HEALTH RESEARCH IN FP7 - gppq.fct.pt · PDF fileContact your NCP ... two must be established in different MSs or ACs. ... particular with patient groups, at the earliest possible stage,

HEALTH RESEARCH IN FP7

Contact

European CommissionDirectorate-General for ResearchHealth Directorate B-1049 BrusselsTel: +32 2 2962964E-mail: [email protected]

Find further informationhttp://cordis.europa.eu/fp7/health/http://ec.europa.eu/research/fp7

Get supporthttp://cordis.europa.eu/fp7/health/support_en.html

Contact your NCPhttp://cordis.europa.eu/fp7/ncp_en.html

In each Member State and Associated State, the National Contact Point (NCP) provides guidance, practical information and assistance on all aspects of participation in the frame-work programmes.

Find FP7 contacts in third countrieshttp://cordis.europa.eu/fp7/third-countries_en.html

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Research-intensive small and medium-sized enterprises (SMEs) are the main economic drivers of health care, biotech-nology and medical technologies.

Recognising their innovative potential, EU-supported research actively seeks SME participation. Inclusion of high-tech SMEs in the health and biotechnology sectors gained momentum during FP6 and SMEs are expected to play an even more prominent role in FP7.

SMEs providing a service, for example management or intel-lectual property expertise, are also eligible to participate.

FP7 IS MORE FAVOURABLE TO SME PARTICIPATION

FP7 has a broader approach to health research than FP6, cover-ing new areas such as medical technologies and public health.

Better fundingFP7 ‘rules of participation’ allow funding of up to 75% for re-search and development activities of SMEs, compared to the 50% offered under FP6. Management and training activities are funded up to 100%.

Better protection of intellectual propertyThe rules governing intellectual property in EU-funded proj-ects have been greatly improved over the course of the past framework programmes, with more attention now paid to the special needs of SMEs.

Reduced need for financial checks and bank guaranteesIn FP7, a guarantee fund replaces the ‘collective financial re-sponsibility’. This fund was set up to cover the financial risks of defaulting project participants.

International cooperation is an integral part of the Health Theme, and project consortia in all areas are encouraged to include organisations from third countries, especially from the International Cooperation Partner Countries (ICPC) and from countries with scientific and technologi-cal cooperation agreements with the EU.

Funding can be provided to participants from the ICPCs, whereas funding for organisations from industrialised third countries may be provided on a case-by-case basis if it is considered to be essential for carrying out the project or if a provision is made in the work programme.

INTERNATIONAL COOPERATION WILL BE IMPLEMENTED VIA FOUR MECHANISMS

General opening of all topics to participation by entities from any country in the world.

Specific International Cooperation Actions (SICA), addressing distinct issues relevant for cooperation with particular countries or regions.

Coordinated topics with certain countries, whereby the cooperating country contributes to the budget by fi-nancing its own researchers.

Programme-level cooperation with industrialised countries, in undertakings that can be divided into several sub-projects that are funded individually by the EC or the cooperating countries.

OPPORTUNITIES FOR SMEs IN HEALTH RESEARCH

INTERNATIONAL COOPERATION IN HEALTH RESEARCH

Further information on SMEshttp://ec.europa.eu/enterprise/enterprise_policy/sme_definition/index_en.htmhttp://cordis.europa.eu/fp7/health/sme_en.html

Further information on International Cooperationhttp://cordis.europa.eu/fp7/capacities/international-cooperation_en.htmlhttp://ec.europa.eu/research/iscp/index.cfm

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HEALTH AS A PRIORITY


LEGAL NOTICENeither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server (http://ec.europa.eu).

Luxembourg: Office for Official Publications of the European Communities, 2008© European Communities, 2008Reproduction is authorised provided the source is acknowledged.Printed in Belgium

PRINTED ON WHITE CHLORINE-FREE PAPER

Photos: © European Commission © Shutterstock

1 The list of countries associated with FP7 (Associated Countries) is provided in the Guide for Applicants.2 The list of international cooperation partner countries (ICPC) is provided in Annex 1 of the Cooperation Programme. 3 With the exception of Brazil, China, India and Russia, for which the required two or more ICPC participants can be located in the same coun-try. However, in this case, at least two different participants must come from two different provinces, oblasts, republics or states within Brazil, China, India or Russia.

Health is a major theme of the Specific Programme on Cooperation under the Seventh Framework Programme (FP7), with a total budget of €6.1 billion over the duration of FP7. The objectives of health research under FP7 are to improve the health of European citizens and to boost the competitiveness of health-related industries and businesses while addressing global health issues.

FUNDING SCHEMES

Collaborative Project

Collaborative Project for Specific Cooperation Action (SICA)dedicated to international cooperation partner countries

Network of Excellence

Coordination and Support Action (coordinating type)

Coordination and Support Action (supporting type)

At least three independent legal entities, each of which is established in a Member State (MS) or Associated Country (AC)1, and no two of which are established in the same MS or AC.

At least four independent legal entities. Of these, two must be established in different MSs or ACs. The other two must be established in different Inter-national Cooperation Partner Countries (ICPC)2, 3.

At least three independent legal entities, each of which is established in a MS or AC, and no two of which are established in the same MS or AC.


At least one independent legal entity.

