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 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 Most refer to applications aimed at social, behavioral and epidemiologic topics Points do not include scientific misconduct 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 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 Goal: Drafts should be circulated to coauthors at least a few weeks before the deadline Consequences: Consequences: −No time for feedback −Typos, details can lack consistency −Grant lacks polish, fabric, cross- referencing, and appearance of a ‘single voice’

4. 9) Wrong Funding Mechanism Goal: Goal: – Communicate with funders to determine agency interest and appropriate funding mechanism – For an R01, present preliminary data to demonstrate feasibility (especially for a trial) – If lacking, consider other mechanisms, such as R21, R03 or R34. Consequences: 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 Goal: To ensure safety of subjects and staff, addressing ‘4 points’, upholding equipoise in the case of RCTs Consequences: 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: Goal: – Study design factors in sufficient power in real-world situations (e.g. attrition, missing data, control for confounders) Exception: pilot study 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

7. 7) Weak Statistical Plan or Study Power Consequences: Consequences: – Reviewers will question feasibility for meeting aims, (‘believability factor’) – PI appears inexperienced – Often a fatal flaw – Statistical plan appears to have been ‘written by someone else’, or ‘cookie- cutter’, inferring inexperience or laziness – Methods can appear passé

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

10. 5) Gaps in Expertise Goal: Goal: – Every content area and method matched to at least one investigator with 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: Consequences: – Proposal appears overly ambitious – Fatal flaw for a new PI

12. 4) Proposal Poorly Organized Goal: Goal: – Background/significance should be concise, present both sides of controversies – Write for the layman, not the expert – Half the proposal should be dedicated to methods Consequences: Consequences: – Background is too long, no room for methods – Lit review appears one-sided, biased – Background too technical, reviewer is lost in jargon – Methods lacking sufficient detail or appear overly dense and hard to digest

13. 3) Missing /Problematic Hypotheses or Weak/Absent Conceptual Framework Goal: 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

14. 3) Missing /Problematic Hypotheses or Weak/Absent Conceptual Framework 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.

15. 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. Goal: Proposal deals with an important, exciting topic re: public health and/or clinical decision-making, or moves the field forward. Consequences: 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

16. “And now, for the #1 fatal flaw of NIH grant submissions…”

17. 1) Overly Ambitious Goal: 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 – Project generates preliminary data to guide future studies

18. 1) Overly Ambitious Consequences: – Threatens the ‘believability factor’ – 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, you stand to risk not being able to meet aims, which can risk your reputation

19. GOOD LUCK!