March 2013
www.caresearch.com.au
EVIDENCE BASED PRACTICE: THE RESEARCH PROTOCOL
A research protocol is the guidebook for a research study. It describes what the
researchers are intending to do and how they will do it. Writing a protocol ensures that
all the major issues are considered in designing and developing a particular research
project.
What is a research protocol?
A protocol includes a background which summarises the
evidence about the issue in the literature and provides a
justification for doing the study. It describes the participants
and the inclusion and exclusion criteria, as well as how they
will be recruited. It can detail specific hypotheses as well as
the aims and objectives.
The document will describe the intervention, what will be
done and how it will be done. It needs to provide sufficient
information for those involved in the study to be able to
understand how they will conduct their work and what
resources they will need to use. The protocol will also outline
what data is going to be collected and how it will be
analysed. It will also describe any safety and security
measures related to a study.
Developing and using research protocols
The research protocol is the basis for ethics applications as it means the issues that ethics committee will look at
have been considered and appropriately planned for.
It is becoming more common for large scale trials to publish their protocol to inform the community of the study and
to ensure transparency in the planning and conduct of the trial.
Some research and clinical organisations will also hold concept or protocol development workshops to debate
elements of the protocol and ensure that the study is as well designed as possible.
Finding out more
•
Recommended format for a Research Protocol
World Health Organisation
•
Developing a research protocol
Duke Translational Nursing Institute
•
Getting Started in Research
CareSearch, Flinders University
CareSearch is funded by the Australian Government Department of Health and Ageing.