On 18 December 2006, the Council of the European Union adopted decisions establishing the Seventh Framework Programme (FP7) of the European Community for research and technological development and demonstration activities for the period 2007 to 2013. FP7 is made up of four specific programmes plus a fifth activity on nuclear research. The Cooperation Programme supports all types of research activities carried out by different research bodies in transnational cooperation and aims to gain or consolidate leadership in key scientific and technology areas.

In 2007, more than 900 proposals competed for funding in the first FP7 call. Only the 153 best projects received funding, receiving a total amount of €641 million.

EUROPEAN-FUNDED HEALTH RESEARCH WILL FOCUS ON THREE PILLARS:

Biotechnology, generic tools and medical technologies for human health

■ High-throughput research■ Detection, diagnosis and monitoring■ Prediction of suitability, safety and efficacy of therapies■ Innovative therapeutic approaches and interventions

Translating research for human health

■ Integration of biological data and processes■ Research on the brain and brain-related diseases, human

development and ageing■ Research on infectious diseases■ Research on major diseases: cancer, cardiovascular

disease, diabetes/obesity, rare diseases, other chronic diseases

Optimising the delivery of health care to European citizens

■ Translation of clinical outcome into clinical practice, including better use of medicines

■ Quality, efficiency and solidarity of health care systems■ Enhanced health promotion and disease prevention

In addition, cross-cutting actions include support for health research

■ Responding to EU policy needs■ Specific International Cooperation Actions

Child health, health of the ageing population and gender-related health are overarching issues of the Health Theme. As translation of basic discoveries into clinical applications is one of the main objectives of this theme, clinical research is expected to be a major tool used in the funded projects.

Special attention will be given to communicating research outcomes and engaging in dialogue with civil society, in particular with patient groups, at the earliest possible stage, regarding new developments arising from biomedical and genetics research.

Consulting the Health Work Programme

To prepare for a proposal, several documents must be consulted and instructions should be followed carefully. The first step is to consult the Health Work Programme, which is published annually1. The applicant should check whether there are appropriate openings for applications. Only then should the other documents be downloaded and read carefully. Furthermore, any specific conditions for the Health Theme, as well as for the different funding schemes, are also set out in the Health Work Programme and the related annexes.

Following the Guide for Applicants

The relevant Guide for Applicants (there is one guide for each funding scheme) should be followed. Special attention needs to be given to page limits of the different sections of the proposal as additional pages will be disregarded during evaluation. Proposals must describe planned activities, information on who will carry them out and specify how much they will cost. Proposals must identify and list all the ethical issues that they may involve. These issues must be described and addressed fully in the appropriate section of Annex 4.

Submitting a proposal

Proposals must be submitted electronically using a special web-based service (EPSS) by a strictly enforced deadline.2

Proposal evaluation

A proposal will have to pass several steps successfully to be retained for funding. Only eligible proposals will go on for sci-entific evaluation.

Eligibility criteria

A proposal will only be considered eligible if it meets all of the following conditions:

■ It is received by the Commission by the deadline given in the call text;

■ It involves at least the minimum number of participants for the distinct funding scheme as given in the call text;

■ It is complete: both the requested administrative forms (part A) and scientific proposal description (part B) are present;

■ The content of the proposal is clearly related to the topic(s) under which it is submitted, and the right funding scheme has been used including any special conditions set out in those parts of the relevant Health Work Programme.

Evaluation process

The evaluation process is a peer review and will be carried out by a panel of external independent experts (each proposal will be reviewed by at least three experts). Following the evaluation applicants will be informed of the outcome. A number of

applicants with highly ranked proposals will be invited by the Commission to negotiate a grant agreement providing for an EU financial contribution, subject to budget availability.

Evaluation Criteria

The evaluation criteria for the Cooperation Programme are:

■ Scientific and/or technological excellence;■ The quality and efficiency of implementation and manage-

ment;■ The potential impact through development, dissemination

and use of project results.

1 Access the Health Work Programme and related documents at http://cordis.europa.eu/fp7/health under ‘Find a call’.

2 Further information on electronic proposal submission is available under http://cordis.europa.eu/fp7/epss_en.html

HOW TO APPLY

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BIOTECHNOLOGY, GENERIC TOOLS ANDTECHNOLOGIES FOR HUMAN HEALTH

The activity Biotechnology, generic tools and technologies for human health aims to develop and validate tools and technologies necessary to gain new knowledge and to translate that knowledge into practical applications in the area of health and medicine.

Below are examples of topics published and projects funded from the fi rst call in 2007.

HIGH-THROUGHPUT RESEARCH

The main objective is to catalyse progress in developing new research tools for modern biology (including fundamental genomics) to signifi cantly enhance data generation and improve data and specimen (biobank) standardisation, acquisition and analysis. The focus will be on new technologies for sequencing; gene expression, genotyping and phenotyping; structural and functional genomics; bioinformatics and systems biology; as well as other ‘omics’.

HEALTH-2007-1.1-2: Temporal and spatial proteomics to study biological processes relevant to human health. (Large-scale integrating project)

PROSPECTS ‘PROteomics SPECifi cation in Time and Space’ is a fi ve-year project in proteomics,

a major new fi eld in biomedical research that deals with the large-scale identifi ca-

tion and characterisation of large groups of proteins, or ‘proteomes’. PROSPECTS

will develop more powerful instrumentation and apply novel proteomics methods

to facilitate quantitative annotation of the human proteome, with respect to protein

localisation and dynamics.

