Informed Assent

When a clinical study involves emergency treatment or incapacitated participants, it is possible to gain consent where:

• A participant meets the emergency conditions and is obviously in a life-threatening position
• Nothing further can be accomplished with currently available treatment.
• There is a fair possibility that the life-threatening risk to the participant can be avoided if the investigational device or medicinal product is used.
• Anticipated benefits outweigh the risks of using the investigational device or clinical trial of an investigational medicinal product (ctIMP).
• If a legal representative cannot be easily reached and informed.

Once the participant has regained consciousness, or as soon as they are able to understand, the research team should explain the study to the participant and allow them time to consider whether they wish to continue within it. This process must be clearly documented in the participant’s medical notes.