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