The project involves 10 partners from 7 countries: Germany, Switzerland, the United Kingdom, Spain, Denmark, Sweden and Israel. EC contribution: €11.8 million

DETECTION, DIAGNOSIS AND MONITORING

The aim is to develop visualisation, imaging, detection and analytical tools and technologies for biomedical research that will be used for prediction, diagnosis, monitoring and prognosis of diseases, and for support and guidance of therapeutic interventions. The focus will be on a multidisciplinary approach integrating areas such as molecular and cellular biology; physiology; genetics; physics; chemistry; bio-medical engineering; nanotechnologies; microsystems; devices and information technologies. Non- or minimally-invasive and quantita-tive methods and quality assurance aspects will be emphasised.

HEALTH-2007-1.2-1: Development of a hybrid imaging system. (Small- or medium-scale focused research project)

MEGMRIThe ‘Hybrid MEG-MRI Imaging System’ project will last four years and

will develop and validate hybrid magnetoencephalography (MEG) and

magnetic resonance imaging (MRI) technology that will allow simulta-

neous structural and functional imaging of the human brain. The fi rst

part of the project will focus on sensor optimisation and low-fi eld MRI

development. The second part of the project will be devoted to building

a prototype that incorporates the best possible sensor and extensive

preclinical validation, covering major brain disorders for adults and

children. The prototype will be used to research major adult and pae-

diatric brain disorders.

The project involves 13 partners from 5 countries: Finland, France, Germany, Italy and Sweden.EC contribution: €4.9 million

http://megmri.tkk.fi

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SUITABILITY, SAFETY AND EFFICACY OF THERAPIES

The objectives are to develop and validate the parameters, tools, methods and standards needed for bringing safe and effective new or improved biomedicines to patients. The focus will be on approaches such as pharmaco-genomics, developing and validating biological markers, targeting and delivery approaches, in silico, in vitro (including alternatives to animal testing) and in vivo methods and models.

HEALTH-2007-1.3-3: Promotion, development, validation, acceptance and implementation of QSARs for toxicology. (Small- or medium-scale focused research project)

OpenToxThe three-year project ‘Open Source Predictive Toxicology Framework’ aims to

develop a predictive toxicology framework that offers a unified access to toxi-

cological data,(Q)SAR (quantitative structure-activity relationship) models and

supporting information. OpenTox will be relevant for REACH because it gives risk

assessors simple access to experimental data, to (Q)SAR models and toxicological

information that adheres to European and international regulatory requirements.

OpenTox will contain high-quality data and (Q)SAR models for chronic, genotoxic

and carcinogenic effects, the endpoints with the greatest potential to reduce ani-

mal testing.

The project involves 11 partners from 7 countries: Switzerland, Germany, Bulgaria, Italy, Greece, Romania and India. EC contribution: €3.0 million

www.opentox.org

INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS

The objectives of the area Innovative therapeutic approaches and interventions are to research, consolidate and ensure further developments in advanced therapies and technologies with broad potential application. The focus will be on gene and cell therapy, regenerative medicine, transplantation, immunotherapy and vaccines and other medicines. Related technologies, such as advanced targeted delivery systems, advanced implants and prosthetics and non- or minimally invasive technology-assisted interventions, will also be addressed.

HEALTH-2007-1.4-2: Innovative approaches for the development of vaccines for young children. (Small- or medium-scale focused research project)

CHILD-INNOVACThe three-year project on ‘Nasal vaccination against respiratory infections in

young children’ aims to develop novel nasal vaccines against two major respira-

tory pathogens: Bordetella pertussis and Respiratory Syncytial Virus (RSV), which

are among the most frequently occurring and severe respiratory pathogens in

young children. Both pathogens have a world-wide distribution and pose sig-

nificant direct burdens on health systems in Europe, in neighbouring developing

countries and in migrant communities.

The project involves 10 partners from 7 countries: France, Belgium, Ireland, Italy, Sweden, the Netherlands and the United Kingdom. EC contribution: €5.0 million

www.child-innovac.org

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The activity Translating research for human health aims to increase knowledge of biological processes and mechanisms involved in normal health and, in specifi c disease situations, to transpose this knowledge into clinical applications, and to ensure that clinical data (including epidemiological data) guide further research.

The areas covered by this activity include: ‘Integrating biological data and processes: Large-scale data gathering, systems biology’; ‘Research on the brain and brain-related diseases, human development and ageing’.


TRANSLATING RESEARCH FOR HUMAN HEALTH – PART 1INTEGRATING BIOLOGICAL DATA AND PROCESSES RESEARCH ON THE BRAIN AND BRAIN-RELATED DISEASES, HUMAN DEVELOPMENTAND AGEING

LARGE-SCALE DATA GATHERING

The objective is to use high-throughput technologies to generate data for elucidating the function of genes and gene products as well as their inter-actions in complex networks that regulate important biological processes. The focus will be on genomics, proteomics, ‘RN-omics’ and population genetics, as well as comparative, structural and functional genomics.

HEALTH-2007-2.1.1-4: Characterisation and variability of the microbial communities in the human body. (Large-scale integrating project)

MetaHIT The four-year project ‘Metagenomics of the Human Intestinal Tract’ will focus on

the microorganisms of the gut, which play an important role in human health

and well-being. The project will open avenues to modulate human gut microbiota,

which may lead to optimising the health and well-being of any individual.

