Ethical considerations
IVD studies are conducted in accordance with ethical principles. These are for example Good Clinical Practice (GCP), ISO 20916 or according to the Declaration of Helsinki.
During the study preparation phase a Risk Assessment is necessary to assess the risk-benefit-relation of the study. This is done according to applicable regulations such as ISO 14971 .
Depending on the objectives and the study category, an ethics commission assessment might be mandatory prior to study start. Potential subjects must receive sufficient information to be able to make a decision about their participation in the respective study (Informed consent process). The study team must protect rights, safety, dignity, and well-being of subjects and is obligated to generate data that are scientifically valid, reliable, and robust. This might also include establishment of a study-specific subject insurance. In addition, written procedures and mechanisms to avoid improper influence must be implemented in the study.
