Application
MHH-internal submissions of applications according to the professional law §15 MBO (non-MPDG and non-AMG studies) could previously be made with a paper copy (original) + electronically via CD, USB stick or e-mail (Ethics Committee@mh-hannover.de). We have switched the application procedure to the digital platform ethikPool. Please note that the application form must bear all signatures. The regulation of purely electronic submission also applies to the MHH-internal submission of amendments to studies in accordance with professional law.
What is ethikPool?
ethikPool is the digital platform for submitting and processing applications in the context of clinical research. As an applicant, you will be guided through the application process and shown which documents need to be submitted. You can view the overall status of your submitted application as well as individual processes and tasks to be completed in ethikPool at any time. In addition, your documents (application documents, votes) are documented and accessible for you in the portal. The internal messaging system ensures effective Communications between you and the Ethics Committee.
Quick guide for applicants
Before submitting an application, you must create a user account. Two-factor authentication using an authenticator app is required. You can find instructions here: Download
Access to the platform: https: //www.mhh-ethikkommission.de/app/
Please enter your name with full title, your Clinical Department/Institute, your OU number and your e-mail address in your user account. For some users an account has already been created by the office. If this is the case for you (you will recognize this by the note in the registration mask that your e-mail already exists), please contact us and we will send you the access data by e-mail from ethikPool.
What about subsequent amendments to ongoing studies in accordance with the Professional Code of Conduct (studies from 01/2018) that were not originally submitted via ethikPool?
- If you have not already done so, create a user account at https://www.mhh-ethikkommission.de/app/.
- Inform the office of the Ethics Committee by e-mail (info@mhh-ethikkommission.de) that you would like to submit an amendment to an existing study (mention the file number) and ask for the study to be transferred to ethikPool.
- As soon as the study has been transferred, you will receive a notification via ethikPool.
- Submit your amendment to the study via ethikPool.
IMPORTANT: Studies for which only the end of the study is to be displayed no longer need to be transferred to ethikPool. In these cases, we accept the notification of the end of the study by e-mail.
The deadline for submission is always 14 days before the meeting.
The meeting dates can be found here. Submissions must be made by 12:00 noon on the day indicated in order to allow for discussion at the next meeting.
The Ethics Committee can only discuss complete applications. Therefore, please check that the documents are complete before submitting them. Otherwise the applicant will receive additional claims.
Submissions of applications in accordance with professional law §15 MBO (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 standardized.
The German Medical Association (BÄK) and the Working Group of Medical Ethics Committees in the Federal Republic of Germany e. V. (AKEK) have adopted a standardized procedure for professional advice. LINK
As of January 2, 2025, all new ethics applications submitted to the MHH will therefore be reviewed using new standardized forms. The advantage of this is that in future only one ethics vote will have to be obtained for multicenter studies (as was previously the case with the first Ethics Committee) and thus applicants from other trial centers 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, are also already participating 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 https://www.akek.de/sonstige-studien/) The documents required for the application must be uploaded in PDF format! Access to the platform: https: //www.mhh-ethikkommission.de/app/
Please also refer to the guidelines for applicants.
For all studies submitted according to the old procedure, the old legal situation will continue to apply. Amendments for these studies will be advised locally if local advice is required under the respective state and statutory law. It must be ensured that applicants receive a vote if this is legally required for them.
0 Cover letter
►Brief description of the project in a few sentences and any important additional information about the project. This helps the office to quickly classify your project and can significantly shorten the processing time.
1 Application form for professional advice in accordance with Section 15
►(Describable 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 - projectplan for a project with data from an existing database / registry (short application)
Variant C: Project with data from existing database / registry (short application)
5 Study protocol checklist - Project plan for retrospective analysis of data from routine clinical practice (short application)
Variant D: Retrospective evaluation of data from clinical routine (short application)
Following the introduction of the Health Data Utilization Act §6 (GDNG) in July 2025, MHH additionally requires a statement from the data protection officer for research on own data (retrospective data analysis) without prior patient consent for data use for scientific purposes. Please upload this to your application in Ethikpool. Furthermore, you need a role and authorization concept after consultation with Data Protection.
6 Study synopsis
7 Declaration of suitability of the study center by the Department/Institute management
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 consent of the department head 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-center studies, this confirmation must be obtained separately for all participating trial centers. The term trial center stands for the location or Department where the study is being conducted.
►(Describable PDF)
8 Information on the financing of the project and declaration of assumption of costs
9 Checklist: Notification of participation in a multicenter project that has already been discussed and voted on by an Ethics Committee
►(Writable PDF)
10 Amendment to an ongoing research project
►(Writable PDF)
- Download
- Attention: From 02.01.2025, this form must also be completed and uploaded to ethikPool for amendments!
11 Guidelines for applicants
12 Checklist for the documents 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 centers
►(Writable PDF)
Dear applicants,
- Please always enclose a cover letter including letterhead and date with your application in which you briefly summarize your research project and highlight the most important points, if applicable. This can facilitate the processing of the application and thus shorten the processing time,
- Please always include page numbers and version dates on all forms (especially on synopses/protocols and patient documents).
- When uploading, please ensure that the documents are legible, correctly arranged and aligned (upright, not overhead).
