Ethical and legal considerations in non interventional health clinical trials in the French context

Abstract

While the development of regulations in the conduct of research in humans, has better allowed risks and associated contraints to be framed, it has also raised further questions. French regulations currently consider that research based on questionnaires or interviews has no impact on the care of patients or on the individual, a view that is too limited and is not shared by the ethics committees charged with the protection of those involved in studies. Any research relating to a person requires his or her active involvement. The intention of the researcher can be perceived by the participant and can therefore affect their responses. Hence, it is important to question the safety of procedures and consider the psychological risks of non-interventional research. Any evaluation process can create a potentially risky situation, not because of the intrinsic qualities of the tools used, but because of the conditions under which they are applied. As members of an ethics committee, our experience has enabled us to observe shortcomings and lack of acknowledgement by study sponsors of issues at stake in the research. This article revisits the foundational texts of the French Jardé law, with which sponsors and investigators in France are required to comply, considers the psychological implications for studies involving questionnaires and/or interviews and ethical questions or dilemmas. Finally, areas for consideration that could improve the framework for non-interventional research are proposed.

Keywords

• Clinical research
• Non-interventional research
• Subjective data
• Risk-benefit ratio
• Ethics committee
• Questionnaire data