Hi ,
We are in the process of rolling out a healthcare professional ( HCP) online survey asking about diagnostics treatment decisions. There will be no patient identifiable data or access to patient data. What regulatory process do we need to submit to? Is ethics approval required?
Many thanks for your assistance.
Best wishes,
Noma
Hello,
We understand from your message that your study does not process personal data of patients or any kind of personal data concerning health. The French public health code (art R.1121-1) specifies that studies aiming at assessing the ways in which healthcare professionals practice are not qualified as studies involving the human person. The article also states that this type of study does not fall under the field of expertise of the ethics committee for studies not involving the human person. Therefore, in your case, it seems that there is no legal obligation to seek for the approval of an ethic committee. However, processing personal data of healthcare professionals falls under the scope of the Genera Data Protection Regulation (GDPR) and the French data protection law (Loi informatique et libertés) that should be respected. In particular, healthcare professionel should be informed of the study (in compliance with art. 13 of the GDPR) and have the possibilty to exercise their rights on their personal data.
Best wishes,
The Health data Hub team