The Foundation for the Promotion of Health and Biomedical Research of the Valencian Region (FISABIO) is a non-profit scientific and assistance organization whose paramount end is the promotion, impulse and development of the scientific-technical, sanitary and biomedical research in the Valencian Region. FISABIO integrates and manages the Health Research Map of the Centre for Public Health Research, Dr. Peset University Hospital Foundation, Alicante University General Hospital Foundation, Elche University General Hospital Foundation, and the Mediterranean Ophthalmological Foundation. In addition, FISABIO assumes the scientific activity of other 18 Public Health Departments of the Regional Ministry of Health.
Thanks to its functional structure, FISABIO provides service to more than 1.500 professionals of the Valencian Health Services network and manages the research work and clinical trials carried out by these specialists. As result of the research activity, more than 500 scientific papers have been published, nearly accounting for 1520 impact factor points. FISABIO represents the effort of Generalitat Valenciana to support the policies of Public Health research so that applied research, with the aim of obtaining new knowledge and tools to increase the level of population health.
FISABIO workforce stands out for its experience and high level of specialisation in the field of managing research projects. Its team consists of a framework of 384 people, a varying number of the 260 scientists assigned to different research projects and 124 staff members for Management Services and Scientific Advancement.
Within FISABIO, the Vaccine Research Department studies the impact that infectious disease, which can be prevented by vaccination, has on society. This involves an understanding of the social burden and costs associated with disease. The vaccines are studied for effectiveness during routine vaccination programmes in the Valencian Region, with the use of epidemiological studies of the disease before and after the start of vaccination. The department carries out the clinical development of vaccines, studies on the vaccine safety and effectiveness, and designs and implements studies (clinical trials) allowing for changes to be made in vaccination guidelines, ensuring coordination with the vaccination calendar.
Currently, thirteen people are conducting several research projects. observational studies and clinical trials in the Vaccine Research Department of FISABIO whose Head is Dr. Javier Díez-Domingo. Five of these thirteen people include Pharmacists, Sociologists, Statisticians and other investigators.

FISABIO as Project Coordinator brings health professionals with a large experience in clinical trials and also in ethics committees, as well as sociologists with experience in gender related problems. Besides there is a team of experienced personnel in the coordination of EU projects, that will also input on the social perspective of the project.

As a third party, of FISABIO, the Universidad Católica de Valencia San Vicente Mártir (UCV) gives the opportunity to provide large experience on the validation of assents for minors participating in clinical trials. UCV will be very important in the assent validation performed in WP3.

Dr. Javier Diez-Domingo is Head of the Vaccine Research Department, MD paediatrician (1987), PhD degree (1990).

He has over 235 scientific papers with more than 2.200 citations. He has devoted more than 20 years of clinical epidemiological research on vaccines and immunopreventable diseases, and has worked as PI in more than 40 clinical trials with vaccines. Expert on evaluation of new drugs in paediatrics for the EMA. Member of different Ethics Committees since 2000 and President of the DG-Public Health EC since 2015. Active member of the European Society for Paediatric Infectious Diseases (ESPID), chair of  the Committee for Education, member of the Spanish Pediatric Society, the Spanish Vaccinology Association and the International Society for Vaccines.

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Phone: (+34) 961925937

Jaime Fons-Martinez

Degree in Sociology and in Business Management and Administration, Master’s Degree in Sociology and Anthropology of Public Policy and Expert in Gender Violence. Has been working as sociologist investigating and developing Strategies for Health Care Providers to Address Gender Violence, and as professor in the Valencian School for Health Studies (EVES) and in the University of Valencia teaching subjects related to sociology, health and gender. He will work as Technical Manager of the project focused in the scientific review of gender and age-related issues of informed consent (Task 1.2). He is also responsible of the IC guidelines development (WP3) and the development of new strategies for improving health literacy for participants in clinical trials (Task 2.7). He collaborates also in Task 1.5 (Legal issues) and Task 1.6 (patient involvement in vaccine research).

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Fernando Calvo-Rigual

MD, PhD. Head of Pediatrics in FISABIO-Hospital LLuís Alcanyís from Xàtiva (Valencia, Spain). He received his MD degree as paediatrician in 1981, and his PhD degree (cum laude) in 1990 from the University of Valencia. He is Bachelor of Philosophy from the UNED. Member of the GIBUV (Bioethics Investigation Team for the University of Valencia). He is involved in the systematic review of the age-related issues associated with the acquisition of informed consent (Task 1.2) and int he validation of the informes consent guidelines (Task 3.3).

