Informed Consent Seminars – LUMSA University

 

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/

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.

 

 

Ethical Challenges in Clinical Experimentation and Vaccines

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.

 

 

 

Press Release – Multicultural and Interreligious Perspective on Informed Consent

 

The UNESCO Chair in Bioethics and Human Rights will hold its 6th international Bioethics, multiculturalism and religion workshop to discuss issues of informed consent and clinical research 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 will focus on the multicultural and interdisciplinary dimension of the ethical requirements of informed consent applied to transnational / clinical research and vaccination. The discussion will take place in the Aula Master of the Pontifical Athenaeum Regina Apostolorum and the European University of Rome, in Via degli Aldobrandeschi, 190 in Rome (reserved entry).

“We do believe in the importance of this day of study and dialogue on such an important topic – says Alberto Garcia, director of the Chair – because in scientific research we find gaps, barriers and practices in the process of requesting informed consent. Too often the human person and his fundamental rights, the cultural and religious diversity of the subjects in biomedical experimentation are not fully taken into consideration. We want to study and fill this gap in response to the main asset of the project launched by the European Union”.

“Informed consent is a subject that is not only medical,” explains Mirko Garasic, researcher of the Chair – “but which invests the person’s culture and religion. To assume that all the world’s traditions are willing to accept that the individual-centric approach of autonomy at the base of informed consent is short-sighted and counterproductive. For this reason, our workshop is important: we need to start from the common values ​​that the various faiths share, to analyze the differences together and to adapt (also) health policies to more complex and less monolithic situations “.

“It is important to discuss and face the limit between the autonomous and relational self in informed consent” – continues Fr. Joseph Tham, LC professor of Bioethics – “together with Prof. Marie Letendre we have analyzed over time the analysis of autonomy in informed consent is changing. It is moving from a concept of autonomous decision-making process to a more articulate and relational relationship between patient-doctor.
Therefore, we aimed to demonstrate the shift from an individualist to a more relational form that helps to understand the autonomy in giving consent, without neglecting the cultural and ethical aspects of the health system”.

The panel of speakers and the audience are international and from different backgrounds; there will be contributions and reflections from influential exponents of various religions (Buddhism, Confucianism, Christianity, Judaism, Hinduism, Islam).

 

APRA Press Office, Dr. Emiliana Alessandrucci ealessandrucci@upra.org

UER Press Office, Carlo Climati carlo.climati@unier.it

Attached – Detailed program

_____________________________________________________

Feb 20, Tuesday

Arrival

Welcoming dinner

 

Feb 21, Wednesday

8:00     Breakfast at hotel

9:00     Greetings by authorities and Introduction

Alberto Garcia, Gonzalo Miranda, Jesus Villagrasa.

10:00   Multiculturalism, Religion and Informed Consent: Mirko Garasic

11:00   Coffee break

11:30   UDBHR and informed consent: Dafna Feinholz

12:15   Informed Consent: From Autonomous to Relational self:

Marie-Catherine Letendre, Joseph Tham

13:00   Lunch

14:30   Buddhism: Ellen Zhang

16:00   Coffee break

16:30   Christianity: Laura Palazzani

18:00   Break

19:00   Dinner in Rome

 

Feb 22, Thursday

8:00     Breakfast at hotel

9:00     Confucianism: Ruiping Fan

10:30   Coffee break

11:00   Hinduism: John Lunstroth

12:30   Departure for lunch and cultural activity

19:00   Public session: Religion, Human Rights and Informed Consent

Ellen Zhang, Martha Tarasco, Ruiping Fan, John Lunstroth, Aasim Padela, David Heyd

Moderators: Joseph Tham and Mirko Garasic

20:30   Refreshment / Cocktail

 

Feb 23, Friday

8:00     Breakfast at hotel

9:00     Islam: Aasim Padela

10:30   Coffee break

11:00   Judaism: David Heyd

12:30   Break

13:00   Lunch

14:30   Conclusion

16:00   Farewell and departure

 

Participants

 

  • Dafna Feinholz, UNESCO, Paris
  • Ellen Zhang, Hong Kong Baptist University, Hong Kong
  • Aasim Padela, University of Chicago, USA
  • Ruiping Fan, City University of Hong Kong, Hong Kong
  • David Heyd, Hebrew University, Jerusalem
  • Laura Palazzani, LUMSA, Rome
  • Martha Tarasco, Anáhuac University, Mexico City
  • John Lunstroth, University of Houston, USA
  • Alberto Garcia, UNESCO Chair in Bioethics and Human Rights, Rome
  • Gonzalo Miranda, School of Bioethics, Regina Apostolorum, Rome
  • Joseph Tham, School of Bioethics, Regina Apostolorum, Rome
  • Mirko Garasic, UNESCO Chair in Bioethics and Human Rights, Rome

Prof. Mirko D. Garasic, UNESCO Chair Research Scholar, published in Bioetica – Rivista Interdisciplinare

Prof. Garasic engaged in a discussion on his book Guantanamo and Other Cases of Enforced Medical Treatment (Springer, 2015) http://www.springer.com/gp/book/9783319226521 has on the Italian Journal “Bioetica -Rivista Interdisciplinare (3;2017; year XXV) where exchanged views on the topic with international scholars Dr. Zohar Lederman (National University of Singapore), Prof. Mario Picozzi (University of Insubria) and Prof. Giovanni Scarafile (University of Salento).