There are no ethical concerns. All patients will receive routine standard of care according to the hospital. There is no research related intervention. Institutional approval will be required by each participating centre in order to get permission for collecting observational clinical information. This approval must be obtained before the start of inclusion.
It is recommended that the patient information/ legal representative information includes the consent for contacting of other persons e.g. relatives or caregiver in case that the patient is not available at the telephone contact on day 30 after intervention.
Each centre must report to the POSE study team their local approval process and send the following two things:
- POSE Approval Documentation Coversheet and
- A letter of approval / notification receipt from their ethics / local authority (letter can be in local language)
New General Data Protection Regulation (GDPR) for centres in the EU:
- Became applicable on 25thMay 2018 for all centres participating in POSE from the EU!
- Considering the updated data protection rights provided for patients in the GDPR, future patient information sheets and consent forms must be adapted to the requirements of the GDPR.
- All centres form the European Union, which were recruiting around 25thMay 2018 or had patients in the follow up period after 25thMay 2018.
- All centres, which already have an ethical approval and have actually started or plan to start their recruitment after 25thMay 2018.
New-Data-Protection-Info-for-Investigators_29.08.18 please send us back the signed second page, if the new GDPR is applicable for your centre.
Templates published on behalf of their authors:
1. The following templates are provided by the National Coordinator from the UK:
- Patient information v1.0 for Consultee
- Consultee declaration form v1.0
- Patient information v1.0 for participant
- Patient consent form 1.0
2. The following templates are provided by the National Coordinator from Ireland. Please note that these documents are based on a pre-version of the study protocol and that the title, some endpoints and other small things have changed after their creation. The updated English documents will be published soon. In the meantime, these documents may be already useful as a basis for your own Ethical application documents. But please, do not only copy the text, without reading the actual study protocol version 1.1.
- Ethical Approval Aachen, Germany
- Patient Information and Consent Form (for patient/ legal representative/ independent physician)
- Patient Information and Consent Form (for patient after regain of capacity to give consent)
- German Study Synopsis
German documents as a WORD file and further ethical approvals from Germany can be obtained by e-mail from firstname.lastname@example.org
- Ethical Approval Rotterdam
- E1.PIF POSE wilsonbekwame patiënten 11-9-2017
- E1.PIF POSE 11-9-2017 wilsbekwaam
- PI Sheet Patient. v 1.0. Spanish. ACTUAL
- IC Patient. v 1.0. Spanish.
- PI Sheet Consulteer. v 1.0. Spanish.
- IC Consulteer. v 1.0. Spanish.