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Cristina Ferrer-Alberto

PhD nurse of FISABIO’s Third Party Universidad Católica de Valencia San Vicente Mártir (UCV). She has large experience on the validation of assents for minors participating in clinical trials. She participates in Task 1.2 in the systematic review of scientific literature of age-related issues associated with informed consent and in the validation of the guidelines of the informed consent in the target population (Task 3.3).

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Monica Vàzquez-Moreno

Chemical Engineer and Master of Advanced Studies in Chemical Engineering (University of Valencia). She has broad experience in the management of EC-funded R&D projects (FP7, H2020, IMI, LIFE, INTERREG, MSCA, etc). She works as Financial Project Manager and is involved in all tasks included in WP5 (Management and Exploitation). She also collaborates in Task 1.1 in the review of previous and on-going EC funded projects for the evalution of their results and establishment of new synergies.

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Libera Università Maria Ss. Assunta (LUMSA) is a highly ranked Italian non public University, mainly located in Rome and Palermo. Lumsa has 1,600 graduate and undergraduate enrolments every year, with a total student population of 6,000 students. Courses of: law, economics, political sciences, languages, communication, psychology, education.

A Center for Studies in Biolaw was established at LUMSA University, from 2003 to 2012, directed by Prof. Laura Palazzani. Since 2013, it became a Research Unit in Biolaw. An Ethics Committee for Scientific Research (CERS), chaired by Prof. Laura Palazzani, was created in 2015, which focuses its attention on both research integrity and research ethics issues.

LUMSA is in charge of drafting the Report on gender and age-related issues associated with the acquisition of informed consent; participation in ethical and legal review of informed consent for minors; in charge of drafting the Report on legal issues concerning informed consent in translational/clinical research and vaccination.

Analysis of existing informed consent in clinical trials; development of a protocol for a standard evaluation of informed consents; devising new strategies aimed at increasing participation of women in clinical trials and fostering the involvement of patients from different cultures, languages and religious backgrounds in clinical trials; development of ICT-based strategies for improving communication between patients and clinicians.

Validation of informed consent processes, guidelines, and questionnaire for minors, pregnant women and for others in vaccines trials.

Prof. Laura Palazzani is a full professor  of Philosophy of Law, Biolaw and Bioethicsat LUMSA University of Roma.

Her main topics of research are: the concept of person; gender issues; biolaw and justice; beginning of life and end of life issues; experimentation on human beings (on women, children, developing countries); biobanks; emerging/converging technologies (ehealth, gene-editing, neurosciences, robotics, AI); enhancement.

Membership: Vicechair of the Italian Committee for Bioethics; member of EGE (EC), IBC (UNESCO); Steering Committee of the Global Suummit, WHO (2016); Italian representative DH-BIO (2014-2017); member of the Ethics Committee of Bambino Gesù Hospital.

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Prof. Dr. Angelo Rinella

Managing legal issues in clinical trials and vaccination.
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Prof. Dr. Fabio Macioce

Ethical and legal issues about involvement in clinical trials of people coming from different cultural backgrounds.
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Dr. Leonardo Nepi, PhD

Ethical review of age-related issues associated with the acquisition of informed consent in clinical research and vaccination.
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Dr. Loredana Persampieri

Ethical review of gender-related issues associated with the acquisition of informed consent in clinical research and vaccination.
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Dr. Maria Francesca Cavalcanti

Legal review of age-related issues associated with the acquisition of informed consent in clinical research and vaccination.
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Dr. Valeria Ferro, PhD

Legal review of gender-related issues associated with the acquisition of informed consent in clinical research and vaccination.
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Dr. Pietro Briganò

Communication Officer
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Synectika is a UK company, founded in 2014, based in Keynsham (near Bristol and Bath). We serve businesses and technology developers in the UK and Europe. At Synectika we believe that the goals of business and society are, ultimately, entwined. We believe in sustainable business growth through responsible innovation and technology development. Our services aim at aligning ethics, privacy, and societal interests with business and technology goals. Services include ethics risk management,  impact assessment, analysis of privacy and data protection matters and reviews of human and fundamental rights issues. Synectika also offers services in research and ethics management, overseeing the production of ethics guidelines and codes of conduct, providing training, expertise and advice on research ethics for technology developers and researchers.

