Basics in Grantsmanship and Ethical Conduct of (MIR 510) Session 1 September 30, 2016

Tools of the trade of grantsmanship Milestones

Year 1 Courses Year 2 Qualifying Exam Year 3

Year 4 Research

Year 5 Milestones

Year 1

Qualifying Exam Year 2

Year 3

Year 4

Year 5 Gain familiarity with:

• Anatomy of scientific research grant • Techniques in effective grant writing • Peer-review process for federal grant applications Faculty Sharon Evans PhD, Immunology Joseph Skitzki MD, Surgical Oncology Scott Abrams PhD, Immunology Brahm Segal, MD, Immunology, Infectious Disease, Director Faculty Development Kristopher Attwood, PhD, Biostatistics and Bioinformatics Brahm Segal, MD, Infectious Disease, Judith Epstein MS, Director, Grants and Foundation Office

Short-term:  Pass QE!

Long-term:  Provide toolbox for successful applications

Outline

 Basic introduction to grant process

 Qualifying exam requirements

 Tips for successful grant writing

 Nuts and bolts of grant application

Sources of Health Research Funding http://nexus.od.nih.gov/all/2013/09/24/one-nation-in-support-of-biomedical-research/ Sally Rockely, NIH Deputy Director for Extramural Research Francis Collins, NIH Director Comments from NIH Director

NIH Budget FY15 “…Well, certainly, everybody's hoping that we might turn the corner in what has been a pretty difficult 12 year period. ….I'm encouraged by the president's putting out this $1 billion increase, 3.3%..... I'm guardedly optimistic, because the one thing that both houses and in both branches seem to agree is that medical research is really important. It's our best hope for answering many of the difficult challenges we have with health, and it's about the best way to stimulate our economy at the same time. …. We are at historically low levels of success for grand applicants actually Francis S. Collins, MD, PhD getting funding…. And if you're a young investigator now trying to get your lab up and - Take home message: many good going, you're facing this one chance in six that your application might get funded...” proposals won’t get funded - higher Chronicle of Higher Education stakes to be competitive. February 11, 2015

Outline

 Basic introduction to grant process

 Qualifying exam requirements

 Tips for successful grant writing

 Nuts and bolts of grant application

Qualifying Exam Schedule

Step 1: June - July (Year 1): Preparation 1 Select research laboratory

Step 2: July – September (end of Year 1): Preparation 2 Student receives their seminar date from the Department. Selection of Thesis committee

Step 3: Sept-January (Year 2): Thesis Committee Meeting Broadly discuss scope of project and aims (further delineation of aims will occur after QE seminar)

Qualifying Exam Seminar

Step 4: March-June (Year 2):

Goals:

• Evaluate student’s ability to clearly present and defend the rationale, hypotheses and Specific aims of proposal in oral format.

• Enable thesis committee and “Thank you for that fascinating presentation. qualifying exam committee member to Who would like to be the first to trash it?” evaluate the proposed Specific Aims. Qualifying Exam Seminar

Guidelines:

• The Specific Aims page must be provided to the qualifying exam committee 1 week prior to the scheduled seminar.

• Student presents departmental seminar on their proposed research topic to entire department.

• Seminar will encompass background information and broadly based specific aims.

• Thesis committee and a member of the qualifying exam committee will meet following the seminar to discuss the student’s performance and will award a pass/fail for this stage. This meeting will also include a detailed of the Specific Aims with the goal of helping the student to improve and/or modify them.

See Immunology graduate handbook for additional details Qualifying Exam Schedule

Step 5: Revision of Specific Aims

• The student will be given 1 week from their seminar date to modify/finalize their specific aims and will provide the thesis committee with a “Specific Aims” page for approval.

• This page will be a single page and will contain a brief intro/background section and the specific aims. The committee will vote to accept or not accept the aims.

Step 6: Proposal Preparation:

• Once the Specific Aims page is approved, the student will be given 4 weeks to prepare a proposal.

• The proposal will be written according to the modified NIH guidelines (7 page limit excluding references).

