Bioethics Law Research Articles

Visions and repercussions of identity-release in oocyte and sperm donors: Descriptive survey among gamete donors

The Bioethics Law of August 2nd, 2021 established access to origins for people conceived by gamete donation. Two years after the implementation of this disposition, what is the proportion of former gamete donors informed about access to origins, and what is their position on this matter? What could be the potential repercussions of this new law on them? Retrospective single-center cohort study using questionnaires. When former gamete donors were asked about access to origins, only 53% of oocytes donors and 71% of sperm donors were aware of this measure. When participants were asked about the ideal method of donation, it emerged that 41% of female donors and 47% of male donors were in favour of access to their identifying data for the person resulting from the donation. More than half were in favour of access to non-identifying and medical data. If one day someone conceived from their donation requested access to their identifying data, 62% of oocytes donors and 56% of sperm donors would grant it. A significant proportion of our participants expressed the desire to benefit from information on possible descendants resulting from their donation. Among the donors interviewed, only half are informed of the legislation introducing access to origins, now two years after its implementation. These results encourage us to strengthen communication efforts around access to origins.

The human body and the body elements—Conditions for their use in genetics under the French bioethics law and beyond

French legislation has strictly regulated genetic analysis since the adoption of the bioethics laws in 1994. Following a historical perspective, we discuss how French laws have provided a stable legal regime for access to and use of the human body and its elements until the recent revision of the laws. We present the main bioethical principles attached to the human body and their jurisprudential treatment. We balance this approach of stability by showing the strong evolution of the provisions regulating genetics in French laws. Initially based on and centred on the protection of the individual, we present and analyse the new possibilities for using genetic analysis in the name of solidarity with family members and with society as a whole, for research perspectives and for public health prevention.

Bioética herramienta para futuros profesionales en elejercicio del Derecho

The impact of medical-scientific and technological advances on the legal field is undeniable. This research aims to propose the inclusion of Bioethics and Bioethical Law in the curriculum of the Faculty of Law and Social Sciences at the Pedagogical and Technological University of Colombia. The methodology used was mixed and developed in three phases. Firstly, a bibliographic review was conducted to establish the relationship between Bioethics and Law. Subsequently, the importance of Bioethics was evidenced through factual situations. Finally, its relevance to the training of lawyers was demonstrated through the application of surveys. In conclusion, Bioethics and Law are interconnected and rooted in the transcendent aspects of the lives of living beings and ecosystems. Bioderecho, as a regulator of medical-scientific and technological practices and advances, prevents the violation of fundamental rights. Therefore, it is crucial to incorpórate Bioethics and Bioderecho into the education of future lawyers to enable them to analyze life decisions with ethical legal judgments.

Premières données françaises sur les demandes de don de spermatozoïdes faites par les couples de femmes

ObjectiveThe new bioethics law, enacted on August 2, 2021, has expanded access to medically assisted reproduction (MAR) with sperm donation to unmarried women and female couples. The implementation of this law led to a significant influx of sperm donation requests at French sperm banks. This major development in the field of ART in France, and in French society as a whole, prompted us to focus specifically on the requests from female couples. MethodA retrospective, single-center study was conducted at a gamete donation center in Paris. The data of women in same-sex couples who attended a first consultation with a biologist between October 1, 2021, and October 31, 2022, were analyzed and compared to those of women in heterosexual couples who also requested MAR with sperm donation during the same period. The ART attempts and their outcomes were analyzed up until May 31, 2024. ResultsA total of 117 women in same-sex couples and 75 women in heterosexual couples were included in the study. The profiles in terms of age, ovarian reserve, and history of gynecological conditions did not differ between the two groups. The only observed differences were related to lifestyle, particularly alcohol consumption, which was slightly higher among women in same-sex couples. Additionally, women in same-sex couples appeared to belong more frequently to the category of intermediate professions, but no differences were observed concerning other occupational categories. Regarding the outcomes of ART attempts, cumulative rates of early and ongoing pregnancies were not different between the two groups. ConclusionThis study thus provides an initial insight into the profile and outcomes for women in same-sex couples who received ART with sperm donation shortly after the enactment of the bioethics law in France. The similarity in profiles and ART outcomes between women in same-sex couples and those in heterosexual couples supports the approach of offering similar medical care, regardless of the couple's configuration.

