Can Someone Else Consent on Behalf of a Research Participant?

When can another person make the research participation decision?

A prospective participant cannot adequately consent because of severe cognitive impairment, unconsciousness, acute illness, or another condition affecting decision-making capacity. Their spouse is present and willing to sign. Can the researcher simply ask the spouse to consent instead?

Sometimes another person can provide legally effective permission. But researchers cannot ordinarily transfer the decision to whoever happens to know the participant best or happens to be available.

Representative consent is a specific legal and ethical mechanism. Whether it is permitted, who may act as the representative, what decisions that person may make, and what role the participant retains depend on the applicable law, research framework, protocol, and ethics approval.

Another person can sometimes consent, but only with the appropriate authority

Representative consent is not simply asking the nearest relative to sign

Start by asking whether the participant can consent for themselves

Before looking for someone else to make the decision, determine whether representative consent is actually necessary.

A diagnosis, disability, inability to read, difficulty speaking, or temporary confusion does not automatically establish that the participant cannot provide informed consent. Communication barriers should be addressed, and genuine concerns about decision-making ability should be evaluated using the appropriate process.

If uncertainty concerns the participant's ability to make the decision, first determine whether the participant has capacity to give informed consent. Representative consent should not become a convenient shortcut around an accessible consent process.

Family relationship alone does not create research-consent authority

Under the U.S. Common Rule, a legally authorized representative is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to participation in the procedures involved in the research. OHRP states that who qualifies depends on the law of the jurisdiction in which the research is conducted. FDA uses a closely corresponding definition for clinical investigations.

That means "next of kin" is not a universal research-consent rule. A spouse, adult child, sibling, caregiver, healthcare proxy, guardian, or other person may qualify in one jurisdiction or circumstance and not in another.

Different research frameworks use slightly different terminology

U.S. HHS and FDA regulations use the term legally authorized representative, commonly abbreviated LAR. ICH E6(R3) uses legally acceptable representative for an individual or juridical or other body authorized under applicable law to consent on behalf of a prospective clinical-trial participant.

The terminology should not distract from the underlying principle: the representative's authority comes from the applicable legal framework, not simply from the researcher's preference or the representative's relationship to the participant.

The representative receives an informed consent process too

Representative consent is not merely obtaining someone else's signature. FDA regulations require consent from the participant or representative to be sought under circumstances providing sufficient opportunity to consider participation, minimizing coercion or undue influence, and using understandable language. FDA guidance similarly emphasizes that consent involves information, opportunity for questions, comprehension, and voluntary agreement.

The representative therefore needs the information necessary to make the participation decision and an opportunity to ask questions. The same basic ethical standards of informed decision-making still apply.

The representative is making a decision for the participant, not for themselves

The representative's task is not simply to decide whether they personally like the study. Their role concerns the interests, rights, preferences, and circumstances of the participant whose participation is being considered.

Where the participant's prior wishes or values are known, they may provide important guidance. Where they are unknown, the governing legal and ethical framework may specify how the representative should approach the decision.

Researchers should avoid quietly turning the question into, "Would you want to participate in this study?" The relevant person is the participant.

The participant should remain involved whenever possible

Lack of capacity to provide legally effective informed consent does not necessarily mean the participant understands nothing or has no meaningful preferences.

A participant may understand a simplified explanation, express willingness, object to a procedure, or consistently communicate that they do not want to participate. Research ethics therefore distinguishes representative permission from the participant's own assent or dissent.

A representative's permission does not necessarily override the participant's objection

The 2024 Declaration of Helsinki states that when a potential participant incapable of giving free and informed consent can provide assent, researchers should seek that assent in addition to consent from the legally authorized representative, and the individual's dissent should be respected.

The precise requirements vary among research frameworks and populations, but the principle is important: representative permission should not automatically erase a participant's expressed unwillingness.

Representative consent may be particularly relevant when capacity is impaired

OHRP states that if an adult lacks capacity to consent because of circumstances such as trauma, some forms of mental illness, or dementia, a legally authorized representative may provide consent under the applicable law, unless the IRB has appropriately waived the consent requirement.

The diagnosis itself is not the trigger. The relevant issue is whether the person lacks the capacity required for the research decision. This is why having a cognitive or mental health condition does not automatically mean someone cannot consent.

Children are usually governed by a separate parental-permission framework

Research involving children should not simply be treated as ordinary adult representative consent. Under HHS regulations, research involving children generally addresses parental or guardian permission together with child assent when the IRB determines that the children are capable of providing assent.

The applicable definition of a child depends on the legal age for consent to the treatments or procedures involved in the research in the jurisdiction where the research occurs. Researchers should therefore follow the child-specific rules applicable to the study rather than applying adult LAR procedures automatically.

Emergency research can follow different rules

Emergency research creates special problems because a prospective participant may be unable to consent and an authorized representative may not be available within the therapeutic window.

FDA regulations provide narrowly defined exceptions from informed-consent requirements for certain emergency research when specified safeguards are satisfied. Those provisions should not be confused with ordinary representative consent. FDA's emergency-research framework also gives family members particular notification or objection roles in some circumstances without thereby treating every family member as an LAR.

An emergency should therefore not be treated as permission to invent a proxy-consent procedure on the spot.

If the participant regains capacity, the consent arrangement may need to change

Capacity can be temporary or fluctuating. Someone unconscious after trauma may recover. Delirium may resolve. Psychiatric symptoms may stabilize.

OHRP states that if a participant who was enrolled through representative consent regains or develops capacity to consent, the participant's own consent must be obtained for further research because the representative's consent no longer substitutes for the participant's own decision.

Studies involving foreseeable changes in capacity should therefore include plans for reassessment and reconsent.

A waiver of consent is not representative consent

If an IRB or ethics committee is authorized to waive informed consent and the relevant criteria are satisfied, research may proceed without obtaining the usual individual or representative consent. That is a different mechanism.

Researchers should not use an informal surrogate as a substitute for obtaining a proper waiver, nor assume that a waiver is needed whenever a participant cannot consent.

When a spouse is present but authority still needs to be verified

The spouse may ultimately be the appropriate representative. The important point is that the authority was established rather than inferred from the family relationship.

Common misconceptions about consent on someone else's behalf

Verify authority before transferring the consent decision

If your study may enroll people who cannot provide their own consent, determine the representative-consent framework before recruitment. The protocol should identify how incapacity will be assessed, which law determines representative authority, how that authority will be verified, how the participant will remain involved, and what happens if capacity changes.

Representative consent protects participants only when the representative genuinely has authority and the process remains centered on the participant. A convenient signature from the wrong person is not a substitute for legally effective informed consent.

Before someone else consents for a participant

Questions about consent on behalf of research participants

Someone else may decide only when the framework actually gives them that authority

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