Protocol Development

A research protocol describes the detailed research plan. Writing a protocol ensures that all the major issues are considered in designing and developing a particular research project. Often the protocol needs to be submitted as part of an ethics submission. Sometimes a protocol is developed by a team of investigators, each one contributing their specific expertise. Protocols may sometimes need to be changed during a project, and a process for managing these amendments is also important, especially when a number of people or sites are involved in a study.

A protocol includes a background which summarises the evidence about the issue in the literature and provides a justification for doing the study, explaining the significance of the issue. It describes the participants and the inclusion and exclusion criteria, as well as how they will be recruited. Quantitative studies such as clinical trials describe the hypothesis and outcome measures, and then under the heading of study methods describe the intervention and how the study will be done. Protocols for qualitative studies describe in detail the processes that will be used to investigate the question. 

Other issues that are addressed in a protocol are how the data will be analysed - quantitative studies need to specify the sample size, which is a statistical estimate of the number of participants needed to answer the research question within a specified degree of probability. This is described as the statistical power of the study. Some studies also have a health economics component, and this is also described in the protocol. Finally, a protocol needs to address issues of feasibility – that is, whether the study design is actually able to be completed in a particular setting, or with given resources, or in a certain timeframe. A number of draft protocols are available online to assist researchers, for example, the Guide to writing a research protocol / QA project plan (945kb doc) of the Mater Medical Research Institute.

Writing a protocol is a key skill for researchers. A number of organisations now hold regular protocol development workshops, and these can be extremely valuable for new and experienced researchers alike. At these workshops, researchers present a draft of either a protocol or a research concept, and experienced researchers provide them with advice and input. These organisations may also help junior researchers to access statistical advice during the planning stages, which can be very valuable. Having access to feedback from experienced researchers can be daunting, but can also make an enormous difference to the ultimate quality of the research, and help ensure that problems are identified early. It also makes it more likely that a study will be able to go forward for funding, and can help new researchers locate others with expertise who can help with their study in many different ways.

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 of the organisations that hold concept or protocol development workshops and accept palliative care studies are:

Last updated 11 January 2018