Subjects who lack capacity

Involve a representative who can communicate the subject’s wishes

• Seek consent from a family member, guardian, carer or friend who knows the potential subject well.
• Check if the subject had made any advanced decisions about participating in research or if they had expressed previous wishes when they still had capacity.
• Keep the subject’s representative informed throughout the study.
• If the subject has no personal representative, consult an independent clinician or patient advocate to decide what would be in the subject’s best interests.

But still involve the subject as much as possible

• The subject’s agreement (i.e. assent) should be obtained if they can have a basic understanding of the study. This should be documented together with their representative’s / guardian’s consent. ⁽¹³⁾
• If a potential subject who lacks capacity refuses to participate, you should respect his / her objection unless there are strong justifications to override them. These justifications should be approved by the REC.

Continue to evaluate capacity throughout the course of the study

• Capacity may fluctuate with the progression of a health condition.
  • For example, a subject who is having delirium due to an infection may improve or deteriorate after taking an experimental antibiotic.
• When a previously incompetent subject regains capacity, you must seek his / her consent again whether to continue participating in your study.
• When a previously competent subject loses capacity, check whether participation in the study is still in his / her best interests, particularly if new information emerges or there are protocol changes that require subjects to be re-consented.