Ethics committee and informed consent

Any study involving human participants, their data or materials must comply with the Declaration of Helsinki and be approved by a research ethics committee, indicating the name of the committee and, if applicable, the reference number in the manuscript. In the event of an exemption, this must be duly justified and documented. 

Authors must ensure that any new procedures, techniques, or instruments used have been ethically approved and have informed consent before application. The Editor may request documentary evidence or contact the ethics committee directly if necessary.

https://jamanetwork.com/journals/jama/fullarticle/2825290