PAHO Guidelines for Writing a Research Protocol (Proposal)

The protocol may not exceed 20 single-spaced, letter-size pages containing approximately 62 characters per line. Proposed studies involving the use of questionnaires or guides for data collection should have an annex containing copies of the instruments and should indicate their stage of preparation (e.g. version for pilot testing, final version, etc.).

To facilitate the investigator's task, a basic outline for writing the proposal and a brief description of each component are provided below. These need not be applied rigidly. How they are applied will depend on the type of study and the methodological approach of each investigator.

Basic Outline of a Research Protocol

• Project Title
• Project Summary
• Statement of Problem (scientific justification)
• Justification and Use of Results (final objectives, applicability)
• Theoretical Framework (argumentation, possible answers, hypothesis)
• Research Objectives (general and specific)
• Methodology
• Type of Study and General Design
• Operational Definitions (operationalization)
• Universe of Study, Sample Selection and Size, Unit of Analysis and Observation: Selection and Exclusion Criteria
• Proposed intervention (if applicable)
• Data-Collection Procedures, Instruments Used, and Methods for Data Quality Control
• Procedures to Ensure Ethical Considerations in Research Involving Human Subjects
• Plan for Analysis of Results
• Methods and Models of Data Analysis according to Types of Variables
• Programs to be Used for Data Analysis
• Bibliographic References
• Timetable
• Budget
• Annexes (data-collection instruments, elaboration on methods and procedures to be used, and more)