The HRA and ClinO as the legal basis for clinical trials
Swiss human research rests on two instruments. The Human Research Act (HRA, SR 810.30) sets the principles: consent, dignity, data protection, the ethics committees and the registration duty. The Clinical Trials Ordinance (ClinO, SR 810.305) adds the machinery: the authorisation procedure, deadlines, safety reporting and sponsor duties.
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The HRA as a framework act
The Human Research Act applies to research involving people, their biological material and their personal health data. It sets what must be protected and who decides, and it delegates the procedural detail to ordinances. If you are looking for a principle, read the act; if you are looking for a deadline, read the ordinance.
What the HRA governs
The act answers the questions that do not change with the type of trial: may this research be done at all, on what terms, and who says so. It sets the primacy of the participant's interests over the interests of research, and makes the ethics committee decision the gate through which every project passes.
- Informed consent, and the special rules for people unable to consent
- Protection of dignity, personality and health, with the participant's interest first
- Data protection in research, and the conditions for further use of data and samples
- Risk categorisation as the basis of the authorisation route
- The cantonal ethics committees, their composition and independence
- The duty to register the trial in a public register
- Liability of the sponsor and the duty to secure it through insurance
What ClinO adds
The ordinance turns those principles into a procedure with dates on it. It defines how an application is filed and reviewed, what the sponsor has to notify and by when, and how long records have to be kept. This is the document your trial master file is built against.
- The authorisation procedure before the ethics committee and Swissmedic
- The decision deadline and what suspends it
- Substantial amendments and how they are approved
- Safety reporting, including SUSARs and the annual safety report
- Sponsor and investigator duties, and GCP compliance
- Documentation, the trial master file and archiving periods
- Notification of the end of the trial and the final report
| Topic | Human Research Act | Clinical Trials Ordinance | Practical consequence |
|---|---|---|---|
| Consent | The chapter on informed consent and on persons unable to consent | The provisions on the consent documents in the dossier | Consent form per site language, reviewed by the committee |
| Categorisation | The chapter on risk categories | The category definitions and the resulting procedure | Category decides whether Swissmedic authorises |
| Ethics committees | The chapter on the committees and their independence | The procedure and the decision deadline | One lead committee in a multicentre trial |
| Safety | The duty to protect participants | The chapter on safety and protective measures | 7 and 15 day SUSAR deadlines, annual safety report |
| Registration | The duty to register the trial | Which register and which data | A WHO primary register or ClinicalTrials.gov, plus the federal portal |
| Liability | The chapter on liability | The requirements on the insurance evidence | Insurance certificate in the dossier before submission |
| Documentation | The general documentation duty | The chapter on documentation and archiving | Trial master file kept and archived for the required period |
Informed consent in a four-language country
Consent has to be informed, which means comprehensible in the participant's own language. In Switzerland that translates into a practical obligation: a consent form per site language, with the versions kept consistent so that a German and an Italian participant are told the same thing. The committees read these documents closely, and a translation that drifts from the approved German version is a reliable source of questions.
Where a participant cannot consent, the act sets additional conditions, including consent by the legal representative and, where possible, the assent of the person themselves. Trials in children, in emergency medicine and in advanced dementia need that section read in full before the protocol is written, not after.
Registration and transparency
Every authorised clinical trial has to be registered in a public register: a WHO primary register or ClinicalTrials.gov, plus the federal portal for human research projects. Registration is due before the first participant is enrolled, and the results have to be posted once the trial ends. Registration is not a formality: the committees check it, and a missing registration blocks publication in most journals.
Insurance and sponsor liability
The sponsor is liable for damage suffered by participants in connection with the trial and has to secure that liability, in practice through trial insurance covering the Swiss sites. The certificate is part of the submission dossier. A global policy usually needs a Swiss confirmation naming the sites and the number of participants, and obtaining that confirmation takes longer than teams expect.
Frequently asked questions
Does the HRA apply to research on existing data only?
Yes, the act also covers research with personal health data and with biological material, with its own conditions for further use. Such a project is not a clinical trial under ClinO but still needs an ethics committee decision.
How long do we have to archive trial documents?
The ordinance sets the archiving periods, and they run for many years after the end of the trial. Plan for a defined location, a responsible person and readable media, because an archive nobody can open is not an archive.
Do we need Swiss insurance if we have a global policy?
A global policy can be sufficient in substance, but the committee needs evidence that the Swiss sites and participants are covered, in a form it can read. In practice that is a Swiss confirmation of cover attached to the dossier.
Is ICH GCP legally binding in Switzerland?
The ordinance references good clinical practice as the standard to be followed, which makes ICH GCP the operative benchmark even though it is not itself Swiss law. Committees and Swissmedic assess against it.
Who is the sponsor in an investigator-initiated trial?
Usually the hospital or the investigator themselves. That means the full set of sponsor duties, including safety reporting, insurance and archiving, sits with an academic team rather than a company, which is worth resourcing explicitly.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.