Chapitre 18. Loi relative à la bioéthique 2021 : de quelques interrogations dans la pratique des équipes médicales.

The law on bioethics of 2 August 2021 introduced a number of innovations that have raised many questions for professionals. For the medical teams at assisted reproduction centres, the disappearance of the notion of medical indication represents a real paradigm shift. Should there be limits on access to MAP methods? The legal texts set certain limits. Are these limits related to human physiology, to the benefit-risk ratio or to social or medico-economic considerations? We will discuss the issues of the age at which a person can benefit from PGM, self-preservation of gametes for his or her own benefit, access to the donor’s identity and special interviews with the multidisciplinary team. Finally, the need for clear, objective information will be emphasised, especially as article 4 of the law provides for a public health plan: prevention/public education, information/female and male fertility, which to date has not been mentioned.

Chapitre 3. Dignité humaine et droit de la bioéthique dans la jurisprudence des Cours européenne et interaméricaine des droits de l'homme.

This contribution analyses the way in which the European and Inter-American Courts of Human Rights handle the concept of Human Dignity in cases that present bioethical stakes. As they do not comprehend it in the same way – ‘Dignity-Freedom’ on the one hand, ‘Dignity-Equality’ on the other – it implies differences of solutions in areas such as the definition of the human person, the right to personal autonomy, the right to health or even the right to a healthy environment. This comparative analysis also allows us to grasp better the limits that a too liberal reading of human rights can represent and to propose some means of improvement. That would involve a review of the equal dignity of human beings by the European Court, thanks to different tools that can be put into action without the Court’s being forced to reconsider the theoretical basis on which its whole system is founded.

Return to Status Quo Ante: The Need for Robust and Reversible Pandemic Emergency Measures.

This paper presents a normative analysis of restrictive measures in response to a pandemic emergency. It applies to the context presented by the Corona virus disease 2019 (COVID-19) global outbreak of 2019, as well as to future pandemics. First, a Millian-liberal argument justifies lockdown measures in order to protect liberty under pandemic conditions, consistent with commonly accepted principles of public health ethics. Second, a wider argument contextualizes specific issues that attend acting on the justified lockdown for western liberal democratic states, as modeled on discourse and accounted for by Jürgen Habermas. The authors argue that a range of norms are constructed in societies that, justifiably, need to be curtailed for the pandemic. The state has to take on the unusual role of sole guardian of norms under emergency pandemic conditions. Consistently with both the Millian-liberal justification and elements of Habermasian discourse ethics, they argue that that role can only be justified where it includes strategy for how to return political decisionmaking to the status quo ante. This is because emergency conditions are only justified as a means to protecting prepandemic norms. To this end, the authors propose that an emergency power committee is necessary to guarantee that state action during pandemic is aimed at re-establishing the conditions of legitimacy of government action that ecological factors (a virus) have temporarily curtailed.

National survey on the opinions of French specialists in assisted reproductive technologies about social issues impacting the future revision of the French Bioethics laws.

INTRODUCTION: France is known for its conservative and unique position in assisted reproductive technologies (ARTs). At the eve of the future revision of French Bioethics laws, we decided to conduct a national survey to examine the opinions of French specialists in ARTs about social issues. MATERIAL AND METHODS: Descriptive study conducted in May 2017 in a university teaching hospital using an anonymous online questionnaire on current issues in ARTs. The questionnaire was sent by email to 650 French ARTs specialists, both clinicians and embryologists. RESULTS: After 3 reminders, 408 responses were collected resulting in a participation rate of 62.7% (408/650). Concerning pre-implantation genetic testing, 80% of the physicians were in favor of expanding the indications, which in France are presently limited to incurable genetic diseases. Authorizing elective Fertility Preservation was supported by 93.4% of the specialists, but without social coverage for 86.3% of them. Concerning gamete donation, 77.4% of the French ARTs specialists were in favor of giving a financial compensation to donors, 92% promoted preserving their anonymity and 80.9% were against a directed donation. ARTs for single heterosexual women were supported by 63.4% of the French specialists and by 72.5% for lesbian couples. The legalization of surrogacy was requested by 55.2%. DISCUSSION: Pending the revision of the French Bioethics laws, this survey provides an overview of the opinion of the specialists in ARTs on expanding ARTs for various social indications.Because of the evolution of social values, a more liberal and inclusive ART program is desired by the majority of ART specialists in France.

