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.
ABSTRACT
The COVID-19 epidemic has led to the intense mobilization of all health professionals, including those involved in research. From the very beginning, research ethics committees (RECs) have been called upon and mobilized to carry out the scientific and ethical evaluations of research projects to achieve a sound analysis of their risk/benefit balance. The aim of this article is to present an ethical reflection on the challenges and consequences of the fast-track procedure for the evaluation of COVID-19 research projects in the context of a public health emergency. Indeed, a large number of protocols of reduced rigor were hastily prepared without collaboration between researchers and in the absence of national regulation. As a result, a number of ethical dilemmas have emerged concerning the opposing needs of pragmatism imposed by the emergency context and the ethical principles that should govern the conduct of research. Moreover, the dispersion of these individual projects, aggravated by excessive media coverage of specific treatments, has resulted in a weakened impact of the research in the epidemic context. This article provides suggestions for the ethical management of ongoing and upcoming research, giving RECs the opportunity to adapt their evaluations to avoid allowing the pragmatism of the emergency context to subvert the inviolability of the epistemological and ethical principles of research on humans. This reflection may strengthen the ethical basis for the formulation of their decisions.
