WRITING AN EFFECTIVE RESEARCH PROPOSAL

1 WRITING AN EFFECTIVE RESEARCH PROPOSAL . Marja J. Verhoef, PhD. Robert J. Hilsden, MD MSc FRCPC. Departments of Medicine and Community Health Sciences University of Calgary Calgary, Alberta, Canada 2001, 2004 RJ Hilsden, MJ Verhoef The purpose of this handout is not to teach you how to design a RESEARCH project. Rather it is to help you translate your RESEARCH plans into an EFFECTIVE RESEARCH PROPOSAL . A well-written PROPOSAL will ease the process of obtaining institutional and ethical approval and will increase your chances of obtaining funding for your project. The WRITING of this booklet was guided by our experience WRITING proposals but also on our experiences as reviewers on institutional and granting agency review panels. The booklet is designed for health sciences researchers conducting quantitative, clinical RESEARCH . However, the general concepts are applicable to most areas of inquiry. WRITING an EFFECTIVE RESEARCH PROPOSAL 2.

2 ELEMENTS OF A RESEARCH PROPOSAL . Title Abstract Study Problem Rationale/Relevance of the Project Literature Review Specific Study objectives RESEARCH methods I. Study design II. Subjects Inclusion/exclusion criteria Sampling Recruitment plans Method of assignment to study groups III. Data collection Variables: outcomes, predictors, confounders Measures/instruments Procedures IV. Intervention V. Statistical considerations Sample size Data analysis Ethical Considerations Consent form Privacy of information Work Plan Budget RESEARCH team Dissemination Plan WRITING an EFFECTIVE RESEARCH PROPOSAL 3. KEYS TO SUCCESS TO WRITING A GOOD PROPOSAL . Overall Quality of the Study Good RESEARCH question Appropriate RESEARCH design Rigorous and feasible methods Qualified RESEARCH team RESEARCH questions matches data collection/data analysis Quality of the PROPOSAL Informative title Self-sufficient and convincing abstract Clear RESEARCH questions Scholarly and pertinent background and rationale Relevant previous work Appropriate population and sample Appropriate measurement and intervention methods Quality control Adequate sample size Sound analysis plan Ethical issues well addressed Tight budget Realistic timetable Identify strengths and limitations Quality of the Presentation Clear, concise, well-organized Helpful table of contents and subheadings Good schematic diagrams and tables Neat and free of errors Adapted from Hulley & Cummings WRITING an EFFECTIVE RESEARCH PROPOSAL 4.

3 Types of Shortcomings in NIH Grant Applications for Clinical RESEARCH That Fared Poorly Type of shortcoming Number of applications A. RESEARCH problem Hypothesis: ill-defined, lacking, faulty, diffuse, unwarranted 120. Significance: unimportant, unimaginative, unlikely to provide new info 77. B. Experimental Design Study group or control: inappropriate composition, number, characteristics 103. Technical methodology: questionable, unsuited, defective 168. Data collection procedures: confused, inappropriate 104. Data management & analysis: vague, unsophisticated 80. C. Investigator Inadequate expertise or unfamiliarity with literature, insufficient time 43. D. Resources Inadequate setting, support staff, lab, equipment. Restricted access to patient population 9. Total number of shortcomings 704. Number of applications 256. BEFORE YOU START. Developing a RESEARCH PROPOSAL takes time. The process starts by identifying a general area or RESEARCH and then developing a focused RESEARCH question to be answered.

4 Next a RESEARCH protocol is created. The protocol needs to be appropriate to the RESEARCH question, but also feasible in terms of time, resources and ethical considerations. The RESEARCH PROPOSAL is the formal description of this process. The first part of the PROPOSAL will include the RESEARCH question to be answered along with a statement of why the area of RESEARCH is important and what is known already. The second part of the PROPOSAL is the methods section, where the plan for answering the RESEARCH question is given. Depending on why the RESEARCH PROPOSAL is being written (ethical approval, submission to funding agency), other sections may need to be included in the PROPOSAL . When you are ready to start WRITING the RESEARCH PROPOSAL , the first step is to carefully read over the guidelines of whatever agency you are submitting it to. These guidelines will give the deadlines for submission and instructions for the length, structure and format of the PROPOSAL .

5 Proposals that are late or do not meet the agency's guidelines will usually be returned without being reviewed. Therefore, it is well worth the effort to obtain and carefully read the guidelines prior to WRITING your RESEARCH PROPOSAL . WRITING an EFFECTIVE RESEARCH PROPOSAL 5. Title Examples: Preoperative Anxiety (too brief). The effects of a counseling program by nurses on preoperative anxiety in children undergoing tonsillectomy. (concise but gives sufficient information). Keys to Success Informative Succinct Interesting STUDY PROBLEM AND GENERAL PURPOSES OF RESEARCH . Study Problem: Health care issue that is a concern or a problem. RESEARCH Purpose: Broad statement indicating the goals of the project. Different types of purposes include: Exploration Description Explanation Prediction/Control Some agencies want to know what are the overall objectives of the RESEARCH program ( long-term goals) and what are the specific aims of the current project ( what is hoped to be accomplished with this project).

