NON-INTERVENTIONAL RESEARCH ETHICAL REQUIREMENTS IN ENGLAND AND FRANCE- SHARED EXPERIENCE FROM A BINATIONAL RESEARCH PROJECT

Author(s)

Guillemot J, Boval M, Gauthier A
Amaris, London, UK

Background: Ethical review for non-interventional research is progressively becoming part of research standards. This evolution ensures that participants in research are respectfully considered. In practice, information on ethical requirements for non-interventional research seems insufficient. Increasing and legitimate expectations from peer-reviewed journals regarding reviews by ethics committees sometimes challenge researchers. In this presentation, we share our experience of investigating ethical requirements for conducting a questionnaire-based research on physicians in France and England. Methods: This investigation consisted of a documentary analysis, including official guidance documents on ethical requirements, communications with institutions and publications reviews.  Documents were identified using an ad hoc search on official websites. Publications were identified on PubMed. Findings: In England, the service of the National Research Ethics Service (NRES) serves as the ethics reviewer. It offers an informal preliminary review of the study protocol and estimates ethical risks associated with non-interventional research projects. Depending of the target population, the methods and the risk level associated with the research project, the NRES states whether a formal ethics application is necessary or not. In case of low risk projects the NRES supplies an email which can be used as a justification for peer-reviewed journals. In France, structures to support ethical reviews for non-interventional research are the result of an on-going reform. Comités de Protection de la Personne, or CPPs, fulfil the role of ethics reviewers although they were initially designed to collaborate for hospital-based research. Gaining ethical review in France was more complex due to the infrequent character of such request from the industry. Conclusion: This experience showed the increasing role of ethical requirements in non-interventional research. It is a domain in constant movement which calls for innovative approaches to compile and disseminate information regarding ethical requirements for non-interventional research across Europe and the world, especially regarding cross-national research projects.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PRM254

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Multiple Diseases

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