Benefits to Participants

Participation in research may bring benefits such as:

• Improvements in the treatment or management of the participant’s condition
• Enhanced quality of health or social care
• Increased knowledge about the causes of the participant’s condition
• Reduced risk of harm, exclusion, or disadvantage

Important: Consider whether there are direct benefits to the individual participant. Always take into account their unique circumstances, preferences, and needs when assessing potential benefits.

Risks to Participants

It is essential to minimise any potential risks to ensure that participation does not:

• Interfere significantly with a person’s freedom of action
• Unduly compromise their privacy or impose restrictive measures

To effectively reduce risks, evaluate participation from two perspectives:

• The research itself: What does it involve, and what are the demands on participants?
• The individual’s context: How might participation impact their personal situation, wellbeing, and daily life?

Remember: Any research benefits for a person who lacks capacity must be proportionate to the burden or inconvenience resulting from participation.

Considering Inclusion

Before including adults who may lack capacity, carefully reflect on these key questions:

• Is it necessary? Can your research question be answered without involving individuals who lack capacity?
• What are the benefits? Does participation offer meaningful benefits to the person? Are those benefits proportionate to any potential burdens?
• What knowledge will be gained? How will the research contribute to understanding the cause, treatment, or care of people with the same or similar conditions?

Establishing clear, reasoned answers to these questions is crucial for achieving a favourable ethical review.