What Should Researchers Do When a Participant and Their Representative Disagree About Participation?

Whose decision controls when the participant and representative want different things?

A legally authorized representative agrees to research participation, but the participant pulls away and says no. In another case, the participant wants to join, but the representative refuses permission. Perhaps the participant's ability to make the decision is uncertain, or their capacity has changed since enrollment.

It is tempting to resolve these situations with a simple hierarchy: either the representative always decides, or the participant's preference always prevails. Research ethics is more conditional than that.

The first question is not who has the stronger opinion. It is whether the participant currently has the capacity and legal authority to make the research decision themselves. If they do, representative consent ordinarily should not substitute for their decision. If they do not, the representative may have formal authority, but the participant's assent, dissent, preferences, and welfare can still matter substantially.

Resolve capacity and authority first, then address assent, dissent, and the study's rules

Not every disagreement is the same ethical problem

First determine whether the participant still needs a representative

A representative's authority to provide research consent generally arises because the participant cannot provide the required legally effective consent themselves. Under OHRP guidance, when an adult lacks consent capacity, only a legally authorized representative may provide consent on the person's behalf unless an appropriate waiver applies. If the participant regains or develops capacity, however, their own consent must be obtained for further research because representative consent no longer substitutes for the participant's decision.

This makes capacity the first branch in the disagreement analysis.

If capacity itself is uncertain, use the approved process to determine whether the participant can make the research decision before trying to resolve the disagreement.

Representative consent does not erase the participant's voice

ICH E6(R3) states that when prospective clinical-trial participants cannot provide informed consent, their legally acceptable representatives should provide consent in the participants' best interest. It also states that potential participants should be informed about the trial in a manner that facilitates their understanding.

The Declaration of Helsinki goes further for people incapable of giving free and informed consent. When they are able to provide assent, researchers must seek that assent in addition to consent from the legally authorized representative, consider the participant's expressed preferences and values, and respect the participant's dissent.

Representative consent therefore should not turn the participant into a passive object of somebody else's decision.

Assent is more than the absence of resistance

Assent generally refers to affirmative agreement from a person who cannot provide the legally effective consent required for participation. Requirements differ among populations and research frameworks.

In pediatric research under HHS regulations, for example, the IRB determines when children are capable of assent. OHRP states that when assent is required, a child's dissent ordinarily prevents participation even when a parent or guardian has granted permission, subject to a specific regulatory exception involving an intervention offering an important prospect of direct benefit available only through the research.

The exact pediatric rule should not simply be transplanted into adult research involving impaired capacity. It illustrates an important principle, however: permission from another person and agreement from the participant are distinct ethical elements.

Dissent can be verbal or nonverbal

A participant does not necessarily need to say the words "I withdraw consent" for researchers to notice unwillingness.

SACHRP recommendations concerning people with impaired decision-making capacity state that IRBs should consider what constitutes dissent, particularly for people with limited communication ability. Nonverbal behavior or actions indicating unwillingness to undergo a research procedure may constitute failure to assent or dissent.

Examples might include repeatedly saying no, pulling away from a research-only procedure, becoming distressed specifically when participation is attempted, or consistently communicating unwillingness through an established communication method.

If a capable participant says no, a representative ordinarily cannot turn that into yes

Once a participant has the capacity and authority to provide their own informed consent, the basis for substitute decision-making generally disappears. OHRP explicitly states that when a participant regains or develops capacity, their own consent must be obtained for further research and the representative's prior consent is no longer valid as a substitute.

This means that a representative's preference for continued participation does not ordinarily override the decision of a participant who has regained the ability to decide for themselves.

Researchers should document the capacity determination and follow the protocol's withdrawal procedures if the participant declines continued involvement.

If the participant lacks capacity and says no, dissent usually deserves substantial weight

The Declaration of Helsinki states directly that the dissent of a participant incapable of giving free and informed consent should be respected.

SACHRP likewise recommends careful attention to assent and dissent for adults with impaired decision-making capacity, including nonverbal expressions of unwillingness.

The precise legal effect of dissent can depend on the jurisdiction, research population, and applicable framework. Researchers should therefore avoid inventing a universal rule for every study. Still, an authorized representative's signature should not be treated as permission to ignore meaningful participant resistance.

