Non-AMG non-MPDG applications
Submissions of applications in accordance with professional law of lower saxony §15 BO (non-MPDG and non-AMG studies) are made via the online database ethikPool (see description here, access to the ethikPool platform: https://www.mhh-ethikkommission.de/app/).
One study - one vote: The procedure for professional advice on research projects has been standardised.
The German Medical Association (BÄK) and the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK) have agreed on a standardised procedure for professional advice. LINK
From 2 January 2025, all new ethics applications submitted to the MHH will therefore be assessed using new standardised forms. The advantage of this is that in future, only one ethics vote will need to be obtained for multi-centre studies, meaning that applicants from other trial centres in their institution will not have to apply for a new follow-up or second vote. The prerequisite for this is that the other ethics committees involved, such as the MHH, also already participate in the ‘One study - one vote’ procedure.
The forms are to be used from 02.01.2025 for both monocentric and multicentric studies (see also the AKEK homepage www.akek.de/sonstige-studien/) The documents required for the application must be uploaded in PDF format! Access to the platform: www.mhh-ethikkommission.de/app/
Please also refer to the guidelines for applicants.
For all studies submitted under the old procedure, the old legal situation will continue to apply. Amendments for these studies will be discussed locally if local counselling is required under the respective state and statute law. It must be ensured that applicants receive a vote if this is legally required for them.
0 Cover letter
►Short description of the project in a few sentences and any important additional information about the project. This helps the office to quickly categorizs your project and can significantly shorten the processing time.
1 Application form for professional counselling in accordance with §15 BO
►(writable PDF)
2 Checklist study protocol - project plan for a prospective study (full application)
Variant A: Prospective study (full application)
3 Checklist study protocol - project plan for a project with material from an existing biobank (short application)
Variant B: Project with material from existing biobank (short application)
4 Checklist study protocol - project plan for a project with data from an existing database / registry (short application)
Variant C: Project with data from existing database / registry (short application)
5 Checklist study protocol - project plan for retrospective analysis of data from clinical routine (short application)
Variant D: Retrospective analysis of data from routine clinical practice (short application)
6 Study synopsis
7 Declaration of suitability of the study centre by the head of department/institute
This form must be uploaded with all study submissions and replaces the consent of the department head on the old and no longer valid forms. Without this acknowledgement and approval of the head of department to conduct the study, consultation by the ethics committee is not possible! This is the nationwide uniform procedure since 01/2025. In the case of multi-centre studies, this confirmation must be obtained separately for all participating trial centres. The term trial centre stands for the location or department in which the study is conducted.
►(writable PDF)
8 Information on the financing of the project and declaration of assumption of costs
9 Checklist: Notification of participation in a multicentre project that has already been discussed and approved by an ethics committee
►(writable PDF)
10 Amendment to an ongoing research project
►(writable PDF)
Attention: From 2 January 2025, this form must also be completed and uploaded to ethikPool for amendments!
11 Guidelines for applicants
12 Checklist for the documentation for PMCF studies (Post-Market Clinical Follow-Up)
Which documents must be submitted for PMCF studies within the intended purpose and without invasive or burdensome procedures?
13 List of participating study centres
►(writable PDF)