The project involves 15 partners from the following 8 countries: France, Denmark, Germany, Spain, Italy, the Netherlands, the United Kingdom and China.EC contribution: €11.4 million

SYSTEMS BIOLOGY

The focus will be multidisciplinary research that integrates a wide variety of biological data, and that develops and applies system approaches to understand and model biological processes in all relevant organisms and at all levels of organisation.

HEALTH-2007-2.1.2-2: Modelling of T-cell activation. (Large-scale integrating project)

SYBILLA The fi ve-year project ‘Systems Biology of T-cell Activation in Health and

Disease’ aims to understand, at the systems level, how T-cells discrimi-

nate ‘foreign’ from ‘auto’ antigens. T-cell activation is a complex process

relying on multiple layers of tightly controlled intracellular signalling

modules that form an intricate network. Defects in this network can

cause severe and chronic disorders such as autoimmune diseases.

The project involves 17 partners from the following 9 countries: The United Kingdom, Germany, Spain, Austria, Switzerland, France, Italy, Finland, Czech Republic, USA and India. EC contribution: €11.1 million

http://www.sybilla-t-cell.de/

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BRAIN AND BRAIN-RELATED DISEASES

The objectives are to better understand the integrated structure and dynamics of the brain, to study brain diseases including relevant age-related illness (e.g. dementia, Parkinson’s disease) and to search for new therapies. The focus will be on gaining a global understanding of the brain by exploring brain functions, from molecules to cognition includ-ing neuroinformatics, and brain dysfunction, from synaptic impairment to neurodegeneration. Research will address neurological and psychiatric diseases and disorders, including regenerative and restorative therapeu-tic approaches.

HEALTH-2007-2.2.1-6: Neuron-glia interactions in health and disease. (Small- or medium-scale focused research project)

NeuroGLIA A four-year project on ‘Molecular and Cellular Investigation of Neuron-Astroglia

Interactions: Understanding Brain Function and Dysfunction’ (NeuroGLIA) aims

to unravel fundamental mechanisms of neuron-astroglia signalling in health and

disease. Astroglial cells are active elements in the brain that sense and integrate

synaptic signals and, by releasing gliotransmitters, regulate synaptic efficacy and

cerebral blood flow. NeuroGLIA seeks to open new perspectives for specific thera-

peutic strategies by investigating neuron-astroglia signalling.

The project involves 7 partners from the following 5 countries: Germany, Spain, the United Kingdom, Italy and the Netherlands. EC contribution: €3.0 million

www.neuroglia.eu

HUMAN DEVELOPMENT AND AGEING

The main objective of this area is to use a wide variety of methodologies and tools to better understand the process of life-long development and healthy ageing. The focus will be the study of human and model sys-tems, including interactions with factors such as environment, genetics, behaviour and gender.

HEALTH-2007-2.2.2-5: Research on human development and/or healthy ageing across the EU. (Coordination or support action)

WhyWeAge The rapid increase of life expectancy in Europe is essentially a positive outcome

of improved health care and socioeconomic progress. Nevertheless, age-related

health deterioration greatly impinges upon the health care and social-security

systems. This 18-month project aims to ally European research on ageing, using

commonly agreed perspectives to develop a roadmap for European research on

the molecular aspects of healthy human ageing. Based on an assessment of the

state of the art in molecular gerontology and breakthroughs in biotechnology, the

project will organise a series of research workshops in an integrative conference.

The conclusions of the workshops and final conference will serve as a reference

tool for European policies on ageing.

The project involves 18 partners from the following 10 countries: Belgium, Germany, Italy, France, Greece, the United Kingdom, Austria, Denmark, Poland and Hungary. EC contribution: €500 000

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The activity Translational research in major infectious diseases: to confront major threats to public health is divided into four main areas of research: ‘Anti-microbial drug resistance including fungal pathogens’; ‘HIV/AIDS, malaria and tuberculosis’; ‘Potentially new and re-emerging epidemics’ and ‘Neglected infectious diseases’.

Below are examples of topics published and projects funded from the fi rst and second1 call in 2007.

ANTI-MICROBIAL DRUG RESISTANCE INCLUDING FUNGAL PATHOGENS

The focus will be combining basic research on molecular mechanisms of resistance, microbial ecology and host-pathogen interactions with clinical research towards new interventions to reduce the emergence and spread of multi-drug-resistant infections.

HEALTH-2007-2.3.1-2: Host-pathogen interactions in infectionsby Streptococcus pneumoniae. (Small- or medium-scale focused research project)

PNEUMOPATHThe three-year project aims to comprehensively dissect host-pathogen interac-

tions during Streptococcus pneumoniae infection. Findings are expected to lead

to new targets for vaccination, diagnosis and treatment of the diseases caused by

pneumococci. PNEUMOPATH will use a systems biology approach with a checker-

board experimental design to uncover molecular determinants of the pathogen’s

virulence and antibiotic resistance, and of the host’s susceptibility and defences

against the pneumococcal infection.

The project involves 16 partners from the following 9 countries: The United Kingdom, France, Iceland, Italy, Germany, Portugal, the Netherlands, Sweden, and Austria.EC contribution: €3.0 million

HIV/AIDS, MALARIA AND TUBERCULOSIS

Research will focus on developing new therapies, diagnostic tools, and preventive tools such as vaccines and chemical barriers (e.g. HIV mi-crobicides). Research efforts will confront the three diseases at the global level but will also address specifi c European aspects of the three diseases as well as hepatitis co-infection. Preclinical and early clinical research activities will be emphasised.

