Application
Including instructions and forms
(as of August 2023)
MHH-internal submissions of applications in accordance with professional law §15 MBO (non-MPDG and non-AMG studies) could previously be submitted with a paper copy (original) + electronically on CD, USB stick or by email (Ethik Commission@mh- hannover.de). We are currently converting the application process to the digital platform ethikPool. Please note that the application form must have all signatures. The regulation of purely electronic submission also applies to the MHH-internal submission of amendments to studies according to 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 communication between you and the Ethics Committee.
Quick guide for applicants
Before submitting an application, you must create a user account, which will be activated by the Ethics Committee office. A 2-factor authentication using an authenticator app is required.
Access to the platform: www.mhh-ethikkommission.de/app/
Please enter your name and full title in your user account, as well as your clinic/institute and your OE number. An account has already been created for some users by the office. If this applies to you (you can tell from the note in the registration form that your email already exists), please contact us and we will send you the access data from ethikPool by email.
What about subsequent changes (amendments) to ongoing studies according to professional regulations (studies from January 2018) that were not originally submitted via ethikPool?
1. If you haven't already done so, create a user account at www.mhh-ethikkommission.de/app/.
2. Inform the Ethics Committee office by email (info@mhh-ethikkommission.de) that you would like to submit an amendment to an old study (mentioning the file number) and ask that the study be transferred to ethikPool.
3. As soon as the study has been transferred, you will receive a notification via ethikPool.
4. Submit your amendment to the study via ethikPool.
IMPORTANT: Studies for which only the end of the study should be displayed no longer need to be transferred to ethikPool. In these cases, we will receive notification of the end of the course by email.
The deadline for submission is always 14 days before the meeting.
The submission must be made by 12:00 p.m. on the specified day in order to enable discussion at the next meeting.
The Ethics Committee can only discuss complete applications. Please check that the documents are complete before submitting them. Incomplete applications will be returned to the applicant.
Information for supervisors of study, 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 for the thesis, naming the candidate. In addition to the title of the work, the application should also contain the address of the supervisor as well as the name and address of the student or doctoral candidate involved, who can also sign the application. A statement from the ethics committee is requested when the work (e.g. dissertation) is submitted. Please note that for legal reasons no subsequent vote can be given.
Study registration for more transparency in research
Before including the first patients in the study, the Ethics Committee recommends, in accordance with the Declaration of Helsinki, the prospective registration of all research projects involving test subjects in a publicly accessible registry that meets the requirements required by the World Health Organization (WHO).
Registration can take place, for example, in the German primary register of the WHO "German Register of Clinical Studies" (DRKS) www.drks.de/drks_web/.
The DRKS in Freiburg offers the opportunity to search for information on ongoing and completed clinical studies in Germany as well as to make your own studies available to other researchers through registration.
Studies not regulated by German Drug or Medical Device Law
Please provide the following documents with your application:
- Application Form (dated 03/18) DOWNLOAD
- Study Synopsis (dated 05/19) DOWNLOAD
- Study Protocol
- Informed Consent Form INFO DOWNLOAD EXAMPLE DOWNLOAD
- In case of application for a biobanking project, please use the following prototype: Mustertext zur Spende, Einlagerung und Nutzung von Biomaterialien sowie zur Erhebung, Verarbeitung und Nutzung von Daten in Biobanken. Beispielvorlage Einwilligungserklärung (DOWNLOAD)
- Letters from other Ethic Committees concerning the same project.
For any uncertainties regarding data protection issues, please ask for advice from the Data Security Officer of Hannover Medical School. Any written information or approval should be included in the ethics submission.
All study related documents should be page numbered and marked with a version number (including short name of document, version number and date of version number). In the case of changes in the documents, the version number should be adapted accordingly.
(last update: 05/19)
Attention
EU-US Privacy Shield does not provide an appropriate legal framework (28.07.2020)
Following the ruling of the European Court of Justice of 16 July 2020 [case number C3-11/18], the regulations of the EU-US Privacy Shield no longer provide a suitable legal framework, particularly against the background of the Clarifying Lawful Overseas Use of Data Act (CLOUD Act) and the Foreign Surveillance Act (FISA). Those responsible should check in each individual case to what extent personal data or data that has the potential for identifying individuals (i.e. also pseudonymised data records as defined in Art. 4 paragraph 5 DSGVO) can be transmitted in a legally secure manner, either on the basis of suitable guarantees (e.g. binding company rules, standard contractual clauses or on the basis of express consent following risk disclosure in accordance with Art. 49 paragraph 1 letter a) DSGVO). With regard to standard contractual clauses in particular, the effects of the ruling and the regulatory guidelines likely to follow remain to be closely monitored by the competent authorities. Sponsors are therefore strongly advised to consult with the competent state commissioner for data protection.