A legal framework is the indispensable foundation for our daily work. The most important aspects are briefly described below. 

Clinical Trials with medicinal products

• Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (CTR)
• Verordnung über das Verfahren zur Zusammenarbeit der Bundesoberbehörden und der registrierten Ethik-Kommissionen bei der Bewertung von Anträgen auf Genehmigung von klinischen Prüfungen mit Humanarzneimitteln (KPBV)
• Medicinal Products Act (AMG)

Clinical trials with medical devices

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR)
• Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte

Studies according to Sec. 15 of the Professional Code of the State Medical Association of Baden-Wuerttemberg

• Professional Code of the State Medical Association of Baden-Wuerttemberg (German)
• Gesetz über das Berufsrecht und die Kammern der Heilberufe (Heilberufe-Kammergesetz - HBKG)

Radiation Protection Act / Radiation Protection Ordinance

• Gesetz zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (StrlSchG)
• Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung

Data Protection

• Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (GDPR)
• Federal Data Protection Act (BDSG)
• Landesdatenschutzgesetz (LDSG)

Additional Directives and Guidelines

• WMA Declaration of Helsinki - Ethical Principles for medical Research involving human Subjects
• WMA Declaration of Taipey on Ethical Considerations regarding Health Databases and Biobanks
• ICH guideline for good clinical practice E6(R2)

Disclaimer

With their judgment dated 12 May 1998, the Regional Court of Hamburg ruled that anyone setting a link is co-responsible for the content of the linked website where appropriate. According to the Regional Court of Hamburg, this may only be prevented by explicitly distancing oneself from the content of such links. 

The Ethics Committee of the Medical Faculty of Heidelberg therefore expressly emphasizes that they are not assuming any liability for the accuracy or completeness of the links cited above. The Ethics Committee is also not responsible for the content of other Internet websites to which reference is made by these links. Insofar as regulations and laws are reproduced, only the official publication of such regulations and laws is binding.