1. Critical Elements of Successful Research Proposals Writing Clear, Logical Specific Aims and Testable Hypotheses Children’s Research Institute Biostatistics/Informatics Unit

2. Aim of Presentation To provide participants with the tools, strategies, and vision to write clear, and logical specific aims and testable hypotheses.

3. Identify a Research Question Critically review the literature to find opportunities Alert Clinician –Greg – Cataracts following Rubella Epidemic It may first be simplest to conceive of the research in the form of a question to be answered –Often leads to a broad statement that can be refined later

4. Research Question Examples Do neighborhood characteristics, e.g. crowding, violence, poverty level influence parenting capabilities and child behavior?

5. New NIH Proposal Format/Focus One Page to Define Study Aims –Introduction –Specific Aims/ Hypotheses Eleven pages to describe research strategy –Significance –Innovation –Approach

6. Introductory part of Aim Page Introductory Statement – Overall Aim –Short summary of problem/issue to be addressed Summarize –Significance of the proposed research Importance of the problem/research question Contribution of proposed research –Gap in knowledge to be filled –Health impact – Other –Impact Sustained and Powerful Influence Long term goals – place this research into the context of broader goals.

7. Example of an Overall Aim This study represents the next logical step in understanding the role that neighborhood factors exert on parenting and child development. The objective of this study is to determine whether neighborhood violence exposure is associated with the depressive symptoms in parents and interferes with parent-child relationships. Overall aims lead into specific aims

8. Specific Aims to Accomplish Overall Goal Achievable goals specific to your research study that are clear, logical, and precise, as well as supported by preliminary data. –2-4 in number are typical –Resist giving the NIH a bargain with a laundry list Specific aims state what you want to do in the order you want to do it. –Concise and to the point –Use active tense – e.g., to determine ….

9. Qualities of Good Specific Aims Clear: terms are operationally defined Logical and cohesive: –make sense –connected Precise: measurable and feasible Supported: preliminary data, prior studies –show that you can do what you say

10. Example of Cohesive Aims Aims relate: –1) maternal violence exposure to parental distress –2) maternal psychological resources to parental distress –3) maternal violence exposure and psychological resources to child behavior

11. Example of a Specific Aim To evaluate the association between violence exposure (interpersonal, community, contextual) and maternal distress and parenting. Specific aims lead to hypotheses

12. What is a Hypothesis? A statement of the expected results of a study – a prediction that can be tested

13. Qualities of a Good Hypothesis Takes a clear side Simple and concise Uses clearly-defined terms TESTABLE Usually contains the following elements Independent variable Specific relationship Dependent variable or constant

14. Examples of Poor Hypotheses Analogs to chemokine receptors can be biologically useful. A wide range of molecules can inhibit HIV infection. Prior therapy experience will predict willingness to disclose in psychotherapy. Propranolol is better than prednisolone in treating symptomatic hemangiomas of infancy. The greatest problems relate to lack of clarity or ambiguity!

15. Examples of Good Hypotheses Analogs to chemokine receptors will inhibit HIV infection. Participants with psychotherapy experience will be more willing to disclose scores on a sexual abuse scenario than participants without such experience. Propranolol is more effective than prednisolone in reducing size and relieving symptoms of hemangiomas of infancy.

16. Example of a Good Specific Aim and Associated Hypotheses Aim 1. To evaluate the association between violence exposure (interpersonal, community, contextual) and maternal distress and parenting Hypothesis 1A: Higher levels of violence exposure will be associated with higher levels of maternal depression, anger and hostility. Hypothesis 1B: Higher levels of violence exposure will be associated with increased maternal use of harsh disciplinary practices, lower levels of maternal monitoring, and less nurturing interactions.

17. Why is the aims page so important? Aims are: the backbone of your study the first (possibly only) impressions If your aims & hypotheses are poorly written, it will compromise the rest of your proposal.

18. Difficult Endeavor Intense Competition –Past funding rate- typically 25-30% Difficulty Increasing –Phasic –Falling below 20%

19. Why are grants not funded? Common Problems Problems with Aims –Lack of Significance, Impact –Lack of Originality –Lack of Focus – too diffuse –Unrealistic – ambitious, too many hypotheses –Shaky Evidence – poor rationale –Descriptive – no hypotheses tested –Untestable Hypotheses

20. Innovation In addition to significance and impact, there is the desire to support innovation –Novel paradigm or approach Treating peptic ulcer with antibiotics Fluoride in water to prevent tooth decay Prove smoking causes heart disease by preventing it in a smoking cessation trial –When possible reflect innovation in aims and hypotheses

21. Only the very best will be funded Keys to funding –Important, well-justified topic –Innovative, but feasible design –Confidence in ability to deliver quality data –Sound inferences based on sound procedures –Clarity, Coherence, and Completeness