What aspects of informed consent matter most to patients?

Before someone joins a research study or clinical trial, they should have clear information and an opportunity to decide whether taking part is right for them. This process is known as informed consent.

Research teams may compare different ways of presenting information, such as a shorter or longer information sheet, paper materials or a web-based format. To understand whether an approach is working well, teams need to decide which outcomes are meaningful to the people being asked to take part.

This archived item highlighted the value of seeking views from patients and public contributors when identifying those outcomes. Experience of research was not required: the focus was on what people consider important when they receive information, ask questions and make a decision about a trial.

Questions that public contributors can help explore

People reviewing consent materials and processes may draw attention to practical questions that are easily missed in technical planning. These can include:

• Whether the purpose of the study is easy to understand.
• Whether possible benefits, uncertainties and commitments are explained in plain language.
• Whether information is offered in formats people can use.
• Whether there is enough time and support to consider the decision and ask questions.
• Whether people know what will happen next, including their options if they decide not to take part.

Using involvement well

When asking public contributors to review consent processes, it helps to explain the specific decisions that are still open, provide materials in advance and feed back on what changed as a result of their input. Teams should also be clear about the difference between advising on research design and joining a study as a participant.

For a wider introduction to involvement, visit the public involvement essentials or read the briefing notes for researchers.