Poland Limited-Capacity Participant and Legal Representative Consent Requirements

When the limited-capacity pathway applies

Conditional. Use this pathway when the prospective adult participant is unable to give informed consent and the trial proposes enrollment under Article 31 of Regulation (EU) No 536/2014.

The protocol and consent procedure should distinguish between a person who lacks capacity for the relevant decision and a person who simply needs communication support. A participant who can understand the trial and make the decision should normally use the standard informed-consent pathway, with accessibility support where needed.

Capacity can also change. If the population can move between incapacity and capacity, describe who assesses capacity, when it is reassessed and what happens to consent when the participant can make the decision personally.

Conditions for enrolling an incapacitated adult

Article 31 adds protections beyond the general informed-consent rule. The Part II documents and protocol should reflect the conditions that actually apply to the trial.

Mandatory. Informed consent must be obtained from the participant's legally designated representative before enrollment unless the separate emergency pathway in Article 35 lawfully applies.

Mandatory. The participant must receive information about the trial in a form adapted to their capacity to understand it. The investigator must respect an explicit wish of a participant who is capable of forming an opinion and assessing the information to refuse participation or to withdraw.

Mandatory. No incentives or financial inducements may be given to an incapacitated participant or the legally designated representative beyond compensation for expenses and loss of earnings directly related to participation.

Article 31 also limits when such trials may be conducted. The protocol should establish the required relationship between the research, the participant's condition and the expected benefit or the permitted minimal-risk and minimal-burden framework. Do not treat representative consent as sufficient on its own if the substantive Article 31 conditions are not met.

Documents to prepare for Poland

The exact document architecture can vary, but the reader should be able to identify the participant's information, the representative's information and the legal consent record without ambiguity.

A typical Poland package includes:

• a Polish information document for the legally designated representative
• a Polish informed consent form for the legally designated representative
• participant-facing information adapted to the participant's level of understanding
• an assent or acknowledgment section where it is appropriate to record the participant's own involvement without falsely presenting it as the legal consent
• the Recruitment and informed consent procedure describing the incapacity and representative pathway
• any optional pregnancy, genetic, biological-sample or secondary-use material adapted to the same decision-making structure

A combined participant and representative document can be acceptable if it remains clear who is being informed, who gives legal consent and which signature records which decision. Separate documents are often easier to control when the two audiences need materially different explanations.

The main adult content still applies. Risks, procedures, alternatives, withdrawal, insurance, compensation, data protection and contacts should not disappear simply because the representative is the legal consent-giver.

Identifying the legally designated representative in Poland

The Clinical Trials Regulation uses the term legally designated representative and leaves the national legal basis for that status to the Member State. The Poland procedure should therefore describe how the site will verify that the person signing has legal authority for the participant's clinical-trial decision.

Do not write a generic statement that any spouse, adult child or close relative can automatically sign. Family relationship and legal authority are not the same thing. The site file should support why the person used as the representative is legally entitled to act in the specific case.

The Polish Clinical Trials Act confirms that the EU Clinical Trials Regulation is the governing framework for medicinal clinical trials. It also amended the Polish Physicians Act so that clinical trials falling under Regulation 536/2014 use the clinical-trial legal framework rather than conflicting medical-experiment consent provisions.

Where the exact representative pathway depends on a participant's legal status, obtain country-specific legal or site advice before finalising the operational instruction. The Part II document should describe the verified pathway used by the trial rather than inventing a broad hierarchy.

Information for the participant

Mandatory. Article 31 requires the participant to receive information adapted to their capacity to understand it. This is an active part of the consent process, not an optional courtesy after the representative signs.

Focus the participant-facing information on what the person will experience. Explain visits, procedures, discomforts, restrictions, possible benefits, choices and the right to object in language the person can understand. Use images or simplified wording only when they improve comprehension and remain accurate.

A participant who can form an opinion must have a practical way to communicate refusal or withdrawal. Site staff should know how verbal and non-verbal objections will be handled when communication is limited.

Do not call every adapted document an ICF if the participant is not the legal consent-giver. Labels such as participant information, assent or acknowledgment can make the legal function clearer.

Refusal, objection and withdrawal

Mandatory. The explicit wish of an incapacitated participant who is capable of forming an opinion and assessing the information to refuse participation or withdraw must be respected.

The representative form should not state that the representative can require continued participation despite the participant's capable refusal. The consent procedure should also distinguish an explicit objection from ordinary discomfort that the protocol already anticipates and manages clinically.

Withdrawal information should be aligned across the representative document and the participant-facing document. Both should explain that participation is voluntary and that refusal or withdrawal does not create a penalty or loss of ordinary care.

If capacity improves or returns

Conditional. If temporary or fluctuating incapacity is foreseeable, build reassessment into the consent process before submission. State who reassesses capacity and what happens when the participant becomes able to make the informed-consent decision personally.

The participant should then receive the information needed for their own decision and the site should document the new consent status. For trials that may begin through an emergency pathway, the European Commission's Recruitment and informed consent procedure template v2.0 expressly asks how re-consent will be handled if a participant regains capacity after initial consent from a legally designated representative.

Do not leave this as an undocumented site practice. The approved procedure and forms should make the transition clear enough for investigators to follow consistently.

Signatures and dating

At CTIS submission, submit the blank controlled Polish versions of the participant and representative materials. The prospective participant and representative do not sign the dossier copies.

When consent is obtained, Article 29 requires the written informed consent to be dated and signed by the person conducting the consent interview and by the participant or legally designated representative, as applicable. Provide the participant or representative with a copy of the informed-consent documentation.

If the representative can consent but cannot write, assess whether the Poland impartial witness consent guide applies to the method used to record the representative's consent.

Compensation and insurance information

The standard Poland compensation information remains relevant. The Patient Rights Ombudsman states that information given before informed consent must explain the Clinical Trials Compensation Fund and the mandatory civil liability insurance of the sponsor and investigator.

Make the explanation understandable to the representative and, in adapted form, to the participant where possible. Do not remove the compensation section because the participant is not the person who signs the legal consent.

CTIS procedure description

The European Commission's Recruitment and informed consent procedure template v2.0 contains a specific section for incapacitated adults. For each Member State concerned, describe the national process and the participant's involvement.

For Poland, the procedure should cover at least:

• how incapacity for the trial decision is assessed
• how the legally designated representative is identified and authority verified
• which Polish documents are provided to the representative and participant
• how participant understanding and opinion are sought
• how refusal or withdrawal is handled
• whether capacity is reassessed and how personal consent is obtained if capacity returns
• how signatures and copies are managed at the site

Use the Poland patient-facing document QC checklist to test the representative logic against the protocol. Return to the Poland CTIS Part II guide hub for the complete Poland guide set.