HEALTH-2007-2.3.2-4: Addressing knowledge gaps in pregnancy malaria.(Small- or medium-scale focused research project)

PREGVAXThe four-year ‘Plasmodium Vivax Infection in Pregnancy’ project will carry

out a cohort observational study in pregnant women in fi ve P. vivax ma-

laria endemic countries which together experience most of the world’s

infections. Pregnant women will be enrolled at each site during routine

antenatal care visits and followed-up at the health facility until delivery

or end of pregnancy. Due to the likely low prevalence of infection in

pregnancy a multicentric study design will be used. Immunological

analysis will be performed to unveil whether there are pregnancy-

specifi c immune responses. Phenotypic and genotypic analyses of

parasites from the placenta should reveal their adhesive proper-

ties and whether the accumulation of infected erythrocytes selects

unique parasite population.

The project involves 9 partners from the following 8 countries:Spain, Sweden, Italy, India, Papua New Guinea, Brazil, Colombia, and Guatemala.EC contribution: €3.0 million

TRANSLATING RESEARCH FOR HUMAN HEALTH – PART 2MAJOR INFECTIOUS DISEASES

1 Pending successful Grant Agreement negotiations.

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POTENTIALLY NEW AND RE-EMERGING EPIDEMICS

The focus will be on confronting emerging pathogens with pandemic po-tential including zoonoses (e.g. SARS and highly pathogenic influenza). Provisions will be made to cover the full spectrum of research, from in-novative basic research to early-stage clinical trials of new prevention, diagnostic and therapeutic measures, to implementation of research findings that will enable effective public health responses.

HEALTH-2007-2.3.3-4: Innovative point-of-care diagnostic tests for influenza. (Small- or medium-scale focused research project targeted to SMEs)

RANGER‘Rapid, Robust and Scalable Platform Technology for Fully Automated Reference

Laboratory-Grade Polymerase Chain Reaction (PCR)-Based Diagnostics Regard-

less of Global Setting’ is a two-year project that seeks to provide an innovative

solution to the immediate need for a rapid, robust, cost-effective and user-friendly

point-of-care (POC) diagnostic for influenza. The RANGER consortium uses WHO

reference sites for human influenza diagnostics as well as world leading compa-

nies to develop and validate a POC influenza diagnostic system. This system will

enable health systems to be better prepared for epidemics by providing innovative

tools for early identification of infection and, thus, timely implementation of con-

tainment and treatment strategies.

The project involves 10 partners from the following 5 countries: The United Kingdom, Italy, the Netherlands, Denmark and Thailand. EC contribution: €2.9 million

NEGLECTED INFECTIOUS DISEASES

The objectives are to improve existing and to develop new approaches for preventing, diagnosing, treating, and controlling neglected infectious diseases which are applicable, acceptable and affordable in disease endemic countries. The main focus of research will be on neglected infectious diseases with a major impact on human health, and with clearly defined unmet medical needs. These include diseases caused by protozoal, bacterial and helminth infections.

HEALTH-2007-2.3.4-2: Development of a Leishmania vaccine. (SICA: Small- or medium-scale focused research project)2

LEISHDNAVAXThe three-year project ‘Development of a DNA Vaccine for Visceral Leishmania-

sis’ focuses on the preclinical development of a DNA vaccine for human visceral

leishmaniasis. The project is based on DNA vaccine technology and immuno-

modulators developed at Mologen AG (Berlin, Germany) that are in clinical de-

velopment for cancer, and on the few known antigens that have demonstrated

profiles of protection in animal models of leishmaniasis. Antigens will be selected

on the basis of preset criteria to assure protection against many different spe-

cies of Leishmania in a high proportion of target populations. In vitro and in vivo

models will be used to evaluate the prophylactic and therapeutic efficacy of the

DNA vehicle with selected antigens alone, and in combination with and without

an immunomodulator.

The project involves 7 partners from the following 5 countries: The United Kingdom, Germany, India, Tunisia and Israel. EC contribution: €3.0 million

2 SICA topics are usually published under a separate section of the Health Work Programme.

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TRANSLATING RESEARCH FOR HUMAN HEALTH– PART 3RESEARCH ON MAJOR DISEASES: CANCER, CARDIOVASCULAR DISEASE, DIABETES/OBESITY, RARE DISEASES AND OTHER CHRONIC DISEASES INCLUDING RHEUMATOID DISEASES, ARTHRITIS AND MUSCULOSKELETAL DISEASES

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CANCER

The focus will be on disease aetiology; new medicines and therapies; identifying and validating drug targets and biological markers that aid in the prevention, early diagnosis and treatment; and assessing the effective-ness of preventive, prognostic, diagnostic and therapeutic interventions.

HEALTH-2007-2.4.1-3: Genomic instability and genomic alterations in precancerous lesions and/or cancer. (Small- or medium-scale focused research project)

GENICAThe three-year project ‘Genomic Instability in Cancer and Precancer’ addresses

the mechanisms leading to genomic instability in cancer and focuses on pre-

cancerous lesions. The project studies the role of DNA replication stress and short

telomeres in driving genomic instability, particularly in precancerous lesions, and

their correlation with tumour progression. Analysis of proteins and genes involved

in the cellular response to DNA replication stress and short telomeres will be used

to identify novel targets for cancer therapy.

