Getting Your Research Funded

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Getting Your Research Funded

• Isaac Zak Kohane, MD, PhD

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Do I Need to Get Funding?

• Yes Important for your career
• confers legitimacy on you and your research
• as prized as publications in best journals
• important in the promotion process, particularly
  from Assistant Professor on up
• Certain types of grant make you movable
• Grants will set you free!

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Do I Need to Get Funding?

• Yes - research ALWAYS costs
• only your time
• the space that you sit in
• your computer, office supplies
• your team -
• high quality research requires at least good data
  management and statistics
• you may be able to hire critical help (e.g. a
  research nurse)

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Do I Need to Get Funding?

• Yes - patient care costs/expenses
• if test are done for research, you/your mentor
  must cover costs
• it is inappropriate (and illegal) to bill
  insurance

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When Should I Apply for Funding?

• Initial grant proposals (apart from fellowships)
  are usually written in the last year of
  fellowship or early junior faculty
• But earlier is better!
• Timing should be carefully planned - stronger
  grant proposals have some carefully collected
  preliminary (pilot) data
• demonstrates commitment
• some experience should translate to a more
  practical proposal
• drive your mentor to help you get that early.

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What Type of Funding Should I Apply for?

• Investigators at all levels should concentrate on
  sources targeted to them
• young investigators should always look for a
  training or mentored grant as a first step
• Ask your mentor for suggestions
• Find out what types of funding other junior
  people in your department got
• Get copies of their grants (the successful ones)

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What Types of Funding are There?

• NIH
• Clear and present danger
• Where the action is.
• Foundation/ Society/Association
• Industrial
• Intramural

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Get with the millenium!
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Seek and ye shall find
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Some Junior Research Grants

• NIH - K08 Mentored Clinical Scientist Development
  Award
• focuses primarily on laboratory based research by
  individuals with clinical training
• NIH - K23 Mentored Patient-Oriented Research
  Career Development Award
• focuses on research conducted in human subjects
  (investigator actually interacts with the human
  subjects)
• NIH - NIH Pathway to Independence (PI) Award
  (K99/R00)
• 2 years of mentored and 3 years independence
• contingent on securing an independent
  tenure-track or equivalent research position

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K23 and K08 Grant Proposals

• The purpose of these mentored grants is to
  prepare you for a career in investigation
• They should be structured like a 5-year
  education-plus-practice program tailored
  specifically to you and your experience and needs
  and leading to independence
• Depending on your background, it may make sense
  to include course work early
• Besides your mentor, some people ask a small
  committee to review their progress at intervals
  (like a doctoral committee)

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What are the Keys to Success?

• YOUR MENTOR OR MENTORSHIP TEAM
• A well prepared proposal, critically reviewed by
  as many reviewer-like people as possible
• Having new or original ideas or approaches
• STARTING AS EARLY AS POSSIBLE

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What are the Keys to Success? (1)

• Keep it simple.
• Think about the mind set of your reader.
• Repeat without being annoying
• Diagram (literally) what you are going to do.
• Time-line it to show you are in touch with
  reality.
• Promise less, do more

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What are the Keys to Success (2)?

• Get your mentor to sign off on Specific Aims
  before anything else.
• Paying exquisite attention to detail of your
  methods
• Precisely describing the logistics of your study
• exactly how will each aspect of your study be done

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Step 1 - Familiarize Yourself with the Funder

• Review grant proposals from other people who were
  successful in getting funded
• Review the types of projects that have been
  funded previously - make sure that yours fits
• Check the web site to find out who reviews their
  grant proposals

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Step 2 - Get Organized

• Meet with your mentor (and CRP)
• map out grant proposal sections
• find out what all the institutional deadlines are
  e.g. budgets, sponsored programs, department
  chair sign off, resources and environment
  statements etc.
• develop a timeline with deadlines you MUST keep

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Step 3 - Start with a Concept Sheet

• A pre-proposal usually 2-3 pages
• Spend time developing and refining your specific
  aims and hypotheses
• You can (and should) come back to these over and
  over, but having them very clear from the start
  will smooth and accelerate and your progress.