General notes on the eTIC form:
- Please always insert a letterhead and do not forget to remove the explanatory text from the template before saving.
- With regard to patient information/consent, please also see the information provided by our Data Protection department (Intranet: Information on informed consent)
We are aware that some forms may appear to be "unnecessary" at first glance. Please pay attention to the additional requirements of the office regarding e.g. list of trial centers, declaration of assumption of costs and declaration of suitability of the trial center. These forms are a formality and should be uploaded in any case.
You make our work easier if you refrain from asking questions about their necessity. All these forms are constantly evaluated and updated. As always, you will be the first to find out about new features or changes on our website. Thank you very much.
1. retrospective data evaluations:
Patient consent: For retrospective data analyses, you must state the legal basis for data access.
For retrospective studies without informed consent for data use, a Data Protection Statement in accordance with Section 6 GDNG has been required since July 2025. Please upload this to your application in ethikPool. Furthermore, you need a role and authorization concept after consultation with Data Protection.
It is NOT permitted to justify your application with:
- The treatment contract and the MHH data protection information provided for this purpose
- Anonymous data, if personal data must first be viewed in order to collect the data, which is then only deleted in the second step.
- The General Terms and Conditions of Contract.
2 Amendments and processing of notices
In the case of amended documents as part of amendments or processing of comments from votes, the tracked change versions of the documents should always be submitted.
3. study registration for more transparency in research
In accordance with the Declaration of Helsinki, the Ethics Committee recommends the prospective registration of all research projects involving test subjects in a publicly accessible register that meets the requirements of the World Health Organization (WHO) before the first patients are included in the study.
Registration can take place, for example, in the German primary register of the WHO "German Register of Clinical Studies" (DRKS) https://www.drks.de/drks_web/.
The DRKS in Freiburg offers the opportunity to search for information on ongoing and completed clinical trials in Germany and to make your own trials accessible to other researchers by registering them.
Notes for supervisors of student research projects, bachelor's, master's and doctoral theses
For the above-mentioned student theses that are written as part of research projects, the application must be submitted by the responsible medical supervisor of the thesis, naming the candidate in ethikPool. In addition to the title of the thesis, the application should also include the supervisor's address and the name and address of the student involved, who can also co-sign the application. The doctoral candidate can also submit the application in ethikPool on behalf of the supervisor. The supervisor will be sent a link by e-mail, via which he/she must declare his/her consent.
A statement from the Ethics Committee will be requested upon submission of the work (e.g. dissertation). Please note that, for legal reasons, no subsequent vote can be issued.
Please refer to the information on the homepage of the Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V.: here
The application procedure for clinical trials has followed the legal requirements of the MDR and the MPDG since 26.05.2021
The Medical Device Regulation (MDR, Regulation (EU) 2017/745)) came into force on 26.05.2021. National implementation is regulated by the Medical Device Law Implementation Act (MPDG), among other things. The latter replaced the Medical Devices Act (MPG) in Germany on 26.05.21 and is binding for manufacturers, operators and other stakeholders. The MPDG only became binding for in-vitro diagnostics (IVD) from 26.05.2022.
The application procedure for clinical trials has followed the legal requirements of the MDR and the MPDG since May 26, 2021.
The legal basis for the new application procedures for clinical trials is the MDR, in particular Chapter VI "Clinical evaluation and clinical trials" and Annex XV, Chapter II in conjunction with the MPDG (Medical Devices Implementation Act), in particular Chapter 4.
Applications are still submitted via the Medical Devices Information System (MPI), Medical Devices Portal DMIDS
Please submit the documents via the DMIDS medical devices portal.
The documents to be submitted for clinical trials in accordance with Art. 62 and 74 as well as 82 MDR can be found in Annex XV Chapter II of the MDR and for clinical trials in accordance with Art. 82 MDR additionally in the MPDG.
Important: The legal requirements set higher requirements for studies that do not serve to demonstrate the benefit, safety and performance of the products, but rather new scientific findings (so-called "other clinical trials"). These requirements essentially correspond to those of clinical trials. Furthermore, proof of sponsorship is regularly required. For "other clinical trials", proof of investigator qualification and suitability of the center must be provided.
MHH-internal applicants should seek advice from the KKS as Coordination Center for Clinical Trials in the Center for Clinical Trials (ZKS) at Hannover Medical School before submitting an application to clarify the type of study and the sponsorship requirement.
Further information on the Internet:
- Compilation on medical device law on the DIMDI website
https://www.bfarm.de/DE/Medizinprodukte/Ueberblick/Gesetze-und-Verordnungen/_node.html - Information on "Clinical trials and performance evaluation trials", provided by the DIMDI
https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DMIDS/Klinische-Pruefungen/_node.html - Information from the Working Group of Medical Ethics Committees in the Federal Republic of Germany:
akek.de
Most common errors when submitting studies according to professional law § 15 MBO: (also applies to the eTIC template):
Incorrect | Correct |
You will not incur any additional costs (in connection with participation in the study). | You will not incur any costs. |
The Ethics Committee has given the project a positive vote. | The Ethics Committee has advised on the project. |
The data protection officer is responsible for data processing. | It is the Clinical Department/Institute/Division Management that must be entered here. |
| XX patients are to be included in our study. | At Hannover Medical School, XX patients are to participate in the study. |