"The Hopkins Mongol Case": The Dawn of the Bioethics Movement.

One of the earliest controversies in the modern history of bioethics was known at the time as "the Hopkins Mongol case," involving an infant with Trisomy 21 and duodenal atresia whose parents declined to consent to surgery. Fluids and feeding were withheld, and the infant died of dehydration after 15 days. The child's short life had a profound impact on the author's career and that of several others and ultimately led to changes in the care of children and adults with disabilities and the way difficult end-of-life decisions are made in US hospitals today. It also contributed to the growth of the modern bioethics movement and scholarship focused on pediatric bioethics issues.

Navigating the Intersection between Genomic Research and Clinical Practice.

The Risk Assessment Program (RAP) at Fox Chase Cancer Center (Philadelphia, PA) is a multi-generational prospective cohort, enhanced for personal and family history of cancer, consisting of over 10,000 individuals for whom data on personal and family history of cancer, risk factors, genetic and genomic data, health behaviors, and biospecimens are available. The RAP has a broad research agenda including the characterization of genes with known or potential relevance to cancer, gene-gene and gene-environment interactions, and their contribution to clinically useful risk assessment and risk reduction strategies. Increasingly, this body of research is identifying genetic changes which may have clinical significance for RAP research participants, leading us to confront the issue of whether to return genetic results emerging from research laboratories. This review will describe some of the important fundamental points that must be debated as we develop a paradigm for return of research results. The key issues to address as the scientific community moves toward adopting a policy of return of research results include the best criteria for determining which results to offer, the consent document components necessary to ensure that the participant makes a truly informed decision about receiving their results, and associated logistical and cost challenges.See all articles in this Special Collection Honoring Paul F. Engstrom, MD, Champion of Cancer Prevention.

How Bioethics and Case Law Diverge in Assessments of Mental Capacity: An Argument for a Narrative Coherence Standard.

Clinical assessments of mental capacity have long been guided by four basic cognitive criteria (understanding, appreciation, ability to reason, communication of decision), distilled directly from widespread legal precedent in common law cases of informed consent and refusal. This article will challenge the sufficiency of these legal criteria at the bedside on the assertion that clinicians and bioethicists who evaluate decisional capacity face questions far deeper than the mere presence or absence of a patient's informed consent. It will then present an additional standard beyond the existing cognitive criteria - to be called the Narrative Coherence Standard - that may begin to bridge the gap between the existing legal standards and higher-order bioethical priorities. This standard will be treated with a philosophical argument for its use, as well as a detailed exploration of its technical components and conceptual underpinnings.

Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia? / ¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia?

Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.

¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia? / Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia?

Resumen La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.

Abstract Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

[Bioethical issues on the access to drugs in the practice of ophthalmology in Colombia]. / Cuestiones bioéticas relacionadas con el acceso a medicamentos en el ejercicio de la oftalmología en Colombia.

Ophthalmology is a high-cost specialty in terms of medical, surgical and technological innovation and treatment. It is worrisome that in some countries patients are affected in their visual health, and therefore in their quality of life because they do not have the necessary resources for timely access to medications, medical appointments or surgical procedures. We searched in four electronic databases (ScienceDirect, MEDLINE/PubMed, ClinicalKey and SciELO), as well as in books on bioethics and Colombian laws, for articles related to bioethical issues and access to medicines in the exercise of ophthalmology. We reflect on the problem of access to ophthalmological drugs, with particular interest on how to apply the principles of bioethics on the clinical practice of patients with ophthalmological conditions. Ethical considerations are approached from the principles of Beauchamp and Childress, especially regarding the principle of justice, in order to provide health professionals in this field with arguments for medical and ethical decisions that benefit the healthcare and access to medicines for patients with ophthalmological conditions.