The project involves 11 partners from the following 8 countries: Switzerland, Finland, Denmark, Spain, Italy, Greece, the United Kingdom and France.EC contribution: €3.0 million

http://genica.unige.ch/

CARDIOVASCULAR DISEASE

The focus will be on diagnosis, prevention, treatment and monitoring of heart and blood vessel diseases, including vascular aspects of stroke, using broad multidisciplinary approaches.

HEALTH-2007-2.4.2-1: Molecular basis of the infl ammatory response and associated vascular remodelling in arteriosclerosis. (Large-scale integrating project)

AtheroRemoThe fi ve-year project ‘European Collaborative Project on Infl ammation

and Vascular Wall Remodelling in Atherosclerosis’ aims to identify novel

infl ammatory mechanisms in vascular remodelling and to develop new

preventive, diagnostic and therapeutic strategies against atherosclerot-

ic cardiovascular disease. A number of novel fi ndings will be translated

into potential clinical applications.

The project involves 18 partners from the following 11 countries: The United Kingdom, Switzerland, France, Italy, the Netherlands, Germany, Greece, Denmark, Finland, Norway and Sweden. EC contribution: €11.7 million

http://www.atheroremo.org/


DIABETES AND OBESITY

For diabetes, the focus will be aetiologies of the different types of dia-betes and their related prevention and treatment. For obesity, the focus will be on multidisciplinary approaches including genetics, life style and epidemiology. For both, special attention will be given to juvenile diseases and factors operating in childhood.

HEALTH-2007-2.4.3-4: Pathophysiological mechanisms related to excess fat. (Small- or medium-scale focused research project)

TOBIThe three-year project ‘Targeting OBesity-driven Inflammation’ aims to analyse

mechanisms provoking adipokine-mediated crosstalk and inflammatory drift in

obese patients, and to develop novel strategies to reduce or reverse insulin resis-

tance and vascular dysfunction. Key molecules of pathophysiological relevance will

be validated for their potential as targets for drug development.

The project involves 10 partners from the following 5 countries: Austria, Germany, the United Kingdom, Italy and France. EC contribution: €3.0 million

RARE DISEASES

The focus will be Europe-wide studies of natural history and pathophysi-ology as well as development of preventive, diagnostic and therapeutic interventions for rare diseases. This sector will include rare Mendelian phenotypes of common diseases.

HEALTH-2007-2.4.4-1: Natural course and pathophysiology of rare diseases. (Small- or medium-scale focused research project)

EUCILIA The three-year project ‘Pathophysiology of Rare Diseases Due to Ciliary Dysfunc-

tion: Nephronophthisis, Oral-facial-digital type 1 and Bardet-Biedl Syndromes’

will study the physiological roles of primary cilia and OFD1, BBS and NPHP

proteins in the formation and function of the primary cilium and ciliary protein

interaction network. The objective is to identify potential therapeutic agents. Re-

sults may shed light on the mechanisms underlying the role of primary cilia in

polycystic kidney disease.

The project involves 4 partners from the following 3 countries: The United Kingdom, Italy and Germany. EC contribution: €2.9 million

CHRONIC DISEASES

The focus will be non-lethal diseases with a high impact on the quality of life during old age, including functional and sensory impairment and other chronic diseases (e.g. arthritis, rheumatic and musculoskeletal diseases and respiratory diseases including those induced by allergies).

HEALTH-2007-2.4.5-3: Osteoporosis: signalling pathways in bone formation and homeostasis. (Small- or medium-scale focused research project)

ATPBoneThe three-year project ‘Fighting Osteoporosis by Blocking Nucleotides: Purinergic

Signalling in Bone Formation and Homeostasis’ will use in vitro and in vivo mod-

els to investigate the role of ATP and purinergic receptor signalling in the control

of bone formation and homeostasis. The potential of the system as a target for

the development of new therapies for osteoporosis will be assessed by small-

scale clinical proof-of-concept studies.

The project involves 7 partners from the following 5 countries: Denmark, the United Kingdom, Belgium, the Netherlands and Italy. EC contribution: €3.0 million

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OPTIMISING THE DELIVERY OF HEALTH CARETO EUROPEAN CITIZENS

The activity Optimising the delivery of health care to European citizens aims to develop new research methods that will generate the necessary scientifi c basis to underpin informed policy decisions on both health systems and more effective, effi cient, evidence-based strategies for health promotion and disease prevention, diagnosis and therapy.

The focus will be on: ‘Translating clinical research into clinical practice’; ‘Quality, effi ciency and solidarity of health systems’ and ‘Enhanced health promotion and disease prevention’.

Below are examples of topics published and projects funded from the second1 call in 2007.

TRANSLATING CLINICAL RESEARCHINTO CLINICAL PRACTICE

The main objectives are to better understand clinical decision making and to establish the appropriate use of behavioural and organisational inter-ventions, new health therapies and technologies that are evidence-based.

HEALTH-2007-3.1-1: Implementation of research into healthcare practice. (Small- or medium- scale focused research project)

EIS The four-year project ‘Development of a European Implementation Score for

Measuring Implementation of Research Into Healthcare Practice Using Vascular

Disease as an Example’ will focus on stroke due to the emerging evidence of effective

new treatments available and because of national initiatives and governmental

policies in this area. The European Implementation Score (EIS) measures how

well new knowledge is implemented in clinical practice in Europe. The EIS will be

used to benchmark the implementation of research results in different health care

settings at different levels of the health care system. It will also be used to inform

health policy on processes required to close the research-practice gap.

