Welcome!

You will find everything you need to know about the submission modalities, meeting dates, contacts, processing times and other helpful information here.  

We work closely with the higher federal authorities in Germany, with the Association of Medical Ethics Committees and with all other national ethics committees. 

Please do not hesitate to contact us directly if you have any questions or are unclear about something. 

We wish you every success for your study project! 

Current Notifications

One study - one vote: options for implementing the resolution in Heidelberg

At its general meeting on 14 June 2024, the members of the Association of Medical Ethics Committees in Germany passed a resolution (German only) according to which, in future, the vote of only one German Ethics Committee is required for Studies according to Sec. 15 of the Professional Code of the State Medical Association and a mere notification will be sufficient for other Ethics Committees responsible for physicians at participating trial sites. However, the implementation of this procedure presupposes that the necessary legal conditions (→ Professional Code of Conduct of the respective Medical Association) are in place. According to the professional code of conduct of the Medical Association of Baden-Württemberg, the review of a research project has to be carried out by each responsible ethics committee. The Ethics Committee of the Medical Faculty of Heidelberg University is therefore currently unable to accept a mere notification of a research project with reference to an existing vote.

What does this mean?

If a study according to Sec. 15 of the Professional Code of the State Medical Association of Baden-Württemberg is conducted by physicians at Heidelberg University Hospital / Heidelberg University / DKFZ Heidelberg, in which other physicians at other locations are involved, the complete set of documents for a so-called Other Study must be submitted to the Heidelberg Ethics Committee for review. If a review has already been carried out by another German Ethics Committee and the corresponding ‘vote’ is available, this ‘vote’ can be submitted with the documents.

The office of the Heidelberg Ethics Committee will check whether it is possible to consider this vote from a formal point of view. The following basic requirements must be met for this:

1. The content of the documents submitted in Heidelberg must be identical to the documents that were submitted to the ‘first-voting’ ethics committee for review.
2. Any necessary formal adjustments to the ICF (→data protection officer, contact person, etc.) can be made, but must be indicated using the automatic “track changes function”. The version and date of the document should not be changed.
3. The ‘vote’ of the ‘first-voting’ ethics committee must contain a list of the documents that were the subject of the review. This list must contain the version and date of these documents.

When will a notification be possible in Heidelberg?

In Heidelberg, it will only be possible to notify the Ethics Committee about research projects that have already been approved by another ethics committee once the professional code of conduct of the Medical Association of Baden-Württemberg has been amended accordingly. The Heidelberg Ethics Committee supports the harmonisation efforts of the Association of Medical Ethics Committees and will work towards implementation as quickly as possible. However, currently it isn’t possible to give a specific date for the transition to the “notification procedure”. 

If you have any questions, please do not hesitate to contact the staff at the office in the Other Studies department.