1. Formulating an important research question Susan Furth, MD, PhD Welch Center for Prevention, Epidemiology and Clinical Research sfurth@jhmi.edu

2. Hi, Honey—how’s everything in the world of academia?

3. Getting Started The absolute requirement for a research project is a good idea. The hypotheses formulated from this idea must be: Clear and testable Of limited scope (i.e., can be completed in less than a lifetime) Important as well as interesting New, unique, extend knowledge, solve an important problem. Focus the research on a better understanding of mechanisms that control a key biological process, or on better disease recognition, prevention, or treatment. :

4. How to get a good idea Talk to mentor, others knowledgeable about research area Develop research problem that matches your interests, background, training, pubiications Base research problem on current knowledge, research problem should present logical next step in progression from what is known, to important issue that is not Determine that the research problem is addressable by experimental (hypothesis driven) approach Identify research resources as well as any constraints :

5. Qualities of a fundable research problem Research must address important question Scope of research must be appropriate (time available) Research must be relevant Research design must be feasible (testable by you at your institution using available resources, affordable in terms of time and money)

6. Qualities of an outstanding research problem Research must contribute new knowledge to field Question must be seminal Research problem should represent a sustainable research interest Research is basis of peer-reviewed publications, recognition

7. Common mistakes in developing a research problem Don’t try to be “research-trendy” Avoid topics as opposed to clearly defined “research problems”

8. Even if you are on the right track, you’ll get run over if you just sit there. Will Rogers

9. Ten commandments for Picking a Research Project Anticipate the results before doing the study Pick an area on the basis of the interest of the outcome Look for an underoccupied niche that has potential Go to talks and read papers outside your area of interest Build on a theme

10. Ten commandments for Picking a Research Project Find a balance between low-risk and high- risk projects Be prepared to pursue a project to any depth necessary Differentiate yourself from your mentor Do not assume that clinical research is easier than basic research Focus, focus, focus

11. The Methods Section begins with a brief (no more than one page) statement of the Specific Aims of the research. The objectives of the Specific Aims page are to: Generate interest Demonstrate importance Give a concise overview of the Research Specific Aims

12. Background and Significance Background Not just a literature review (although this must be included). Provides the rationale for what you propose to do. Puts your proposed research in perspective (what it will do and the importance of the results). Preliminary Data Demonstrates feasibility. Can it be done? Can you do it? Will the results be accurate? Are your methods state-of-the-art? Will the hypotheses probably be supported?

13. Methods Study design Population: inclusion/exclusion criteria Analytic plan/ methods.

14. Methods Statistical design and analyses How will data be interpreted? Alternatives (if the primary approach fails) Pitfalls, and how they will be handled Summary What will be learned? How will the results prove they hypotheses and support the specific aims and goals? How will the results be new and important?

15. Things to include that often are not-- Gaps in our knowledge that this project will fill Why this is important (essential) to do

17. An understandable but inappropriate form of rebuttal.

18. Remember, Columbus didn’t get it right the first time either.

19. What it takes to recover from a setback— What you did—10% What you do next—90%

20. Give them what they want.

21. 1. Significance State how this study addresses an important problem. State how, if the aims of the application are achieved, scientific knowledge will be advanced. State what the effect of these studies will be on the concepts or methods that drive this field.

22. 2. Approach State how the conceptual framework, design, methods, and analyses are adequately developed, well integrated, and appropriate to the aims of the project. State/Acknowledge (with specific examples) potential problem areas and alternative tactics.

23. 3. Innovation State how the project employs novel concepts, approaches or methods. State how aims are original and innovative. State how the project challenges existing paradigms or develops new methodologies or technologies.