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Ethics Committee

Ethics Committee

Fakultät Kommissionen Ethics Committee

Ethics Committee of the Medical Faculty of Heidelberg University

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.

Links in emails or cover letters

Please note that the complete documentation must always be transmitted with every submission to the Ethics Committee. Sending a link in an email or in a PDF file, which leads to a website or a cloud location from which the documents are to be downloaded is not accepted.  The same applies to links to “secure e-mail portals”. 

Ethics Committee employees will generally not open any links in emails or in PDF files for information security reasons! 

Instead, please use our online platform for your submission: https://ek01-hd.de. This is very easy to use and secure as the transmission to our server is encrypted and the size of the submission is not limited. 

If it is not possible for you to submit your documents via our online platform, you may also send your submission to one of the following email addresses: 

Application documents AMG aF: V-ETHIK.AMG(at)med.uni-heidelberg.de

SUSARs: SUSAR.ETHIK(at)med.uni-heidelberg.de 

Other studies: submission via e-mail is not possible! 

However, we advise against a submission via email, as the transmission is not encrypted and the size per email is limited (max. 20 MB/email), which represents a possible source of errors for large submissions which have to be divided into several emails. 

accepted file formats

When submitting documents, please also note that the Heidelberg Ethics Committee (EKHD) does not accept the following file formats: 

.doc / .docx (Microsoft Word)

.ppt / .pptx (Microsoft Powerpoint)

.xls / .xlsx (Microsoft Excel)

.odt (OpenOffice / Libre Office Writer)

.odp (OpenOffice / Libre Office Impress)

.sxc (OpenOffice / Libre Office Calc)

Documents should preferably be submitted as PDF files. 

Alte Glockengießerei 11/1
69115 Heidelberg

Tel.: +49 6221 56 26460
Fax: +49 6221 56 33434

ethikkommission-I@med.uni-heidelberg.de

Office Hours:

Monday - Friday
9:00 AM - 3:00 PM

The EKHD is the first and only ethics committee in Germany which has a certified integrated management system according to DIN EN ISO 9001 and DIN EN ISO/IEC 27001. The results of the internal/external audits and the continuously collected key data document the quality of our services.  

DQS certificate symbol ISO 9001
DQS certificate symbol ISO 27001
EN