Qualifying Exam Schedule

Step 7: Oral Examination (Completed by September of 3rd year):

• Oral exam is scheduled by the student and chair of the QE at least 1 week, but no more than 2 weeks after the committee and a member of the qualifying exam committee receives the final draft of the proposal.

• Exam is a closed session and will cover areas of general immunology and the proposal.

Qualifying Exam Schedule

Step 7: Oral Examination

• This exam will not include a formal seminar, however the student can present an abbreviated seminar (3-4 slides maximum) summarizing overall scope of the project, rationale, impact, and Specific Aims.

• The committee will vote to pass or fail the student based on this exam.

• In some cases students will be required to take an oral retest (and in some cases rewrite the proposal) if their performance is deemed unacceptable. An additional QE committee member will participate in the retest. The student must pass the retest to remain in the graduate program.

Outline

 Basic introduction to grant process

 Qualifying exam requirements

 Tips for successful grant writing

 Nuts and bolts of grant application

Things to Keep in Mind

. Writing successful grant applications is a long process that begins with an idea.

. Money begets money!

. Individuals awarded grants in the past are more competitive and thus more likely to receive funding in the future. Preparation of QE Written Proposal

Professional grant writing OR Grant writing as a profession!

www.CartoonStock.com Magic Formula for Success

Work hard at it!

www.CartoonStock.com The Big Picture

 Is it new, not me-too?  Is it practical?  Can you do it?  Is it fundable? What Boosts an Application?

 Originality  Clarity of message & approach  Your credentials  Clear and testable hypothesis  Potential for impact on field: fill a gap!  Presubmission review  Understanding the criteria for evaluation What Sinks an Application?

 Lack of originality and/or significance  Poor knowledge base  Lack of clear hypotheses and approaches  Essential expertise and/or resources not demonstrated  Inadequate communication Preparing the Proposal

Write Outline project Get feedback (lab meeting) Identify strengths/weaknesses Revise Draft proposal Get feedback Identify strengths/weaknesses Revise Submit Submit Know Your Target Audience

 Assume you are addressing a colleague who is knowledgeable in the general area, but who does not necessarily know the details about your research question.

 Most readers are ‘lazy’ (overloaded) and will not respond well to a poorly organized, poorly written, or confusing proposal.

 Remember that reviewers learn a lot about you from your application. Clear Communication is Critical

 Abraham Lincoln believed in extensive editing and being concise. – 272 words in Gettysburg Address

 Need exciting, accessible, cohesive narrative to generate enthusiasm

 Spend more time on application strategy before writing.

 Make everything as simple as possible, but not simpler. – Albert Einstein Beginning to Write

 Allow enough time

 Make a schedule for each section – stick to it! Set a timeline - Choose a grant deadline - March 12th at midnight (for example) - Count backward to create initial deadlines - (A) start specific aims and review with mentors - (B) begin first draft - (C) first full draft and seek criticism - (D) begin work on final draft - (E) mentor review of final draft

4 wks 4 wks 2 wks 4 wks 4-6 wks A B C D E deadline

Total MINIMUM time – 5 months Pay Attention to Format

ALWAYS write from carefully crafted outline (topic sentence!!)

 Use subheadings – function as ‘mini-headline’

 Make sure there’s lots of white space – don’t overcrowd the page

 Make sure figures large enough to be legible with concise legends Grab the Reviewer’s Attention Up Front

Find creative ways to separate your proposal from the pack Keep the Reader Interested

 A successful proposal reads like a detective novel

 The reviewer should want to keep reading and is led to an ‘aha’ moment when he/she is convinced that this is the most important thing to do next.

Context, Context, Context  It is essential to frame ideas in the context of current dogma

 Demonstrate knowledge, expertise; be wary of jargon, cookie-cutter narrative

 Express your individuality & personality The Proposal at the Formative Stage

Gut–check:  What is the topic? Why is it important?

 What are your hypotheses?

