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What's a research protocol?

Emeritus Professor, Dental Health Unit, Manchester

Jeanette A Mooney

Research Associate, University Dental School, Manchester

A clinical trial needs a carefully structured, written plan in order not only to ensure its smooth running and successful conclusion but also to gain the compulsory agreement of an ethical committee. Such a plan is called a protocol. It consists of several stages. These are:

1 An introduction;

2 A statement of aims, objectives, hypotheses and the calculation of sample size;

3 A detailed account of the methodology, which itself is divided into a number of sections including the methods used in the statistical analysis of the data;

4 A study schedule and costing;

5 Any necessary appendices; and

6 A supporting bibliography.

This article describes these stages in detail in the hope that a beginner can better understand the planning of a study involving members of the public.

Key Words: clinical trials • protocol • ethical permission

Health Education Journal, Vol. 63, No. 4, 374-384 (2004)
DOI: 10.1177/001789690406300408


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