is not part of form; for reference only

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47. 9/15/2015LSUHSC-NO ORS Training Series 47 Detailed Budget Spreadsheet is not part of form; for reference only

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64. 9/15/2015LSUHSC-NO ORS Training Series 64 Application Complete… …Next Steps

65. 9/15/2015LSUHSC-NO ORS Training Series 65 Be sure to save the completed application package Clicking the “Check Package for Errors” button will only check for Grants.gov errors – not NIH errors. NIH errors will be caught either during ORS review, or by the validation process in eRA Commons. Applications are submitted to the NIH, via Grants.gov, by authorized Office of Research Services Personnel. See “Grants.gov” presentation for more information.

66. 9/15/2015LSUHSC-NO ORS Training Series 66 Resources NIH has developed 2 Application Guides specific to the SF424 (R&R) http://grants.nih.gov/grants/funding/424/ Includes instructions embedded in the actual forms as well as agency- specific instructions Agency-specific instructions are denoted by the HHS Logo:

67. 9/15/2015LSUHSC-NO ORS Training Series 67 Resources Details of 2010 Application Changes: –http://enhancing-peer- review.nih.gov/docs/application_ changes.pdfhttp://enhancing-peer- review.nih.gov/docs/application_ changes.pdf Overview of Enhancing Peer Review: –http://enhancing-peer- review.nih.gov/http://enhancing-peer- review.nih.gov/

68. Coping with Time Constraints The #1 observation we receive when delivering these sessions is that “time constraints” impede the success of our participants. Here are some general tips:  Follow the proposed “9-month timeline” we presented in the “Grants.gov” session to determine what tasks need to be completed, and when;  Invest your time in attending the ORS PDS sessions so that you don’t waste time downstream looking things up that you could have learned during a single session;  Use the resources available to you, including this presentation, which is posted to the ORS web site. It will provide you with text for every single “standard field”, so again, you don’t waste time looking things up; and  Delegate much of the “form-filling” to one or more laboratory or administrative persons. Spreading the burden around automatically breaks the big task into smaller, more manageable pieces – and provides grad students and postdocs to early and frequent exposure to the NIH application process. 9/15/2015LSUHSC-NO ORS Training Series 68

69. Questions?

70. Thank You!