Ethical and regulatory considerations

BG Bertrand Gachon
TS Thomas Schmitz
FA France Artzner
OP Olivier Parant
RT Renaud De Tayrac
GD Guillaume Ducarme
CR Camille Le Ray
AP Anne Cécile Pizzoferrato
CG Charles Garabedian
DR Didier Riethmuller
FP Fabrice Pierre
SR Stephanie Ragot
XF Xavier Fritel
request Request a Protocol
ask Ask a question
Favorite

This study involves only volunteers for anonymous online questionnaire answering, without any identifying information collection and with a total independence from any medical care. This considered, regarding the French legislation about medical research involving human person (Loi Jardé), an ethical committee approbation is not required (https://www.legifrance.gouv.fr/codes/id/LEGISCTA000032722874/2017-06-14/).

The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 (NCT 04446780). The INSTRUMODA project have been approved by an ethical committee: Comité de Protection des Personnes Nord Ouest IV (ID RCB: 2020-A01974-35).

Do you have any questions about this protocol?

Post your question to gather feedback from the community. We will also invite the authors of this article to respond.

0/150

tip Tips for asking effective questions

+ Description

Write a detailed description. Include all information that will help others answer your question including experimental processes, conditions, and relevant images.

post Post a Question
0 Q&A