La oftalmología se constituye como una especialidad de alto costo en lo que respecta a tratamiento médico, quirúrgico y de innovación tecnológica. Es preocupante que en algunos países los pacientes se vean afectados en su salud visual, y por ende en su calidad de vida, por no contar con los recursos necesarios para un acceso oportuno a medicamentos, citas médicas o procedimientos quirúrgicos. A partir de la búsqueda de artículos relacionados con cuestiones bioéticas y el acceso a medicamentos en el ejercicio de la oftalmología en cuatro bases de datos electrónicas (ScienceDirect, MEDLINE/PubMed, ClinicalKey y SciELO ), así como en libros de bioética y leyes de la jurisdicción colombiana, realizamos una reflexión sobre el problema del acceso a los medicamentos oftalmológicos, centrándonos en el interés por la aplicación de la bioética en la práctica clínica y en el acceso a medicamentos de los pacientes con patologías oftalmológicas. Las consideraciones éticas se abordan desde una mirada del modelo principialista de Beauchamp y Childress, en especial considerando el principio de justicia, de modo que brinde a los profesionales de la salud en este campo, argumentos para la toma de decisiones médicas y éticas que beneficien la atención y el acceso a medicamentos de los pacientes con patologías oftalmológicas.

[Gamete donation: (un)answered social and ethical issues in Portugal]. / Doação de gametas: questões sociais e éticas (não) respondidas em Portugal.

Awareness of the discussion surrounding the social and ethical challenges regarding gamete donation is crucial for good governance of assisted reproduction techniques. In this article, we analyze the topics that guided the debate in the Portuguese ethics organizations, discussing their connections with themes addressed internationally. To that end, in March 2018, we systematically searched the websites of the National Council of Medically Assisted Procreation and of the National Ethics Council for Life Sciences. We carried out a thematic content analysis of 25 documents. Results indicate that the debate was focused on accessibility, anonymity and donors' compensation and, to a lesser extent, on professional responsibilities. We observed heterogeneous positions and tensions between multiple rights and ethical principles associated with recipients, donor-conceived individuals and donors. These invoke three similar arguments: the scarcity of scientific evidence; experiences from other countries; and regulations from in international entities. Literature addressed additional topics, namely: a double track that combines donor anonymity/identification; the implementation of reproduction registries for recipients and donors; limits to the genetic screening of donors; donations by family members/acquaintances; and donors' role in decisions regarding the fate of cryopreserved embryos and in choosing the characteristics of recipients of their gametes. There is room to expand the debate and to promote research on the social and ethical implications of gamete donation, considering the participation of all citizens.

Conhecer a discussão em torno dos desafios sociais e éticos da doação de gametas é fundamental para a boa governança das técnicas de reprodução assistida. Neste artigo, analisam-se os tópicos que orientaram o debate nas organizações de ética portuguesas, discutindo as suas conexões com os temas abordados internacionalmente. Para tal, em março de 2018, pesquisamos sistematicamente os websites do Conselho Nacional de Procriação Medicamente Assistida e do Conselho Nacional de Ética para as Ciências da Vida. Procedemos à análise de conteúdo temática de 25 documentos. Os resultados indicam que o debate se centrou na acessibilidade, no anonimato e na compensação de doadores e, em menor extensão, nas responsabilidades profissionais. Observaram-se posicionamentos heterogêneos e tensões entre múltiplos direitos e princípios éticos associados a receptores, a pessoas nascidas com recurso à doação de gametas e a doadores. Esses têm em comum três alegações: a escassez de evidência científica; as experiências de outros países; e regulamentações oriundas de entidades internacionais. Na literatura abordam-se tópicos adicionais, nomeadamente: uma via dupla que conjugue anonimato/identificação de doadores; implementação de sistemas de registo reprodutivo para receptores e doadores; limites do rastreio genético a doadores; doação por familiares/conhecidos; e o papel dos doadores na decisão quanto ao destino de embriões criopreservados e na escolha das características dos receptores dos seus gametas. Há espaço para expandir o debate e promover a pesquisa em torno das implicações sociais e éticas da doação de gametas, considerando a participação de todos os cidadãos.

