Decision-Making
Learn how to make ethical decisions about including adults with potential capacity concerns in research. This section outlines the step-by-step decision-making process, from assessing capacity and providing supports to consulting personal or nominated consultees, ensuring participants’ rights and wishes are respected.
The process for the recruitment of people to a study is outlined in this video:
Flowchart of the decision-making process
Summary
No concerns about capacity?
If there are no concerns about capacity:
- The person makes their own decision about participation.
- Outcome: Include or Exclude based on their choice.
Concerns about capacity?
If there are concerns about whether the person can:
- Understand the study
- Retain information about it
- Weigh up the implications of taking part or not
- Communicate their decision
Adjustments and Supports: Provide resources to support decision-making in the context of the study.
If the person is now able to make a decision:
- The person makes their own decision about participation.
- Outcome: Include or Exclude based on their choice.
If the person is still unable to make a decision:
Seek advice from a Personal Consultee, someone who is:
- Known to the person and trusted regarding their welfare
- Not paid to provide care
- Not involved in the study
- A friend, family member, attorney, or court-appointed deputy
- If positive advice about inclusion: Include
- If negative advice about inclusion: Exclude
If there is no Personal Consultee available, seek advice from a Nominated Consultee, someone who:
- May or may not know the person
- May provide paid care or professional services (e.g., a doctor)
- Is not connected to the study or employed by the sponsor
- If positive advice about inclusion: Include
- If negative advice about inclusion: Exclude