What a Representative May and May Not Agree To

Part of Consent and Vulnerable Populations: Consent by a Legal Representative.

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

Why this matters

Establishing who may consent is the first question. The second is what they may consent to, and it is not everything.

A representative is not standing in the participant's shoes with the participant's full freedom. They are exercising a constrained authority, and the constraints exist because the person affected cannot object.

The constraints that commonly apply

The research must relate to the condition causing the incapacity, or to a condition the person has. A trial unrelated to the reason a person cannot consent is generally not something a representative may authorize on their behalf, because the justification for research on people who cannot consent rests on their prospect of benefit or on knowledge relevant to their own group.

The research must not be possible in people who can consent. If the question can be answered in a population able to consent for itself, doing it in one that cannot is not justified.

The risk and burden thresholds are stricter. Regulation (EU) No 536/2014 requires, for trials on incapacitated subjects, that there are grounds for expecting participation to produce a direct benefit outweighing the risks and burdens, or, where there is no direct benefit, that the trial relates to the condition and entails only minimal risk and minimal burden.

That second limb is what permits research that does not benefit the individual, and its threshold is genuinely low. "Minimal" is not a synonym for "acceptable."

The person's own wishes govern where known. A previously expressed objection to research, or to this kind of research, must be respected. A representative may not consent against a view the person expressed when they could.

The person's present objection counts. This is the one most often overlooked. A participant who lacks capacity to consent may still express refusal, through words, distress, or resistance to a procedure, and that expression must be respected. It is not overridden by the representative's agreement.

The objection that is not framed as refusal

Consistent distress at a procedure. Turning away. Withdrawing an arm. Repeated attempts to leave.

These are communications. Treating them as symptoms to be managed rather than as expressions of refusal is the characteristic failure in research with incapacitated participants, and it is comfortable precisely because the alternative reading is inconvenient.

The discipline is to record what happened and escalate it, rather than to interpret it in the direction that allows the visit to continue.

What a representative is deciding

Not what they would want. What the participant would have wanted, so far as it can be known, and failing that, what is in the participant's best interests.

This is a genuinely different question and representatives frequently do not realize they are being asked it. A representative who says "I would want him to have every chance" has answered about themselves.

The conversation that helps is a direct one: what do you think he would have said about this, if we could ask him. Many representatives find that question clarifying, and some change their answer.

In practice

A coordinator obtains representative consent for a participant with severe dementia to join a trial involving monthly blood samples and a cognitive assessment.

The representative consents. At the second visit the participant becomes distressed during the blood draw, pulls his arm away twice, and is verbally resistant.

The nurse's instinct is to reassure and continue, because the participant is often distressed by procedures and settles.

The coordinator stops. The behavior is recorded as it happened, the investigator is informed, and the representative is consulted, not to authorize continuing but to discuss what the participant's reaction means.

The outcome is that blood sampling is discontinued for this participant while the cognitive assessment, which he engages with willingly, continues.

The trial loses a data point. The participant's refusal, expressed the only way available to him, was respected.

What this looks like when it goes wrong

A trial enrolls participants with advanced dementia through representatives. The protocol includes a procedure some participants find distressing.

Site staff are trained to use distraction and reassurance, which is good clinical practice for a necessary procedure.

It is applied here to a research procedure that produces no direct benefit to the participant. Over two years, several participants are repeatedly distressed and the procedure is completed each time through skilled management.

Nothing is recorded as an objection, because it was categorized as distress to be managed.

An ethics committee reviewing the trial's conduct asks how participants' assent and dissent were monitored. The answer is that representatives consented and no participant withdrew.

No participant could withdraw. Several expressed refusal repeatedly, in the only way available to them, and the trial's process had no category for it.

Key takeaways