Netherlands CTIS Healthy Volunteer Consent Requirements

When to use this variation

Use the healthy-volunteer variation when eligibility does not depend on the condition the investigational product is intended to treat. It is common in Phase I, bioavailability, food-effect, interaction, mass-balance and other clinical pharmacology trials.

If the study includes both healthy volunteers and patients, create separate information where risks, expected benefit, procedures, restrictions, compensation or alternatives differ. Do not make a patient read irrelevant healthy-volunteer sections or suggest that a healthy person may receive therapeutic benefit.

Dutch document and language

Mandatory. Provide the healthy volunteer with Dutch information and consent material. The reviewing MREC or CCMO assesses only the Dutch version.

For volunteers aged 16 or older, IVO version 1.1, dated 14 August 2026, is strongly recommended and becomes mandatory on 1 January 2027. The official IVO includes trial-specific wording for healthy participants and early-phase dose studies. No separate national healthy-volunteer template replaces it.

If recruitment of a non-Dutch-speaking group is planned, prepare understandable translations and follow the Dutch translation-certificate procedure. Oral information must also be provided in a language the volunteer understands.

Main differences from a patient document

No direct benefit

Mandatory. State plainly that the volunteer is not expected to benefit medically. Explain that participation may help researchers understand the investigational product, its safety, dose, absorption or another stated objective.

Payment is not a clinical benefit. Keep compensation in its own section and do not use it to soften risk language.

Early-phase uncertainty

Describe whether this is the first administration in humans, the first use at a dose, formulation or combination, or an exposure with limited human experience. Explain that not every side effect is known.

Present the three main or most decision-changing risks on the cover page. In the main text, list symptoms that require immediate contact. Put the fuller expected-risk list in the appendix. Align it with the investigator brochure, protocol, dose-escalation rules and safety monitoring.

Screening and eligibility

Explain all screening procedures, including medical history, examination, blood and urine testing, electrocardiogram, drug or alcohol testing, pregnancy testing and genetic or viral testing where applicable. State what happens to screening data and samples if the person is not enrolled.

If a screening result may reveal a health issue, explain whether and how it will be communicated and whether a general practitioner or specialist may be contacted.

Confinement and practical burden

State the number and duration of residential periods, outpatient visits, overnight stays, follow-up contacts and total blood volume. Explain fasting, standard meals, posture, activity restrictions, repeated procedures, cannulation, biopsies or radiation in practical terms.

The document should make the worst realistic time commitment visible before consent, not only in a schedule appendix.

Behavioural and medication restrictions

List restrictions that affect daily life, such as prescription or non-prescription medicines, supplements, alcohol, nicotine, caffeine, recreational drugs, strenuous exercise, sun exposure, blood donation, driving and food. Give the start and end of each restriction.

Explain washout between cohorts or studies when it is part of the protocol. If the site checks prior volunteer participation through a research-participation system, explain what personal data is checked and why.

Pregnancy prevention

Conditional. Describe pregnancy testing, contraception, sperm or egg donation restrictions and the period after the last dose. Use wording appropriate to the person's reproductive potential rather than relying on sex labels alone.

State what the volunteer must do if they or their partner becomes pregnant. If the trial plans to collect data directly from a pregnant partner, that person needs a separate information and consent pathway. See the Netherlands pregnancy follow-up requirements.

Compensation and reimbursement

Healthy volunteers are often compensated in the Netherlands. CCMO explains that compensation should reflect time and burden and is commonly based on the minimum wage. The reviewing MREC assesses the amount.

Mandatory when payment is offered. State the gross amount or calculation method, payment schedule, conditions for partial payment, travel reimbursement and possible tax treatment. Explain what happens if the volunteer fails screening, withdraws, is withdrawn for safety or does not follow restrictions.

Do not make payment dependent on completing unsafe procedures or remaining in the trial after the person wants to stop. Keep the participant document consistent with the mandatory Dutch P1 compensation, funding and arrangements form.

Insurance and harm

Explain the Dutch WMO participant-insurance coverage and claims route, or an authorised exemption. Include the IVO insurance appendix when coverage applies. Identify the insurer, policy details and claims contact.

Separate expected side effects from insurance coverage. A disclosed expected risk is not automatically compensated under the Dutch insurance scheme. Do not promise reimbursement beyond the policy and statutory terms.

Consent choices

The core consent should cover trial participation and the data or samples required for the study. Optional future activities need separate Yes or No choices, including remaining-sample storage, other research, future contact, DNA work outside the core question or external travel services.

Healthy-volunteer payment must not be tied to agreeing to optional data or sample use. The Netherlands secondary-use consent guide explains the optional structure.

Signatures and conduct

At consent, the volunteer and the researcher or authorised interviewer sign and date the form. Give the volunteer the complete information sheet and a signed copy. Document the discussion, questions and any language support.

Where a capable volunteer understands the trial but cannot complete writing in the normal way, an authorised witness pathway may be used. It is not a substitute for capacity or comprehension. See the Netherlands impartial witness consent guide.

Final checks

• The Dutch text uses the current IVO or the still-permitted PIF transition intentionally.
• No direct medical benefit is implied.
• Risks and uncertainty match the dose and available human exposure.
• Screening and confinement burden are complete.
• Restrictions have clear start and end points.
• Pregnancy-prevention wording matches the protocol.
• Compensation matches the P1 form and is not coercive.
• Insurance wording matches the submitted certificate or exemption.
• Optional data and sample choices do not affect eligibility or payment.
• Contact details cover urgent symptoms during and after confinement.

Return to the Netherlands English CTIS hub for the complete guide series.