1. UNESCO Rregional Conference INTERNATIONALIZATION OF RESEARCH INSTITUTES AND BIOETHICS FOCUSING ON EU FP7 THEBERA PROJECT AS A ROLE MODEL By: Sanaa Botros Professor of Pharmacology Theodor Bilharz Research Institute, THEBERA Coordinator Chair of TBRI Research Ethics Committee “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

2. INTERNATIONALIZATION OF RESEARCH  Provides new opportunity for business to draw on local strengths and specialization.  It is the global trade in knowledge.  Strengthening economies through R&D can provide economic benefits similar to other farms of trade  R&D are now shifting from supply –side models towards demand driven approaches entailing collaboration between researchers in different public, private institutes and industry. UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

3. INTERNATIONALIZATION OF MEDICAL RESEARCH AND HEALTH CARE  Strong public science base and well educated human talent  Good connection between science base and industry  Intellectual property rights that appropriately balance protection and mobility of knowledge  Strengthening of bioethics to govern ethical conduct of research UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

4. FP7 ERAWIDE PROJECT THEBERA THEODOR BILHARZ INTO THE EUROPEAN RESEARCH AREA FP7 INCO.2010-6-2 ERAWIDE Project number 266581 FP7 ERAWIDE PROJECT THEBERA THEODOR BILHARZ INTO THE EUROPEAN RESEARCH AREA FP7 INCO.2010-6-2 ERAWIDE Project number 266581  A response to the EU-ERAWIDE call aiming to reinforce the cooperative capacities of research centers located in the ENP to allow for coherent international health research schemes across the Mediterranean by the integration of approaches and resources. UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

5. Strengthening the capacity of TBRI excellence for participation in European health research initiatives by expanding cooperation and integration with the ERA while realizing it as an international excellence centre for liver disease research & management including liver surgery excellence THEBERA Project Objective UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

6. THEBERA Partner Organizations  Theodor Bilharz Research Institute (TBRI): A medical governmental research institute focusing on control and management of endemic diseases prevalent in the region  PISA University (UINIPI): A regional referral center for major hepatobiliary and liver transplant surgery, acute liver failure and liver trauma, the liver transplant program of Pisa is the second largest in Italy.  Academy of Scientific Research and Technology (ASRT): A non profit organization providing public service by ensuring independent assessment of sciences and presenting it both within Egypt and internationally  Europe for Business Ltd (EFB): A high growth knowledge Co., focusing on innovative management, providing support to PP organizations in product innovation, TT,IT solutions and R&D projects UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

7. THEBERA SCIENTIFIC ACTIVITIES WP6 (lead ASRT): DISSEMINATION AND NETWORK FACILITATION M1 M2 M6 M7 M8 M10 M11 M12 M14 M18 M24 M1 WP 1 (lead TBRI) : PROJECT MANAGEMENT M24 WP2(TBRI): Analyze the current sate of the art regarding liver disease WP4 (UNIPI) : Capacity building for liver disease BP based on WP2 & SWOT similar EU experience WP3 (ASRT): Build capacity for international cooperation  Enhanced participation in international activites  Ethical conduct of research  IPR WP5 (UNIPI): THEBERA center strategy to internationalize TBRI & to establish it as an excellence center for liver disease research & management EXTERNAL EXPERTS UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

8. Building capacity for international cooperation Effectively plan, organize and implement training sessions : a)Intensively train the TBRI Staff concerning EU Framework Programs to familiarize them with the procedures and opportunities for co-operation in the FP7 and related programs b) Support the TBRI staff in organizing future project consortia to address relevant research challenges for future calls on liver disease, UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011 c)Transfer knowledge to TBRI to help them learn how to manage IP, reinforce and ensure ethics applications regarding medical practice

9. Training Workshop Topics FP7: General presentations, funding opportunities, how to prepare proposals, contracting rules, project management including financial Ethics : Research ethics committees, research misconduct, informed consent, ethics of stem cells, liver transplantation and biological samples IPR : IPR related agreements, patent drafting, licensing, TT and contractual issues  Three workshops /2 years, each for three days  Participants number is 25-30  Egyptian and international experts UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

10. Theodor Bilharz Research Institute IRB Operational guidelines:  The establishment of operational policies addressing ethical issues for sound implementation of research activities to ensure an institutional culture of research excellence  TBRI, IRB is multidisciplinary and multi-sectorial in composition involving medical and non medical, scientific and non scientific members with balanced gender  A template for applying to Ethics BC including name, address, proof of acceptability of research design, recruitment procedure, clinical & laboratory tests to be carried out, the number of subjects, risks & benefits to participants, example of informed consent and Helsinki declaration  A checklist for protocol evaluation in view of international agencies SOP’s to unify criteria for evaluation  Meetings are scheduled to be monthly with prepared agenda and minutes registered UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011

11. Concluding Remarks UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011  Globally there are wide disparities in economic development, in burden of disease, and in health outcomes  it is likely that the increasingly internationalized medical research and health care without the requisite safeguards and protection of human rights, will worsen health inequalities  Encourage educational opportunities for academics, researchers and health professionals in ethics related to performing research involving human subjects to increase the number of scientists, health professionals and relevant academics with in-depth knowledge of the ethical considerations, concepts and applications in clinical and public health research.  An oversight body for all ethical committees in Egypt with unified operational guidelines and a national ethical code that considers Helsinki declaration with ethical principles conforming with cultural and religious perspectives