Netherlands CTIS Patient Information and Consent Requirements

Which model applies

Recommended until 31 December 2026. Use IVO version 1.1 for a new submission involving participants aged 16 or older. CCMO recommends the model because it is written in accessible language and supports faster review.

Mandatory from 1 January 2027. New Dutch information sheets for participants aged 16 or older must use the IVO model. A PIF already authorised for an ongoing trial does not need to be converted solely because of the new model, including when a substantial modification is later submitted.

The English IRP is a drafting aid and cannot be submitted for the Netherlands. The ethical review is based on the Dutch IVO. Follow the Dutch model text and instructions, even when an English master document is used upstream.

Dutch language and translations

Mandatory. Submit only the Dutch information sheet and consent form for the Dutch ethical review. The same rule applies to appendices and other material forming part of informed consent.

If a potential participant does not understand Dutch well enough, written and oral information must be provided in a language that person understands. The sponsor is responsible for the translation and for keeping its content and tone aligned with the authorised Dutch document.

Conditional. When inclusion of non-Dutch-speaking participants is planned, submit a translation certificate with the first Part II substantial modification. CCMO does not require the certificate for an unexpected individual case, for an English version when the authorised Dutch document is a direct translation of that English version, or for later changes to the information sheet. A certificate is also not required for recruitment material or other documents shown to participants.

Document the language used for the oral discussion in the participant's medical record. An interpreter or witness does not remove the need for understandable written information where it can be prepared.

Readability and document design

The IVO uses layered information. The cover page gives the main decision points, followed by the research-specific explanation, appendices and general CCMO information.

Follow these model rules:

• Write the Dutch participant text at B1 language level.
• Keep the cover page to no more than two pages.
• Keep the complete IVO to no more than 4,000 words, including the consent form and appendices. A complex trial may exceed this only with a reason in the cover letter for the MREC to assess.
• Use an accessible sans-serif font listed in the official model at no less than 12 points or 16 pixels.
• Retain the standard text unless the model permits editing or deletion.
• Delete instructions, unused options and irrelevant sections before submission.
• Keep questions, tick boxes and completion fields that the model treats as part of the consent discussion.
• Have the trial-specific wording checked by a lay reader from the intended population where possible.

The document should let a potential participant understand the trial without reading the protocol. Do not copy technical risk language or eligibility criteria directly from the protocol.

Main information sections

Study purpose and design

Explain why the trial is being conducted, whether it tests safety, dose, effectiveness or another question, and whether allocation is randomised. Identify placebo or comparator use in plain language. State the number of groups and what can happen to the participant.

Eligibility, procedures and time commitment

Describe screening tests, the total duration, number and location of visits, hospital stays, calls, questionnaires, treatment and follow-up. Separate research procedures from usual care. A short schedule can clarify repeated visits and procedures.

Risks, side effects and safety contacts

The IVO deliberately layers risk information. Put the main decision-changing risks on the cover page. In the main body, identify effects that require the participant to contact the study team. Use an appendix for the fuller side-effect list and procedure risks.

Explain unknown risk, radiation, invasive procedures and practical burden where applicable. Provide a clear safety contact and state what the participant should do if a specified symptom occurs.

Benefits and alternatives

State whether direct benefit is possible, uncertain or absent. Do not imply therapeutic benefit for a healthy volunteer. Explain the standard treatment or other reasonable options when the participant can decline the trial and continue care.

Pregnancy and contraception

Conditional. If the investigational product or procedures can affect pregnancy, fertility, an embryo, fetus or infant, explain who must avoid pregnancy, the required contraception, duration, pregnancy testing, reporting and what happens after a pregnancy is identified. Match the protocol and safety plan exactly.

If pregnancy follow-up will collect information from a pregnant partner who is not the trial participant, use a separate information and consent pathway for that person. The Netherlands pregnancy follow-up guide explains the distinction.

Data protection and medical-record access

Explain what personal data is collected, which special categories are used, why it is needed, how it is coded, who can see identifiable data, where it is stored and for how long. Identify the controller or joint controllers, relevant data-protection officer and complaint contact.

Ask explicitly for any access to medical records or information from a general practitioner, specialist or pharmacist. Explain transfers outside the European Union and the safeguards used. Do not call coded data anonymous.

Biological samples

Describe each sample, collection procedure, testing, storage location, retention period and transfer. Keep trial-required analysis separate from optional future research. Genetic testing, artificial-intelligence use and secondary storage need clear descriptions and separate choices when optional.

The Netherlands secondary-use consent guide explains the optional Yes or No structure in the IVO.

Insurance, compensation and reimbursement

Explain whether Dutch WMO participant insurance applies or an exemption was granted. Include the required insurance appendix unless exempt. Match the insurer, policy details, claims contact and coverage language to the evidence submitted in Part II.

State participant compensation, travel reimbursement and possible tax treatment without presenting payment as a benefit. Keep these amounts consistent with the Dutch P1 form.

Withdrawal and end of participation

Explain that participation is voluntary and can stop without giving a reason. State any safe treatment-discontinuation steps. Explain what happens to data and samples already collected, what future collection stops, and which trial follow-up may remain necessary.

Also describe circumstances in which the investigator, sponsor, authority or reviewing committee may end participation, and how important new information will be communicated.

Contacts and complaints

Provide the principal site contact, study-team contact, emergency contact where needed, complaints route, data-protection contacts, insurer and claims contact. The independent-expert role is no longer automatically required under the CTR, so include such a contact only when it is actually part of the authorised process.

Consent choices and structure

Consent to take part must be clear and separate from optional activities. The core form normally confirms that the person received and understood the information, could ask questions, had enough time, chose voluntarily, and agrees to trial data and sample processing needed for the study.

Use separate Yes or No choices for optional items such as:

• storage and use of data for other research
• storage and use of remaining bodily material for other research
• future contact about another study
• disclosure of treatment allocation after the trial
• DNA research outside the core trial question
• artificial-intelligence analysis outside the core trial question
• personal-data use by an external travel provider

Refusing an optional choice must not prevent participation or reduce ordinary care. Do not combine all optional items into one blanket consent.

Signatures and dates

At CTIS submission, upload a blank Dutch information sheet and consent form with its version and date. Do not upload participant-signed forms.

When consent is obtained, the capable participant signs and dates the form. The researcher or authorised representative who conducted the process also signs and dates it. Give the participant the complete information sheet, cover page and a signed copy of the consent form.

Recommended. Give enough time for a considered decision. CCMO presents at least 48 hours as a useful benchmark rather than a fixed rule. The appropriate period depends on the trial, urgency, burden and participant circumstances.

Different signature logic applies to children, adults lacking capacity, emergencies and people who cannot complete written consent in the usual way:

• Netherlands minor consent and assent requirements
• Netherlands limited-capacity and legal representative consent
• Netherlands emergency enrollment consent
• Netherlands impartial witness consent

Healthy volunteer wording also needs specific benefit, compensation and restriction language. See the Netherlands healthy volunteer consent guide.

Submission and final check

Describe every informed-consent procedure in the protocol, including legally designated representatives and deferred consent where relevant. Upload the main information and consent document as L1. Use L2 only for a non-ICF document that is genuinely integral to the consent process.

Before upload, confirm that the Dutch text matches the protocol, investigator brochure, insurance, P1 form, R1 form and biological-samples form. Use the Netherlands patient-facing document QC checklist for a structured review. Return to the Netherlands English CTIS hub for the complete guide directory.