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Ethics, research, translations (ETRES)

The emerging team directed by Marie-France Mamzer (Ethics, Research, Translations: ETREs).

The current landscapes of medical and research practices tend to overlap through complex translational processes that favor innovation implementation into clinical practices. Translational research in medicine is an evolving field that combines disciplines and expertise with the aim of promoting the transfer of knowledge and discoveries from basic science to healthcare. The efficiency of the approach lies on the effectiveness of a bidirectional process that begins with the identification of clinical needs and ends with the development of new tools to be brought back into the healthcare pathway. These emerging practices erase the traditional and artificial boundaries among basic, clinical research, and other applied research to let place to a continuum that gives rise to a multidirectional spectrum of more or less direct interactions. Numerous new ethical issues are arising from these new practices that overwhelm the old ethical codes for protection of human subject, encompass the field of scientific integrity and transparency, and may interfere with national legal and regulatory existing frameworks.
The team is attached to the doctoral school ED 262 and provides master and doctoral level education in ethics applied to the field of health.
The team project focuses on the translational practices and processes in the field of health and proposes a “translational ethics” research program, through two traditionally distinguishable approaches: biomedical research, and medical care :

1/Translational ethics research program dedicated to translational research practices:

Dynamic consent and health democracy

Using a pragmatic research approach, embedding patients the whole process long, we are contributing to develop an integrated research program within the SIRIC CARPEM, addressing, in the field of translational research for cancer, the issues of patients’ information and consent, research results return, data and samples sharing, data linkage and health democracy. In this program we aim to build an “ethics by design” e-dynamic consent platform and test both the feasibility and the acceptance of such a platform in real life.

Observatory of translational research practices

Our team is also building an observatory of translational research practices within the CRC ‘s team practices to identify, analyze and deliberate about the ethical issues rising from the research, and to develop strategies to respond to these ethical issues and to propose procedure, if applicable (for instance, recommendations before IRB review process). To reach this goal, the team proposes support actions dedicated to the promotion of ethical, legal and good research practices for CRC teams, thus creating a Research ethics consultation service according to the model developed in US Clinical Translational Science Award (CTSA) institutions: to provide legal and regulatory information to researchers.

2/ Translational ethics research program dedicated to medical care practices in “extremes situations” such as end of life context and medical care of victims of attacks.

End of life contexts: Translational research and precision medicine are aiming to provide new therapeutic pathways in an attempt to better respond to the current medical challenges. In this context, all patients and citizen might be concerned to contribute to the production of new scientific knowledge by giving their informed consent to either the use of their data and samples for the purpose of non-interventional research or to participate to a therapeutic trial. The objectives of this research program is to favor the emergence of a palliative medicine research program per se, dedicated to both identify the end-of-life patients’ specific need and acceptable ways to allow their participation to research programs, while guaranteeing them access to palliative care. The feasibility of this program will be ensure by the existing collaboration with medical units and our group.
Medical care of victims of attacks: The recent occurrence of terrorist attacks on the French
territory has shown that, from a medical point of view, these events were different from
catastrophes or some catastrophic accidents with limited impact which are usually in the care of emergencies units. Scientific studies are needed to identify their specificities from a medical and a societal point of view. These specificities might be linked to the specific context of terrorist attacks and to the terrorists’ strategies, to the weapons used and the characteristics of the induced injuries leading to the need to translate the military medicine experience in civil context. Translational studies are crucial to adapt Hospital Emergency Plans and specific Care Pathways. This program will be developed in collaboration with the SAMU de PARIS.

 

Team Leader:  Marie-France Mamzer (PUPH; Univ Paris Descartes)

 

Team Members:
Researchers: Pierre CARLI (PU-PH; Univ Paris Descartes), Caroline DESPRES (Cherch Ass; CDD), Jean-Claude DUPONT (Cherch Ass; AP-HP), Bernard ENNUYER (Cherch Ass em; Univ Paris Descartes), Irène FRANCOIS-PURSSELL (PU-PH; Univ Dijon), Olivier LESIEUR (PH; CHR La Rochelle), Marie-Caroline MEYOHAS (PU-PH; Sorbonne Université), Sophie MOULIAS (PH; AP-HP), Charlotte NGO (MCU-PH; Univ Paris Descartes), Richard POTTIER (PU-PH em; Univ Paris Descartes), Eva SEGURA (ATER; CDD), Marcel-Louis VIALLARD (PH; AP-HP).

Young Researchers: Cédric GESBERT (PhD Student), Elise JACQUIER (PhD Student), Marie-Caroline LAI (PhD Student), Safia TAIEB (PhD Student).

 

Publications:

  • Mamzer MF, Dubois S, Saout C; participants of Round Table «Topical Subject» of Giens XXXIII, Albin N, Béhier JM, Buisson A, Diebolt V, Delaitre O, Duguet C, Fagon JY, Gaillard S, Le Jeunne C, Mazars R, Micallef J, Nabarette H, Piazza L, Raynaud C, VaroqueauxN. How to strengthen the presence of patients in health technology assessments conducted by the health authorities. Therapie. 2018 Feb;73(1):95-105
  • Mamzer MF, Duchange N, Sylviane D, Marvanne P, Rambaud C, Marsico G, Cerisey C, Scotté F, Burgun A, Badoual C, Laurent-Puig P, Hervé C. Partnering with patients in translational oncology research: ethical approach. J Transl Med. 2017 Apr 8;15(1):74.
  • Stoeklé HC, Mamzer MF, Vogt G, Hervé C. 23andme : a new two-sided data-banking market model. BMC Medical Ethics 2016 ; 17 :19
  • Carli P(1), Pons F(2), Levraut J(3), Millet B(4), Tourtier JP(5), Ludes B(6),Lafont A(7), Riou B(8).The French emergency medical services after the Paris and Nice terrorist attacks: what have we learnt? Lancet. 2017 Dec 16;390(10113):2735-2738
  • Lesieur O, Leloup M, Gonzalez F, Mamzer MF; EPILAT Study Group. Eligibility for organ donation following end-of-life decisions: a study performed in 43 French intensive care units. Intensive Care Med. 2014 Sep;40(9):1323-31

 

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