Denmark CTIS Part II Healthy Volunteer Consent Requirements

When the healthy-volunteer variation applies

Use this variation when a participant is considered healthy in relation to the trial. Danish ethics guidance describes healthy research subjects broadly enough to include a person with an unrelated condition when that condition has no relevance to the research project.

The PIS should make clear that the participant is not being recruited because the investigational treatment is expected to treat an illness they have. Any potential direct benefit should be stated accurately. In many healthy-volunteer studies there is no expected therapeutic benefit, and the information should say so plainly.

Documents to prepare

Mandatory. Prepare the Danish Participant Information Sheet for the healthy-volunteer cohort and the applicable capable-adult ICF.

Conditional. Add separate participant information and consent for optional substudies that are a defined part of the trial. Add recruitment advertisements if used. Add pregnancy or reproductive follow-up material if the protocol requires it. Add translated versions for people who do not understand Danish.

VMK encourages use of its CTR standard consent form for competent persons. The form can be adapted with trial-specific information and versioning.

Healthy-volunteer risk and burden information

The PIS should describe the practical burden as carefully as the pharmacological risk. Depending on the trial, this can include fasting, confinement, repeated blood sampling, cannulation, pharmacokinetic sampling, biopsies, imaging, exercise testing, sleep disruption, dietary restrictions and restrictions on medicines, alcohol or other activities.

Where first-in-human or dose-escalation features are relevant, explain the uncertainty in language a lay reader can understand. Do not imply that careful monitoring removes the possibility of an unknown or serious adverse effect.

If biological samples are collected, include the Denmark-specific sample details described in the main consent guide, including amount, purpose, analysis location, storage duration and disposition.

Compensation and reimbursement

Conditional. If compensation or reimbursement is offered, the financial arrangements belong in Part II and the participant information should describe what the participant can expect.

Danish ethics guidance distinguishes inconvenience compensation, documented loss of earnings, documented transport costs and other benefits. Healthy volunteers may receive inconvenience compensation because they do not participate for therapeutic benefit. The amount should be assessed in relation to the actual invasive nature, duration, pain, inconvenience and burden of the study.

Compensation must not be structured so that it improperly influences the decision to participate. Explain whether payment is prorated if the participant leaves early and distinguish reimbursement of expenses from payment for inconvenience.

Insurance and treatment for injury

Explain the compensation or insurance system applicable to trial-related injury. The sponsor is responsible for coverage at Danish sites. If the site is covered by Patienterstatningen, the Part II application can state that coverage without uploading a stand-alone independent insurance policy. A site outside that scheme needs the appropriate independent arrangement.

The PIS should describe the arrangement in participant-friendly terms rather than copying contractual language.

Language and signature process

The normal healthy-volunteer PIS and ICF should be in Danish for Danish-speaking participants.

If a participant does not understand Danish, provide a validated written translation of both documents into the participant's native language or another language understood to the same degree. The oral information conversation must also be supported appropriately in that language.

The blank ICF submitted through CTIS is not signed by the participant at submission. When consent is obtained, the participant and the Danish-authorised physician who performs the interview sign and date the consent document.

What does not change just because the participant is healthy

Healthy-volunteer status does not remove Denmark's requirements for:

• understandable privacy information
• patient-record or source-data access wording where relevant
• sample and future-use explanations
• significant-health-finding procedures where relevant
• separate consent for defined optional substudies
• pregnancy and reproductive safeguards where relevant
• the right to withdraw without detriment

Use the Denmark secondary use consent guide if samples or data will be used outside the defined main-study purpose. Use the Denmark CTIS hub for the full guide set.