unesco rregional conference internationalization of research institutes and bioethics focusing on eu...

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.



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



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.



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



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



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,



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



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



Concluding Remarks



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

unesco rregional conference internationalization of research institutes and bioethics focusing on eu...

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