Who Assesses Capacity, and What Gets Recorded

Part of Consent and Vulnerable Populations: Capacity and How It Is Assessed.

About 5 minutes. Free, in your language, no account needed.

Why this matters

A capacity assessment is a finding with consequences. It determines whether a person decides for themselves or whether someone decides for them, which is among the most significant things that can be done to an adult.

It therefore has to be made by someone entitled to make it, on a stated basis, and recorded in a way that shows what was actually assessed. Most capacity documentation in clinical research fails the third of these and frequently the second.

Who may assess

The answer is jurisdictional and there are consistent principles.

It is usually the person seeking the consent who must satisfy themselves that the participant has capacity. Capacity assessment is not a specialist referral in the ordinary case; it is part of obtaining consent competently.

A specialist assessment is warranted where capacity is genuinely in doubt, where the condition under study affects cognition, where the decision is complex or high-risk, or where an initial assessment is equivocal.

The assessor must be qualified for the assessment they are making, and the delegation log must show they were permitted to make it. A coordinator assessing capacity in a dementia trial, without that being a delegated and trained task, is performing a clinical assessment outside their delegation.

The investigator remains responsible, whoever performs the assessment.

What must be recorded

The common documentation is a tick box reading "participant has capacity to consent." That records a conclusion and nothing else, and it is worth almost nothing.

A useful record contains:

The decision assessed, named specifically. Capacity to consent to participation in this trial, not capacity in general.

The date and time, because capacity fluctuates and an assessment is a statement about a moment.

Who assessed, and their role.

What was actually done. What the person was asked, and what they said. This is the part that turns a conclusion into a finding.

The conclusion, with its basis. Not merely that the person had capacity, but on what observed ability.

Any support provided, since a person who has capacity with support has capacity, and the record should show what enabled it.

Recording the person's own words

The single most useful thing in a capacity record is a short quotation of what the participant said when asked to describe the trial.

It is brief, it takes seconds, and it is the only element that allows anybody afterwards to form their own view. "Participant stated the study involves a new tablet that may or may not help, that she will come in every month, and that she can stop if she wants" is evidence. "Capacity confirmed" is an assertion.

When the assessment is equivocal

Sometimes the honest answer is that it is not clear, and the record should be able to say so.

An equivocal assessment leads to one of three actions, all legitimate: try again with better support at a better time; obtain a specialist assessment; or proceed on the basis that the person lacks capacity for this decision and follow the representative route.

What is not legitimate is resolving the uncertainty by recording a conclusion the assessment did not support, which is what a tick box invites, because a tick box has no way to express doubt.

In practice

A coordinator on a trial in Parkinson's disease, where some participants have cognitive involvement, uses a short structured record.

For each participant: the decision, the date and time, the assessor, four short notes on what the person said when asked to describe the trial, the risks, what would happen if they declined, and whether they could stop; then the conclusion; then any support provided.

It takes about three minutes beyond the consent conversation itself.

Fourteen months later an ethics committee asks how the site assured itself that participants with cognitive involvement had capacity. The site produces the records.

The committee can see what was asked and what was answered, and forms its own view. The alternative answer, that the coordinator was satisfied in each case, is not something a committee can assess and would have led to a much longer conversation.

What this looks like when it goes wrong

A trial's consent process includes a capacity checkbox on the consent form, ticked by the person taking consent.

Every form in the study has it ticked. There are 400 participants.

An inspector asks about one participant whose medical record notes significant confusion on the day of consent.

The site's position is that capacity was assessed and confirmed, and the evidence for that is the tick.

There is no record of what was asked, what the participant said, what time of day it was, or whether the confusion noted in the medical record was considered. The tick is compatible with a thorough assessment and with no assessment at all, and nothing distinguishes them.

The finding is not that the participant lacked capacity, which cannot now be determined. It is that the site cannot demonstrate that capacity was assessed for any of its 400 participants.

Key takeaways