 What are your research methods? Get Feedback and Revise

The best writing is re-writing. E.B. White Establish Mentor Relationships

. If you are seeking a mentored grant (eg Predoc grant, K award), - you will need a mentor - or mentors

. If you are seeking an independent investigator award, - you will need a mentor - or mentors Good Mentor Relationships

- Mentor should be well-funded - Mentor should be senior (tenured at least) - Mutual benefit - you need your mentor - you benefit your mentor - Shared space - Shared resources - Must be willing to take time with you - to give criticism - to help with grants Steps to Success

. HAVE SOMEONE ELSE READ THE GRANT before you send it in (give them time)

. Start early

. Work off a preliminary budget – sure fire way to prevent ‘expansiveness’

. Determine early who you need to help

. Use the reviews to make yourself better (even if grant is funded) Outline

 Basic introduction to grant process

 Qualifying exam requirements

 Tips for successful grant writing

 Nuts and bolts of grant application

Grant Writing Wisdom

Impact, impact, and impact………

Essence of success

Impact – the likelihood that a project will have a sustained and powerful influence on the field.

NIAID Funding News Evaluation Criteria Guide What Makes it Into the Proposal

. SIGNIFICANCE . INVESTIGATOR . INNOVATION . APPROACH . ENVIRONMENT Nuts and Bolts of the Proposal

. TITLE – never under-estimate its importance – sets up proposal; don’t be too specific

. ABSTRACT – provides readers with first (and last) impression of your project Should explicitly explain key elements: (1) the purpose, (2) specific goals, (3) , (4) methods, and (5) significance (contribution and rationale) Research Plan (for 6 p proposal)

. Specific Aims (1 p)

. Significance (1 - 2 p)

. Innovation (½ p)

. Approach (3 - 4 p) Specific Aims

. The MOST important page of Research

Plan (1 p limit)

. New focus on impact of results on the field

. This page sells grant (including study

design) to non-assigned reviewers – may

be only page they read Specific Aims

. Creates focus for application . Conveys big picture – impact, significance, innovation . Conveys relevance to public health . Explains why you chose the project . Milestone-driven objectives that will provide useful data whether outcome is positive and negative Grab reviewer’s attention Define Specific Aims . Goals that test hypotheses . Specific exploratory aims may be used, but should be explained . Achievable during the grant funding period

Specific Aims are the foundation of any grant Specific Aims

Common pitfalls: . Lack of original or innovative idea Specific Aims

Common pitfalls: . Too ambitious Specific Aims

Common pitfalls: . Fishing expedition Specific Aims

Common pitfalls:

. Endpoints not quantitative

. Incremental advances in knowledge

. Not achievable during funding period

. No significant impact (even if aims achieved) on the field

. Too many aims (> 1/y) The universe is vast – why would it matter if you completed the proposed studies? Significance

. “Explain importance of problem or critical barrier to progress in field being addressed”

NIH description Significance

. “Explain how project will improve scientific knowledge, technical capability, and/or clinical practice”

NIH description Significance

. “Describe how concepts, methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if proposed aims are achieved”

NIH description Significance

. Establish significance through review of published/unpublished data in field (including own)

. Identify gaps in current knowledge

. Justify hypotheses & approach

. Clearly state public health implications

. Suggested length: 1 – 2 p

NIH description Significance

Common pitfalls: . Inappropriate, incomplete or haphazard use of literature

. Limited rationale for proposal (no evidence that data obtained will be new or fill gaps)

. Uncertainty regarding future direction or significance of results

. Insufficient or missing discussion of relevant published literature Innovation Innovation Innovation

. “Explain how application challenges and seeks to shift current research or clinical practice paradigms”

. “Describe any novel theoretical concepts, approaches, , instrumentation, or interventions to be developed or used and any advantage gained” NIH description Innovation versus Significance

. Significance is why the work is important to do

. Innovation is why the work is different (better than) what has been done before

Innovation

. Demonstrate the potential gains are not merely incremental . Explain why concepts & methods are novel to your field . Summarize (without detailed data) novel findings to be presented as preliminary results in Approach Innovation

Adhesion & Transmigration

Aim 3 P P Immune Inflammation AP1 IRE Icam1 Surveillance HEC sIL-6R/gp130 IL-6 Aim 2 Aim 1