If the participant wants to participate but the representative refuses, agreement from the participant may not be enough

The opposite disagreement creates a different problem. A person who lacks the capacity required for legally effective consent may be enthusiastic about participating, but if the governing framework requires permission from an authorized representative, the participant's assent alone does not necessarily authorize enrollment.

ICH E6(R3), for example, states that for potential trial participants unable to provide informed consent, the legally acceptable representative should provide consent before participation.

Similarly, in HHS-regulated pediatric research where parental permission has not been waived, OHRP states that a child's assent does not permit enrollment without the required parental or guardian permission.

Researchers should not therefore convert assent into legally effective consent merely because the participant appears eager to enroll.

Disagreement may reveal that capacity needs to be reassessed

Suppose a representative says the participant cannot possibly understand the study, while the participant gives coherent explanations of the procedures, risks, alternatives, and reasons for wanting to participate. That disagreement should not automatically be resolved in favor of the representative.

Conversely, a participant may insist on joining while demonstrating substantial misunderstanding that persists after appropriate explanation.

In either case, disagreement can be a signal to reassess rather than a reason to choose whichever speaker seems more persuasive. The question remains whether the participant currently possesses the abilities required for this particular decision.

The representative's role extends beyond signing the enrollment form

SACHRP notes that the role of an LAR will often extend beyond initial enrollment to ongoing monitoring and research decision-making. It recommends safeguards tailored to the study's risks and benefits.

This matters in longitudinal research. New risks may emerge. Procedures may change. The participant's condition may improve or deteriorate. The representative and participant may begin to disagree only after months or years of participation.

The protocol should therefore anticipate ongoing decision-making rather than treating representative consent as a one-time administrative event.

Researchers should distinguish disagreement from conflict of interest

A representative may have interests that do not perfectly align with the participant's. Participation might provide access to additional clinical monitoring, reduce caregiving burden, provide compensation, or satisfy the representative's hope for an experimental intervention.

That does not automatically make the representative inappropriate. It does mean researchers should remain attentive to whether the decision appears centered on the participant's interests, preferences, and welfare.

ICH E6(R3) specifically states that legally acceptable representatives providing consent should act in the participant's best interest.

The representative must actually have authority before their disagreement matters as representative disagreement

A family member who strongly opposes research is not necessarily the participant's legally authorized representative. Nor does being the participant's caregiver automatically confer research-consent authority.

Researchers should first verify who actually qualifies as a legally authorized representative under the applicable law. OHRP emphasizes that LAR status depends on the law of the jurisdiction in which the research is conducted.

A disagreement with an unauthorized relative may still matter socially or practically, but it is not the same legal consent problem.

Do not pressure either side into agreement for the sake of recruitment

The goal is not to persuade the participant and representative to produce the enrollment decision the research team prefers.

Researchers can clarify misunderstandings, explain each person's role, allow time for discussion, and identify whether disagreement arises from inaccurate information. But informed consent must remain voluntary. OHRP emphasizes that consent from either the participant or legally authorized representative must be sought under circumstances providing adequate opportunity to consider participation and minimizing coercion or undue influence.

Sometimes disagreement will remain after everyone understands the study. Ethical research needs a procedure for that outcome too.

Complex disagreements should be escalated rather than improvised

A protocol involving participants who may lack consent capacity should ideally specify how assent, dissent, withdrawal, fluctuating capacity, and representative decision-making will be handled. The IRB or research ethics committee should review those safeguards prospectively.

If an unanticipated disagreement raises uncertainty about legal authority, capacity, participant safety, or whether continued participation is permissible, investigators should seek guidance through the appropriate institutional and ethics channels rather than creating a new rule during the encounter.

Investigators remain responsible for conducting research according to the IRB-approved protocol and consent requirements.

When the representative wants participation but the participant resists

The representative's consent remained legally and ethically relevant, but it was not treated as unlimited permission to override the participant's meaningful resistance.

Common mistakes when participants and representatives disagree

Use a decision sequence rather than choosing sides immediately

Participant-representative disagreement should trigger a structured review. The order matters because the answer changes substantially depending on the participant's current capacity and the representative's actual authority.

The safest question is not "Who wins?" It is "What authority does each person have, what is the participant currently capable of deciding, what are they communicating, and what does the approved ethical and legal framework require?"

When the participant and representative disagree

Questions about participant and representative disagreement

Do not resolve disagreement by assuming either person automatically outranks the other

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