A research protocol is a detailed plan that outlines your research study’s purpose, methodology, and ethical considerations. It’s not just a roadmap for your study—it’s also a critical document required for Institutional Ethics Committee (IEC) approval. A well-written protocol ensures clarity, compliance, and credibility.
In this blog, we’ll explore:
- What is a research protocol?
- Why is it important for IEC approval?
- Standard structure of a research protocol.
- Standard guidelines to follow.
- Supporting documents to attach.
What is a Research Protocol?
A research protocol is a formal document describing the objectives, design, methodology, and ethical considerations of a research project. It ensures that the study meets scientific and ethical standards.
A protocol acts as a contract between the researcher, funding body, and ethics committee. It safeguards the rights and well-being of participants. It also ensures methodological rigor.
Why is a Research Protocol Important for IEC Approval?
The Institutional Ethics Committee (IEC) reviews your research protocol to ensure compliance with ethical guidelines such as:
- Respect for participants’ rights.
- Minimization of risks.
- Scientific validity and necessity.
Without a robust protocol, the IEC cannot approve your study as it may violate ethical or scientific standards.
Standard Structure of a Research Protocol
Here’s a recommended structure, based on global standards like ICH-GCP and National Ethical Guidelines for Biomedical and Health Research in India (2020):
1. Title Page
- Title of the study.
- Name and designation of the investigator(s).
- Institutional affiliations.
2. Abstract
A concise summary of the study, including objectives, methodology, and expected outcomes.
3. Introduction
- Background and rationale for the study.
- Review of literature.
- Gaps in existing research.
4. Objectives
Clearly define primary and secondary objectives.
5. Methodology
- Study design: Specify if it’s observational, interventional, descriptive, etc.
- Population: Target demographics and inclusion/exclusion criteria.
- Sample size: Justification and calculation.
- Intervention: If applicable, describe in detail.
- Outcome measures: Define both primary and secondary outcomes.
- Statistical analysis plan: Mention how data will be analyzed.
6. Ethical Considerations
- Informed consent process.
- Confidentiality measures.
- Risk-benefit analysis.
- Adverse event management plan.
7. Timeline
Include a Gantt chart or a brief timeline of study activities.
8. Budget
Outline estimated costs with justification.
9. References
Follow a standardized citation style.
10. Annexure
It includes the Information sheet. It also has informed written consent in English and respective regional languages. Additionally, it contains scales and tools planned to be used in the study.
Key Guidelines to Follow
When drafting your protocol, ensure compliance with these globally recognized guidelines:
- ICH-GCP (International Council for Harmonisation – Good Clinical Practice):
Focuses on participant safety and data integrity. - Declaration of Helsinki:
Ethical principles for medical research involving human subjects. - Indian Council of Medical Research (ICMR) Guidelines:
Provides ethical frameworks for health research in India.
Supporting Documents for IEC Submission
Along with the research protocol, the following documents are commonly required:
- Informed Consent Form (ICF): In regional and English languages.
- Investigator’s Brochure (IB): For studies involving drugs or interventions.
- Case Report Forms (CRF): Templates for data collection.
- Permission Letters: From institutional heads or collaborators.
- Funding Approval Letters: If applicable.
- Clinical Trial Registration Number: For interventional studies.
Pro Tips for Writing a Successful Protocol
- Be Concise: Avoid jargon; aim for clarity and brevity.
- Use Diagrams: Flowcharts and tables enhance readability.
- Follow Formatting Standards: Use clear headings, numbered sections, and consistent fonts.
- Review Before Submission: Seek peer feedback and cross-check for errors.
Call to Action
Need help crafting a research protocol for IEC approval? Contact A&M Research Solutions for expert guidance tailored to your needs.
