Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research

In recent years engineers developing new technologies with assistive or medical purposes have become aware that to create acceptable and usable solutions they need to involve final users, patients and stakeholders in the design, development and evaluation of systems as well as in the device certification processes. Involving stakeholders in such processes has several ethical and legal implications. It has become evident that it is still difficult for engineers in Europe to know which ethical and legal processes should be carried out as they have not been previously trained in these issues during their studies. This article is a review of the laws, standards and recommendations applicable in Europe concerning human involvement in new technologies research, with the aim of helping researchers in the region in question to identify the ethical and legal issues that could arise during those tasks. This review has been carried out in response to the identified need on the part of technological researchers. The design of a flowchart is presented as a summary of the interpretation of the documentation reviewed with the aim of helping the researchers to take the ethical and legal decisions that apply to research involving humans. The flowchart presented has been validated with various research projects in which the authors have participated. The proposed conceptual design can be used for taking decisions, but it is suggested that a tool based on this design be built with the aim of making decision taking easier for researchers in this area.