What is Research Protocol? How to Write It (with Examples) 

One of the most important aspects of clinical research is creating an accurate and carefully thought-out research protocol. This article not only explains why research protocols are important but also provides a step-by-step guide on how to write an impactful one. Let us start by understanding what a research protocol is.  

Research protocols offer a blueprint for the proposed research. They outline the framework for conducting research and present the study’s objectives, design, and methodologies. They explain how the research will be carried out and present details like participant profiles, the duration of the study, conditions to be met, related tests, and other such information.  

Importance of research protocols  

Clinical research is often complex and typically involves collaboration with various stakeholders, including participants, sponsors, regulatory authorities, and sometimes even government members. In this scenario, a well-structured research protocol helps researchers stay focused on their objectives. It offers clear guidelines to ensure that the research being undertaken is thorough, ethical, reproducible, and scientifically valid.  

It also helps researchers obtain necessary ethical approvals as it outlines how the study will protect participants and maintain integrity. Additionally, detailed research protocols are required not only for securing funding but, importantly, for publishing research findings. 

Components of a research protocol 

As with most academic documents, research protocols must be structured appropriately. Given that research protocols are essential to successful clinical trials, it must have the following specific sections:

• A title that must be concise, easy to understand, and clearly convey the main focus of the research.
• An abstract that briefly summarizes the research question, objectives, methodology, and the expected impact of the study.
• The background and significance of the research provide context for the study, outline available knowledge, and help identify gaps in existing research. They explain why the research being undertaken is necessary and highlight its relevance and potential impact.
• The objectives define the goals of the study and clearly state what researchers hope to accomplish through their research.
• The research design and methodology section details the type of study (e.g., experimental, observational), participant selection criteria, and intervention methods.
• Data collection and analysis presents a clear plan for data collection, management, and analysis. It typically mentions statistical methods and software that are to be used to analyze data.
• Ethical approvals are critical to clinical research. Therefore, research protocols must outline the process for obtaining ethical approvals from relevant bodies. The protocol must clearly mention potential risks to participants and how they will be managed. Importantly, this section must also clearly state that participants have given their informed consent.

A step-by-step guide to writing a research protocol 

Writing an effective research protocol can be daunting for first-time researchers. In fact, given that the research protocol may actually impact how effectively and successfully the research is conducted, even experienced researchers have been known to grapple with the task. Here is a step-by-step guide to help you write an impactful research protocol –

• Step 1: Start by defining a clear and focused research question that will guide your research efforts. The question must be specific, measurable, and relevant
• Step 2: Undertake a detailed and thorough review of existing literature to gain insight into your current understanding of the topic of your research. This is crucial as it will help you to identify gaps in knowledge and will consequently shape the rationale for your study
• Step 3: Create a detailed outline or research design. Include the methodologies you will be using, the tools and strategies you will be applying, and the procedures for data collection and analysis
• Step 4: Ensure that you have a strategy for collecting, storing, and analyzing data collected during the research. This should include details on data security, software management, and statistical analysis techniques
• Step 5: Review research plans to ensure that ethical research practices are followed. This includes obtaining informed consent, ensuring confidentiality, and obtaining necessary approvals from institutional review boards or ethics committees. This is imperative as it gives your research a certain credibility, which will help you gain the trust and support of funding agencies
• Step 6: Specifically mention gender issues. Since both biological and gender-related differences can influence the research’s outcome, it is essential to ensure that gender is always considered when analyzing results
• Step 7: Present a carefully thought-out plan to communicate research findings with scientific media, policymakers, and the wider community. It is also important to have a structured publication policy that mentions and acknowledges team members and key contributors
• Step 8: State the expected duration of the research and mention the time that is likely to be taken for completion of each phase of the study  
• Step 9: Provide a detailed budget for the research. It must include the expected expenses on specific items and services so that those funding the research can understand exactly how resources are being utilized
• Step 10: Finally, present a list of researchers and institutes participating in or supporting the research

Sample template of a research protocol 

1. Research Protocol Title 
2. Background and Rationale for the Research  
3. Objectives of the study 
4. Study Design (suggested sub-headings): 
   1. Type of Study  
   2. Data Sources/Collection 
   3. Population/Sample size 
   4. Expected duration of research and start times 
   5. Statistical analyses
5. Ethical Considerations (suggested sub-headings): 
   1. Recruitment and selection of participants  
   2. Informed consent  
   3. Enrolment procedure 
   4. Confidentiality and Privacy 
   5. Safety 
   6. Data storage and Record Retention 
6. Gender Issues 
   1. References 
   2. Appendices 
7. Patient Information and consent forms 
8. Questionnaires 
9. Data collection sheets 
10. Case Report Forms 
11. Advertisements 

Whether you are new to the field or an experienced researcher, mastering the art of writing a research protocol is a crucial part of your career. By following the steps outlined above and considering the essential components of a research protocol, researchers can ensure that their work is well-organized, credible, and impactful. 

References 

https://icahn.mssm.edu/files/ISMMS/Assets/Research/IHCDS/Guidelines%20for%20Writing%20the%20research%20protocol%20by%20WHO.pdf 

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