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.
Role in the project
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
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.
PROF. DR. ANGELO RINELLA
Managing legal issues in clinical trials and vaccination.
PROF. DR. FABIO MACIOCE
Ethical and legal issues about involvement in clinical trials of people coming from different cultural backgrounds.
DR. LEONARDO NEPI, PHD
Ethical review of age-related issues associated with the acquisition of informed consent in clinical research and vaccination.
DR. LOREDANA PERSAMPIERI
Ethical review of gender-related issues associated with the acquisition of informed consent in clinical research and vaccination.
DR. MARIA FRANCESCA CAVALCANTI
Legal review of age-related issues associated with the acquisition of informed consent in clinical research and vaccination.
DR. VALERIA FERRO, PHD
Legal review of gender-related issues associated with the acquisition of informed consent in clinical research and vaccination.
DR. PIETRO BRIGANÒ