Medical research

An information letter on the reimbursement of expenses for professional counselling can be found here (opens in a new window). (This PDF is not accessible).

The Regensburg Ethics Committee usually meets once a month. The current meeting dates of the Medical Ethics Committee and the respective application deadlines can be found here.

You can access our application portal Ethikpool here (external link, opens in a new window). If you do not yet have a user account, you can also create a new account via this link.

Once you have registered, you can create a new application in the Ethikpool. If you have any questions or need help, please do not hesitate to contact us.

We fully implement the new "One study - one vote" procedure for standardised professional advice in Germany. Detailed information on the procedure can be found on the homepage of the Working Group of Medical Ethics Committees (external link, opens in a new window) (AKEK).

This procedure also applies to applications for amendments to studies already voted on in the coordinated procedure. Consultation in the coordinated procedure has been discontinued.

If the Regensburg Ethics Committee is only involved locally, please submit a notification dossier consisting of the notification form (opens in a new window). (This PDF is not accessible) and the form on the suitability of the local trial centre (opens in a new window). (This PDF is not accessible).

Here you can download templates of the documents required for your application. The protocol templates can also be downloaded from Ethikpool during the application process. You then submit the completed documents to us via Ethikpool (external link, opens in a new window).

• Structured synopsis
• Study protocol: Please select the appropriate protocol for your application type.
  • Study protocol version A: Prospective study
  • Study protocol version B: Biobanks
  • Study protocol version C: Registry studies
• Information on funding
• Site suitability information
• Information and consent documents for adults: Please select the appropriate files for your application.
  • Patient information of the UR
  • Consent form of the UR
  • Patient information of the UKR
  • Consent form of the UKR
  • Patient information blank
  • Consent form blank
• Information documents for children and adolescents: If applicable.
  • Patient information for adolescents of the UKR
  • Patient information for adolescents of the UR
  • Patient information for adolescents Blank
  • Patient information for children of the UKR
  • Patient information for children of the UR
  • Patient information for children Blank
• Biobank documents: If applicable.
  • Supplementary text data protection DSGVO
  • Patient information and consent
  • Patient information and consent for minors (7-11 years)
  • Patient information and consent for adolescents (11-17 years)
  • Patient information and consent for legal guardians
  • Information and consent for use outside the Study Plan

In some cases, you can also submit a simplified application for professional counselling free of charge. This is usually possible if the following points are met:

• You only analyse data retrospectively, e.g. routinely collected data from patient records, and
• you do not have any additional, study-related contact to patients.

You can find the application form for retrospective data anylsis here (opens in a new window). (This PDF is not accessible).

A checklist for your application in the simplified procedure can be found here (opens in a new window). (This PDF is not accessible).

If you are unsure whether a simplified application is suitable for your project, please contact us in advance, providing a brief project description.

Please note that studies related to AI can currently only be subitted under this simplified procedure in exceptional cases. Please contact us in advance.

You can create an amendment for an ongoing study yourself at any time in your study folder in Ethikpool. Please only submit those documents in your amendment for which changes have been made. Please make sure that any changes to the previous version can easily be identified in the new documents (e.g. tracked-changes).

You can download the application form for an amendment here (opens in a new window). (This PDF is not accessible).

Please note that it is currently not possible to upload this form in Ethikpool when creating an amendment. However, after submitting the amendment, you can upload the form as an attachment to a message in the amendment.

For multi-centre studies, please note that amendments within the framework of "One study - one vote" are generally only submitted to the ethics committee responsible for the overall study management. The amendment will only be reported to a local ethics committee in the following cases:

• The local trial centre is newly included in the study
• The local trial centre is deregistered
• The amendment concerns documents that were submitted to the local ethics committees as part of the notification procedure in accordance with Section 4 of the AKEK application guidelines.