Research Study Informed Consent

Informed consent in human research is not a signature on a document — it is a state of understanding that the document evidences. HFG Article 16 requires it in writing, and the practical consequence is that a participant who signs without comprehension has produced a valid-looking record of an invalid consent, which is worse than no record at all.

Comprehension is the thing being documented

Digital consent also improves participant comprehension. A participant who reads the information sheet on their own device, at their own pace, before signing is more genuinely informed than one who is handed a form in a busy clinic. The World Health Organization and ICH GCP E6 guidelines both recognise that adequate time for reflection is a precondition of valid consent.

HFG Article 16 requires that informed consent be documented in writing. The Swiss Federal Act on Electronic Signatures (ZertES) recognises electronic signatures created with qualified certificate as legally equivalent to handwritten signatures. Schweizerform's encrypted digital signature captures a legally binding consent record, with a timestamp and immutable submission that satisfies both HFG and ZertES requirements.

What the form captures

• Participant confirmation of study information sheet receipt
• Understanding of study purpose and procedures
• Acknowledgement of risks and benefits
• Consent to specific data uses including secondary research
• Right to withdraw without consequence — confirmed and understood
• Data retention and anonymisation policy acknowledgement
• Contact details for questions to the responsible investigator
• Voluntary participation statement
• Dated signature

The elements HFG requires

A compliant informed consent form must address each of the following elements:

• Study purpose — what the research seeks to find out and why
• Procedures — what the participant will actually do
• Risks and discomforts — any reasonably foreseeable risks
• Benefits — potential direct benefit to the participant or to science
• Alternatives — what other options the participant has
• Confidentiality — how data will be stored, who can access it
• Voluntary participation — the right to refuse or withdraw at any time without penalty
• Withdrawal — how to withdraw and what happens to data collected
• Contact — who to contact with questions about the study or participant rights

Withdrawal, and what happens to data already collected

Under HFG Article 16, a participant may withdraw consent at any time. However, data already collected under valid consent may generally be retained in anonymised form, subject to your ethics approval conditions. Your protocol should specify the withdrawal and data retention procedure explicitly.

Research data under HFG, nFADP and GDPR

Research data involving health information is among the most sensitive data in existence. HFG Article 32 requires that research data be anonymised as soon as the research purpose permits. The Swiss nFADP requires appropriate technical and organisational measures. GDPR Article 9 requires explicit consent and documentation. End-to-end encryption ensures that only the principal investigator and their authorised team can access signed consent records.

Retention: fifteen years

ICH GCP E6 requires retention for at least 15 years after study completion. Swiss HFG and Swissmedic requirements may extend this for certain study types. Configure your document management system accordingly and document the retention period in your data management plan.

Running consent

Questions research teams ask

Is a digital signature on this form legally valid under Swiss HFG?

Yes, when used with a qualified electronic signature under ZertES. The encrypted signature captured by this form creates an auditable consent record. Confirm with your ethics committee whether a qualified electronic signature is required for your specific study type.