Application procedure and forms // University of Oldenburg

On this page you will find a description of the application procedures, the necessary forms and, where applicable, sample texts for communicating with the Medical Ethics Committee of the University of Oldenburg (MEK).

Guide for Applicants

If you have any questions regarding proposals, further information is available in our FAQs. If you have any further questions about specific research projects, please contact the secretariat by email or during office hours, quoting the MEK reference number where applicable.

General Information

To enable the MEK to process proposals efficiently, please note the following points when submitting your documents (unless otherwise required by law or specified in the information on the procedures):

The application documents, including the cover letter, must be submitted electronically (searchable, OCR-compatible PDF files, with each document individually named, dated and versioned) by () and subsequently also in paper form.
Please ensure that the paper and electronic versions are identical.
After the initial submission, please always quote the Medical Ethics Committee’s first reference number and, where applicable, the reference number of the current case (e.g. amendment).
The pages of the various application documents must be numbered and marked with a version number and a version date.
Please check that all signatures are present, at least in the paper version.
A declaration of cost coverage or a proposal for exemption from fees must be attached to all application/notification procedures and amendments.

If you have any queries, please always quote the Ethics Committee’s reference numbers. (For telephone enquiries, please note the office’s opening hours! If necessary, arrange a telephone appointment by email.)

Important note: The sample texts provided or linked to on this page are intended as guidance. They are neither binding nor suitable for every research project. Accordingly, when using the sample texts, applicants must review them critically and adapt them to their specific research project.

The Medical Ethics Committee recommends:

The use of the sample texts provided by the Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V.
The eTIC tool can help you with this; see also the information under eTIC – electronic Tool for Informed Consent documents – AKEK – Working Group of Medical Ethics Committees ( ONLY for the preparation of patient information and informed consent forms)
⇒ However, we ask that you use our currently valid forms; you will find a compilation of these under the respective drop-down menus below.
Further documents and templates for university research projects can be found at the Data Protection and Information Security Unit

Enquiry about the duty to provide advice

If you are not sure whether the Medical Ethics Committee (MEK) has a duty to provide advice or whether the MEK is the ethics committee responsible for you in accordance with state law, you can submit an enquiry to the MEK office to check the duty to provide advice and responsibility. Please use this form and the corresponding instructions, sign it and send it by post or to the Medical Ethics Committee.

As a rule, you will receive a binding answer from the office within 14 days at the latest as to whether there is a duty to consult and a full application must be submitted or whether there is no statutory or professional duty to consult (waiver).

Notification of research projects according to § 15 BO ÄKN or according to the statutes: Initial vote

The German Medical Association (BÄK) and the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK) have issued a joint press releaseon the standardisation of the procedure for professional advice on research projects. This press release refers to a corresponding procedural proposal for the harmonisation of professional advice in accordance with Section 15 MBO-Ä. The Medical Ethics Committee has endorsed this.

If the research project has already been advised by an ethics committee formed in accordance with state law, the initial vote and any further votes must be submitted with amendments.

The following documents must be submitted:

Cover letter
Notification to a local ethics committee incl. checklist (form)
Initial vote of the ethics committee responsible for the entire study project (this must show that the local study centre is already registered)
If applicable, acknowledgement that Oldenburg is already registered as a local study centre
German-language synopsis ( sample form)
Declaration of assumption of costs/proposal for fee exemption (form)
List of participating study centres including the locally responsible physicians (form)
Declaration of suitability of the local study centre (form)

Further information on the procedure for reporting an amendment can be found on the AKEK website.

Advice on research projects according to § 15 BO ÄKN or according to the statutes: Initial application (as the responsible ethics committee)

The documents to be submitted are:

Cover letter
application form (Form), always required!
Study protocol:
German-language synopsis (Sample form)
List of participating study centres (for multicentre studies), including the locally responsible doctors (form)
Where applicable, list of medical devices used (form)
CVs of the doctors (researchers) involved at each study centre and declarations regarding the suitability of the respective study centres (Form)
Declaration of cost coverage/proposal for exemption from fees, stating the billing address / cost centre or the grounds for exemption from fees (Form)

Notification of the start of the study

The start of the trial (commencement of subject recruitment) must be notified to the Medical Ethics Committee using the following form. It is sufficient to submit a scanned copy of the signed form by email (the form will be sent with the committee’s decision).

Interim reports

If requested in the approval decision, the relevant interim reports must be submitted. The relevant forms will be sent with the approval decision.

Reporting of adverse or unexpected events
Notification of new findings regarding the benefit-risk assessment of the research project

If adverse or unexpected events occur during the course of the research project, or if new risks to trial participants, or new findings regarding diagnostics, therapy, study-related measures or alternative treatments, a reassessment by the responsible researchers (in particular doctors) is required. The Medical Ethics Committee must be informed of this (where applicable, an amendment to the updated benefit-risk assessment must be submitted to the study protocol).

final report

The form for reporting the completion of the study is enclosed with this report. A summary of the results and any publications arising from the research project should be attached to this.

Advice on research projects according to § 15 BO ÄKN or according to the statutes: Amendments

Changes to the study protocol, the Informed Consent or the participating study centres or responsible persons must be reported to the Ethics Committee. The following documents must be submitted, stating the process number of the vote / file number of the initial proposal:

Cover letter including a summary of the planned changes
Amendment application for an ongoing research project (form)
In the case of substantial changes to the study protocol, these must be confirmed with the signature of the following persons:
- Applicant and head of department of the leading institution
- For interventional studies or studies with invasive or stressful study-related measures: Signature of the person responsible for the study design (incl. case number planning)
When registering new participating physicians (scientists): CVs and updated declaration of suitability of the local study centre (form)
Declaration on the assumption of costs/proposal for fee exemption and indication of the financial centre/billing address (form)

Please submit a signed copy of the documents in writing as well as an electronic version (PDF) by email. Study protocol, informed consent, questionnaires, etc. must be re-versioned and submitted once in amendment mode and once in corrected mode.

Studies in accordance with the Medicinal Products Act

The Medical Ethics Committee of the University of Oldenburg is currently not certified to evaluate research projects in accordance with the AMG.

Studies according to medical device law

A clinical trial of medical devices (§ 20 ff MPG) or a performance evaluation trial (§ 24 MPG) may only be started if the authorisation of the higher federal authority and the approving assessment of the responsible ethics committee have been received.

The proposal must be submitted electronically via the centralised registration system of the German Institute of Medical Documentation and Information (DIMDI).

Assistance, forms and samples can be found on the website of the Working Group of Medical Ethics Committees in the Federal Republic of Germany. We would particularly like to draw your attention to the

Checklist for application documents for clinical trials according to the MPG,
the checklist for investigator qualification/trial site suitability for clinical trials according to the MPG
as well as the sample information and consent forms.

Further information can also be found here:

Research projects for the development of biomaterial banks or sample collections

This section is currently under construction and will be updated.

If you have any questions, please send an email to

Notification of the start of a study

Form A for the notification of the start of a study can be found here.

Notification of the termination of a study

Form B for the notification of the termination of a study can be found here.

Notification procedure according to StrlSchG

Please find the necessary information and forms on the website of the Working Group of Medical Ethics Committees

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Application procedure and forms