swissethics Newsletter Nr 2018/6

 

Quick links

Webpage swissethics
       New versions
BASEC Front-end
       Safety form
BASEC Back-end
       Safety form
Advance training for EC members
Summary report of the HRA working group

 

Webpage swissethics

New versions

Scale of fees (Gebührenreglement, Règlement des émoluments): administrative changes only, revision date 09.07.2018.

The ‘Swiss’ definition of a multicentric research project has been added in a footnote for clarity;

  • Forschungsprojekt, welches nach einheitlichem Plan, aber in mehreren Zentren in der Schweiz und unter Beteiligung mehrerer EKs durchgeführt wird.
  • Étude multicentrique : Projet de recherche réalisé sur la base d’un protocole unique dans plusieurs centres de recherche en Suisse relevant de la compétence de plusieurs commissions d’éthique.

No changes have been made to the fees nor to the regulation.

Protocol template: Human research other than clinical trials (minor change without changes to the version Nr and version date)

Added in chapter 7.2. the obligation to ensure data quality and data traceability throughout the study, when using software’s without audit trail.

Protocol templates: Further use with informed consent and further use Art. 34. New versions (v2.1, 02.07.2018) in DE, FR, IT.

Added a signature page for the local project leaders in multicentric research projects.

Template for the notification of the end of a clinical trial or of a research project. New version v2.1, 11.07.18.

Instructions have been added on page 1: The study end report is submitted on screen 6, category 39 Miscellaneous/Varia, while the final clinical trial report (ClinO only) is submitted on screen 6 category 41 Final report.

No changes have been made to the questions and tables.

BASEC Front-end

Safety form

The owner of the safety form can now enter an ‘internal identification number or text’ on screen 2 Basic project info. This text will be displayed with the BASEC ID in the applicant ‘my account/manage my applications’ and on the automatic emails from BASEC. This will facilitate the PV dept. of large organizations to more easily identify the concerned protocols, who can’t always easily do so with the BASEC ID only.

BASEC Back-end

Safety form

New e-mail templates are available with text in EN, DE, FR, and IT in case a safety form is submitted to the local EC in a multicentric trial and in case the safety form account owner generates two or more safety forms per project. The e-mails remind the account owner on the correct use of the safety form.

Before sending the emails, you can manually change the headers or remove one or more languages from the e-mail templates, as you wish. The headers are ‘study number’ + 'safety form sent to local EC' and ‘study number’ + 'safety form dublicate'.

Advance training for EC members

As previously announced with a dedicated Newlsetter, the registration for the continuing education in Zurich on November 13, for members of the ethics committees and staff of the scientific secretariats is available online.

The program can be viewed under the following link. The continuing education event in Zurich is in German.

The registration for those interested is obligatory and can be done online here.

Summary report of the HRA working group with proposals for the revision of the law and the ordinances

In recent months, a swissethics working group has drawn up proposals to show where the ethics commissions believe the Human Research Act (HRA) and the ordinances need to be revised. The final summary report, written in German, is published on the swissethics webpage and can be accessed under the following link. This document is aimed at all stakeholders who are involved in research involving human beings and at the legislator. The proposals are to be considered as a basis for the further dialogue.

 

Watch out for the next communication on GDPR on the webpage, which is due shortly.

 

That’s it !