website: where you can find all necessary forms! NIH Grant Writing 101 ASCEND March 2015

How do I start? Have a research idea! Get Excited! Get knowledgeable! Get Ready (get into writing mode)! Give yourself enough time! Be prepared to rewrite a lot and to get feedback before submitting! Think about the longer term (Impact Statement!) –What are my ultimate goals for this research? –What is my capacity within my institutional context and career trajectory?

The NIH grants format (as modified for ASCEND) Face page, Project Summary, Project Relevance, performance site/personnel (NIH format pages) Budget (form) Budget justification (2 pages max) Biosketch (4 pages max) The Research Plan(6 pages total!!) Specific Aims (1 page) Research Strategy (5 pages total) – Significance – Innovation – Approach – Impact

The NIH grants format (as modified for ASCEND) Face page, Project Summary, Project Relevance, performance site/personnel (NIH format pages) Budget (form) and budget justification (2 pages max) Biosketch (4 pages max.) The Research Plan(6 pages total!!) Specific Aims (1 page) Research Strategy (5 pages total) – Significance – Innovation – Approach – Impact

Specific Aims Rule of Thumb – no more then 3 aims for a small grant like this; 1 or 2 Aims may be OK What is a Specific Aim? How does it differ from a research goal or objective? How to structure the specific aims page? – Note: this page is the “calling card” of your application!!

How to structure the Specific Aim page? Should be “stand alone” (a reader should know exactly what you want to do in the grant and why): – Briefly explain the significance of the project – Provide the rationale for the research based on the “gap in the literature” the project addresses – State the overall research goal – Brake-down the research goal into specific aims that explain what will be done and how, to address the stated goal

Research Strategy (section 5.5 page I-46 in the PHS 398 guide) Significance (no more the ½ page) 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. Innovation (no more the ½ page) 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 intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s). Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

Research Strategy (section 5.5 page I-46 in the PHS 398 guide, modified for ASCEND) Approach (this should be the largest section of your proposal! Here is were you need to convince the reviewer that you know what you are doing and have the necessary skills to pull it off) 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. 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. If you have preliminary data to support project feasibility, show them here! If you have used the proposed techniques in other (published) studies, indicate this here! Point out 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 below.

Impact ( ASCEND proposal requirement) The ASCEND mission is to Build sustainable research infrastructure! A detailed personal development plan should address: – How will this funding “jump start” your ability to attract external funding in near future? – How will you disseminate (publish!) your results? – How does or will this funding impact your own and your department’s overall research infrastructure and (undergraduate/graduate) training capacity? – How will this funding support your ability to engage in interdisciplinary collaborations on- or off-campus;? – If you are a beginning investigator, identify (a) mentor(s) (on or off campus) with appropriate research expertise!

Other important sections Budget Justification – Must explain in detail how $$ will be used and why specific items are essential to the project. If an item is not sufficiently explained is likely to be cut! Project Summary – This is your grant “abstract” and also should be “stand alone”; it will be used in assigning your reviewers. (I suggest that this is the last part of the proposal you write!) Project Relevance – This is a one or two sentence statement that should identify how/why this project is relevant to NIH goals (public health relevance!

The “New” NIH biosketch A. Personal Statement Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application. Within this section you may, if you choose, briefly describe factors such as family care responsibilities, illness, disability, and active duty military service that may have affected your scientific advancement or productivity.

IRB and IACUC If you are proposing to use human subjects, you will need to get Institutional Review Board (IRB) approval for your protocol; Contact Dr. Edet Isuk (chair) for information on how to apply; If you are proposing to use vertebrate animals you must get approval from the Internal Animal Care and Use (IACUC) committee. Contact Dr. Pamela Scott Johnson (chair); Your protocols should be submitted for review at the time the grant proposal is submitted but do not have to have completed the approval process until the start of funding.

Strategies for a Successful Proposal Know your background literature well and cite up to date information; If the reviewer catches you on 1 or 2 sloppy or inaccurate citations, you loose credibility. Even if much of the background is based on your own, previous citations, make an effort to include the perspective that other’s have on this area of research. Even if not much new data exist in the field, place your work into an up to date conceptual framework with up to date citations.

Strategies for a Successful Proposal Keep your reviewer happy and submit a “clean” proposal Comply with the required format so your reviewer does not have to hunt for the information; Read the directions carefully and follow them to the Point! Leave yourself enough time to edit your writing and to have someone else with relevant expertise give you feedback about clarity; Make sure your proposal has been proof-read well, for typos etc. by someone other then you! Beware of cutting/pasting from previous proposals; its easy to miss sentences and phrases that should have been edited out.

Strategies for a Successful Proposal Get the “nitty/gritty” (structure and wording) right Do your Specific Aims to actually test what you want to find out? Are your Aims aligned so they are not contingent on the specific outcome of an experiment? How to design your studies so you actually get the answers you are going for. My perspective: You cannot do this on your own! You need to discuss this with colleagues you trust and get honest critical feedback, even if it hurts.

NIH resources Grants process overview (not needed here but informative for future): Original NIH forms (for references) are available at: s398.html – For this grant, use the set of forms posted on the ASCEND website.

Good Luck!