DC FRC

. Focus on innovation in study design & outcomes . Spell it out - give reviewer talking points for discussion . Suggested length: ½ p Innovation

Common pitfalls: . No novelty in concept or methods Innovation

Common pitfalls: . No novelty in concept or methods . No measurable impact on biomedical research and/or clinical care . No ‘paradigm shift’ . Too similar to other funded or published research Approach Approach

. Develop well designed game-plan to describe overall strategy, , and analyses to be used to accomplish specific aims. Approach Steps to Success

. Do the last experiment first . They give you money to do what you already have done . You write a grant to give your ‘friends’ a reason to give you money . Be visible in your field – publications & presentations . Make your first submission the best you can (first impressions matter) even if it means holding up a cycle Approach . Preliminary studies/data intercalated throughout to demonstrate experience & establish feasibility . “Describe how data will be collected, analyzed, and interpreted” . “Delineate strategy to establish feasibility & address management of any high-risk aspects of work” . Take into account rigor and reproducibility . Publication record is critical – shows that you “NIH description” can deliver Approach

Plan B . Anticipate problems & include Plan B – illustrate decision tree branching to Plan A next steps

. Suggested length: 3 - 4 p

www.CartoonStock.com Approach Common pitfalls: . Diffuse, superficial, unfocused design . Methods do not test hypothesis or achieve specific aims . Lack of experience/publications in essential methodology . Unrealistic timeline . No difficulties anticipated, no solutions proposed . Inadequate attention to data analysis, interpretation, and/or application Environment

. Emphasize unique resources, equipment . RPCI – NCI-designated Cancer Center Support Grant . Immunology Program – NIH/NCI T32 Predoctoral Training Program . Unique features of training program, opportunities (regional/national meetings; embedded in cancer institute) . Intellectual environment – 24 faculty focused on tumor immunology, Session 2 – Anatomy of Specific Aims Page (Evans)

. Dissect Specifc Aims (1 pg limit) . All the elements should be present  Significance  Investigator  Innovation  Approach  Environment IMPACT – score driving

Session 2 – Review Process Evans, Abrams, Skitzki,

. Discuss review process

. Watch 20-30’ video of study section meeting; watch how dynamics can change during live review at committee meeting

. Review handout on guidelines for study section review; emphasize importance of getting significance, impact, innovation up front in review criteria Grantsmanship Resources . Cambronero JG et al, Writing a first grant proposal. Nature Immunol 13:105, 2012. . Preparing Competitive NIH Applications for Enhanced Peer Review (NIAID) http://writedit.wordpress.com/grantsmanship-downloads/

. Mike T Lotze, MD, University of Pittsburgh

. Kenneth M Blumenthal, PhD, Associate Dean for Research & Education, University of Buffalo http://medicine.buffalo.edu/faculty_and_staff/nih_grant.html

. Market Your Science LLL, 601D W Main St, Carrboro, NC 27510, Morgan Giddings; Implement the “Bucket brigade’ in your proprosal. Grantsmanship Resources . The Chronicle of Higher Education: Manage Your Career, David A Stone http://chronicle.com/article/How-Your-Grant- Proposal/47471/ . Grant Proposals (or Give me the money!), U

North Carolina . American Cancer Society (statistics) . Cancer Education Consortium, NIH . Grant Writers’ Seminars and Workshops, The Grant Application Writer’s Workbook, Stephen W. Russell and David C. Morrison Natalie Brock has this workbook on reserve NIH Grantsmanship Resources . Medical Writing, Editing & Grantsmanship – writedit.wordpress.com – writedit.wordpres.com/nih-paylines-resources/ . NIH Grant Cycle Explained & Grant Tutorials – www.niaid.nih.gov/ncn/grants/cycle/default.htm – www.niaid.nih.gov/ncn/grants/default.htm . NIH Grant Basics – grants.nih.gov/grants/grant_basics.htm . Clinical Research Toolbox – www.nia.nih.gov/Researchinformation/CTtoolbox/ . Changes in peer review/applications – enhancing-peer-review.nih.gov/ – grants.nih.gov/grants/peer/reviewer_guidelines.htm