'Femi Fajimi

Writing the Participant Information Sheet: A Practical Introduction

By ‘Femi Fajimi | 15 May 2025

The Participant Information Sheet (PIS) is one of the most important documents a medical writer may help prepare during the early phases of a clinical trial. In plain and respectful language, it explains what the study is about, what participation involves, and what rights and protections participants have.

While the Informed Consent Form (ICF) contains the actual consent statement to be signed, the PIS provides the context: the “why,” “how,” and “what” of the trial. Together, they support the principle of informed consent, a key pillar of Good Clinical Practice (GCP) and ethical research.

What Does a PIS Include?

A Participant Information Sheet typically answers the following questions:

• What is the purpose of the study?
• Why have I been invited?
• What will happen if I take part?
• What are the possible benefits and risks?
• What are my rights if I join or decide not to?
• How will my information be kept confidential?
• Who is organising and funding the research?
• Who can I contact for more information?

Each section must be written with the participant’s understanding in mind, often aiming for a reading level of around 12–14 years old. Tone matters; the language must be simple, factual, and never coercive.

The Medical Writer’s Role

From my perspective as a developing writer, contributing to a PIS means more than simplifying language. It’s about making sure the information is:

Ethically accurate (aligned with protocol and patient rights)

Consistent with other study documents

Plain and respectful (avoiding jargon and promises)

Structurally clear (logically ordered and readable)

Medical writers may work directly with clinical teams, ethics advisors, or communications specialists to ensure every detail, from study procedures to withdrawal rights, is correct and understandable.

Final Thoughts

Writing a Participant Information Sheet is about clarity, ethics, empathy, and trust. The PIS stands at the intersection of science and human understanding, and it plays a vital role in helping individuals make truly informed choices about their involvement in research.

For medical writers, the challenge lies in communicating complex, protocol-driven information in a respectful, honest, and easy-to-understand tone. The manuscript is one of the first documents a potential participant will read, and it sets the tone for their entire research experience.

Along the way, I’ve also learnt that even how we number sections in a PIS matters to support readability and participant understanding.

As I develop further in this field, I recognise the Participant Information Sheet as a key instrument for supporting ethical research through clear, accurate, and participant-centred communication.