Ten Fatal Flaws of NIH Grant Submissions and how to avoid them

1. Ten Fatal Flaws of NIH Grant Submissions (and how to avoid them) Steffanie A. Strathdee, PhD Thomas L. Patterson, PhD

2. Disclaimers These points reflect the opinion of a few seasoned NIH-funded researchers who are also chartered reviewers; but are admittedly somewhat subjective Most refer to applications aimed at social, behavioral and epidemiologic topics Points do not include scientific misconduct Points in italics reflect actual quotes that we have received in our own summary statements , and those we have written in reviews of others� applications

3. 10) Waiting Until the Last Minute Goal: Drafts should be circulated to coauthors at least a few weeks before the deadline

4. 9) Wrong Funding Mechanism Goal: Communicate with funders to determine agency interest and appropriate funding mechanism For an R01, present any required preliminary data to demonstrate feasibility (especially for a trial) If lacking, consider other mechanisms, such as R21, R03 or R34. Consequences: Feasibility questioned Study appears premature Often considered to be a fatal flaw

5. 8) Human Subjects Concern Goal: To ensure safety of subjects and staff, addressing �4 points�, upholding equipoise in the case of RCTs Consequences: Actual or perceived human subjects violation Infers inexperience and/or disregard for ethical scientific conduct Can be a fatal flaw If proposal receives a fundable score, NGA is not awarded until HRPP removes Human Subjects Concern

6. 7) Weak Statistical Plan or Study Power Goal: Study design factors in sufficient power in real-world situations (e.g. attrition, missing data, control for confounders) Exception: pilot study Power and analysis sections shown for each aim and hypothesis should link back to conceptual framework and measures present alternative strategies Should include up to date statistical techniques and software Consequences: Reviewers will question feasibility for meeting aims threatening the �believability factor� PI will appear inexperienced Often a fatal flaw statistical plan appears to have been �written by someone else�, inferring inexperience methods can appear pass�

8. 6) Lack of a Back-up Plan Goal: Present a logical, feasible plan for alternate strategies if experiment/hypothesis is not borne out as hoped Success of one aim should not depend on the success of another Consequences: Reviewers will consider this a fatal flaw Aims appear as a �house of cards�

9. 5) Gaps in Expertise Goal: Every key area and method is matched with at least one investigator who has relevant expertise Co-investigator % effort matches what is required to meet the aims Consultants included (with letters of support) to fill any gaps in expertise Consequences: Proposal appears overly ambitious Fatal flaw for a new PI

10. 4) Proposal Poorly Organized Goal: Background/significance should be concise, present both sides of controversies Need to write for the layman, not the expert Half the proposal should be dedicated to methods Consequences: Background appears one-sided, biased Background too technical, reviewer is lost in jargon Methods lacking sufficient detail or appear overly dense and hard to digest

11. 3) Missing /Problematic Hypotheses or Weak/Absent Conceptual Framework Goal: Aims should be linked to clear, testable hypotheses for which the outcome is not already well established Aims and hypotheses should map onto conceptual framework, measures, power and analysis Consequences: Application appears merely �descriptive� Hypotheses appear �pedestrian in nature� Research questions and design appear murky Study design �lacks focus� Power and statistical analysis section appears to be �cookie cutter� since they do not tie back to hypotheses/framework.

12. 2) Lack of Significance/Innovation Goal: Proposal deals with an important, exciting topic re: public health and/or clinical decision-making, or moves the field forward. Consequences: Reviewers will be bored, significance rating will significantly hamper overall score Proposal has a hard time competing with others A beautifully designed study that has no real significance or innovation will not be funded

13. �And now, for the #1 fatal flaw of NIH grant submissions��

14. 1) Overly Ambitious Goal: Project is designed to be feasible within the time frame Aims support one coherent project, not 2 or more Provide enough detail for reviewers to understand novel methods and measures Consequences: Threatens the �believability factor� Projects with too much innovation viewed as too ambitious Budget may not realistically support the aims Makes PI appear inexperienced; possible fatal flaw Reviewers may propose cutting an entire aim or 2, or may unscore the proposal after deciding they �cannot re-write it for the PI� If you are funded, stand to risk not being able to meet aims, which can risk your reputation

15. GOOD LUCK!