Application procedure and forms

Application procedure and forms

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

If you have any questions about proposals, you can find further information in our FAQs. If you have any further questions about specific research projects, please contact the MEK office by email or during office hours, quoting the MEK's reference number.

General information

To enable the MEK to process proposals efficiently, we ask you to observe the following points when submitting your documents (unless otherwise required by law or otherwise described in the information on the procedures):

  • The application documents, including the cover letter, must be submitted electronically (searchable, OCR-capable PDF files, individually named, dated and versioned documents) by ) and then additionally in paper form.
  • Please ensure that the paper and electronic forms are identical.
  • After the initial submission, please always state the first procedure number of the Medical Ethics Committee and, if applicable, also that of the current procedure (e.g. amendment).
  • The pages of the various application documents must be numbered and labelled with a version number and a version date.
  • Please check that all signatures are present, at least in the paper version.
  • A declaration of assumption of costs or a proposal for fee exemption must be attached to all application/notification procedures and amendments.

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

Important note: The sample texts offered or linked on this page are intended as aids. They are neither binding nor suitable for every research project. Accordingly, if the sample texts are used, they must be critically reviewed by the applicants and adapted to the research project.

The Medical Ethics Committee recommends

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 has already been 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

Notification of the start of the study

The start of the study (start of recruitment of trial subjects) must be notified to the Medical Ethics Committee using the following form. It is sufficient if the signed form is scanned and submitted by email (form is sent with vote).

Interim reports

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

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

If adverse or unexpected events occur in the course of the research project, or if new risks for the trial participants or new findings on diagnostics, therapy or study-related measures or treatment alternatives become known, a reassessment by the responsible scientists (especially doctors) is required. The Medical Ethics Committee must be informed of this (if necessary, an amendment to the updated benefit-risk assessment in the study protocol must be submitted).

Final report

The form for reporting the completion of the study is enclosed with the vote. This should be accompanied by a summary of the results and publications of the research project.

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. (including case number planning)
  • Declaration of assumption of costs/proposal for fee exemption and indication of the funding 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

(Changed: 09 Mar 2026)  |  Kurz-URL:Shortlink: https://uol.de/p55359en
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