On December 10th and 11st, our Director Alberto Garcia and Research Scholar Mirko Garasic, will participate in the Coordination Meeting in Madrid to discuss the progress of the i-Consent project.
By Santiago Marcet –
On October 10th and November 12nd, Prof. Alberto Garcia, Director of UNESCO Chair in Bioethics and Human Rights, attended LUMSA’s venues in Rome and Palermo to give a presentation on the details of the European project of i-CONSENT, as well as to explain the intricacies that go along the practical and theoretical notion of informed consent (IC) in clinical research.
On a theoretical level, Prof. Garcia highlighted the importance of taking into consideration the factors of gender, age and cultural and religious background if one’s approach to constitute successful patterns of informed consent is to be effective. Thinking about these vulnerability factors will help consolidate i-CONSENT as a person-centered project, as it considers how the above mentioned factors change the way in which patients understand information and communicate with others.
He also approached the tensions that arise from a conceptualization of IC that depends on a notion of individual autonomy that is not shared by all cultures and religions: while western culture tends to give importance to the individual and his or her rights, eastern traditions use to put more weight on community and the duties that derive from it. Thinking about how each major religious tradition (namely Buddhism, Confucianism, Christianity, Judaism, Hinduism and Islam) views IC in accordance to their doctrine and traditions will help to outline defined goals for the effectiveness of i-CONSENT.
Prof. Garcia went on to talk about the practical expected outcomes of the project: i-CONSENT intends to be beneficial both for patients and researchers, in a way that will benefit society as a whole. In its person-centered approach it will develop different tests and will aim to involve different physicians in accordance to the profile of the patient, effectively incorporating its principles with their presence on regulatory bodies and ethics groups. The overall goal, according to Prof. Garcia, is to increase the standards of clinical research by making IC form and the whole process more comprehensive and mindful of the patient’s particularities.
You can read more about the i-CONSENT project as it is approached by the UNESCO Chair in Bioethics and Human Rights here: http://www.unescobiochair.org/2017/06/02/new-eu-project-works-on-improving-guidelines-for-informed-consent-including-vulnerable-populations-under-a-gender-perspective/
Visit i-CONSENT’s official website: https://i-consentproject.eu/
This October, Prof. Alberto Garcia, Director of the UNESCO Chair in Bioethics and Human Rights, will participate in the Workshop “Vaccines, Anti-Vaccination Movements and Communication (Fake News)” within the project COMPARE that has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 643476. The panel is multidisciplinary and multi-sectoral precisely because the meeting’s objective is not to discuss vaccines but trying to understand why citizens often do believe in false myths or fake news. The first day will be dedicated to the analysis of the communication among politicians, patients and journalists, while the second day will be focused on the analysis of the “correlation” that exists between vaccines and autism. In this context Prof. Alberto Garcia will have the possibility to share the results of the research on vaccines and guidelines of Informed Consent carried out during the year through the i-Consent project within the Horizon 2020 research and innovation program under grant agreement No 741856. Read the program by clicking on this link.
Video – Extracts from “Multiculturalism and Interreligious Perspective on Informed Consent” Workshop
The UNESCO Chair in Bioethics and Human Rights hold its 6th international Bioethics, multiculturalism and religion workshop to discuss issues of informed consent and clinical research on February 21-23. As part of the i-Consent consortium (a project funded by the European Union – Horizon 2020), the ethical reflections of the workshop focused on the multicultural and interdisciplinary dimension of the ethical requirements of informed consent applied to transnational / clinical research and vaccination.
By Fausto Martinez & Andrea Iannone –
Bioethics is the discipline that studies human behavior in healthcare and life sciences. It also examines values, rational, and moral principles at the basis of decisions in medicine and biology. Bioethicists recognize that mankind has always pursued greater knowledge, and that the goal of scientific research is to obtain concrete benefits for patients. Therefore, bioethicists are often concerned about the researcher or doctor on one hand, and the patient as the subject of experimentation on the other. In between them lie a vast array of recent technological developments (for example, biotechnology) that stimulate a series of questions. Is science “unstoppable” or does it have limits? Is biomedical technology truly morally neutral? Is emphasizing the human utility of scientific investigation and experimentation ethically relevant?
Researchers addressed these and other questions at the third symposium by A.S.I.E.R.I (Asociación de Investigadores Españoles en la República Italiana, the Association of Spanish Researchers in Italy) on May 18, 2018, at the the Real Academia de España en Roma, Italy. The topic of the conference was “Responsible Innovation and Research”. Further discussion centered on the I-Consent project, funded by the European Union Horizon 2020 Programme. Briefly put, the project aims to improve guidelines on informed consent in vulnerable populations under a gender perspective.
Innovation and research can be defined as “responsible” if they respect human rights. Based on the ethical and juridical principles of the Universal Declaration on Bioethics and Human Rights, human rights are human beings’ inherent moral and legal entitlements to dignity, liberty, and equality at any historical moment, in any context. Therefore, the human dignity of both the patient and the researcher must be respected in scientific research and medical practice.
Since they can experience pain, distress and lasting damage, animals are also entitled to humane treatment in medical and scientific research. Whenever possible, appropriately licensed scientists should experiment with specimens with lower neurophysiological sensitivity, thus reducing the number of live vertebrates involved. When animals with higher pain sensitivity are necessary for experimental purposes, researches are advised to adopt techniques to avoid suffering, stress, or injury.
During the symposium, Prof. Alberto García, Director of UNESCO Chair in Bioethics and Human Rights at Università Europea di Roma and the Pontifical Athenaeum Regina Apostolorum, underscored the importance of respecting the human patient’s privacy. This process includes compliance on the part of the experimenting institution with data collection and sharing regulation being paramount. Patients have a right to know what data is collected, with whom it is shared, and how they can rectify or delete it – if they so choose – in the future.
According to García, non-discriminatory and non-stigmatizing medical research practices ensure the equal treatment of patients. He also stated that patients’ rights need to be observed not only during research, but also after its completion. Once a drug has been released onto the market, there must be a phase of pharmaceutical vigilance to monitor identify and evaluate previously unreported adverse reactions to the drug.
In his last point, Garcia discussed the I-Consent project. In particular, our UNESCO Chair will explore and analyze baseline knowledge of IC for the development and validation of ethical issues concerning informed consent in translational/clinical research and vaccination. Clear informed consent procedures ensure that patients’ dignity is upheld. Informed Consent is a document of utmost important for a patient since it allows him to voluntarily decide to participate in research. However, the research’s objectives are often not shared with the concerned stakeholders. That is why informed consent must become a process during which patients have the essential information clearly presented to them. Innovative tools, such as videos, comic strips, or apps might favor communication among all stakeholders. If not, those unable to consent – often the most vulnerable among us – risk seeing their human rights violated.