Regulations

Organization Governance Rules / Statutes

Request from Mark Adams.

Data entry rules

Level III:

MNDS: all live-born infants 22 0/7 to 31 6/7 weeks gestation or < 1501 g birth weight, regardless if already registered by another NICU.

B34: all live infants 32 0/7 to 33 6/7 weeks gestation. If child transferred within 48 hours after birth, the receiving unit must enter the data.

Level IIB:

MNDS: all live-born infants 22 0/7 to 31 6/7 weeks gestation or < 1501 g birth weight, admitted to your unit, if not transferred from a Level III unit to you.

B34: all live infants 32 0/7 to 33 6/7 weeks gestation. If child transferred within 48 hours after birth, the receiving unit must enter the data.

Ensure that data entries have an INFORMED CONSENT, except infants who die within the first week. If no informed consent is available, infants must be registered for quality assessment based on the mandate for quality assessment by the Intercantonal Agreement on Highly Specialiced Medicine.

Research Study Governance Rules 

(Version 3.2, Published 10.07.2026)

Any multi-centre research study performed with data from SwissNeoNet must adhere to the following regulations. Monocentric research studies are governed by the local centre's regulations. 

Your primary SwissNeoNet research coordinator is:

 

Abstract phase

1. Interested researchers generate a new project entry in the SwissNeoNet web app (https://app.swissneonet.ch/project) and design a short abstract containing title, background, aim, methods (including study collective), clinical impact, PI, collaborators, and timeline of the envisioned study. If required, the research coordinator can previously be contacted for a preliminary analysis of the planned project to ensure the required data is available.
2. The PI informs the research coordinator (see table above) of the new project entry. The research coordinator will then circulate it by e-mail to the representatives depending upon the targeted study collective and the included hospitals.
3. The representatives have 2 weeks to communicate if they are interested in participating actively in the planned study. Active participation is defined as improving / enriching a study by considerable effort in extra data acquisition, data evaluation, analysis of evaluation, research for discussion part, and / or acquisition of finances.
4. The PI records the representatives' responses in his/her SwissNeoNet project entry.

 

Protocol phase

1. The group of interested collaborators assembled during the abstract phase meets to design a detailed study protocol. The study protocol needs to address the following issues: background of study, aims, patients and methods (study collective, acquisition of data, anonymisation of data, statistical analysis), approval from the ethical board (if necessary), time schedule, and list of investigators / author list with the concrete tasks of each participant.
2. The PI sends the protocol to the research coordinator who will then circulate is it by e-mail to the representatives depending upon the targeted study collective and the included hospitals.
3. Each centre is given a 30-day-period to answer in one of the following ways:

• Study accepted: centre participates (should a centre not have announced participation during abstract phase, the centre must specifically show where further participation in the study is required for the study to improve)
• Study accepted: centre gives clearance for their data
• Study declined: centre does not wish that their data is included
• Please note: No response means that the study is accepted and the centre gives clearance for their data.

1. At the end of this phase, the PI submits the Data Transfer and Use Agreement (DTUA) based on the SPHN template DTUA for third parties. No further addition to the author list needs be accepted by the PI.

 

Evaluation phase

Once the protocol has been accepted, the PI is responsible for acquiring ethical approval. SwissNeoNet has a basic approval from BASEC to perform research with its collected data as of 2000 (PB_2016-02299). However, each new study requires its own ethical review board (ERB) approval specifically listing its approach and data required. The application can be submitted to one leading ERB. More information on previously approved studies can be found here: https://app.swissneonet.ch/project/basec. Sample applications can be requested from the research coordinator.

Upon receipt of the DTUA, the data is exported from the database. Data is de-identified: date of birth is removed without replacement, the hospital patient identifier and the hospital name are replaced by codes. Centre-to-centre comparisons require explicit permission by each centre involved even if coded. Subsequent publication of the results must not allow identification of either patient or centre involved (including own).

 

Publication phase

Original Research Publications containing data from SwissNeoNet need to fulfil the following requirements:

• BASEC approval (see above)
• Each publication must list the Swiss Neonatal Network (& Follow-up Group) as last author (see standard)
• Each manuscript must contain a list of participating clinics with the representatives in charge of the study collective in an acknowledgement (see standard). The representatives may change their listing in the acknowledgment representatives listed. With most journals, this list of representatives will lead to a pub med citation of each representative.
• A final version of the manuscript must be submitted to the research coordinator who then circulates it for 30 days to all the representatives who received the study protocol. These representatives are then responsible to forward to their teams if they see the need. Representatives may review the document based on the received protocol. Note: No response of clinic means that the manuscript is accepted.

Abstracts and Posters for conventions need to fulfil the following requirements:

• Abstracts and Posters must remain within the scope of the study protocol
• There is no previous consent from representatives required
• Copies of Abstracts must be sent to representatives prior to submission
• Posters do not need to be circulated

All other forms of disseminating research or any other kind of information based on multicentre data from SwissNeoNet that have not been previously published require a written approval from the Steering Committee. Requests must contain an abstract of the contents and information on the chosen media.

A list of current studies / research projects can be found here:

SwissNeoNet member platform