Legal Framework of the JIR Cohort- Switzerland

Transparency Portal: View all ongoing JIR projects and manage consent here

1. The general framework of Swiss regulations

In Switzerland, research based on existing health data is governed by a set of laws and authorities that regulate its reuse for scientific purposes while ensuring the protection of individuals.
The main applicable texts are:
• The Human Research Act (HRA) and its Ordinance (HRO),
• The Federal Act on Data Protection (FADP), revised in 2023,
• And the ethical evaluation procedures defined by swissethics, the national platform for ethics committees (REC).
These provisions apply to any project using personal health-related data, even when no new intervention is planned.

Etape	Étape Ce qu’il faut faire / Points clés Rôle ou appui de la JIR Cohorte	Role or support of the JIR Cohort
Transparency	Register the project on the RAPS public register.	Ensures additional publication on the JIR transparency portal.
Data protection	Compliance with the Data Protection Act (LPD): processing register, security, notification, and oversight by the Data Protection Officer (DPO).	Guarantees certified hosting and compliant pseudonymization.
Consent	Obtain informed or general consent specifying the purpose, pseudonymization, and patient rights.	A single general JIR consent allows for data reuse across all projects.
Contracts	Formalize a data transfer or processing agreement between institutions.	Framework agreement with all JIR centers, valid for all future projects.
Ethical Submission	Submit to the relevant committee via BASEC (swissethics). Single-center project: one committee. Multi-center project: a lead committee coordinates local approvals.	Assistance with preparing the submission file.
Define the scope	Verify that the project involves reusing existing data and that the data originates from a system with valid consent.	Helps to classify the project type and verify its compliance with LRH/HRO.

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2. The five pillars of the JIR Cohort adapted to the Swiss context

The JIR Cohort simplifies and secures the implementation of projects in Switzerland.
Its contractual, ethical, and technical framework allows teams to focus on the scientific value of the project, while ensuring patient protection and data security.

1.Contract

2.Consent

3.Protocol
& Ethical approval

4.Safety

5.Transparency

1. Contract

The JIR is based on a single framework agreement signed between the RES Foundation and each participating center.
This agreement simplifies the process:
• A single agreement covers all projects carried out via the JIR;
• The projects are administratively monocentric (a single competent ethics committee), but scientifically multicentric, as the data comes from several hospitals;
• Data exchanges take place within a framework that already complies with the Federal Act on Data Protection (FADP) and the Federal Act on Health Insurance (HIA).

This model reduces the administrative burden and ensures consistent compliance, while preserving the methodological richness of multicenter studies.

2. Consent

Patients enrolled in the JIR signed a general JIR consent form in accordance with the Federal Act on Data Protection (FADP), authorizing the reuse of their pseudonymized data for research purposes.

In Switzerland, inclusion of patients in the registry does not require prior approval from an ethics committee.
For reference, see the Swissethics overview on data registries and biobanks.

3. Protocol and ethical approval

All JIR projects based on the reuse of existing health data undergo a two-step validation process:

• A scientific evaluation by the SDAC (Scientific Data Access Committee),

• An ethical review by the Cantonal Ethics Committee (CER) via the BASEC platform (swissethics).

This two-tiered evaluation process ensures scientific and regulatory quality while simplifying the preparation of the application:

• JIR projects are scientifically multicenter but administratively monocenter, which means that only one ethics committee is involved and administrative formalities are reduced.

• The JIR supports the project leader in ensuring compliance and compiling the application.

• The documents submitted are harmonized and aligned with BASEC requirements.

A. Scientific validation by the SDAC
Each JIR project is based on a structured scientific protocol, which is first evaluated by the Scientific Data Access Committee (SDAC) before any ethical submission.
The submission file is compiled in close collaboration with the JIR team (see section “Conducting a research project with the JIR”).
The protocol validated by the SDAC contains the elements required by Swiss committees: objectives, scientific justification, description of data, methodological analysis, security, etc.
This step provides scientific and ethical added value: it guarantees a specialized critical review, strengthens the credibility of the file, and reduces back-and-forth exchanges with the ethics committee.
SDAC validation takes place prior to submission to the ethics committee and constitutes a preliminary scientific opinion, subject to final validation by the competent Swiss ethics committee, which takes precedence over any other authority.

B. Ethical submission in Switzerland (CER / BASEC)
In Switzerland, any project based on the reuse of existing health data must be submitted to a cantonal ethics committee (CER) via the BASEC platform (swissethics).
Thanks to the prior structuring of the JIR protocol, the preparation of the ethics file is simplified:
• most of the documents required by BASEC are already available;
• any additional information requested by the ethics committee is drafted jointly with the physician leading the project, based on pre-filled templates provided by the JIR;
• the JIR supports the project leader until the final submission to BASEC.
This double validation—scientific (SDAC) and then ethical (CER)—is a guarantee of quality and consistency: the file is complete, compliant with national law, and scientifically robust.

