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As in other retrospective studies designed to assess current clinical practice [ 10], the current regulations of ethics committees in Italy require only standard written informed consent at the time of device implantation (obtained from all patients in line with national regulations) and anonymous publication of scientific data.
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Given that ethics training is only superficially covered in the formal medical and nursing curricula, and that the regulation of ethics is also weak in the country, research about how the hidden curriculum may be teaching ethical violations became an important topic for us to pursue.
The first Regulations on Ethics Review of Biomedical Research Involving Human Subjects were issued in 1998.
According to the regulations of the ethics committee of the Leipzig Medical School an explicit ethical approval was deemed not necessary.
The study was performed in accordance with the local regulations of the ethics committee (General Medical Council Hamburg, Ärztekammer Hamburg, reference number WF 11/16).
Mammary gland tissue was obtained from healthy women undergoing reduction mammoplasty at the Nymphenburg Clinic for Plastic and Aesthetic Surgery, in accordance with the regulations of the ethics committee of the Ludwig-Maximilian University, Munich, Germany (proposal 397-12).
All volunteers received a complete explanation of the study protocol and signed the appropriate consent forms in compliance with the regulations of the ethics committee at Centro de Investigación en Alimentación y Desarrollo, AC.
Others see bioethics as a field in need of formal professional accreditation and regulation, codes of ethics, etc. as would be the case for members of the various medical professions [ 28, 29].
While handling the data, the regulations of the Ethic commission of the Ruhr-University Bochum were fully respected (ClinicalTrials.gov Identifier: NCT00713102, Ethical Review Board of the Ruhr-University Bochum, Germany, registration number: 3207-08).
Informed consent was obtained from all participants in accordance with the medical ethical regulations of the local ethics committee.
According to the regulations of the local ethics committee (Department of Psychology, University of Münster), no ethics approval was needed for this study.
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