Informed consent is about ensuring that participants fully understand what they agree to and feel empowered to make a free and informed choice. Achieving truly informed consent means going beyond formalities to foster clarity, trust, and respect. So, without further ado, let’s think about how you can make the consent processes more effective and participant-centred.

1.       Use Clear, Accessible Language in Your Documents

Participant-facing materials like the Participant Information Sheet (PIS) and consent forms should be written in plain language. Avoid jargon, technical terms, or overly complex sentences. Aim for a reading age of around 11–12 years old, and don’t underestimate the power of formatting. Use bullet points, headers, and white space to break up text and guide the reader. A PIS doesn’t need to be tens of pages long to be thorough; in fact, overly lengthy documents can overwhelm or disengage participants. Keep it concise, relevant, and reader-friendly.

2.       Create Space for Questions and Dialogue

Informed consent is not a one-way transmission of information, it should be a conversation. Encourage participants to ask questions and take the time to answer them clearly and patiently. Let them know there’s no pressure to sign immediately and give them space to reflect or discuss their decision with yourself or others if they wish. When possible, offer to talk through the documents. This is especially helpful for participants with limited literacy or different communication needs.

3.       Tailor Consent Processes to Your Population

Consider the needs and preferences of the people you're working with. For example, if your study involves adolescents, individuals with disabilities, or people from diverse linguistic or cultural backgrounds, adapt your materials and approach accordingly. This might involve providing translated versions, easy-to-read formats, audio or video explanations, or working with community and linguistic advisors to ensure your materials are appropriate and respectful.

4.       Check for Understanding, Don’t Just Assume It

Rather than asking, “Do you understand?” ask participants to explain in their own words what the study is about and their involvement. This helps you assess their true understanding of what they’re agreeing to - here’s where the informed of informed consent comes into play. It also allows you to identify any misunderstandings early and gives you the chance to clarify key points in a supportive way.

5.       Remind Participants of Their Ongoing Rights

Informed consent is not a one-time event. It’s important to remind participants (especially in longer or multi-stage studies) that they can withdraw, skip questions, or change their minds without any consequence at any time. Reiterate this verbally and build it into your study processes wherever possible.

Truly informed consent empowers participants and strengthens the integrity of research. It’s not just a box to tick, but a process built on trust, clarity, and mutual respect. By committing to accessibility, transparency, and genuine engagement, we ensure that consent is not simply informed by name, but by its very nature.

Lois Ann Parri

Originally written on March 2024 – London, England UK