Getting started in research: the research protocol

Abstract

To be efficient and precise, research needs a 'road map', called the 'research protocol', which follows a standard format. It includes an abstract, study description, ethical considerations, significance of the study, the budget and a description of the investigators. Study description spells out the study question, the rationale for the study, including previous studies on the subject, the objectives, hypotheses and aims, design and methods, project management, strengths and limitations and a list of references. The objectives, hypotheses and aims are developed by outlining a general research topic (the objective), developing a hypothesis from the broad objective, translating it into the null hypothesis and then listing the steps by which the null hypothesis will be refuted or accepted (the aims). The design and methods describe the type of study to be undertaken, the population in which the study is carried out, including the sample size and statistical power, the selection of subjects, the methods of data collection, and outline of data management and statistical analysis. The detail of the protocol ensures that the study will be carried out successfully and is essential for all health research.