swissethics Newsletter Nr 2017/6

 

Webpage swissethics:

Template, new Versions:

  • New version (v2.0, 19.07.2017): Template for study protocol involving human subjects with the exception of clinical trials (HRO, chapter 2). The template is only available in English.
    • Vorlage Protokoll für ein Forschungsprojekt mit Personen mit Ausnahme der klinischen Versuche (HFV, Kapitel 2).
    • Modèle pour l’élaboration d’un protocole pour les projets de recherche impliquant des personnes conformément à l'ORH Chapitre 2.
    • Modello protocollo di studio per i progetti di ricerca sull’essere umano ad eccezione delle sperimentazioni cliniche (ORUm, capitolo 2).

Note: This new version is a total revision of template v1.0 (paragraphs have been simplified, merged, or even completely deleted).

 

  • New version (v2.0): Staff list. The template is only available in English.

Note: The submission of the staff list to the Ethics Committee is optional. Yet, the Ethics Committees can request the staff list for high risk projects (e.g. phase I clinical trials).

Note: The ‘Staff list’ does not fulfill the requirements set by ICH-GCP E6 4.1.5, and as such it can’t be used as ‘delegation log’.

 

  • The French versions of the templates for the patient information and declaration of consent according to ClinO and HRO for the relatives /legal representative, have been reviewed to facilitate the readability of the text, correct few typos, and to harmonize the ICFs between languages.
    • New version (v1.1) : Modèle de swissethics pour l’élaboration d'une feuille d’information écrite pour les proches/représentants légaux /parents, conformément à l’OClin.
    • New version (v1.2) : Modèle de swissethics pour l’élaboration d'une feuille d’information écrite pour les proches/représentants légaux /parents, conformément à l’ORH.

That's it!