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Step 3 - Start with a Concept Sheet

• Provide key background points
• why your aim is important (e.g. public health)
• justify need and timeliness of your approach
• Describe what you have already done to start to
  address this problem
• Outline (e.g. with diagram) a possible study
  design, explaining key items such as
• intervention, controls, outcomes

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Step 4 - Get Everyone to Review

• Review with ALL your mentors
• Review with other potential reviewers, as
  directed by your mentors
• When optimized, under your mentors guidance
  consider discussing with contact people at
  Foundations, NIH

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Whats in an NIH Type Grant Proposal-
Administrative

• Face Page - complete at end
• Description (abstract), list of places where
  grant work will be done, list of key personnel -
  done towards the end
• Table of Contents - complete at end
• Budget and Budget Justification - work with
  mentor, CRP/GCRC ASAP

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K23 and K08 Grant Proposals

• Budget issues
• You must spend at least 75 of your time on
  grant-related work
• Salary maximum for K23s is 75,000 from the
  grant
• If this is supplemented it must be from
  non-federal funds
• For K23s, up to 25,000 additional funds for
  other expenses
• These can be course fees, materials and supplies,
  tech support, statistical services, travel
• Occasionally these can be increased to 50,000
• Overhead is paid at 8

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Health Professions
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Research PhD
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Whats in an NIH Type Grant Proposal -
Administrative

• Biosketch and other support for all key personnel
  and consultants - get as early as possible
• Resources - work with mentor. If this is a
  clinical research grant, work with CRP, GCRC ASAP
• space, equipment, etc.
• CRP, GCRC, etc.
• Checklist - complete at end

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Whats in an NIH Type Grant Proposal - Research
Plan

• Sufficient information to evaluate the research
  project - independent of any other document (e.g.
  Appendix)
• maximum 25 pages (Research Plan 13 page)
• conform precisely to type size and space
  requirements - proposal will be rejected if it
  does not

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Research Plan

• Organized as follows
• Section A Specific Aims
• Section B Background and Significance
• Section C Preliminary Studies
• Section D Research Design and Methods

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Research Plan - Specific Aims - Section A

• Content - lt 1 page
• purpose of proposed research (1-2 sentences)
• explain very briefly how your research came about
  - previous work, pilot data, etc.
• list your specific aims (the overall objectives
  of the research)
• keep the number down, but, at the same time, be
  sure they are adequate for the whole grant period
  (2-5)
• specific hypotheses that you will test
• Tie these to the Specific Aims (1-2 per SA)

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Research Plan - Background and Significance -
Section B

• Content - 2-4 pages
• suggest splitting into sub-sections
• B.1 public health importance of the work
• B.2-B.x review the knowledge to justify your
  specific aims, experimental/observational
  approach
• B.x1 restate the importance of your work in the
  specific context of your field of investigation -
  consider using bullet points

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Research Plan - Background and Significance -
Section B

• Get across
• significance of your research
• that you have reviewed the literature critically
• where the gaps in knowledge are
• how your work will fill gaps in knowledge
• Dont make this section too long
• Young investigators often get carried away, eager
  to show their scholarship. This is a proposal,
  not a review.

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Research Plan - Preliminary Studies, Section C

• Content 6-8 pages
• describe YOUR past experience, accomplishments
  directly relevant to the research topic -
  emphasize anything published
• critically interpret your data - show how they
  support your proposed research
• document your experience with getting required
  patients - mentors experience OK

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Research Plan - Preliminary Studies, Section C

• Content 6-8 pages continued
• document your experience (or mentors or team
  members) with precisely the methods or approach
  that you plan to use
• ideally document track record of working with
  your mentor, other team members, etc.
• break text up with figures, diagrams

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Research Plan - Research Design and Methods,
Section D

• Content - rest of pages up to 25
• suggest splitting up into sections
• Always organize by specific aims
• Be sure to address all your hypotheses

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Research Plan - Research Design and Methods,
Section D

• Content - rest of pages up to 25, continued
• justify everything - design, intervention,
  outcome measurements and timing of measurement
• In studies on human subjects, describe precisely
  who will be studied - have formal and specific
  inclusion and exclusion criteria
• explain how these people will be recruited and
  again show how you will have more than enough to
  complete the study

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Research Plan - Research Design and Methods,
Section D

• Content - rest of pages up to 25, continued
• explain exactly what the study logistics are and
  provide a patient specific data collection
  schedule
• describe the reliability, accuracy of all your
  measurements
• dont gloss over difficult measurements - explain
  precisely how you will solve the problem
• focus on novel measurements and how you will
  establish their accuracy, reliability, etc.

