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UNESCO Rregional Conference
INTERNATIONALIZATION OF RESEARCH INSTITUTES AND BIOETHICS FOCUSING ON
EU FP7 THEBERA PROJECT AS A ROLE MODEL
By: Sanaa Botros By: Sanaa Botros Professor of Pharmacology Professor of Pharmacology
Theodor Bilharz Research Institute ,Theodor Bilharz Research Institute ,THEBERA Coordinator THEBERA Coordinator
Chair of TBRI Research Ethics CommitteeChair of TBRI Research Ethics Committee
“Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011
INTERNATIONALIZATION OF RESEARCHINTERNATIONALIZATION OF RESEARCH
Provides new opportunity for business to draw on local strengths and Provides new opportunity for business to draw on local strengths and specialization.specialization.
It is the global trade in knowledge. It is the global trade in knowledge.
Strengthening economies through R&D can provide economic benefits Strengthening economies through R&D can provide economic benefits similar to other farms of tradesimilar to other farms of trade
R&D are now shifting from supply –side models towards demand driven R&D are now shifting from supply –side models towards demand driven approaches entailing collaboration between researchers in different public, approaches entailing collaboration between researchers in different public, private institutes and industry.private institutes and industry.
UNESCO Rregional Conference
“Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011
INTERNATIONALIZATION OF MEDICAL RESEARCH INTERNATIONALIZATION OF MEDICAL RESEARCH AND HEALTH CAREAND HEALTH CARE
Strong public science base and well educated human talentStrong public science base and well educated human talent
Good connection between science base and industryGood connection between science base and industry
Intellectual property rights that appropriately balance protection and Intellectual property rights that appropriately balance protection and mobility of knowledge mobility of knowledge
Strengthening of bioethics to govern ethical conduct of researchStrengthening 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
FP7 ERAWIDE PROJECT FP7 ERAWIDE PROJECT
THEBERA THEBERA THEODOR BILHARZ INTO THE EUROPEAN RESEARCH AREATHEODOR BILHARZ INTO THE EUROPEAN RESEARCH AREA
FP7 INCO.2010-6-2 ERAWIDEFP7 INCO.2010-6-2 ERAWIDEProject number 266581Project number 266581
A response to the EU-ERAWIDE call aiming to A response to the EU-ERAWIDE call aiming to reinforce the cooperative capacities of research centers reinforce the cooperative capacities of research centers located in the ENP to allow for coherent international located in the ENP to allow for coherent international health research schemes across the Mediterranean by health research schemes across the Mediterranean by the integration of approaches and resources.the integration of approaches and resources.
UNESCO Rregional Conference
“Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011
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 ProjectTHEBERA ProjectObjective Objective
UNESCO Rregional Conference
“Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011
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
THEBERA SCIENTIFIC ACTIVITIESTHEBERA SCIENTIFIC ACTIVITIES
WP6 (lead ASRT): DISSEMINATION AND NETWORK FACILITATIONM1 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 cooperationEnhanced participation in international activitesEthical conduct of researchIPR
WP5 (UNIPI):THEBERA center strategy to internationalize TBRI & to establish it as an excellence center for liver disease research & management
EXTERNAL EXPERTSEXTERNAL EXPERTS
UNESCO Rregional Conference “Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011
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
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 25-30Egyptian and international experts
UNESCO Rregional Conference
“Current Challenges in Women’s Health Care and Medical Research,Cairo7-8 December 2011
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
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 outcomesit 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 Encourage educational opportunities for academics, researchers and health professionals in ethics related to performing research involving human professionals in ethics related to performing research involving human subjects to increase the number of scientists, health professionals and subjects to increase the number of scientists, health professionals and relevant academics with in-depth knowledge of the ethical considerations, relevant academics with in-depth knowledge of the ethical considerations, concepts and applications in clinical and public health research.concepts and applications in clinical and public health research.An oversight body for all ethical committees in Egypt with unified An oversight body for all ethical committees in Egypt with unified operational guidelines and a national ethical code that considers Helsinki operational guidelines and a national ethical code that considers Helsinki declaration with ethical principles conforming with cultural and religious declaration with ethical principles conforming with cultural and religious perspectivesperspectives
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