The project involves 6 partners from the following 4 countries:The United Kingdom, Germany, Italy and Sweden. EC contribution: €2.8 million

QUALITY, EFFICIENCY AND SOLIDARITY OF HEALTH SYSTEMS

This research should enable countries to promote more effi cient and accessible high-quality health care services in Europe by encourag-ing learning from the experience of others while taking into account national contexts and population characteristics. The focus will be organisational, fi nancial and regulatory aspects of health systems.

Health-2007-3.2-3: Mobility of health professionals. (Small- or medium- scale focused research project)

MoHProfThe three-year project ‘Mobility of Health Professionals’ aims to determine

the impact of different types of mobility on national health systems. Migration

fl ows to, from and within the EU will be analysed with regard to underlying

motives, circumstances and social context (push-and-pull factors). This

research includes comparative studies in major non-European sending and

receiving countries and will explore what mobility of health professionals

means both for the health system concerned and the individuals and

organisations involved. Conceptual models for monitoring systems of

health professional mobility will be developed to enable national decision

makers to base human resource policies on sound empirical evidence.

The project involves 6 partners from the following 6 countries:Germany, Belgium, Bulgaria, Poland, the Philippines and the USA. EC contribution: €2.3 million


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ENHANCED HEALTH PROMOTION AND DISEASE PREVENTION

This area aims to develop evidence for effective public health interven-tions addressing wider determinants of health, such as diet, tobacco or alcohol use and socioeconomic, environmental, and behavioural factors, on both the individual and community level.

HEALTH-2007-3.3-1: Promoting healthy behaviour in children and adolescents. (Small- or medium- scale focused research project)

TEMPESTThe four-year project ‘Temptations to Eat Moderated by Personal and Environmen-

tal Self-regulation Tools’ investigates how personal and environmental approaches

may complement each other in order to develop more effective preventive in-

terventions that will encourage young people to develop a healthy lifestyle. The

prevalence of obesity amongst European children and adolescents has risen at

an alarming rate in the past decades, with major repercussions for their health in

the short and long term. Existing prevention programmes to combat the epidemic

highlight either a public health or an individual-educational approach. Until now,

both approaches have met with limited success.

The project involves partners from the following countries: the Netherlands, Belgium, Denmark, Finland, Germany, Poland, Portugal, Romania and the United Kingdom. EC contribution: €2.4 million

SPECIFIC INTERNATIONAL COOPERATION ACTIONS FOR HEALTH SYSTEM RESEARCH2

These actions on particular priorities such as health systems, health policy, maternal and child care, reproductive health and neglected communicable diseases aim to reinforce the research and cooperative capacities of candidate, neighbourhood, developing and emerging countries. Particular attention will be paid to facilitating access to these actions for these countries, in particular developing countries.

HEALTH-2007-3.5-2: Universal and equitable access to health care and health financing. (SICA: Small- or medium- scale focused research project)

SUREThe five-year project ‘Supporting the Use of Research Evidence for Policy in

African Health Systems’ seeks to improve access to and use of policy-relevant

syntheses of research evidence that are contextualised and tailored to meet the

needs of decision makers in low- and middle-income countries. SURE will develop

capacity for evidence-informed health care policy and undertake a comparative

evaluation of initiatives between policy makers, researchers, and civil society

using a range of different strategies.

The project involves 12 partners from the following 11 countries: Norway, France, Sweden, Canada, Burkina Faso, Cameroon, Central African Republic, Ethiopia, Mozambique, Uganda and Zambia as well as the World Health Organization. EC contribution: €3.0 million

2 SICA topics are usually published under a separate section of the Health Work Programme.

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OTHER ACTIONS ACROSS THE HEALTH THEME

Under the activity Other actions across the Health Theme, three types of actions will be covered: ‘Coordination and support actions across the theme’, ‘Responding to EU policy needs’ and ‘Specifi c International Cooperation Actions’ (SICA).

Below are examples of topics published and projects funded from the fi rst and second1 call in 2007.

COORDINATION AND SUPPORT ACTIONS ACROSS THE THEME

Such actions are intended to support the research actions and policies of the Health Theme in FP7.

HEALTH-2007-4.1-3: Assessment and valorisation of project outcome for high-technology and research-intensive SMEs participating in Framework Programmes of Research in the health care sector. (Coordination or support action)

KAPPA HealthThe three-year project aiming at ‘Key Performance Factor Assessment and Valori-

sation for Successful EU-FP Project Participation of Innovative SMEs in the Area of

HEALTH’ will accelerate and enhance the dissemination and exploitation of project

outcomes, ultimately providing a published ‘Decalogue’ of golden rules for the

success of innovative SMEs.

The project involves 7 partners from the following 6 countries: Belgium, Germany, Switzerland, Israel, France and Greece. EC contribution: €750 000

HEALTH-2007-4.1-4: Identifying patients’ needs in the clinical trials context. (Coordination or support action)

RESPECTThe four-year project ‘Relating Expectations and Needs to Participation and

Empowerment of Children in Clinical Trials’ will aim primarily to clarify the

expectations and needs of children who have participated or who might participate

in clinical trials for new drugs in Europe and their families. It also seeks to identify

methods by which those expectations and needs can be translated to empower

and motivate participants of future clinical trials. Greater participation in clinical


trials will result in more valid and reliable products available for children as

envisaged by the Paediatric Regulation EC 1901/2006.

