basics in grantsmanship and ethical conduct of research ... · - (a) start specific aims and review...

Basics in Grantsmanship and

Ethical Conduct of Research (MIR 510) Session 1

September 30, 2016

Tools of the trade of grantsmanship

Milestones

Year 1

Year 2

Year 3

Year 4

Year 5

Courses

Qualifying Exam

Research

Milestones

Year 1

Year 2

Year 3

Year 4

Year 5

Qualifying Exam

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

Long-term:

Provide toolbox for

successful applications

Short-term:

Pass QE!

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














Francis S. Collins, MD, PhD

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

getting funding…. And if you're a young

investigator now trying to get your lab up and

going, you're facing this one chance in six that

your application might get funded...”

Chronicle of Higher Education

February 11, 2015

Comments from NIH Director

- Take home message: many good

proposals won’t get funded - higher

stakes to be competitive.

Outline





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

“Thank you for that fascinating presentation. Who would like to be the first to trash it?”

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

qualifying exam committee member to

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 evaluation of the Specific Aims with the goal of helping the

student to improve and/or modify them.

See Immunology graduate handbook for additional details


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).


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.


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





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!


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

Submit

Outline project

Draft proposal

Submit

Get feedback (lab meeting)

Identify strengths/weaknesses

Revise

Get feedback

Identify strengths/weaknesses

Revise

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

Total MINIMUM time – 5 months

deadline A 4 wks

B 4 wks

C 2 wks

D 4 wks

E 4-6 wks

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

- 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

Good Mentor Relationships

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





Grant Writing Wisdom

Impact, impact, and impact………

Essence of success

NIAID Funding News

Impact – the likelihood that a project will have a

sustained and powerful influence on the field.

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) research design, (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

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

Define Specific Aims

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

“Explain how application challenges and

seeks to shift current research or clinical

practice paradigms”

“Describe any novel theoretical concepts,

approaches, methodologies,

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

Focus on innovation in study design & outcomes

Spell it out - give reviewer talking points for discussion

Suggested length: ½ p

Adhesion &

Transmigration

IL-6

DC FRC

sIL-6R/gp130

AP1 IRE Inflammation Immune

Surveillance

Aim 1

Aim 2

Aim 3

Icam1

HEC

P 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, methodology, 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

can deliver “NIH description”

Approach

Anticipate problems &

include Plan B – illustrate

decision tree branching to

next steps

Suggested length: 3 - 4 p


Plan A

Plan B

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

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,

Environment

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

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