The Ethics Committee considers ethical and legal issues associated with research projects involving human volunteers (healthy individuals and patients) and/or human data and material. Each employee of Hannover Medical School has to ask for ethical advice when planning such as study, no matter of which profession.
The Ethics Committee of Hannover Medical School is registered with all relevant national and international institutions to allow counselling of research in Germany (German Drug Law, German Medical Device Law, studies using ionizing radiation).
Protection of Clinical Research Study Participant
Participants have to declare their own free will to participate in a study. Rejection of the request to participate must not lead to any disadvantage of the individual, especially not in terms of medical help if a patient is asked.
The consent to take part in a study requires a detailed oral and written information of the individual about all study related procedures and risks, time requirements, data protection precautions, legal rights, insurance information, and the possibility to withdraw consent at any time without any disadvantage. If treatment is part of the study, alternative treatment approaches should be described to the patient.
The individual has to sign the informed consent form. In the case of children and adolescents, both parents must sign the informed consent form and special forms should be prepared in appropriate language for different age groups (see "Application for Ethical Advice").
Protection of Investigators
Because of the manifold national and international regulations that deal with human research, asking for ethical advice is the best way for researchers to avoid legal conflicts. Nonetheless, the ultimate responsibility for all actions taken within a study rests with the investigator therefore, responsible investigators and deputies must be identified to the Ethics Committee in the application form.
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