'Femi Fajimi

Writing for Ethics Committee Submissions: Practical Insights from a Developing Writer

By ‘Femi Fajimi | May 2025

Writing for ethics committee submissions is a key responsibility in regulatory medical writing. It requires clarity, accuracy, and respect for participant rights. As I continue to build experience in this field, I understand the importance of approaching these documents with scientific rigour and ethical sensitivity.

While clinical teams often develop the technical content, the writer helps present that information in a structured, compliant, and accessible way, especially when preparing participant-facing materials.

What Is an Ethics Committee Submission?

Before a clinical trial begins, it must be reviewed and approved by a Research Ethics Committee (REC) in the UK (or an Institutional Review Board, IRB, in other regions). These independent bodies assess whether a study is ethically acceptable and whether participants are adequately protected and informed.

A typical submission includes:

• Clinical Study Protocol (or synopsis)
• Informed Consent Form (ICF)
• Investigator’s Brochure (IB)
• Participant Information Sheet
• Safety information or risk summaries
• Recruitment materials or questionnaires
• Cover letter and application form

Writers may not be responsible for drafting these documents, but understanding how they fit together is essential.

The Medical Writer’s Role

From my experience so far, the writer’s contribution often includes:

• Preparing or reviewing the protocol or synopsis to ensure clarity, accuracy, and alignment with GCP
• Drafting or editing the ICF and participant-facing documents, applying plain language principles and ethical tone
• Ensuring all documents are consistent, especially concerning procedures, visit schedules, and safety information
• Formatting materials according to REC or HRA guidance
• Maintaining version control and documenting rationale for revisions
• Supporting the submission process by helping collate documents into a cohesive, well-organised package

Key Considerations I’m Learning to Apply

• Use plain, respectful language, especially in the ICF and participant information
• Be transparent about procedures, risks, and voluntary participation
• Avoid promotional language, Focus on facts, not persuasion
• Check for internal consistency across documents and appendices
• Ensure dates, version numbers, and references are correct; small details carry weight in regulatory review

Final Thoughts

Ethics committee submissions sit at the intersection of science, communication, and ethics. As a developing medical writer, writing for these submissions helps sharpen technical accuracy and human-centred thinking.

This stage of the clinical trial process reminds me that our role as writers goes beyond compliance. Through clear, structured communication, we help support participant understanding, safety, and informed choice.