Norway CTIS Healthy Volunteer Consent Requirements

When to prepare a healthy-volunteer version

Mandatory when the trial enrolls healthy volunteers. Use a dedicated form or a clearly separated population version where procedures, risks, payments or benefit statements differ from patient participants. Submit the blank Norwegian form in Part II.

Do not describe screening as clinical care or imply that participation offers treatment. Explain that the purpose is research and that the volunteer may receive no health benefit.

Information that needs special emphasis

• why a healthy population is scientifically needed
• the absence of expected therapeutic benefit
• investigational-product uncertainty, dose escalation, sentinel dosing or stopping rules where relevant
• confinement, fasting, diet, alcohol, nicotine, exercise and medication restrictions
• blood volumes, biopsies, lumbar punctures, imaging, radiation or other burdens
• reproductive restrictions, pregnancy testing and contraception where relevant
• washout periods and restrictions after dosing
• follow-up after adverse events or early withdrawal
• the difference between compensation for time or burden and reimbursement of expenses

Payment must not exert undue influence. Describe the amount, schedule and any pro rata payment after withdrawal. Do not suggest that a volunteer loses payment already earned by deciding to stop.

Recruitment, consent and signatures

Recruitment advertisements used in Norway must be in Norwegian and submitted in Part II. Avoid language that presents payment as the main reason to participate or understates risk.

Written and oral information must be provided before enrollment. The participant and the person conducting the consent interview sign and date the approved form when consent is obtained. The blank CTIS submission copy is not signed.

The information-giver should be qualified and part of the research group. The consent-taker should not have a dependent relationship with the volunteer. If consent is electronic, describe secure identity verification such as BankID or another two-factor method in the recruitment procedure.

Insurance, injury and withdrawal

Explain the valid Norwegian injury coverage accurately and provide contact or reporting information relevant to the participant. The Part II dossier must include a valid certificate issued by the Norwegian Medicines Liability Association and identify any additional trial-specific insurance.

Explain what happens after stopping the investigational product, withdrawing from procedures or withdrawing consent. Separate continued safety follow-up from optional research contact. Explain how previously collected data are handled under applicable law.

Use the Norway patient-facing document QC checklist before submission. Return to the Norway CTIS hub for the full guide series.