Decision-Making

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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.

Decisions about research participation should be guided by the individual's capacity, wishes and preferences, with appropriate adjustments and supports provided wherever needed.

This video outlines the decision-making process for recruiting adults to research studies, including how to respond to concerns about capacity and when to seek advice from a personal or nominated consultee.

Read the video transcript

Capacity and decision-making

A person meets the eligibility criteria for a study. With no issues with capacity, the person is able to make a decision about their participation as to whether they want to include or exclude themselves.

But what about when there are concerns about a person's capacity?

These concerns could be related to whether the person can understand the study, retain information about the study, weigh and consider the consequences of both taking part and not taking part in the study, and whether they can communicate their decision about taking part in the study.

In this instance, we can look at adjustments and supports, resources that are used to support decision-making in the context of the particular study.

The outcome of this determines whether the person can make their own decision or if they're unable to do so.

If the person is unable to make this decision themselves, they could seek the advice of a personal consultee. This would be someone who is known to the person and trusted regarding matters of welfare. Someone not paid to provide care, a friend or family member, or an attorney or deputy appointed by the Court of Protection, and someone not involved in the study.

Following positive or negative advice about the person's inclusion, a decision can be made whether to include or exclude them from the study.

But what if a personal consultee is not available?

In this instance, a nominated consultee can perform these duties instead. This would be someone who may be known to the person, someone who can provide paid care or professional services, for example, a medical doctor, and someone who is not connected to the study or employed by the sponsor.

Once again, based on positive or negative advice about the person's inclusion, a decision can be made whether to include or exclude the person from the study.

Flowchart of the decision-making process

The following flowchart provides a visual overview of the process, from identifying concerns about capacity to providing adjustments and supports or seeking advice from a consultee.

Flowchart illustrating the decision-making process for research participation, including capacity assessment, adjustments and supports, and consultation with personal or nominated consultees. A text summary is provided below.

View larger flowchart

Summary of the decision-making process

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

The consultee advises on the person's likely wishes and feelings about participation.

  • If positive advice about inclusion: Include, subject to the relevant research requirements and the person's wishes.
  • If negative advice about inclusion: Exclude.
If no personal consultee is available

Seek advice from a nominated consultee, someone who:

  • May or may not know the person
  • May provide paid care or professional services, for example, a doctor
  • Is not connected to the study or employed by the sponsor

The nominated consultee also advises on the person's likely wishes and feelings about participation.

  • If positive advice about inclusion: Include, subject to the relevant research requirements and the person's wishes.
  • If negative advice about inclusion: Exclude.

Remember: A consultee provides advice about the person's likely wishes and feelings; they do not give consent on the person's behalf. The individual should continue to be supported to engage in the research decision-making process, and any indication that they do not wish to participate must be respected.

Last modified: Monday, 26 October 2026, 12:25 PM