Writing a research protocol
An introduction to protocols
Within the world of screen, ‘show bibles’ are created for each production; full reference documents detailing the film or TV series’ characters, settings, backstories, and major plotlines. As series continue or more films are made, show bibles are updated to include important details, such as a character’s mother’s name, or his/her favourite food, ensuring that all future plotlines are accurate and have internal consistency. Show bibles have several aims, including:
- 1. Explaining the rationale for the production: who it is targeted at, what it will achieve, why there is a gap in the market for it, and what its impact might be
- 2. Explaining how the production will unfold: where the story will take place, what the plot lines will be, who the characters are, and how they interact with one another
- 3. Discussing the feasibility of the production: how long the series will be, over what timescale it will be set and filmed, how many characters are involved, and which actors might play the parts
The information in the show bible is important both to the production team members, ensuring that the relevant details have been worked out in advance of the filming commencing to ensure it runs smoothly, and to any partners, funders, and stakeholders, showing what the production actually entails and aims to achieve.
Much like the world of screen, the world of research also has its own ‘show bibles’: research protocols. Protocols share similar aims to show bibles:
1. The rationale: a research protocol is an opportunity to present a strong and convincing rationale for a study, showing where the key gaps lie in the current literature, demonstrating that there is a need for research that fills these gaps, showing that the research question can be researched, detailing precisely what the aims and objectives are, and explaining what the implications of this will be for future research and practice
- 2. The methods: the protocol should demonstrate how the study will go about answering the research questions: which design and methods will be used, why these are appropriate, how these will prevent issues of bias, how these fit in with legal and ethical regulations, and whether results will be generaliz- able or applicable beyond the immediate research setting
- 3. The feasibility: the protocol should explain how the study will be carried out, what the timescale is, where the responsibilities lie, what resources are needed, how and at what rate participants will be recruited, whether the team have the appropriate experience to carry out the study, and the benefits and risks of participation for individuals
As with show bibles, protocols have multiple audiences. They are important internal documents for those involved in the study, mapping out the responsibilities and activities required; they can seek to convince stakeholders and possible funders of the value and integrity of a study; and they form the core document underpinning all ethical approval applications (see Chapter 12). Protocols often undergo multiple iterations, and it is possible too that they change once a proj ect is under way. However, once a study has ethical approval, changes may require resubmitting for approval, so protocols are often very detailed and well-worked through to avoid the delays that this resubmission causes. For studies involving arts interventions, it may not appear on the surface that research protocols are necessary: participants are engaging in enjoyable arts-based activities with no evident risks. However, as Chapter 12 will discuss, even arts-based interventions can involve significant ethical risks. Furthermore, the principles of clearly explaining the rationale and carefully mapping the logistics of a study both for internal and external records remain, just as in other non-arts studies. So even if an organization does not officially require a protocol, it is recommended that one be created for these reasons.
Different organizations have different templates for research protocols that vary in exact format depending on the nature of the study. For example, studies involving vulnerable populations have to include large sections on participant safeguarding; studies involving observational research but no active intervention may be much shorter; and studies involving identifiable patient records may need to demonstrate clearly their modes of data protection and confidentiality. However, the broad headings and sections of research protocols generally remain the same. Consequently, this chapter provides a template protocol suitable for a range of research projects, whether a small pilot or a large-scale randomized controlled trial. The key headings found in research protocols are outlined and for each section a description is given of what it normally entails. It is up to each individual study and the organizations involved to determine which sections require the most attention, or which sections may not be required.
To facilitate the use of this template, the following symbols are used throughout the chapter:
^ Sample text that could be included in a protocol if it is appropriate for the study
© Explanations of terms that may be unfamiliar