The REDCap@UniFR team published study protocol templates covering data management and IT aspects. A guide published by Swissethics containing key AI-specific questions is now available. The University also supports you in drafting the necessary contracts for your research projects.

Study protocol templates for data management on REDCap

For projects subject to the HRA that use the University's REDCap servers, the REDCap@UniFR team has recently released study protocol templates for data management. You can learn more about this topic here. As a reminder, REDCap is a Clinical Data Management System funded by the NIH and widely adopted for over 20 years across the human health research community.

The templates are available in three versions tailored to HRO, ClinO and ClinO chapter 4 protocols. They are automatically delivered with each REDCap project creation request, after completing this form. They can also be downloaded from the webpage of the legal support for research on human beings.

These templates have been reviewed by the ethics committee of the canton of Vaud (CER-VD), responsible for Fribourg projects. Of course, they must be adapted specifically to your own research project and study structure (especially the parts highlighted in yellow).

Currently, the templates cover the specific chapters that pertain to data management and related technical IT components. But they may soon be extended to other relevant research aspects (e.g., open data, data archiving, etc.). Finally, the REDCap@UniFR will ensure that the templates are regularly updated to reflect the latest changes to Swissethics templates.

If you’d like to contribute to the effort or have any question about these templates, do not hesitate to reach us at redcap@unifr.ch.

New Swissethics guide on artificial intelligence

When submitting a research project involving artificial intelligence (AI), ethics committees require that the key AI-specific issues be addressed in the research protocol.

Swissethics has published a guide on the aspects to consider, containing a set of key questions. The document was developed by a group representing each ethics committee. It is intentionally written in general terms to include all possible uses of AI in research. Given their diversity, and since not every point applies to every project, it should be read as a reminder of minimum requirements.

Collaboration contracts and support

Your research projects often involve collaborations with other institutions: project carried out at several sites, investigators from different institutions, reuse of data or samples collected in another institution. Agreements must then be established between the institutions involved (universities, hospitals, clinics). Ethics committees require them to validate your project. To save time in the process, it is ideal to submit these signed contracts with your initial BASEC application.

We assist you in drafting these agreements. Please contact us as soon as possible as exchanges between institutions and obtaining signatures often take several weeks. More information is available here.

The contact person for this area is Julie Perriard. She is also available to support you in your communications with ethics committees, before or after submitting your authorization request. Do not hesitate to contact her.