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European Research Horizon 2020 - Science with and for Society: I-Consent SwafS-17-2016

I-consent project

Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective



Starting date: 1 May 2017
End date: 30 April 2020 - extended till March 2021

Project coordinator

LUMSA research unit leader
Prof. Laura Palazzani

Members of LUMSA research unit
Prof. Angelo Rinella
Prof. Fabio Macioce

Leonardo Nepi, Loredana Persampieri, Valeria Ferro, Margherita Daverio, Valeria Sala

Overall EU contribution:
Euro 3 077 197,50
Contribution received by LUMSA:
Euro 303 356,56

I-Consent Project Consortium
I-Consent project is developed by an international consortium, composed of partners from public health institutes, academia, hospitals, patient associations, the pharmaceutical industry and enterprises.

Project goals
 I-Consent project aims at achieving the following goals:

  • Identifying existing barriers and gaps in the process of acquisition of informed consent.
  • Devising key requirements and the necessary actions to improve the process of acquisition of informed consent.
  • Designing innovative information strategies – also through the use of new information and communication technologies – tailored to the needs of the person from whom informed consent is sought, with particular regard to vulnerability conditions (women, children, migrants).
  • Elaborating and validating guidelines, at the European level, in order to improve and encourage participants’ enrolment in clinical trials.
  • Validating procedures for the acquisition of informed consent in vaccines, with special emphasis on HPV (Human Papilloma Virus), meningitis and RSV (Respiratory Syncytial Virus).

Project contents
Participation in a clinical trial is a very sensitive decision, which must be free and autonomous; for this reason, informed consent to experimentation is a topic of paramount bioethical and biolegal importance. The relationship between science and society should foster the involvement of people in the informed consent process, with special consideration for gender (sexual difference) and age-related issues.

Accordingly, informed consent forms should have specific characteristics: completeness/relevance of information; clarity/understandability. However, informed consent forms often turn out to be lengthy and complex documents, difficult to read and drafted without taking into account the patent’s perspective. Moreover, clinical trials may be carried out on vulnerable subjects, such as minors or fertile, pregnant or breastfeeding women; hence, the information must be conveyed in an appropriate manner, adapted to the categories of people it is meant for.

The project will focus on validation of informed consent for three different vaccines, and the elaboration of guidelines aimed at all relevant stakeholders. A particular emphasis will be placed on vaccines against Human Papilloma Virus (preadolescents and adolescents), vaccines to protect against meningitis (adults) and vaccines against Respiratory Syncytial Virus (pregnant women); therefore, mainly considering vulnerable populations, notably minors and women. 

The work conducted by LUMSA research unit will specifically explore the ethical and legal aspects related to the acquisition of informed consent in scientific research, especially with reference to the issues raised by the enrolment of women of childbearing age and minors, as well as migrants, therefore attaching primary importance to the topic of vulnerability of subjects, also in relation to their cultural backgrounds.
International Workshops

3 October 2017, at 11.00 am, Sala del Consiglio, Via Pompeo Magno 22
Prof. Marie-Jo Thiel
Professor of Ethics and Moral Theology, University of Strasbourg
Director of the European Centre for the Study and Teaching of Ethics (CEERE), University of Strasbourg

13 October 2017, at 9.00 am, Sala del Consiglio, Via Pompeo Magno 22
Prof. Federico De Montalvo Jaaskelainen
Professor of Constitutional Law, Universidad Pontificia Comillas, Madrid
Deputy Chair of the Comité de Bioética de España
Member of the UNESCO International Bioethics Committee (IBC)

23 November 2017, at 4.00 pm, Aula 2, Via Pompeo Magno 22
Prof. Antonio Addis
Department of Epidemiology and Prevention of the Lazio Region
Member of the Technical-Scientific Committee of the Italian Medicines Agency

29 November 2017, at 4.00 pm, Sala del Consiglio, Via Pompeo Magno 22
Prof. Christiane Druml
Director of the Josephinum – Collections of the Medical University of Vienna; UNESCO – Chair for Bioethics and former Vice Rector of the Medical University of Vienna
Chair of the Austrian Bioethics Commission
Former member of the UNESCO International Bioethics Committee (IBC)

4 December 2017, ore 9.00, Sala Giubileo, via di Porta Castello 44
Prof. Christiane Woopen
Professor of Ethics and Theory of Medicine, University of Cologne
Chair of the European Group on Ethics in Science and New Technologies (EGE)
Former member of the UNESCO International Bioethics Committee (IBC)

Consortium Meetings
11-12 May 2017 – Valencia (Spain)
4-5 December 2017 – Roma (Italy)
14-15 May 2018 - Bristol (UK)

For further information:
Dr. Filomena Canadé
LUMSA Office of Scientific Research
Via delle Fosse di Castello, 7
00193 Roma