When conducting medical research projects that coincide with the processing of personal data, the pertinent data protection law must be complied with. Basically, the Ethics Committee will only conduct a cursory check of the legal data protection aspects. Through the involvement of the Ethics Committee applicants are not released from their own legal responsibility in the various areas. Special procedural obligations exist, particularly in data protection law, which are not dealt with by the activities of the Ethics Committee (e.g., involvement of the data protection officer [Art. 39 GDPR], entry into the record of processing activities [Art. 30 GDPR], and where appropriate, data protection impact assessment [Art. 35 GDPR] as well as under special circumstances, the “prior consultation” with the data protection supervisory authority [Art. 36 GDPR]). 

As an aid to the preparation of study documents (in particular the information sheets for the study participants and the informed consent declaration) we urgently recommend that you use the existing sample texts:

• For studies of medicinal products, medical devices and also biobanks we recommend the sample texts of the Association of Medical Ethics Committees, which are provided on their website for downloads. 
• For Studies according to Sec. 15 of the Professional Code of the State Medical Association the sample texts of the Heidelberg Ethics Committee are recommended, which are available for download on the page Application Documents & Templates in the area of Other Studies.