Synectika is leader of WP1: A multi-layered approach to informed consent, investigating methods and techniques for improving informed consent, and examining key determinants that influence beliefs and attitudes toward the informed consent process.

In addition, Synectika contributes with an analysis of ethical, privacy and data protection issues associated with the use of ICT for obtaining informed consent.

Dimitris Dimitriou is a director at Synectika Research and Consulting Ltd.

Prior to his directorship, Dimitris served as a Lead Researcher for Zadig Srl and the Centre for Science, Society and Citizenship in Rome, and as a Research Officer for the British Standards Institution (BSi Group) in London. Dimitris has also served as a volunteer for NGOs in Greece, taking action to defend fundamental rights of children and prevent the social exclusion of young people. He has wide experience in international research projects, mostly focusing on ethical issues in surveillance technologies, risk communication and public health crises. Dimitris holds an MSc degree in Health Psychology, from the City University of London, and a MSc degree in Environmental Psychology, from the University of Surrey.

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Dr. Andrew P. Rebera

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MRF is a UK-based charity registered with the Charity Commission of England. MRF is constituted as a non-for-profit governed by a Board of Trustees, who are directors of the company. MRF offices reside in Bristol, Edinburgh, Belfast and a linked organisation in Dublin, Ireland.

MRF was founded by parents and other family members of people affected by meningitis who wanted to combat the disease by funding research, and to educate and raise awareness of the disease to improve outcomes. MRF remains a membership based organisation and represent approximately 17,000 families affected by meningitis, mainly in the UK.

MRF is an international research funder, supporting research to improve the prevention, detection and treatment of meningitis.  Our research focuses on vaccine development and implementation both in the UK, and internationally as well as improvements in diagnosis and treatment.  We work to maximise the immediate practical and clinical benefit from the research we fund, and seek opportunities to disseminate learning from research through developing educational material to the public and health professionals, engaging the public with our research through a programme of discovery days, and helping individuals and families to benefit directly from our research and clinical networks through annual Pushing the Boundaries days for members with meningitis sequelae. We also run professional conferences and workshops for scientists and clinicians.

MRF is a leading advocate for vaccination and improved health care.  In partnership with experts, we also contribute to the development of national health standards, training and guidelines for health workers in the UK.
Alongside research funding, MRF have a significant public facing role.  MRF provides practical and emotional support to families affected by meningitis, as well as engaging in targeted awareness raising activities, providing evidence based symptoms information to members of the public, and campaigning for research-informed improvements to public health policy.

MRF Team Leader for Work Package 1 Explore the patient perspective and involvement relating to informed consent for vaccine trials (childhood meningitis, cervical cancer, RSV vaccination in pregnancy).

To work on the task that will explore the patient perspective and involvement in vaccine research, aiming to identify existing issues and particular challenges relating to informed consent for vaccine trials in the three proposed areas (childhood meningitis, cervical cancer, RSV vaccination in pregnancy) applying a gender perspective. MRF will draw from latest relevant national and international guidelines and policies.

This may include:
– Questions about children’s assent/parental proxy consent and the ages at which they apply and format
– Comprehension of patient information for informed consent desirability of interactive/quiz based consent processes to test comprehension
– Fairness in regard to compensation/inducement for participation (acceptability of compensation for adolescent vs adult)
– Patient expectations from research: personal therapeutic gain
– Feedback of research results to participants

The issue of participation in clinical trials and translational research will also be explored for patients, identifying best practices and strategies implemented at national or international level.

To this end, a number of patient associations (between 6-10) from at least three countries across Europe, will be actively involved by taking part in a one-day workshop, in order to gather feedback and perspectives from patient group representatives, on issues identified within the scope of the task. The overall aim will be to reach consensus on priority of issues in terms of their importance and difficulty, and further explore potential solutions to identified challenges. Patient organisations may include meningitis patient groups, patient groups dedicated to healthy childhood, parenting, healthy pregnancy, infections in pregnancy, health issues in adolescence, cervical cancer.

Mrs. Linda Glennie is the Head of Research, Evidence and Policy at MRF.

