Make room for risks, benefits and alternatives

Research involves uncertainty

A study may or may not provide a direct medical benefit. Possible burdens can include side effects, procedures, extra visits and time away from everyday responsibilities. The details depend on the study and your circumstances.

It helps to separate three questions: What might happen? How likely is it? What would the team do if it happened? If a number is available, ask what group it came from and whether it applies to the treatment being studied now.

Create three columns

On a piece of paper, label columns ‘known,’ ‘still uncertain’ and ‘important to me.’ Put each answer in the right place. This is an organizing exercise, not a formula for deciding whether a study is safe or suitable. A blank in the ‘known’ column is a reason to ask another question.

• Describe the main possible benefits without assuming they will happen.
• List the risks or procedures you want explained more clearly.
• Name the practical burden that could affect your decision most.
• Ask what options are available if you choose not to participate.
• Record who can discuss a concern between scheduled visits.

Consider the full choice

You might be willing to travel often but uncomfortable with a particular procedure. Someone else may feel differently. Try to describe your concern specifically rather than deciding that you are being ‘difficult.’ The study team needs to understand the questions that would otherwise remain unspoken.

Take your notes to your usual healthcare professional when comparing research with established care. A tool, article or study listing cannot make that comparison for you. The aim here is a clearer conversation and a decision based on the actual information available.