Germany CTIS Healthy Volunteer Consent Requirements

When to use the healthy-volunteer variation

Use this document when eligibility depends on the person being healthy or when participants are not enrolled because they have the condition the medicine is intended to treat. Common examples include first-in-human, pharmacokinetic, food-effect, drug-interaction, bioavailability, and bioequivalence trials.

Do not use the label healthy volunteer for a person with a condition merely because the study offers no therapeutic benefit. The document title and content should match the protocol population.

Required German documents

Mandatory. Submit a blank German healthy-volunteer information sheet and consent form under Part II section L. Use a descriptive CTIS name such as L1_SIS and ICF_healthy volunteers_DE.

Mandatory. Include the healthy-volunteer pathway in the K1 recruitment and informed-consent procedure. Explain screening, capacity, time to decide, the physician who conducts the interview, and any electronic or remote elements.

Conditional. Submit German recruitment material under K2 when advertisements, online campaigns, call-center scripts, or other recruitment tools will be used.

The blank documents are not signed at CTIS submission. At enrollment, the volunteer and the physician who conducts the consent interview sign and date the form in writing or through a compliant electronic process.

Main differences from a patient consent document

No therapeutic purpose for the volunteer

State that the purpose is research and that direct medical benefit is not expected. Do not describe screening tests, close monitoring, or free examinations as a health benefit.

Greater emphasis on uncertainty

For early development, explain what is known from nonclinical studies, previous human exposure, related medicines, or earlier cohorts without implying more certainty than the data support. If the medicine has not previously been given to humans, say so plainly.

Screening and incidental findings

Explain screening tests, exclusion criteria, screening failure, repeat screening, medical-record checks, drug and alcohol testing, pregnancy testing, and what happens to screening data and samples. Explain how clinically relevant unexpected findings may be handled without promising a complete health assessment.

Confinement and behavioral restrictions

Describe inpatient stays, fasting, standardized meals, posture, exercise, smoking, alcohol, caffeine, other medicines, supplements, driving, blood donation, and contraception restrictions. State the exact periods and practical consequences.

Blood and sample burden

Give the number of collections and total volume in understandable terms. Explain cannulas, biopsies, lumbar punctures, imaging, or other research-only procedures and their risks.

Payment and reimbursement

Explain payment for time and inconvenience separately from expense reimbursement. State the total possible amount, payment schedule, prorating after withdrawal, and conditions for payment. Avoid wording that penalizes a volunteer for withdrawing or makes payment an undue influence.

Insurance

Provide the German trial-insurance details and practical instructions after a possible injury. The information must match the certificate and policy terms submitted in Part II.

Consent choices

Keep main participation, health-data processing, and truly optional activities separate. Optional genetic analysis, extra samples, future research, re-contact, or pregnancy follow-up should have their own clearly labeled choices.

Refusal of optional future research must not reduce the volunteer's payment for completed main-study activities. If a sample or procedure is essential to the main trial, describe it as part of participation rather than presenting a false optional choice.

German language and non-German volunteers

The information and consent form must be in German for German-speaking volunteers. If non-German-speaking volunteers are planned, AKEK expects a commitment to qualified translation and to communication in a language the volunteer understands throughout the trial.

Recruitment ads and screening scripts used with the target population should follow the same language plan.

National template

AKEK publishes a CTR model text for clinical trials with capable adult healthy volunteers, titled for Probanden. It is recommended as a drafting baseline but must be adapted to the protocol, risk profile, site, payment, insurance, data, and sample arrangements.

Use the Germany patient-facing document QC checklist before submission.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub contains the complete document and population guide series.

Other language versions

Read this guide in German.