How To Write a Research Protocol (Plus Definition)

By Indeed Editorial Team

Published March 25, 2022

The Indeed Editorial Team comprises a diverse and talented team of writers, researchers and subject matter experts equipped with Indeed's data and insights to deliver useful tips to help guide your career journey.

A research protocol is a document that helps researchers plan their clinical and scientific studies. Investigators can benefit from completing their research protocols before they start conducting research. Understanding how to write a research protocol can help an investigator conduct a successful study that they can use to address real-world issues. In this article, we provide instructions on how to write a research protocol and define what a research protocol is.

Related: Types of Research: Definitions and Examples

What is a research protocol?

A research protocol is a physical record that details a research study. This document helps researchers conduct their studies as smoothly as possible without interruptions or impediments. A well-written research protocol addresses the research question and describes specific elements of the study, such as its methodology, design and objectives. Scientists who are conducting clinical research use a research protocol to clarify what they can and cannot study, which is especially important when they work with human subjects.

Related: What Is Research Methodology and Why Is it Important?

How to write a research protocol

Here's a list of steps on how to write a research protocol:

1. Write a project summary

A project summary is similar to the abstract of a research paper. It's usually a couple of hundred words and contains a brief synopsis of the protocol's central elements. For example, you may summarize information about the protocol's expected outcomes, time frame, populations, methods, objectives and rationale. Ideally, a reader can interpret the project summary on its own without referring to subsequent sections.

Related: How To Write a Research Paper Step-by-Step

2. Create a section for basic information

The next section of a research protocol contains basic information. This information may include the protocol's identifying number, title and starting date. You may also use this section to include contact information to promote organization and accountability. You may list the names and titles of all relevant investigators, the addresses and phone numbers of all research sites and the names and addresses of any clinical laboratories you're using.

3. Offer the rationale for your research study

After you create a section for basic information, you can provide the rationale for your research study. This section can state the need you hope to fulfill or the problem you hope to solve with your study. Your rationale may explain what some potential causes of the problem are and how your proposed solutions may help resolve it. You may choose to explain how your work can become relevant to real-life applications. You can also provide context by explaining factors like affected geographical locations, demographic considerations and the magnitude of your study.

4. State the study's goals and objectives

It's important to distinguish your study's goals and objectives and list them both clearly. Goals are broad declarations that state what the proposal wants to achieve. Goals help establish a setting for the researcher's proposal. Objectives are more specific, as they're assertions of the research question. You can first list a primary objective and include secondary objectives as necessary. All objectives are specific and simple, and it's essential to state them before conducting your research.

5. Detail the study design

Establishing the study design in your research protocol can contribute to your study's credibility and integrity. Your study design can include information like the study's type, exclusion criteria, inclusion criteria, withdrawal criteria, expected duration and sampling frame. As you write the study design of your research protocol, you can also consider how you'd describe your study. For example, you may want to describe your study as the pursuit of basic social science or epidemiological research. You may also be able to describe it in other ways. For example, the study may be experimental, interventional or observational.

Related: Types of Research Methods (Definition and Best Practices)

6. Define the methodology

The methodology of your research protocol describes what's going to happen throughout your study's duration. It may include information about the researchers' interventions, procedures, observations and investigations. It details how researchers plan to collect relevant and accurate data. This section also highlights what kinds of measurements the researchers plan to use so that they can collect standardized, consistent data, even if testing occurs across multiple sites.

7. List safety considerations

Different research studies may come with varying levels of risk. You can create a section to list potential safety risks and how your team can manage them. Listing safety concerns can help keep the study's researchers and participants safe throughout the study's duration. Ideally, this section includes a method for reporting incidents and handling the aftermath if anything occurs unexpectedly.

8. Create steps for the follow-up process

Once a study includes, you and other researchers may want to revisit certain elements of the study. You can make this process as simple as possible by highlighting follow-up procedures. This can help you more easily interpret your results even after your team completes the initial data collection process.

9. Explain the policies for data management

Include information on how you want your team to manage the data you collect. This may include procedures for handling and coding certain data types for verification, monitoring and analysis by computers. You may also choose to outline specific reasoning for statistical analysis, like why you chose a certain sample size.

Related: Data Management Skills: Definition and Examples

10. Describe the expected outcomes

Be sure to describe how you want your study to advance professionals' understanding in a certain area. This may include how you plan to use the results. You may also explain how your results may affect social, environmental or health policies or systems.

11. Clarify the publication process

Depending on the success and uniqueness of your experiment, you may get the opportunity to publish your results. These results can be useful for making a lasting impact on the general or scientific communities. Be sure to clarify who has the publishing rights and who can receive recognition in published results.

12. State the responsibilities of each team member

It's important to highlight all the project management aspects within your research protocol. This can include the responsibilities and roles of each individual team member. Establishing expectations early in the process can help you and your fellow researchers work more efficiently without delays.

13. Record ethical considerations

A good research protocol records all ethical considerations that relate to the study. You can describe any situations that may result in ethical concerns and how you plan to acquire consent from any affected participants. You may also explain how you plan to seek approval for performing any observations or experiments that may result in ethical concerns.

14. Discuss financial information

Research studies often incur significant costs for materials and labor. You can create a budget section to adequately plan for the costs that you have to cover. You may discuss the sources of the funding you plan to receive and other financial factors like insurance coverage.

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