An introduction to research for primary dental care clinicians part 3: stage 5. Writing a protocol.

Abstract

A. What is a protocol and why is a written protocol necessary? A research protocol is a detailed plan of a proposed project that provides written evidence of the need for the proposed study and its feasibility. It is the starting point for all quality research and indicates that the proposers have, as far as possible, considered all relevant points before starting the project. Research ethics committees, research and development committees, and funding bodies will only consider an application if it is accompanied by a protocol. It allows any individual or organisation the opportunity to make a judgment about the scientific and ethical aspects of a proposed project. It also supplements any application forms that have been submitted and can be used as a resource to provide answers to questions arising from the application form. The protocol also provides its authors with a reference point during a project as it can (and should) constantly be referred to in order to check that all stages of the project are being satisfactorily completed within the schedule. Some organisations, such as the Department of Health and the Medical Research Council, issue specific guidelines on the contents of a protocol. Before writing, it is therefore wise to check whether the organisation to which the protocol is to be submitted has such guidelines. Time spent in designing a protocol is time well spent and will benefit the subsequent stages of the project. Help and advice should be sought before writing it. A wide range of opinion should be canvassed from statisticians, ethics committee chairpersons and clinical colleagues. A protocol should include justification of the need for the project and a detailed plan that sets out for the investigation: • What is to be investigated. • Where and when it will take place. • Procedures and methods to be used. • Proposed timetable. • Resources required (technical, scientific, and financial).