Conocer la discusión en torno a los desafíos sociales y éticos de la donación de gametos es fundamental para el buen gobierno de las técnicas de reproducción asistida. En este artículo se analizan los temas que orientaron el debate en las organizaciones de ética portuguesas, discutiendo sus conexiones con los temas abordados internacionalmente. Para este fin, en marzo de 2018, investigamos sistemáticamente las páginas webs del Conselho Nacional de Procriação Medicamente Assistida y del Conselho Nacional de Ética para as Ciências da Vida. Asimismo, procedimos al análisis de contenido temático de 25 documentos. Los resultados indican que el debate se centró en la accesibilidad, anonimato y compensación de donadores y, en menor extensión, en las responsabilidades profesionales. Se observaron posicionamientos heterogéneos y tensiones entre múltiples derechos y principios éticos, asociados a receptores, a personas nacidas gracias a la donación de gametos y a donadores. Estos tienen en común tres alegaciones: la escasez de evidencias científicas; las experiencias de otros países; y las regulaciones procedentes de entidades internacionales. En el literatura se abordan temas adicionales, en particular: una vía doble que conjugue anonimato/identificación de donadores; implementación de sistemas de registro reproductivo para receptores y donadores; límites del rastreo genético a donadores; donación por familiares/conocidos; y el papel de los donadores en la decisión respecto al destino de embriones criopreservados y en la elección de las características de los receptores de sus gametos. Existe espacio para abrir más el debate y promover la investigación en torno de las implicaciones sociales y éticas de la donación de gametos, considerando la participación de todos los ciudadanos.

Maqasid al-Shariah Based Islamic Bioethics: A Comprehensive Approach.

Maqasid al-Shariah based Islamic bioethics is an Islamic bioethics concept which uses the objectives of the Shariah (maqasid al-Shariah) as its approach in analysing and assessing bioethical issues. Analysis based on maqasid al-Shariah based Islamic bioethics will examine any bioethical issues from three main aspects namely intention, method, and output or final goal of the studied issues. Then, the evaluation will be analysed from human interest hierarchy, inclusivity, and degree of certainty. The Islamic bioethics concept is a manifestation of dynamic Islamic jurisprudence which can overcome new complex and complicated bioethical issues such as tri-parent baby technology issues. Therefore, this article will introduce and explain the concept of maqasid al-Shariah based Islamic bioethics and outline a general guidance of maqasid al-Shariah based Islamic bioethics to determine a maqsad (objective) based on standards of human good or well-being (maslahah) and harm (mafsadah).

It is never lawful or ethical to withdraw life-sustaining treatment from patients with prolonged disorders of consciousness.

In English law there is a strong (though rebuttable) presumption that life should be maintained. This article contends that this presumption means that it is always unlawful to withdraw life-sustaining treatment from patients in permanent vegetative state (PVS) and minimally conscious state (MCS), and that the reasons for this being the correct legal analysis mean also that such withdrawal will always be ethically unacceptable. There are two reasons for this conclusion. First, the medical uncertainties inherent in the definition and diagnosis of PVS/MCS are such that, as a matter of medical fact, it can never be established, with the degree of certainty necessary to rebut the presumption, that it is not in the patient's best interest to remain alive. And second (and more controversially and repercussively), that even if permanent unconsciousness can be unequivocally demonstrated, the presumption is not rebutted. This is because there is plainly more to human existence than consciousness (or consciousness the markers of which can ever be demonstrated by medical investigations). It can never be said that the identity of the patient whose best interests are at stake evaporates (so eliminating the legal or ethical subject) when that person ceases to be conscious. Nor can it be said that the best interests of an unconscious person do not mandate continued biological existence. We simply cannot know. That uncertainty is legally conclusive, and (subject to resource allocation questions and views about the relevance of family wishes and the previously expressed wishes of the patient) should be ethically conclusive.