How to Write your Discovery Project Proposal

A successful proposal (and a successful study) begins with a simple, clear purpose. The purpose should be reflected in each of the components of the study described below. Specifically, the purpose will dictate which subjects to study, what study design to use, what variables to measure, and what analyses to perform.

Your Project Proposal should be brief; in addition to the Cover Sheet, Project Timeline, Human and Animal Subjects Form, and Faculty Mentor Statement, it should be 3-4 pages, double spaced, 12-point font, and clearly describe what you plan to do. The reviewer committee includes faculty from a variety of clinical and basic science departments, so write your proposal for a broad audience. You are welcome to use images or graphs to help convey your plan. Key items to include in your Project Proposal are:

Following are guidelines explaining what to include in your proposal. Because each study is different, not all items will be pertinent to every study. The general Project Proposal structure is:

1. Background & Hypothesis
2. Study Design & Methods, to include:
   1. Population (inclusion/exclusion criteria; recruitment procedures)
   2. Sample Size (ideal vs. achievable)
   3. Variables and how they will be measured (outcomes; exposures; potential confounders)
   4. Procedures for data acquisition (attach data sheets, questionnaires, etc.)
   5. Methods for data analysis
3. Expected Significance of Results
4. Clearly define your role in the project
5. Preliminary Literature Search (5-10 references that address your research question)

Provide a brief introduction to the problem you are investigating. This might include:

• What is the research problem?
• Why is the problem important?
• What is already known about the problem and what remains unknown?
• How will your study contribute to this field of knowledge?

State your research question in specific, measurable terms. A hypothesis is a testable assertion about the relationship between variables in your study. If you are investigating a clinical rather than a theoretical question, the hypothesis should include an effect size. For example, “Hospital length of stay will be at least 10% lower in the intervention group than in the comparison group.” The study hypothesis is different from the null hypothesis, which is only a statistical construct.

This section is where you likely need to most guidance from your Faculty Mentor. Please work with your Faculty Mentor early to be able to understand the project details in order to write this section.

Start this section by stating your study design. The study design is the logical structure of the study. This has to do with how subjects are selected and grouped and whether an intervention is imposed. Specifically:

• Is this an experimental study (where you impose an intervention) or an observational study (where you collect data, but do not intervene)?
• If it is experimental, is there a separate control group or will you compare the same subjects before and after the intervention? Experimental study designs include randomized control trials, and quasi-experimental study design.
• If it is observational, are subjects chosen and grouped based on their outcomes (e.g., survival status) or based on their antecedent conditions (e.g., smoking status)? Observation study designs include cohort studies (prospective or retrospective), case-control studies, and cross-sectional studies.

The study design and methods section should also include the following:

1. Population. The generalizability of your results depends, in part, on the population you study, so it is important to specify what that population is. Inclusion criteria define the broad category of subjects to be included (e.g., women 18-40 years of age, who have never been pregnant and who are currently using oral contraceptives). Exclusion criteria define subsets of otherwise eligible subjects who will be excluded (e.g., women with BMI < 22). Also describe how you will identify subjects (patients from a particular practice, volunteers from posted flyers, etc.).
2. Sample size. How large of a sample will you be obtaining data from? How did you arrive at this number? From the goals of the study, it is possible to calculate the goal sample size needed to achieve sufficient statistical power. In other words, this is a sample size that is large enough to demonstrate the effect you are looking for but not so large that resources are wasted. Obtaining the calculated sample size may not be practical for your project, but your Faculty Mentor can help you determine if this is the case.
3. Variables and measurements. List variables by category: independent, dependent, and confounder. Independent variables (or exposures) are putative causal factors being investigated. Dependent variables (or outcomes) are the results being investigated. Potential confounders (or control variables) are additional factors that, if not considered, can lead to misinterpretation of the main results. Most measurable factors can and do play different roles in different studies, so make the category clear. Also, describe how variables will be measured and defined. For example, if your study compares non-drinkers, social drinkers, and heavy drinkers, how will those categories be defined? If your study looks at pain as an outcome, how will pain be measured?   If you plan to use them, attach drafts of pre-existing instruments, scales, questionnaire forms, etc. to your proposal. Whenever possible, use instruments that have been used by other investigators with similar populations. This will save you work, will usually provide some insight into the reliability and validity of the instrument, and may enable you to compare your results directly with those of others. If you are developing a new questionnaire, justify why this is necessary.
4. Procedures for data acquisition. Describe the sequence of events that will take place during the study. For some studies, this can be done from the subject’s point of view. Step-by-step, describe what will actually take place.
5. Methods for data analysis. How will you use the measurements you collect to test your hypothesis? The statistical procedures you choose will depend on the purpose and study design of your project along with the scale of measurement of the variables.

Briefly describe what you expect will be the significance of the results you achieve. What difference will the answer to your research question make for the field, future research, or patient care?

Empirical research is seldom a solitary endeavor! If you will be working as part of a research team, describe what your responsibilities will be.

List 5-10 references that address your research question.