Developing a Research Protocol

This guide can be used to develop your research idea into a full fledged protocol. Once developed, it will not only serve as the cookbook for your study, but can also be used for your IRB application. It will also serve as the backbone for your presentation and manuscript

1-TITLE
Descriptive title of the research project; keep it tight, no 100 word titles.

 

 

2- RESEARCH QUESTION
Identify the specific aims for your study.

 

 

3- SIGNIFICANCE
Using the literature, establish any previous work related to your research question. This section should describe the gaping hole in the literature and how your specific aims will attempt to address it.
Remember to cite your references throughout your proposal! Pick a style from your favorite journal. Most people use numbered superscripts. The main thing is to be consistent.

 

 

4- METHODS
The next four sections encompass the methods. Traditionally, this grouping has been headed “Methods” or “Materials and Methods” but studies involving human subjects usually label this section “Patients and Methods”.

 

 

 

5- DESIGN
What research design will be used to address your specific aims? Examples include: case series, case-control, retrospective cohort, cross-sectional, prospective cohort, and randomized controlled trial.

6- SUBJECTS/SAMPLE OR STUDY POPULATION
This is where you’ll plop your patient information but, truth be told, not all studies involve patients so adjust your heading accordingly. You should describe where you will obtain your subjects, over what time period and the specific inclusion and exclusion criteria you will use.

 

 

7- PROCEDURES/VARIABLES/DEFINITIONS
This section basically describes your experimental treatments/interventions (if any), your methods of obtaining data and a description of your variables.  Provide information about a chart review in this section. Provide information about your primary outcome variable as well as all secondary outcome variables. At times it will be necessary to define these variables, so be precise.

 

 

8- ANALYSES
Use this section to provide a thorough description of the statistical tests planned, your sample size justification (if pertinent to your study) and your criterion for significance (e.g., P < 0.05).

 

 

9- REFERENCES
Use this section to provide all of the references used throughout your study. Pick a format from your favorite journal and use it consistently.

 

 

10- DATA FORM
This form is used to capture the data. The form should be constructed so that most of the information can be recorded as a short answer or a check-box. Most likely, in this day and age, a lot of the actual data accrual will be recorded directly to a computerized database or spreadsheet. Nevertheless, for the purposes of thinking through your study, and for the IRB, you will need to have your data in document form.

11- INFORMED CONSENT FORM
This may be a necessary component for IRB review. Although some studies do not require an informed consent process (e.g., retrospective designs) the majority of prospective studies do require it. The general idea is to describe your study to the patient using an 8th grade reading level.

Click here to download a Word version of the Research Protocol