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When you’re planning to conduct scientific or clinical research, you may need to create a research protocol.
Research protocols are documents that guide scientists throughout the research process, ensuring that all researchers are on the same page when it comes to the study’s objectives, methodology, and ethical considerations.
In this article, we’ll have a look at why research protocols are so vital and which elements they comprise.
Why Are Research Protocols Important?
Having a clear and well-defined research protocol is absolutely crucial in some areas of research, especially where clinical trials are concerned.
This is because the protocol states what is and is not allowed, as well as what the objectives and planned methods of research are, which ensures that the study is safe for its participants and researchers.
What’s more, adhering to the rules outlined in the research protocol helps make for valid and reproducible results as all scientists follow the same transparent process.
Again, this increases the safety of the study because it makes it possible to repeat the same experiment multiple times before arriving at the conclusion that it’s safe to apply the findings in real-world scenarios (for example, distributing a new type of medicine).
Research Protocol VS Research Proposal
If this is your first time conducting a study, remember not to mix up a research protocol with a research proposal.
Here’s what a research proposal does:
- It tries to convince its readers of the validity and importance of the planned study
- It usually strives to receive funding or other forms of support from organizations
A research protocol, on the other hand, aims to:
- Meet certain ethical standards and safety rules
- Outline the specifics of the planned study to ensure it contains safe and reproducible methods
RELATED READ: How to Write a Research Outline
How to Write a Research Protocol
Research protocols tend to follow a specific structure that comprises multiple important factors.
Let’s break it all down into 15 steps.
1) Project Summary
A project summary is very similar to a research abstract – it contains a few hundred words that outline the basics of the study, such as the objectives, rationale, and expected outcomes.
Don’t make it too long – you’ll have the chance to get into the specifics in the later steps.
2) General Information
Remember to include:
- Title and identifying number of your protocol
- Date
- Names of investigators
- Names and addresses of research sites
- Names and addresses of clinical laboratories
3) Rationale and Context
This section offers reasons and explanations for why the study is being conducted and how it fits in with other studies and existing knowledge in the field.
You should state:
- The problem you are hoping to solve
- Potential causes of the problem
- Potential solutions to the problem
You can also refer to various literature sources that are relevant to the topic at hand to support your arguments.
4) Goals and Objectives
This part is very important because it serves as a guide that will help the investigators stay on track during the research process.
While the goals of the study are broader descriptions of what your research aims to accomplish, objectives are concrete points that closely relate to the research question.
Objectives should be clear and simple, and you should state them before your research begins.
5) Study Design
This is where we get into the specifics of the study itself.
A study design includes:
- Type of study
- Participation criteria
- Sampling frame
- (Expected) duration
- Descriptions of the study (for example, experimental or observational)
6) Methodology
Methodology is the most crucial part of the research protocol because it’s what describes the ins and outs of the research process.
When you’re writing your methodology section, aim to unpack:
- Procedures that will be applied
- Measurements that will be taken
- How data will be collected
- Observations that should be noted
…and anything else that relates to the way the study ought to be conducted.
This is especially important if multiple different research sites are working on the same study because a standardized and clear methodology allows for valid, credible, and reproducible results that all research sites achieve in the same manner.
7) Safety Considerations
Research protocols revolve around safety measures a lot because they aim to ensure that the study adheres to ethical norms and is conducted in a safe environment.
This is why it’s essential that you outline the potential risks and preventive measures that are to be taken, as well as the step-by-step process for managing possible accidents.
Both participant and investigator safety are important.
8) Follow-up
If you’re working with human subjects, describe what kind of follow-up will be provided to participants and for how long.
A follow-up occurs when you investigate the aftereffects of the study on the participants after the study has been concluded.
9) Data Management
Discuss how you will manage the collected data, how you’ll go about completing a statistical analysis, and which programs or methods you will use to achieve the expected results.
10) Expected Outcomes
Your expected outcomes are to contribute to the field in some way or to be applied in real-world scenarios.
This is the section where you describe in more detail how you expect to use your findings and how they may affect different systems, for example health policies.
11) Publication Process & Responsibilities
If there are multiple researchers, the research protocol serves to highlight which responsibilities and tasks belong to whom.
What’s more, it also states who has publishing rights and whose names will be associated with the study if it ever gets published.
12) Ethical Considerations
Since research protocols aim to ensure that the study abides by certain ethical standards, a section where you discuss ethical considerations is of the utmost importance.
Explain how you will receive consent from the participants and how you plan to address any ethical concerns related to your research.
13) Budget Breakdown
To display complete transparency and integrity, create a clear plan for how you plan to distribute your funds and other financial resources.
You might also mention all the different sources of funding you’ve acquired for the study.
14) Investigator Details
List all other research projects conducted by the participating investigators, as well as their CVs.
You should also strive to mention all researchers, institutes, and sites that have agreed to collaborate with you on this study.
15) References
Finally, don’t forget to include all relevant references to increase the validity of your research protocol and to give credit where credit is due.
RELATED READ: Research Paper: MLA Format Fundamentals
Conclusion
Research protocols are incredibly important documents that serve as both a guide and a safety rulebook.
When writing a research protocol, remember to state your objectives in clear and simple terms, make your methodology section as comprehensive as possible, and take all ethical considerations and potential safety risks into consideration.
