Ethics

According to the Code of Ethics of the University of Bremen, decisions of a competent body of the University on the implementation or promotion of a research project according to Section 1 Paragraph 2 No. 1 of the Code of Ethics shall take place only when the Ethics Committee has passed a resolution in favor.

The decision of the Ethics Committee does not relieve the person responsible for the research project of the responsibility for carrying out pertinent investigations.

Applications to be reviewed by the Ethics Committee must be submitted to Ms. Schmidt6 weeks prior to a meeting. Applications submitted after this date cannot be dealt with until the following meeting.

Please note that data protection issues must be clarified before submitting the ethics proposal. The most important data protection issues must be clear from the ethics proposal and understandable in themselves (i.e. no references to a data protection concept or similar). In addition, please also submit all documents that are made available to study participants (or comparable groups of persons) (e.g., declarations of consent, information letters, questionnaires, etc.).

Applications must be submitted in the form of the evaluation criteria.

If your project is part of a larger collaborative project, please also submit a brief description (1 - 2 pages) of the collaborative project.

Please pay attention to wording, grammar, and spelling.

Submit your application as a not write-protected Word document. Subsequent additions or changes must always be identified in editing mode.

Please note that in the case of research projects carried out as part of examination work (e.g. bachelor's, diploma or master's theses) the vote from the Ethics Committee can only be requested by the respective supervisor.

• Ethikverfahrensordnung 

• Richtlinie - Hinweise zur Ethikverfahrensordnung 

The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) are striving to harmonize the work of ethics committees in the Federal Republic of Germany. To this end, the BMBF sponsored a project, the results of which were published in the report “Recommendations for the review of clinical trials by ethics committees” [Raspe 2005]. The Ministry also urges to transfer the recommendations to non-clinical studies, in particular epidemiological studies.

The Ethics Committee of the University of Bremen supports the initiative and has therefore adopted the recommendations for non-clinical studies and research on humans. In order to explain the work of the Ethics Committee to potential applicants of the University of Bremen and to present the evaluation criteria in a transparent manner, the test points are summarized in the following table and briefly explained.

In order for the Ethics Committee of the University of Bremen to carry out evaluation of a study, the application must contain information on the points mentioned below. Applicants are also asked to submit a short and concise presentation of approx. 5-10 pages. Wherever possible, please adhere to the sequence of the points listed below. If any point is not applicable to the application, this should be briefly noted.

Applications must be submitted no later than 6 weeks before the date of a meeting to Ms. Schmidt!

If the application refers to a project whose results are based on a statistical analysis of data, the following criteria should be considered:

1. Is it a) an explorative or heuristic evaluation or should b) statistically significant evidence be  provided.
2. If b): Please specify the required number of cases specifying the probability of error 1. Fehler 1 Art, der Power und des nachzuweisenden Effekts
3. Describe the statistical method with which you want to carry out the evaluation. Please note that the method you want to use for evaluation must match the one you used for the case number estimation.

• Evaluation criteria 
• Statistical analysis 

It is a manadory requirement that the committee has a quorum.

This may not be the case in rare cases due to absenteeism of the members.

The meetings are not public (Section3 sentence 1 of the Code of Ethics).

Applications must be submitted to Ms. Schmidt at least 6 weeks before a meeting of the committee.

Dates for 2020

• Declaration of Helsinki
• General Data Protection Declaration
• Bremisches Ausführungsgesetz zur EU-Datenschutz-Grundverordnung

The exampels are only in german availabale:

• Datenschutzkonzept 
• Informationsschreiben 
• Einwilligungserklärung