Research Study Informed Consent
An encrypted informed consent form for research studies compliant with Swiss HFG Art. 16, ICH GCP and GDPR Art. 9. Captures participant understanding, data handling consent, right to withdraw and voluntary participation.
About this template
This template provides research institutions, universities, hospitals and independent investigators with a complete informed consent form for research studies involving human participants. It captures each element of valid informed consent as required by Swiss HFG Article 16: study purpose, procedures, risks and benefits, data handling, right to withdraw, and voluntary participation. All data is encrypted end-to-end.
What it 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
HFG Art. 16 and GDPR Art. 9 compliance
Under Swiss HFG Article 16, informed consent for research involving human participants must be explicit, documented and retained. GDPR Article 9 requires explicit consent for processing health data. This form satisfies both requirements: it is encrypted end-to-end, captures structured consent declarations and creates an auditable record.
How to use it
Use this template
Click 'Use template' to create a copy in your dashboard.
Insert study-specific information
Update the study description, procedure details, risk list and data retention period to match your protocol and information sheet.
Link the participant information sheet
Reference your approved participant information sheet in the description block so participants can read the full details before signing.
Obtain ethics committee approval
Confirm your consent form has been approved by your ethics committee (EKNZ, KEK or equivalent) before distributing.
Why digital informed consent forms are valid under Swiss law
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.
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.
Elements of valid informed consent under HFG
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
Data protection in human research: 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.
Frequently asked questions
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.
What happens to signed consent forms if a participant withdraws?
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.
How long must signed consent forms be retained?
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.