Presenting Author: Dr. Joana Namorado MD, Scientific Officer at European Commission
There are two visions of Ethics Review:
· A Burden, burocratic distraction
· Risk anticipation and mitigation
Ex-ante process used in the EU was pioneered by Health. Has been followed by ERC, Marie Curie, will be taken up more and more by other agencies and services.
Many Member States are taking it up, and increasingly, in the US, particularly since law-suits have reaches the proportions they have. An Ex-ante ER Identifies the issues, the risks, Offers processes/solutions to mitigate them, Protects the researcher, the project and the funding bodies, Minimizes adverse impact, to the patient, for a very small investment.
Internal review processes have NO VALUE in court. Risk for researchers of being blocked by third parties – even at publication stage (cf. avian flu case). Results of the EU Experience – out of thousands of Projects (basic research to the Product, huge Cooperative Projects+ Translational+Funding Vaccination Clinical Trials).Only one critical case, resolved out of court; thanks to the Ethical Review process, both the Researchers and the Commission could offer satisfactory answers and safeguards to the EP.
However, there are ways to make this effort work for you. If a product results from research, with an ethics review that was conducted vigorously, All products can have traceable regulatory "ID Card".
Dr Joana Namorado MD
Dr. Joana Namorado MD is Scientific Officer at European Commission, DG Research & Innovation, F1 - Ethics
· First in the Cancer sector, and since 2006, in charge of Ethics Review and management of Health Projects.
· Previously: Official of the Council of Ministers of the EU drafting legislation as Desk Officer. And namely, Blood, Tissues Directives
· Doctor in Medicine, MD, (Cytopath.) , Master Phil (Ethics)
· Consultant in Cytopathology, Lecturer in Histopathology, in charge of Cytopathology and Aids unit– Lisbon – Portugal
· Research Fellowship in Cytolopathology –( Ludwig Inst, UK and Charing Cross), research into gynaecological and urinary cytology, HPV and diagnosis of tumours and of P. Carinii in Aids patients– London
· Consultant in clinical cytopathology– India
· Assistant-Professor at the Institute of Histology and Embryology of the Faculty of Medicine Lisbon – Portugal;
· Research Fellowship and MSc (Clinical Cytopathology and Oncology) - USSR Academy of Sciences –
Medical Associations (Pt, Be, UK, India) European Biochemistry Society, Société Française de Colposcopie, Sociedade Portuguesa de Bioquímica, Society for Stem Cell Research (Pt).