Romania CTIS Part II Healthy Volunteer Consent Requirements

Start from the main Romania consent document

Use the main Romania patient information and consent guide as the baseline.

Mandatory. Participant-facing information should be in Romanian. The consent interview should be conducted by a physician who is a member of the investigation team and is appropriately trained on the protocol and good clinical practice.

The blank consent form is submitted in CTIS and is signed later when consent is obtained.

Explain the absence of therapeutic benefit clearly

Healthy volunteers should not be left with the impression that participation is treatment.

Explain the scientific purpose of the study, the investigational status of the product, dose escalation where applicable and the fact that direct medical benefit is not expected unless the study design genuinely provides one.

For first-in-human or dose-escalation trials, describe uncertainty and safety monitoring in participant-friendly terms without reproducing technical protocol text.

Describe the practical burden

State the number and duration of admissions or visits, fasting requirements, activity restrictions, blood-volume burden, sample collections, monitoring, contraception and pregnancy testing where applicable.

If the trial requires confinement in a Phase I unit, explain the duration and restrictions clearly.

Romania Phase I site requirements

Conditional. When the study is Phase I or bioequivalence, the Romanian unit must meet the national authorisation requirements in Order 3390/2022 and Government Emergency Ordinance 29/2022.

The national rules cover facilities, emergency infrastructure, transfer arrangements, staff and other operational requirements. This is assessed separately from the participant information, but it affects whether the planned site can conduct the study.

Compensation and reimbursement

Mandatory. Disclosure when payments or reimbursements are offered. Romania's national compensation form asks whether participants receive travel, accommodation, food, loss-of-earnings compensation, cash or non-cash payments.

The participant information should match the national compensation form. Explain payment amounts or calculation logic and timing without making payment look like a guarantee of benefit from the investigational product.

CNBMDM assesses participant compensation and broader financial arrangements as part of the ethics review.

Recruitment

If healthy volunteers are recruited through advertisements, posters, digital channels or other materials, include the planned recruitment procedure and the materials in Romanian.

Electronic recruitment resources are subject to prior CNBMDM approval. The recruitment procedure should describe how responses are handled and how potential volunteers who are not eligible are managed.

Consent and withdrawal

Explain that participation is voluntary and that the volunteer can withdraw from further trial participation.

The national recruitment form asks when and where consent is obtained, how much time is allowed for the decision and how understanding is confirmed.

If a volunteer cannot write, use the Romania impartial-witness consent pathway.

Final Romania healthy-volunteer package

For a typical healthy-volunteer trial, prepare the Romanian information and consent form, recruitment and informed-consent procedure, any recruitment materials, compensation information and the standard site and investigator documents.

For Phase I trials, confirm that the Romanian site has the required ANMDMR authorisation before treating site readiness as complete. The Romania Part II document checklist covers the full dossier. Return to the Romania CTIS hub for the other guides.