Organization Governance Rules
Request from Mark Adams.
Research Study Governance Rules
These regulations cover any and all research and publication performed with data from either the preterm (MNDS), the extended preterm (B34), or the asphyxia and cooling (ASP) registry (with or without additional follow-up data, i.e. FU1, FU2, FU5).
Interested network researchers design a short abstract containing a title of the envisioned study and a short description. If required, M. Adams can previously be contacted for a preliminary analysis of the planned project to ensure the required data is available. The abstract is sent to M. Adams who will then circulate it by e-mail to the above NEO- and/or FU-contacts depending on the nature of the study, i.e. if neonatal and / or follow-up data is required.
The contacts 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.
Each new study needs to be registered within the "Projects" registry of SwissNeoNet under https://app.swissneonet.ch/project. This entry must be kept up to date until the final manuscript is published!
Study protocol phase
The group of interested collaborants 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.
The protocol is sent to the contacts listed above. Each center is given a 30-day-period to answer in one of the following ways:
- Study accepted: center participates (should a center not have announced participation during abstract phase, the center must specifically show where further participation in the study is required for the study to improve)
- Study accepted: center gives clearance for their data
- Study declined: center does not wish that their data is included
Please note: No response means that the study is accepted and the center gives clearance for their data.
The data is exported from the database fully anonymized and without center-identification before it is transferred to the principal investigators. Center-to-center comparisons require explicit permission by each center involved. Subsequent publication of the results must not allow identification of either patient or center involved (including own). At the end of this phase, no further addition to the author list needs be accepted by the principal investigators.
Publications containing data from the Swiss Neonatal Network and Follow-up Group need to fulfill the following requirements:
- Each publication must list the Swiss Neonatal Network (& Follow-up Group) as last author (see standard)
- Each publication must contain a list of participating clinics with the representatives in charge of MNDS and/or FU data in an acknowledgement (see standard). The clinics may change the representatives listed.
- With most journals, this list of representatives will lead to a pub med citation of each representative.
- The members of the workgroup form the remaining authors (see above).
- Four weeks before a publication is submitted to a journal, a final draft must be sent to all centers involved. Papers are sent to the current representatives who are then responsible to forward to their teams if they see the need.
Please note: No response of clinic means that the publication is accepted.
Abstracts and Posters for conventions:
- Abstracts and Posters must remain within the scope of the study protocol
- There is no previous consent from centers required
- Copies of Abstracts must be sent to centers prior to submission
- Posters will not be circulated
All other forms of disseminating research or any other kind of information based on multicenter data from SwissNeoNet that has 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: