How to Write a Research Protocol

As if conducting academic research wasn’t difficult enough, there are plenty of tasks and responsibilities that come as part of the package – including the research protocol.

Worry not, though! This article serves as a quick manual to writing a research protocol that withstands scrutiny and helps guide all researchers involved in the process.

Here’s how to write a research protocol, step by step.

What Is a Research Protocol?

Alright, let’s get the basics out of the way first – what even is a research protocol and how does it differ from, say, a research proposal?

A research protocol is essentially a blueprint that outlines why and how your study will be conducted. It helps all researchers understand what the primary goal is, what all the specific steps included in the methodology involve, and which limitations or requirements they must take into consideration.

While the main goal of a research proposal is to convince someone (an organization or a person of importance, for example) that your study is worthy of funding or serious consideration, the purpose of a research protocol is to ensure that the study in question is safe, transparent, and reproducible.

Why Is a Research Protocol So Important?

Academic research takes a long time, and oftentimes, multiple people are involved in the process. Sometimes, the research itself even takes place at two or three different research sites.

This naturally means that all researchers need something to ensure they’re on the same page when it comes to ethical considerations, safety rules, methodology, and more.

And that’s, of course, where a research protocol comes in.

It doesn’t stop there, however. There are many other reasons why a research protocol is so vital to high-quality research:

• It enables researchers to replicate the study if needed, leading to more accurate results
• It ensures compliance with ethical standards, making the study safe and confidential
• It facilitates the research process because it outlines the research methodology in detail
• It defines clear objectives, ensuring all researchers know what the main goals are
• It helps secure funding (as many agencies or institutions require a research protocol in order to assess whether your study should get funded by them)

How to Write a Research Protocol: 13 Key Components

The good news is that every research protocol should include specific elements – and as long as you know what those elements are, you’re good to go.

Without further ado, these are the 13 key components of a high-quality research protocol:

1. Basic information: The title of your study, names of the investigators, names and addresses of research sites or clinical laboratories, the date, and the version number (this helps track updates)
2. Project summary: A few hundred words that summarize the rationale, objectives, and expected results of the study (it’s a bit like a research abstract)
3. Background and rationale: A comprehensive overview of the topic, including a summary of existing literature (and any gaps within it), a statement of the issue this study aims to address, and an explanation of why it’s important
4. Objectives: The primary and secondary goals of the study (which should be stated in clear and simple terms)
5. Study design: The type of the study (e.g., experimental, quantitative, cross-sectional), participation criteria (e.g., inclusion criteria and exclusion criteria), the expected duration, the sampling frame, and any other details that are worthy of mentioning
6. Methodology: A step-by-step guide to the procedures, a manual for measurements, a specification of how and where data will be collected, a description of tools or other types of equipment, and an explanation of which observations should be noted
7. Data analysis plan: Statistical methods that will be applied, details about the software tools that will be used, and other information about the management of collected data
8. Safety considerations: An outline of all potential risks and preventive measures and a guide to managing potential accidents
9. Ethical considerations: The process for obtaining consent from participants, the measures you will take to protect participant data, the potential risks and benefits to participants involved in the study, and documentation of approval from specific institutions or committees
10. Expected outcomes: Which outcomes you are hoping to achieve, how you will assess them, and how these results could be applied to real-world scenarios
11. Logistics: Which facilities and types of equipment your study requires, what the estimated costs are, and what your funding sources are
12. Publication process: Publishing rights of the investigators involved in the study and an explanation of how the tasks and responsibilities will be divided
13. Appendices: References and any supplementary materials, such as copies of questionnaires or consent forms

Conclusion

And that’s your research protocol outlined step-by-step! Now comes the harder part – you actually have to sit down and write it.

Need some help? Reach out to FirstEditing and talk to a professional academic editor.

And before you go, remember that while a research protocol may seem like an overwhelming task, everything is manageable if you break it down into smaller steps.

All you need to do right now is to take the first one.