General Rules

General Rules

  1. All applications have to be provided in paper form and in electronical form (CD or email). The number of paper copies depends on the nature of the project (1 or 10, please ask for advice). All applications have to be sent to the Ethics Committee Office.
  2. Please consider the appropriate deadline for application. Applications that are complete with one paper copy are not subject to the deadline.
  3. All forms that require a signature (see below) must be submitted with at least one original signature form. If mandatory original signatures are missing, the application will not be considered as complete and will not be handled until an original signed copy has been submitted.
  4. Mandatory signatures are from the project leader, the deputy, and the head of the department, institute or clinic. Students and individuals not employed at Hannover Medical School do not qualify for an application.

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.

Studies not regulated by German Drug or Medical Device Law

Please provide the following documents with your application:

  1. Application Form (dated 03/18) DOWNLOAD
  2. Study Synopsis (dated 05/19) DOWNLOAD
  3. Study Protocol
  4. Informed Consent Form   INFO DOWNLOAD    EXAMPLE DOWNLOAD
  5. 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)
  6. 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)