Patients, care and autonomy · France and Switzerland : separate country-labelled rules
5 checks before giving human-research consent
Human-research documents must identify the project category and governing regime before explaining consent or withdrawal. French RIPH categories and EU medication-trial rules are not interchangeable; Swiss human-research legislation has its own safeguards. Compare the information sheet, consent or non-opposition, reflection and withdrawal provisions. The document review does not recommend joining a study or promise deletion of every previously collected datum.
- Research category
- Information received
- Applicable consent form
- Withdrawal and data handling
- Official texts cited
- Sources checked on
- Drafted with AI assistance, our method
General legal information with official references and dated checks. It is not personalised advice: for a decision that commits you, have your situation checked by a qualified professional.
Julie by AlphaDeep
What information was provided before deciding?
Compare purpose, methods, duration and applicable risks or alternatives against the notice. Keep its date and version.
Read the referencesYour question concerns “5 checks before giving human-research consent”. I can help organise the facts and records. Which document have you received or prepared, and is this a French or Swiss matter?
3 free questions at signup. Avoid names and sensitive information.
Which research category is involved?
France's L1121-1 distinguishes human-research categories; medicine trials have a separate EU framework referenced by L1124-1. Do not treat every study as identical.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Which records are still missing from your file?
Indicate which records you have. The result identifies gaps and prepares a complete question for Julie, without requiring an account.
Fictional example · Your preparation
Point to complete: Withdrawal and data handling. Identify the study contact and actual process. Refusal or withdrawal does not automatically settle all retained-data or sample questions.
- Research category
- Record available
- Information received
- Record available
- Applicable consent form
- Record available
- Withdrawal and data handling
- Needs checking
- Records indicated
- 3 / 4
- Who explains refusal and withdrawal?
This worksheet organises records; it does not establish admissibility, entitlement or a procedural outcome.
Which preparation steps come first?
Editorial preparation order, not a popularity or success-probability ranking. Identify the research category before the consent form and withdrawal process.
Research category and regime
France's L1121-1 distinguishes human-research categories; medicine trials have a separate EU framework referenced by L1124-1. Do not treat every study as identical.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Understandable information
Compare purpose, methods, duration and applicable risks or alternatives against the notice. Keep its date and version.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Applicable consent form
L1122-1-1 distinguishes written category1 consent, express category2 consent and category3 non-opposition, with specific exceptions. Classification comes first.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Refusal, withdrawal and contact
Identify the study contact and actual process. Refusal or withdrawal does not automatically settle all retained-data or sample questions.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Separate handling of data
Participation, retention and further use may follow different conditions. This worksheet does not promise complete deletion after withdrawal.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
What information was provided before deciding?
Compare purpose, methods, duration and applicable risks or alternatives against the notice. Keep its date and version.
Is written consent always required in France?
L1122-1-1 distinguishes written category1 consent, express category2 consent and category3 non-opposition, with specific exceptions. Classification comes first.
Which documents answer which questions?
| Record or information | Issue to check |
|---|---|
| Research category | France's L1121-1 distinguishes human-research categories; medicine trials have a separate EU framework referenced by L1124-1. Do not treat every study as identical. |
| Information received | Compare purpose, methods, duration and applicable risks or alternatives against the notice. Keep its date and version. |
| Applicable consent form | L1122-1-1 distinguishes written category1 consent, express category2 consent and category3 non-opposition, with specific exceptions. Classification comes first. |
| Withdrawal and data handling | Identify the study contact and actual process. Refusal or withdrawal does not automatically settle all retained-data or sample questions. |
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Who explains refusal and withdrawal?
Identify the study contact and actual process. Refusal or withdrawal does not automatically settle all retained-data or sample questions.
What does Swiss LRH require separately?
LRH7 and16 address informed consent or non-opposition as provided, understandable information and written consent subject to exceptions. They are not a universal rule for all research reuse.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Which official provision helps explain this situation?
Aucune recherche mentionnée au 2° de l'article L. 1121-1 ne peut être pratiquée sur une personne sans son consentement libre, éclairé et exprès.
In plain English: LRH7 and16 address informed consent or non-opposition as provided, understandable information and written consent subject to exceptions. They are not a universal rule for all research reuse.
Does a signed form prove complete information?
No. Record the information supplied and questions answered. A signature alone establishes neither category nor full understanding.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Which data and sample issues remain separate?
Participation, retention and further use may follow different conditions. This worksheet does not promise complete deletion after withdrawal.
What does the consent-preparation grid deliver?
It organises category, notice, form and contact. It recommends no participation and certifies no protocol approval.
What other questions arise in this file?
What information was provided before deciding?
Compare purpose, methods, duration and applicable risks or alternatives against the notice. Keep its date and version.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Who explains refusal and withdrawal?
Identify the study contact and actual process. Refusal or withdrawal does not automatically settle all retained-data or sample questions.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
What does Swiss LRH require separately?
LRH7 and16 address informed consent or non-opposition as provided, understandable information and written consent subject to exceptions. They are not a universal rule for all research reuse.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Which data and sample issues remain separate?
Participation, retention and further use may follow different conditions. This worksheet does not promise complete deletion after withdrawal.
Code de la santé publique art. L1121-1Code de la santé publique art. L1122-1Code de la santé publique art. L1122-1-1Code de la santé publique art. L1124-1810.30 : Art. 7 Consentement810.30 : Art. 16 Consentement éclairé
Which official references should you consult?
- Code de la santé publique art. L1121-1Légifrance
- Code de la santé publique art. L1122-1Légifrance
- Code de la santé publique art. L1122-1-1Légifrance
- Code de la santé publique art. L1124-1Légifrance
- 810.30 : Art. 7 ConsentementFedlex
- 810.30 : Art. 16 Consentement éclairéFedlex
Texts cited last checked: 1 November 2026