Handout for
Whitaker Foundation Biomedical Engineering Research Conference
Preparing a
Successful NIH Grant Application
Savio L-Y. Woo, Ph.D., D.Sc.
Whiteford Professor and Director
Musculoskeletal
Department of Bioengineering
Credits:
- ORS/OREF/AAOS Grant Writing Workshop, April 2003
- The Orthopaedic Research Society
- Dr. Timothy M. Wright
- Dr. Adele Boskey
- Dr. Richard A. Brand
It is not worth discussing
if one does not have
• a
good idea/novel way to address/answer/solve a clinically related problem.
• an
excellent team of investigators
• an
outstanding research environment and administrative support
I. In the Proposal
A. Specific Aims - The essence of the entire proposal, do this first
• Rationale – why the study is important
- Beyond “to increase understanding… “, rather to change the way we think, we do, etc.
• Clear, unambiguous, testable hypotheses or research questions
- Logic, past observations & data
• Include general methods
• The Hypothesis
- Clear and unambiguous path
- Clear rationale
- Posed in terms of variables
Note: Slight differences in wording may make the
difference in whether it’s important and whether it is testable by the methods
proposed
• Avoid “serial” or “contingent” specific aims
• Avoid superficial goals & objectives or statement of the obvious
Note:
Limit to 2-4 major aims
You are not going to solve
the whole world’s problems in one application.
B. Background & Significance
• Set the stage by precisely stating the problem is important
- Amplifies the specific aims
• Findings will change thinking/practices - why it’s important to know
• Your knowledge is clear, balanced and focused
• Tell a complete story (concisely)
• Ending with significance – specific to your findings
- Preliminary Studies
• Amplify critical concepts and new data you have generated to prove feasibility
- But with appropriate references
• Document your technical expertise in critical methods
- Use subsections (with titles for each)
Example
C.3.2 In situ Forces in the ACL and ACL
replacement graft during in vivo
activities
Preliminary studies were performed to demonstrate the feasibility of acquiring in vivo knee kinematics from volunteers, reproducing these motions on cadaveric specimens, and determing the corresponding in situ forces in the ACL and ACL replacement graft (For detailed methods, see Sections D.4.2-D.4.4).
C.3.2.1 Evaluation of variation of data with point cluster technique
The point cluster technique is known to have a maximum potential error of 2 mm (1.5 mm about the anterior-posterior axis, 1.5 mm about the medial-lateral axis, and 1.0 mm about the proximal-distal axis). To determine the effect of this variation in kinematics on the forces in the ACL and ACL replacement graft, we performed an experiment using two human cadaveric knees. A 134 N anterior tibial load was applied to the intact knee at 0, 30, and 90 degrees of flexion and the six DOF kinematics were recorded. Translation error corresponding to the error reported was then added randomly to each axis of knee motion. Using the same knee, the corresponding changes in the in situ force in the ACL were found to be 30±15 N, 37±17 N, 27±15 N at 0, 30, and 90 degrees of knee flexion, respectively (Figure 7). Subsequently, ACL reconstruction using a semitendinosus/gracilis tendon was performed on the same knee and the test was repeated. The changes in in situ force in the ACL graft were 25±12 N, 36±4 N, and 31± 3 NH at 0, 30, and 90 degree of knee flexion, respectively. These variations in magnitude are on the order of magnitude of those found for biological variation between cadaveric specimens, where one standard deviation is approximately ±30 N [Appendix 5].
Note: Not too little, not too much… just the right
amount!
D. Research Design & Methods
• Follow NIH guidelines – read them
• Organize this section with respect to specific aims. In each subsection, how the design/results will verify (refute) the corresponding hypothesis
- Helps to maintain reviewers’ enthusiasm
• No design is airtight
- So get the reviewers on your side by teaching & convincing them
- Appropriate and adequate so the hypothesis/research questions can be addressed
- Write defensively & cover your bases
- Include a credible power analysis
• Varying ways to organize this section
- start with an overview of design
- explain methods first (prevents skepticism)
• A list of keywords
- novel
- new
- lead the reviewers
Remember: The more novel the method and the
newer the investigator, the more the reviewers want validation
Summary - Main Points
• Research design will accomplish Specific Aims
• Methods are feasible and well developed
• Approach is original
• Data will be analyzed correctly
• Sufficient power to lead to conclusive results
• Limitations are of minor concern
• Study can be accomplished in requested time
Fianally - Close the loop!
• Test the hypothesis or answer the research question
Remember: So, don’t take any
section lightly; they’re all important!!
II. Practical Tips To Avoid Annoying the Reviewers
A. Think about the reviewer’s workload
• 80 applications to review three times a year
• 12 personal assignments
• 6 reviews to write
• 4 weeks to get it all done
• 3 days away from home and the office
• 1 big pain in the …. !
B. Make the reviewer’s job as easy as possible
• A good reviewer approaches every application wanting to support it
• You need to convince/or help the reviewer to be your advocate
• So, 1) Neatness counts
2) Follow instructions, and
3) Don’t require backtracking
Remember: You never get a second chance to make a first impression
C. Read reviewer’s mind
• I may not have time to and should not need to study your application
- Write clearly, accurately, and concisely
- Write for a qualified scientist in a related field
- Have a qualified colleague to carefully review (or better yet, study) your application and provide critical feedback
• I don’t want to have to second-guess your intentions
- Begins with the hypotheses or research questions
• I may not have time to read the appendices or go to the library
- Provide the entire story of what you propose to do and why you want to do it in a clear, concise manner
- If you include an appendix, be sure it’s worthwhile and it fully supports your proposal
- We usually bind our appendices of 10 papers into a book form so it won’t get lost
• At study section
- Reviewers not assigned to your application probably haven’t read it
- Instead, they glance at:
• Abstract
• Specific Aims/Hypotheses
• Budget & budget justification
• Biographical sketches
• Letters of support/collaboration
III. The Don’ts
• The “hide & seek” hypothesis
• Too many specific aims
• The “here’s everything I know” Background & Significance section
• The ‘here’s everything I’ve done” Preliminary Studies section
• Small font sizes
• Too high a density
• Compartmentalization (don’t overdo it)
- Part I, Section A, Subsection 2b, paragraph I, line 3
• Acronyms, abbreviations, jargon:
- “the MLB of the ICGHL”
- “the ATT of the AM bundle of the ACL after ATL
- “the Ult. Load of the FGTC”
• If you didn’t read it, then why should I?
- Typographical errors
- Word processor errors (cut and paste errors, etc.)
- Incomplete sentences
- Incorrect citations (especially from study section members)
• Figures that are unintelligible
- The unreadable caption
-
Is it a datum point or is it a smudge?
Figure 2: Plot of nothing vs. everything
IV. Successful Proposals
• An idea with IMPACT
• Significant, focused hypotheses
• Reasonable, related specific aims
• Seductive preliminary studies
• Appropriate (innovative) methods
• Clear path to strong conclusions
• Reasonable budget
• Start writing (not just thinking ) 3 or 4 months before the deadline
V. Final Analysis
• The above are easier said than done
• Pray to God or Buddha a lot!
• Good luck/Happy writing