She has day to day contact with many individuals affected by meningitis and has developed close links with health professionals and scientists working in this field. She is responsible for managing the Foundation’s research programme, developing educational resources for the public and health professionals, and organising the scientific programme for MRF’s international conferences, regional symposia, and public engagement events.  She is responsible for the charity’s patient stakeholder relationships with medical, scientific and statutory bodies.

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Phone: (+44) 3334056270

Dr. Azeem Arshad

Project Manager
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Dr. Liz Rodgers

Research Officer
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On July 2009, UNESCO signed an agreement to establish a UNESCO Chair in Bioethics and Human Rights with the Università Europea di Roma and Ateneo Pontificio Regina Apostolorum. The two universities, in cooperation with UNESCO, established this UNESCO Chair at the Bioethics and Human Rights Institute. The UNESCO Chair offers a university framework of reflection and study, providing information and fostering the application of bioethical principles in science, medicine and new technologies based on the UNESCO Declaration on Bioethics and Human Rights.

The UNESCO Chair operates in the Faculty of Bioethics of Ateneo Pontificio Regina Apostolorum. The main research activities of the Chair are related to bioethical issues of emerging technologies (neuroscience, nanotechnologies) and in the multicultural and multi-religious dialogue in bioethical issues.

The Chair seeks to create a forum of diverse bioethics thought leaders. Collaborating in a spirit of respect and friendship, our mission consists of deliver a common framework to guide the application of bioethical principles in the light of the UNESCO Declaration. In this manner, the Chair intends to inform and enlighten ethical, legal and public opinions, decisions and actions relative to medicine, life sciences, and human rights and responsibilities.

UNESCO Chair in Bioethics and Human Rights is the responsible WP1.4 on Ethical and Legal issues. The Chair will be involved in the ethical, social and legal assessment and validation of design and implementation of the project.

They have the responsibility for the scientific and administrative management of the assigned task and supports the integration and sharing of information between the different tasks and WPs.

Prof. Alberto García is Doctor in Law from Complutense University in Madrid.

Presently, he is Professor of Philosophy of Law and International Law at the School of Bioethics of Athenaeum Pontificium Regina Apostolorum in Rome. Furthermore, he is a researcher of the Human Rights Institute at Complutense University. For 5 years, he has been member of the Steering Committee of Bioethics in the Council of Europe and in 2005 he has been honoured with the National Prize of the Spanish Royal Academy of Doctors in the field of legal and social sciences. Member of the following Ethical Advisory Boards: ITERA (International Tissue Engineering Research Association) Life-Science Network, Cryo-Save and EU Projects CASCADE and REBORNE (within 7th Framework Program).

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PhD Chiara Ariano

Research scholar
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PhD Mirko D. Garasic

Research scholar
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Dr. Serena Montefusco

Communication
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GlaxoSmithKline S.A in Tres Cantos, Spain, is a GlaxoSmithKline (GSK) Local Operating Company dedicated since 2001 to the development and commercialization of new medicines, vaccines and Consumer Healthcare products. Within GSK S.A. the Clinical Research Area is responsible for the set up and conduct of clinical research programs activities. These activities range from identifying investigational sites, preparation of clinical trials and Epidemiologic documentation for Competent Authorities and Ethical Review Boards (including development of informed consent forms), monitoring the study conduct and publication of results.

GSK will contribute providing the Industry Sponsor point of view in Clinical Research. Pharmaceutical Industry accounts for a large percentage of the clinical trials conducted in EU and therefore the private pharmaceutical experiencie and perspective can help to better understand the current situation and to facilitate adoption of the new guidelines resulting of this project in the future. As an Innovative Industry looking for new treatments, GSK SA works in partnership with Health Institutions, Physicians, nurses, RECs and Authorities to develop new drugs and vaccines to cover unmet medical and public health needs. GSK will take part in all the project WPs with its highest dedication in WP3.

Olga Maria Martinez-Casares is head of clinical research strategy, clinical development early phases, and patient advocacy in the Medical Department of GSK.

She has a degree in Pharmacy and a Master degree in Direction and Management of Research, Development and Innovation in Health Sciences.

She has a long experience both in technical and managerial positions in clinical research, including team and matrix leadership in local and international teams.