6 Some agencies require that RESEARCH address specific areas or goals set by the agency. Examples: 1. What are problems related to unplanned caesarean deliveries? 2. Is colonoscopy accessible to all Canadian health care consumers? WRITING an EFFECTIVE RESEARCH PROPOSAL 6. Keys to Success Relevant Clear Logically argued Examples of Problems The purpose of this study is to determine the major concerns of women after a cesarean delivery. Which operative method of treating a fractured pelvis is better the Miller procedure or the Morgan procedure? Does the administration of analgesic by nurses vs. by patients themselves affect how older patients feel during postoperative recovery? WHY SHOULD THIS RESEARCH BE DONE? STUDY RATIONALE. In this section, you are arguing why your study should be done. Granting agencies may have specific high priority areas. Be sure to explain how you study fits into those areas. Ask yourself: 1.

7 Will this study generate new knowledge? 2. Will the study benefit patients, advance understanding or influence policy? 3. Will the study fill gaps in existing knowledge or resolve current controversies? Generally a study should do more than just generate new knowledge. The knowledge should in some way be useful, either by leading to a tangible benefit such as improved patient care, or a less tangible one such as addressing an area of controversy Keys to Success Positive answer to question 2 and/or 3 above Fits in the granting agency's terms of reference/mandate WRITING an EFFECTIVE RESEARCH PROPOSAL 7. WRITING an EFFECTIVE RESEARCH PROPOSAL 8. LITERATURE REVIEW. A critical summary of RESEARCH on a topic of interest, generally prepared to put a RESEARCH problem in context or to identify gaps and weaknesses in prior studies so as to justify a new investigation. RESEARCH tends to be a cyclical Theory process RESEARCH findings lead to theory development, theory leads to further RESEARCH .

8 As a Revision of Theory Hypothesis researcher, you can jump into this cycle at many places. In the literature review, you should Hypothesis confirmed or show that you are jumping in at rejected Data the appropriate place. If little is known in an area, then very Findings basic descriptive studies designed to give a preliminary understanding about a phenomenon are appropriate. However, if the area is well advanced, that type of study will be inappropriate. When reading the literature review section, a reviewer will be looking to see whether you are sufficiently knowledgeable about the area and whether your proposed work is appropriate for the level of knowledge currently existing in that area. Keys to Success Thorough, complete and up to date, but not a recitation of every study ever conducted Logical Original RESEARCH Primary sources Focus on original RESEARCH and systematic reviews Well organized/synthesized Critical appraisal Build a case for a new study Describe any controversial areas objectively Include evidence for and against your position Identify any gaps in existing knowledge WRITING an EFFECTIVE RESEARCH PROPOSAL 9.

9 WRITING an EFFECTIVE RESEARCH PROPOSAL 10. objectives / RESEARCH QUESTIONS/HYPOTHESES. Identifying the RESEARCH problem and developing a question to be answered are the first steps in the RESEARCH process. The RESEARCH question will guide the remainder of the design process. RESEARCH objectives A clear statement of the specific purposes of the study, which identifies the key study variables and their possible interrelationships and the nature of the population of interest. RESEARCH Question The specific purpose stated in the form of a question (descriptive/exploratory RESEARCH ). Hypotheses The specific purpose stated in terms of a tentative prediction or explanation of the relationship between two or more variables. A prediction of the answer to the RESEARCH question (explanatory RESEARCH ). Examples: 1. The purpose of this study is to determine the major physiologic, psychosocial and lifestyle concerns of women two weeks and eight weeks after an unplanned cesarean delivery.

10 2. Does the administration of analgesic by nurses vs. by patients themselves affect pain intensity during the first postoperative recovery day in older adults? 3. The objective of this study is to determine which operative method of treating a fractured pelvis is associated with a lower risk of postoperative infection the Morgan procedure or the Miller procedure? 4. Patients resided in rural areas of Alberta are less likely than urban patients to undergo a colonoscopy within 18 months of a curative resection for colorectal cancer. Functions 1. Provide reviewers with a clear picture of what you plan to accomplish. 2. Show the reviewers that you have a clear picture of what you want to accomplish. 3. Form the foundation for the rest of the PROPOSAL . WRITING an EFFECTIVE RESEARCH PROPOSAL 11. 4. Will be used to assess the adequacy/appropriateness of the study's proposed methods . Keys for Success Only one or two primary RESEARCH questions or hypotheses: focus on the important question.