The project involves 7 partners from the following 5 countries: Sweden, Germany, Belgium, Slovenia and Italy.EC contribution: €500 000

HEALTH-2007-4.1-5: Science communication actions. (Coordination or support action)

HEALTH-TVThe 12-month project ‘Enhancing Public Awareness on the Results of European

Health Research Actions through Television Media’ will exploit and customise a

highly innovative TV media communication model. The project expects to have

each of its audiovisual productions broadcast by at least eight major national TV

stations throughout Europe and to reach an overall public audience of several

millions of people.

The project involves 4 partners from the following 3 countries: Italy, France and Germany. EC contribution: €700 000

HEALTH-2007-4.1-7: Studies on the impact of EU legislations on health research and related developments and applications.(Coordination or support action)

TISS.EUThe three-year project ‘Evaluation of Legislation and Related Guidelines on the

Procurement, Storage and Transfer of Human Tissues and Cells in the European

Union: an Evidence-Based Impact Analysis’ will analyse the impact of current

EU legislation and guidelines on biomedical research and will identify regulation

defi cits and inconsistencies.

The project involves 10 partners from the following 9 countries: Germany, the United Kingdom, Sweden, Hungary, Italy, Ireland, France, the Netherlands and Lithuania.EC contribution: €798 000

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RESPONDING TO EU POLICY NEEDS

Research on emerging needs will be implemented on the basis of ‘bot-tom-up’ and ‘focused’ initiatives, in coordination with other themes. This will include a broad and interdisciplinary research portfolio. Support for unforeseen policy needs may address, for example, living and working conditions, health impact assessment, risk assessment, statistical indi-cators, management and communication in the public health domain, as well as obligations under international health treaties.

HEALTH-2007-4.2-1: Adapting off-patent medicines to the specific needs of paediatric populations. (Small- or medium-scale focused research project)

LOULLA&PHILLAThe consortium of the three-year project ‘Development of Six Mercaptopurine and

Methotrexate Oral Liquid Formulations for the Maintenance Treatment of Acute

Lymphoblastic Leukaemia in Children’ will perform nonclinical and clinical devel-

opment with the crucial objective of making its adapted formulations available by

2010 at the latest.

The project involves 7 partners from the following 4 countries: France, Denmark, the Netherlands and the United Kingdom. EC contribution: €3.3 million

HEALTH-2007-4.2-3: Research to assess the economic dimension of occupational health and safety. (Coordination or support action)

HEALTHatWORKThe three-year project ‘An Inquiry into Health and Safety at Work: A European

Union Perspective’ aims to review current knowledge and issues related to the

economic impact of health at work. It will carry out a comparative EU-wide as-

sessment of the structure and dynamics of health and safety at work. Policy

recommendations aiming to improve health and safety at work, in the context of a

changing labour-market environment, shall be detailed with particular reference

to the ageing population, the feminisation of the labour markets and the increase

in small and medium -sized enterprises (SMEs).

The project involves 19 partners from the following 13 countries: The United Kingdom, France, Lithuania, Denmark, Greece, Belgium, Finland, Germany, Spain, the Netherlands, Poland, Hungary and Italy. EC contribution: €1.1 million

SPECIFIC INTERNATIONAL COOPERATION ACTIONS (SICA)

The Specific International Cooperation Actions are different from other topics in the Health Theme as they address distinct issues relevant to cooperation with particular countries or regions and require the par-ticipation of International Cooperation Partner Countries (ICPC). The minimum requirement is for two participants from Member States or Associated Countries and two from different ICPCs. Topics are chosen with a view to special qualities or requirements of the partner countries. These may be the result of bi- or multilateral dialogues or workshops with the target regions.

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ETHICS ISSUES IN HEALTH RESEARCH

Ethics in research is considered essential by the European Commission. Therefore, in all proposals submitted to FP7 calls, ethics issues must be identifi ed and addressed, and ethics concerns fl agged. Although clarifi cation may be sought, this will cause delays in the application process.

Consider ethics issues from the outset, as this enhances the quality of research. Take time to consider both the potential benefi t and burden of each work package. Consider the impact of research not only in terms of its contribution to the advancement of science but also in terms of its human and cultural impact. Consider the ethical and social effects of your research, and whether the objectives and means are balanced.

ETHICS REVIEW IN PRACTICE

All proposals are evaluated by independent experts on three criteria:

Ethics review and reviewers

Ethics review is automatic if a proposal includes:

New in FP7

Take-home message:

ETHICS ISSUES THAT MUST BE FULLY ADDRESSED

AREAS EXCLUDED FROM FUNDING

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3

DUAL USE

DOUBLE STANDARDS

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No system in the world offers a higher guarantee of respect of fundamental ethics principles.

FIND FURTHER INFORMATION

INFORMED CONSENT

When is it needed?

What’s in a consent form?

procedure

How to deal with informed consent in practice?

PRIVACY AND DATA PROTECTION

Data affected by privacy issues

How to address data protection and privacy?

HUMAN EMBRYONIC STEM CELL RESEARCH (hESC)

RESEARCH ON ANIMALS

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Contact







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KI-81-08-344-E

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Documents

HEALTH RESEARCH IN FP7 - gppq.fct.pt · PDF fileContact your NCP ... two must be established in different MSs or ACs. ... particular with patient groups, at the earliest possible stage,