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Reyes Boceta Muñoz

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Elena Lopez Santos

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Francisco Javier Rubio Pomar

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Maria Cubillo Diaz-Valdes

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Sparks & Co is a science communication agency specialized in European projects. Our team of experienced communicators make research accessible to all audiences and give projects the widest visibility.

Horizon 2020 research projects deserve the best communication strategy and that is why Sparks & Co have entered the FIT4RRI project as Communication and Dissemination partner.

Its activities range from creating a visual identity for a project, creating the right communication materials – cleverly targeted to reach the designated audiences – designing and regularly updating the project’s website, handling press relations, developing a social media strategy to best suit the project needs and measuring research outcomes impact.

Sparks & Co is the work package leader on Communication, Dissemination and Exploitation activities for the project.

Mrs. Joy Cremesty is Work Package leader for communication and dissemination activities.

She manages both scientific, technical partners and her team to give the project the best communication strategy as well as a smooth implementation for an ultimate project impact.

Camille Cocaud

Contributes to the communication and dissemination strategy.
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Ellie Dana

Communication Assistant
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The Bambino Gesù Paediatric Hospital (OPBG) is a Scientific Institute for Research, Hospitalization and Health Care, Italy’s main paediatric Hospital providing advanced health care for children and performing basic, clinical and translational research activities.

OPBG pursues excellency in health care, while constantly referring to Catholic principles and ethical values that inspired it’s foundation and ensure it’s continuous development. OPBG’s excellency in health care is achieved through advanced research and clinical activities, while managing resources to ensure administrative/financial balance and constantly improving processes to exploit the progress of biomedical science.

The Hospital is part of the Italian National Healthcare System and is widely recognized as referral centre for all paediatrics specialties at national and international levels. With its 11 Departments, covering all aspects of paediatrics care, the Hospital provides a complete range of healthcare services to children. OPBG has a total permanent staff of approx. 2,500, of which 550 physicians, 45 biologists and pharmacists, involved both in clinical and in research activities. OPBG has a research staff on a non-permanent position of 180. There are also approx. 50 post-graduate trainees (medical and surgical) and over 100 students and interns. Yearly clinical activities consist of approx. 27,000 inpatient admissions, 77,000 day hospital admissions, 6,000 day surgery treatments and over 1,500,000 outpatient visits.

The Hospital’s clinical activities run side by side with its scientific research, aiming at constantly improving and innovating diagnostic and therapeutic procedures. Research activities are organized in “Research Areas”: genetic and rare diseases, multifactorial and complex diseases, immunology, infectiology and development of paediatric drugs, onco-haematology, clinical management and technological innovations.

The Bambino Gesù Paediatric Hospital (OPBG) is the leader of the Work Package 2 (Innovation in informed consent). The main tasks carried out by the OPBG are the analysis of existing informed consents in clinical trials (past and current). Other activities are to Identify and analyse latest trends in eHealth/mHealth and relevant initiatives for eConsent in healthcare systems worldwide. The OPBG focused it research on the analysis of potential sensitive issues in specific domains as per case studies in different languages/cultures through social network analysis and the analysis of ethical, privacy and data protection issues associated with the use of ICT for obtaining informed consent. The main scopes are to develop new strategies for increasing participation of women in clinical trials, of patients from diverse cultural and religious backgrounds in clinical trials and new strategies for improving health literacy for participants in clinical trials and communications between patients and clinicians.

Dr Tozzi is a pediatrician and an epidemiologist with experience in vaccine trials and in surveillance of infectious diseases.

He has worked as a researcher with the Italian National Health Institute for more than 15 years. He had responsibilities in surveillance of infectious diseases at the European level, and in supporting recommendations on immunization (Italian Ministry of Health). He has been part of the coordination group of a clinical trial on pertussis vaccines. He was responsible for a study on the effect of thimerosal (US CDC). After he joined the OPBG’s epidemiology unit. He worked in vaccine preventable diseases. He has been a consultant for WHO for activities on polio and on vaccines’ adverse events. He is a component of the Expert Vaccine Group of the European CDC.

Tasks performed for the project: Coordinate the activities of developing tailored strategies to inform the development of IC. He will manage the taskforce to develop different tools for the administration of the informed consent.

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Phone: (+39) 0668592401

Dr. Pascal Vignally

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Ms. Simonetta Zezza

Communication Officer
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