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Research Plan - Research Design and Methods,
Section D

• Content - rest of pages up to 25, continued
• have a well described section on how you will
  evaluate and monitor the safety of study
  participants - contact CRP for help
• need a strong statistical section
• how exactly did you decide to study the specified
  number of patients - what assumptions did you
  make
• how exactly are you going to analyze your data
• precisely what will you do when patients drop
  out, etc.

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Research Plan - Research Design and Methods,
Section D

• Content - rest of pages up to 25, continued
• explain exactly how your data will be managed to
  ensure high quality - contact CRP for help
• describe what you will do ensure that information
  of the highest quality will be collected -
  contact CRP for help

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Research Plan - Research Design and Methods,
Section D

• Content - rest of pages up to 25, continued
• explain how your study team will be organized
  e.g. do you have a scientific advisory board,
  data and safety monitoring board - contact CRP
  for help
• describe potential problems - things that
  reviewers are likely to target and how you have
  already solved that problem in section D.x above
• either here or in the budget justification,
  provide a detailed time-line indicating what you
  will have achieved when

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Research Plan - Human Subjects, Section E

• Provide detailed description of exactly what will
  happen to human subjects who participate in the
  research
• Address issues of gender, children, and minority
  inclusion. This often may seem trivial in
  pediatrics, but it is very important to the NIH.
• Explain exactly what research material will be
  obtained and whether patient identifiers will be
  attached to this material - how will you ensure
  patient confidentiality

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Research Plan - Human Subjects, Section E

• Describe the subject recruitment plan and
  approach to informed consent/assent, indicating
  that the research will be submitted to the IRB.
• It is often helpful to discuss with the IRB ahead
  of time.
• Describe any potential risks - physical,
  psychological, social, legal - assess likelihood
  and seriousness - describe alternatives that will
  be offered to patients

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Research Plan - Human Subjects, Section E

• Focus on what procedures you have put in place to
  protect against or minimize risk - including loss
  of confidentiality, adverse events, etc.
• Describe why the risks are reasonable in relation
  to anticipated benefits to subjects and in terms
  of importance of knowledge that can be expected
  from the research

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Research Plan - Human Subjects, Section E

• If it is appropriate (e.g. a clinical trial),
  explain how safety monitoring will take place.
• Often helpful to have one or more outside people
  as part of a Monitoring Committee who at regular
  intervals review the data so far for safety.

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Research Plan

• Section F - Vertebrate Animals
• Section G - Literature - be concise, standard
  format
• Include relevant references by known reviewers
• dont misspell a reviewers name!
• Section H - Consortium/Contractual Arrangements -
  contact Sponsored Programs if this applies

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Research Plan

• Section I - Consultants - attach glowing letters
  indicating that they think the research is
  important and that they will do what they say
  they will do
• Appendix
• do not use to get around the 25 page limit
• appendix only goes to primary reviewers
• provide material that supports your capabilities

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Information for K08 or K23 Grant Proposals

• Specialized Information
• letters of reference (need 3 - referees address
  your competence, potential for an independent
  career - cannot come from your mentor)
• your background, career goals, career
  development, training plan during award
• statement by sponsor - explaining how the award
  will enhance your career
• environment and institutional commitment to you

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BIG NEW Challenge

• Electronic submissions!
• 1 month pre-deadline (changing again in 2009)
• Get your OSP lessons.

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Foundation Grants

• Variable instructions
• Most follow similar structure to the NIH grants
• Learn from previously successful applications

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Common Reasons for Failure?

• Lack of clarity and focus in the specific aims
• Lack of acceptable scientific rationale
• Lack of knowledge of published relevant work
• Lack of pilot data, no-one in your team has
  experience in essential methodology

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Common Reasons for Failure?

• Lack of attention to detail in your research
  methods - superficial, overly ambitious
• Lack of a critical approach
• Lack of recognition of potential problems and
  proposed solutions
• Lack of value of the proposal - result and
  methods already well established

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Common Reasons for Failure?

• Lack of confidence that you will complete the
  protocol
• it must be clear that you (and other relevant
  people) will spend enough time on the project
• demonstrate that you have all the necessary
  people, PATIENTS and laboratory resources to be
  successful

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Common Reasons for Failure?

• STARTING TOO LATE or
• SEEKING HELP TOO LATE