List of documents requested by Swiss ethics committees (BASEC)
For the submission of a research project based on the reuse of health data – Further use of health-related data and/or biological material with consent.

This table lists the documents required by swissethics and specifies the JIR's supporting role in preparing the application.

Key:

R = Required A = Applicable if conditions (mandatory if applicable)

BASEC document title	EC obligation (R/A)	Factual description	Role or support of the JIR Cohort
1. Covering letter	R	Project presentation: project leader, scientific purpose, link with the JIR, and legal basis.	Provides a standard template.
2. Synopsis of the study plan Not required if the protocol is less than 20 pages long.	R	Summary of the project (objectives, methodology, duration, data used).	The JIR protocol includes all the elements to facilitate the synopsis.
3. Participant information sheet and informed consent (ICF)	R	Copy of the information and consent form.	The JIR consent form complies with the Federal Act on Data Protection (FADP).
4. Study plan (protocol)	R	Signed and dated main document describing the scientific justification, safety, governance, and data protection.	The JIR protocol includes the elements required by BASEC. Additional elements are reviewed in collaboration with the JIR team depending on the projects.
6. Investigator's/Project Leader's CV	R	Signed and dated CV of the principal investigator.	Help with formatting.
9. Agreement between sponsor/commissioned institution/grant provider or other third parties and the investigator	A	Document defining roles, responsibilities, and funding.	Already covered by the JIR framework agreement, avoiding the need to sign a contract for each project.
14. Information on secure handling and storage of biological material and personal data	R	Description of technical and organizational measures for data security and storage.	Elements described in the BASEC protocol drafted with the JIR team.
15. Information on reviews by other Ethics Committees or Regulatory Authorities	A	Mention of previous evaluations (other RECs or authorities).	Centralize these opinions in the SDAC documentation made available.
30. Proof of secure and correct coding	R	Description or proof of the pseudonymization and coding process.	Elements described in the BASEC protocol drafted with the JIR team.
31. Authorizations granted by Ethics Committees in Switzerland	A	Copy of authorizations previously issued for a project related to the same data.	Supports documentary consistency in the event of project continuity.
38. Sponsor's delegation letter	A	Formal delegation when the applicant is not the official sponsor.	For JIR projects, it is the data controller (project sponsor's institution) who submits the project.
39. Miscellaneous	A	Additional unclassified documents (appendices, correspondence, technical explanations).	Assists with preparation and checks the overall consistency of the file.

4. Safety

For each requirement set out in Swiss data protection regulations, JIR provides a technical and organizational solution that is already integrated into its security system.

Data flow for a research project:

Entered by the centers directly into the JIR EDS.
Pseudonymized extraction by project by the JIR team
Data processing by the JIR team in accordance with the statistical analysis plan (SAP)
Made available to authorized persons in secure environments (NetExplorer or EasyMedStat).

This set of secure spaces constitutes the "JIR Bubble," where data is analyzed without ever being transferred or exported.

The following requirements are taken from Swiss reference texts (LPD, HRO, BASEC – swissethics):

Swiss requirements	Implementation by the JIR Cohort
Data security and storage	Data security and storage: Secure hosting, certified servers, closed environment.
Pseudonymization and anonymity	Pseudonymization prior to transfer, no personally identifiable information accessible.
Access control	Personalized access, prior authorization from SDAC, control by the JIR team.
Action traceability	Complete audit trail available on the various JIR Bubble platforms.
Limitation of data used	Extractions validated by SDAC, limited to necessary variables.
Prevention of unauthorized transfers	Analyses performed only in a secure environment.
Documentation in the BASEC file	Technical data sheet "Handling and storage of data" provided, ready to be integrated into the protocol.
Responsibilities and compliance	Data controller: carrier's establishment; data processor: RES Foundation.
International transfers (if applicable)	Verification by the RES Foundation in accordance with the LPD.

5. Transparency

Transparency is both an ethical and regulatory requirement.

These requirements aim to ensure traceability, responsible publication, and public visibility of research projects.

Legal constraints in Switzerland	Source/Official reference	Implementation by the JIR Cohort
Declare projects to the Swiss public registry RAPS.	HRO, swissethics guidelines (public registry)	The JIR team assists the data controller in declaring the project to the RAPS register.
Make validated projects and their results accessible to the public.	HRO / swissethics transparency and publication	Projects and publications are listed on the JIR Transparency Portal, which is accessible online.
Ensure the responsible and transparent publication of results.	Helsinki Declaration, LRH, Swissethics guidelines	Results are disseminated in aggregated and anonymized form, without identifiable data.

Official references

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