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

Neurobioethics Research Group Presents the 2017/18 Research and Training Program Scheduling

by Giulia Bovassi

The 2016/17 closing meeting of the Interdisciplinary Research Group in Neurobioethics (GdN), chaired by Coordinator F. Alberto Carrara, LC, took place in the afternoon of June 23, with the active participation of various members and collaborators. The occasion was conclusive, but at the same time opened to the 2017/18 research and training program scheduling, which will focus on the theme “From head transplantation to personal identity, from human rights to eschatology. A year of considerations on Trans-Humanism last frontiers”.

The seminar, held at the Ateneo Pontificio Regina Apostolorum in collaboration with the “Science and Faith Institute” and the “UNESCO Chair in Bioethics and Human Rights”, has proposed, through a detailed and participatory study, the general lines of the research and study path which it intends to pursue for the next academic year 2017-2018; a year when one of the most exciting and emerging topics in neurosciences and bioethics studies, trans-humanism, will figure as protagonist. We are talking specifically about the issue of the “long-waited” head transplantation, which will be attempted for the first time in December 2017, and about the persistent problem of personal identity, related to the phases before and after the event.

As clearly explained in the seminar’s introduction, and then repeated during the interventions, the subject will find space for analysis and discussion under different perspectives: from neurosurgery to neurosciences; from psychiatric and psychological contributions to philosophical, theological approaches and, then, achieving Law, adopting particular emphasis on the Informed Consent in condition of vulnerability, and about the value of physicality along with the awareness of body’s importance in relation to the person.

The first human head transplantation (or, as highlighted by Professor A. Carrara, “most of the body transplantation”) has to be considered a decisive step towards trans-humanist aspirations, reason why the news not only remains under the national media spotlights, but also it’s pointed out by active and influential contemporary movements devoted to trans-humanism, as well as it certainly represents a milestone for scientific research. The Italian neurosurgeon, Dr. Sergio Canavero, will lead the team that will collaborate with him on the “Human Head Transplantation” procedure, which currently seems it will be performed in China at Harbin Medical University, on a healthy body volunteer whose identity is still uncertain (initially it had to be a Russian quadriplegic, then replaced by a Chinese man, condemned to capital punishment, to overcome compatibility issues).

During the meeting, the GdN, coherently with its interdisciplinary character, saw the presentation of several expert voices, each of which, as spokesperson of a different type of contribution, suggested questions or topics useful to the research project for the year 2017-2018, thus already sketching a 360-degree coverage for the entire route; this will take its final shape during the second module of the APRA Faculty of Bioethics / Science and Faith Summer Course, scheduled for July 2018 and focused on “Enhancement and Emerging Technologies”, but it will be preceded by a “mature fruit”, namely the Brain Awareness Week promoted by the DANA Foundation.

Seminars and roundtable discussions will be carried out around this topic: from neurosurgical, bioethical, legal, psychological, anthropological, philosophical and psychiatric aspects to health and social issues, until the consequences that follow the so-called “head transplantation” and its scientific-cultural backgrounds, ensuring so the possibility to arrive, through the gradualness and orderliness proper of an academic and multidisciplinary study pathway, at the point where significant and solid conceptual instruments are nimbly avalaible in order to face the open discussion about identity and subject’s approach towards its own body (which is semantically extended more than its physicality).

UNESCO Chair in Bioethics and Human Rights contribution to the research program has been revealed in advance by the Director of the Chair, Professor Alberto Garcia: the contribution will be focused on the delicate and specific issue of Informed Consent, primarily raised for what concerns the relationship between the transplantation perspective and the position of the subjects considered to be most vulnerable, such as quadriplegic patients or who is affected by pathologies which weaken the motor system; this is valid also for the people whose political-social and cultural context does not allow, directly or indirectly, the full exercise of the rights established by the Universal Declaration of Human Rights.

The principles invoked focus on the effective awareness of an eventual consent, adopting a deep attitude of prudence and caution on evaluating as consciously free the decision to undergo to specific interventions in a personal situation soaked and driven by suffering, or characterized by a sometimes desperate past (topic also touched by Professor Cotroneo together with the hypnotherapy role on patients close to the transplantation therapeutic option, starting from the already feasible operations -hand, arm, etc…- whose discomforts are equally attested and present in literature). Then if we add to this the temporal hypothesis, namely future side effects and perspectives reasonably expected from the quality of life’s point of view, the impasse quickly emerges on several fronts.

I-CONSENT (Improving guidelines for Informed Consent, including vulnerable populations, under a gender perspective) is the European project of considerable reach, provided by Horizon 2020, the European Union Research and Innovation Framework Program, won by the consortium in which participates the UNESCO Chair in Bioethics and Human Rights, which will take care over three years to investigate the bays of Informed Consent, with particular regard to vulnerable populations.

It is a project in which the collaboration between the different partners aims to improve the reference guidelines in the theoretical and practical treatment of the theme extended to both sexes, beyond age limits and pre-emptively compared to the rise of cultural or religious barriers in the concrete of specific situations, which lead to the practice of consensus. A special focus will be applied on the issue of vaccinations (crux and difficulties, related especially to children/teenagers, women, even more specifically pregnant women, will be handled rigorously and systematically) and of ethical issues regarding the IC in medicine, particularly in the scientific research; a desired perspective of a result that not only can ensure close proximity between citizens and healthcare, rather a collaborative relationship and a rational, in all respects, informed interconnection.

The group of UNESCO-led researchers working on the project will discuss ethical, legal, scientific tools to be provided to the community to fill some of the current situations of “emptiness”/difficulties at managing consensus in comparison with cultural and religious pluralism, from which we have the duty to protect and respect liberty and, in this case, the self-determination of the subjects involved, first of all those who trust the doctor, the specialist and the research.

Clearly, at this last meeting of GdN, the interesting collaboration with i-CONSENT will consist on constantly bring attention to the freedom of patients suffering from invasive pathologies, which lead to an existential past of suffering and that sometimes affects the decision of the subject to undergo certain interventions or treatments, as might happen in the case of head transplantation.

Here so the Program will adopt as horizon not exclusively the legal term of patient’s avalaibility to informed consent and the legal validity of research, but it will overcome ethics and deontology while remaining complied to one of the major social problems currently facing the healthcare sector: the balance between trust and distrust; possible or illusory hope; legality or wrongfulness, mutually interconnected and not rarely stumbling.

Next year we will then see many disciplines and authoritative personalities work together, united by the common interest towards man and his benefit within neuroscience innovation.