Understanding Informed Consent Forms (ICFs)
By ‘Femi Fajimi | 24 April 2025
Informed Consent Forms (ICFs) are at the heart of ethical clinical research. They represent the intersection between science, ethics, and patient communication. As I learn and grow in regulatory medical writing, I appreciate the depth and responsibility of developing these documents.
Although I’m a beginner in this field, my background in medicine and public health gives me a firm foundation for understanding the importance of informed consent and the precision it demands in both tone and content.
What Is an Informed Consent Form?
An Informed Consent Form is a document that provides a potential clinical trial participant with all the necessary information to make an informed decision about participating in a study.
Its purpose is not to persuade, but to empower. It must present the facts clearly, outline potential risks and benefits honestly, and respect the individual’s right to choose. Participation in any clinical trial must be voluntary, and the ICF supports that principle.
What Should an Informed Consent Form (ICF) Include?
An ICF must be both informative and structured. While formats may differ slightly between sponsors or countries, a standard ICF includes key elements that ensure transparency and participant protection. These are typically organised into two main parts:
- Part I: Information Sheet – explains the study
- Part II: Certificate of Consent – confirms the participant’s agreement to take part.
PART I: Information Sheet
1. Title and Purpose of the Study
States the study’s title and explains in simple terms what is being researched and why.
2. Type of Intervention and Procedures
Describes what the study involves; treatments, tests, number of visits, use of placebo, and any unfamiliar procedures.
3. Participant Eligibility
Explain why the person is being invited and confirm that joining is optional.
4. Risks and Discomforts
Address any known side effects, discomfort from tests, and potential unknown risks.
5. Benefits
Outline any personal or broader benefits while clearly stating if no direct benefit is expected.
6. Voluntary Participation
Reaffirms that participating is voluntary and withdrawal is allowed at any time without affecting care.
7. Confidentiality
Explain how personal data will be protected and who may access it.
8. Reimbursements
States, if compensation is provided for travel or time, it aligns with local ethics guidance.
9. Sharing Results
Describes how study results will be shared (e.g., in publications and community meetings) without revealing identities.
10. Contact Information
Provides names and details of the study contact and approving ethics committee.
PART II: Certificate of Consent
1. Participant Declaration
They confirm they’ve read (or been read) the form, asked questions and agreed to participate.
2. Signatures
Includes space for the participant, witness (if needed), and the person obtaining consent.
3. Researcher Statement
Affirms the study was explained clearly and consent was voluntary.
As a regulatory medical writer, writing an ICF is not just about “dumbing down” the protocol. It’s about translating scientifically complex material into accurate, clear, and meaningful language for the layperson.
Some of the techniques I’m learning and applying include:
- Plain language usage: Avoiding jargon or explaining medical terms where necessary. For example, replacing “adverse events” with “side effects” or explaining what a “placebo” is straightforward.
- Using the active voice: “You will be asked to attend six clinic visits” reads more clearly than passive alternatives.
- Respecting tone: The ICF should reflect a neutral, respectful tone, informative but not alarmist, and reassuring without being promotional.
Disclaimer:
This sample Informed Consent Form (ICF) was created for educational and illustrative purposes only. The sponsor name MolerDiiP Pharma Ltd, product name Dermalexiin, and study details used in this document are fictional and do not represent a real clinical trial. This content is not intended for actual research use and has not been approved by any regulatory or ethics authority.
This sample is shared to demonstrate understanding of ICF structure, language, and regulatory considerations in clinical research.
Avoiding Promotional or Misleading Language
Even though ICFs are non-promotional documents, they must still reflect ethical and regulatory standards such as those outlined in the ABPI Code of Practice. That means:
- No guarantees of benefits or safety
- ❌ “This drug will improve your condition”
- “This study will explore whether the treatment may help improve your condition”
- Balanced presentation of risk and benefit
- Acknowledging potential risks with clarity and honesty is essential and supports the ABPI Code (Clause 7.2) and GCP guidelines.
- Transparency around uncertainty
- The form must openly communicate if certain risks or outcomes are unknown, especially in early-phase trials.
Why ICFs Matter to Me as a New Writer
Informed Consent Forms allow me to apply my clinical understanding and my growing writing skills. They remind me that regulatory writing is not just about structure or compliance; it’s about ethics and people.
Learning to write these documents has helped me develop the following:
- A more precise, patient-centred writing voice
- Awareness of regulatory expectations
- An appreciation for how language influences decision-making in healthcare
Final Thoughts
As I continue developing my career in regulatory medical writing, I see the ICF as more than just a beginner’s assignment; it’s vital to trial transparency and participant protection. It’s where clarity matters most, and where thoughtful writing has real-world impact.
Informed Consent Forms may look simply, but behind every one is a layered process of translation, ethics, and accountability. And for a writer like me, that’s precisely where I want to grow.
References
- International Council for Harmonisation (ICH). E3: Structure and Content of Clinical Study Reports. 1995. Available at: https://www.ich.org/page/efficacy-guidelines
- Association of the British Pharmaceutical Industry (ABPI). ABPI Code of Practice for the Pharmaceutical Industry 2021. Available at: https://www.abpi.org.uk
- European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1). 2013. Available at: https://www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Clinical Study Reports: General Considerations for Submission. 2018. Available at: https://www.fda.gov
- World Health Organization (WHO). Informed Consent Template for Clinical Studies. WHO; 2022; link
'Femi Fajimi 
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