swissethics Newsletter Nr 2017/8

 


Quick links

Webpage swissethics

1. Templates

New documents
New versions

Note

2. BASEC

Policy on submission / handling of PW protected files
Filtering and displaying project lists
Edits in back-end
Projects’ statuses before the release of the new submission form


 

Webpage swissethics:

 

1 Templates:

New documents:

New template (v1.0, 22.09.2017) of the protocol for the submission of research projects ‘Research Involving Deceased Persons’ according to HRA/HRO. The template is available in German, French and Italian.

New Versions:

New version (v2.0, 25.09.2017) of the protocol for the submission of research projects “further use without consent” according to HRA Art. 34 / HRO. The template is available in German, French and Italian.

New version (v2.0, 25.09.2017) of the protocol for the submission of research projects “further use with consent” according to HRA / HRO. The template is available in German, French and Italian.

The following chapter has been added to the two new versions:

Finanzierung / Veröffentlichung / Interessenerklärung: Beschreiben Sie die Finanzierungsquellen, die Veröffentlichungspolitik des Projekts, die Datenaustauschpolitik und mögliche Interessenkonflikte. Gegebenenfalls verweisen Sie auf Verträge oder Dokumente, in denen diese Informationen erfasst werden. Bei multizentrischen Projekten, wenn kein Vertrag oder eine schriftliche Vereinbarung zwischen den Institutionen besteht, können hier die Einzelheiten der Zusammenarbeit angegeben werden.

Financement / publication / Déclaration d’intérêt: Décrire les sources de financement, la politique de publication du projet, la politique de partage des données et les conflits d'intérêts possibles. Le cas échéant, renvoyer aux contrats ou aux documents où sont contenues ces informations. Le cas échéant, dans le cas de projets multicentriques, s'il n'y a pas de contrat ou d'accord écrit entre les institutions, les détails de la collaboration peuvent être consignés ici.

Finanziamento / Pubblicazione / Dichiarazione d’interesse :  Descrivere le fonti di finanziamento, la politica di pubblicazione del progetto, la politica di condivisione dei dati e i possibili conflitti di interesse. Se del caso, riferirsi ai contratti o ai documenti in cui tali informazioni sono indicate. Se del caso, nei progetti multicentrici, in assenza di un contratto o di un accordo scritto tra le istituzioni, possono essere indicati qui i dettagli della collaborazione.

Note:

Because there is no legal basis for the EC and swissethics to force the researchers to use the templates, we have added following text to the page ‘templates / recommendations’ on swissethics.ch :

Die Vorlagen beinhalten alle Aspekte, die die gesetzlichen Regelungen in der Schweiz vorgeben. Es ist daher sehr empfehlenswert, sich an die Vorlagen zu halten, um den Anforderungen vollumfänglich nachzukommen. Sie erleichtern und beschleunigen zudem die Begutachtung durch die schweizerischen Ethikkommissionen. Die Vorlagen sind je nach Studientyp sinngemäss anzuwenden.

Les modèles prennent en compte toutes les prescriptions de la législation suisse applicable. Il est donc fortement recommandé de respecter les modèles afin de satisfaire pleinement aux exigences. Ils facilitent et accélèrent également l'évaluation par les commissions d'éthique suisses. Le modèle à employer dépend du type de recherche mené.

I modelli prendono in conto tutti gli aspetti richiesti dalla legislazione svizzera applicabile. Si raccomanda pertanto di attenersi ai modelli per soddisfare pienamente i requisiti. Il loro utilizzo agevola e accelera inoltre la valutazione da parte delle commissioni etiche svizzere. I modelli sono da utilizzare conformemente al tipo di ricerca.

The templates meet all the aspects required by the Swiss legislation. It is therefore highly recommended to stick to the templates to meet the requirements in full. The use of the templates also facilitates and accelerates the assessment by the Swiss Ethics Committees. The templates shall be applied according to the type of study.

Some templates might still instruct the researchers that the use of the template is mandatory. We will modify update the text any time the templates are updated.

 

2. BASEC:

Policy on submission / handling of PW protected files in BASEC:

The new policy on submission / handling of PW protected files in BASEC, which consist of a policy for the front-end users and one for the back-end users is attached for your advanced information and for internal use only.

The BASEC users will be informed about the front-end users’ chapter of the new policy with the next external Newsletter and with a note in BASEC.

Filtering and displaying project lists:

A new FAQ in back-end about filtering and displaying project lists, which includes a link to a video (screencast): http://swissethics.ch/basec_help/knowledgebase.php?article=29

Edits in back-end:

It is forbidden to edit the submitted form in back-end by the EC. As a general rule, if changes are needed, the EC needs to ask the applicant to do the changes in front-end.

Reason: In the back-end, there are no safeguards against wrong or incomplete entries. Therefore, it is dangerous to manipulate submitted forms through the back-end. Exceptions might be simple corrections of typographical errors. A FAQ has been written on this subject:  http://swissethics.ch/basec_help/knowledgebase.php?article=43

Projects’ statuses before the release of the new submission form:

A PDF file of each project in its status before the release of the new submission form is available in the ‘document manager’ of each project. Excel-exports are stored in swissethics-cloud.

 

That's it!