Profils et motivations des femmes demandeuses d’autoconservation ovocytaire en France: enquête sur deux ans

Objectives. The new bioethics law of August 2, 2021 allows French women to self-preserveMethods. National observational survey over 2 years based on an online questionnaire conducted under the aegis of GEDO (Groupe d’Études pour le Don d’Ovocytes).Results. The average age of the 282 women who answered the questionnaire, 34.5 years, is consistent with the benefit/risk balance described in the literature. The most educated women, also very vulnerable, remain the most affected. They are single and childless, but most of them see themselves as a couple and want to become mothers in the future. Their main motivation is to have the choice to postpone a pregnancy without fear of infertility until they have found a suitable partner. Careerist or selfish motivations are anecdotal. The projected fate of unused vitrified oocytes is above all donation to others.Conclusion. This study shows that oocyte self-preservation is undeniably experienced as a societal victory and is perceived as a step towards gender equality. While oocyte self-preservation is not an absolute guarantee of having a future child, it is part of a primary preventive strategy for age-related fertility decline. Public authorities and health professionals will have to widely disseminate accurate and complete information to allow everyone to have access to an informed reproductive choice.

GPT-4o vs. Human Candidates: Performance Analysis in the Polish Final Dentistry Examination.

Background This study aims to evaluate the performance of OpenAI's GPT-4o in the Polish Final Dentistry Examination (LDEK) and compare it with human candidates' results. The LDEK is a standardized test essential for dental graduates in Poland to obtain their professional license. With artificial intelligence (AI) becoming increasingly integrated into medical and dental education, it is important to assess AI's capabilities in such high-stakes examinations. Materials and methods The study was conducted from August 1 to August 15, 2024, using the Spring 2023 LDEK exam. The exam comprised 200 multiple-choice questions, each with one correct answer among five options. Questions spanned various dental disciplines, including Conservative Dentistry with Endodontics, Pediatric Dentistry, Dental Surgery, Prosthetic Dentistry, Periodontology, Orthodontics, Emergency Medicine, Bioethics and Medical Law, Medical Certification, and Public Health. The exam organizers withdrew one question. GPT-4o was tested on these questions without access to the publicly available question bank. The AI model's responses were recorded, and each answer's confidence level was assessed. Correct answers were determined based on the official key provided by the Center for Medical Education (CEM) in Łódź, Poland. Statistical analyses, including Pearson's chi-square test and the Mann-Whitney U test, were performed to evaluate the accuracy and confidence of ChatGPT's answers across different dental fields. Results GPT-4o correctly answered 141 out of 199 valid questions (70.85%) and incorrectly answered 58 (29.15%). The AI performed better in fields like Conservative Dentistry with Endodontics (71.74%) and Prosthetic Dentistry (80%) but showed lower accuracy in Pediatric Dentistry (62.07%) and Orthodontics (52.63%). A statistically significant difference was observed between ChatGPT's performance on clinical case-based questions (36.36% accuracy) and other factual questions (72.87% accuracy), with a p-value of 0.025. Confidence levels also varied significantly between correct and incorrect answers, with a p-value of 0.0208. Conclusions GPT-4o's performance in the LDEK suggests it has potential as a supplementary educational tool in dentistry. However, the AI's limited clinical reasoning abilities, especially in complex scenarios, reveal a substantial gap between AI and human expertise. While ChatGPT demonstrates strong performance in factual recall, it cannot yet match the critical thinking and clinical judgment exhibited by human candidates.

P-379 Fertility outcomes several years after fertility preservation for endometriosis

Abstract Study question To study the fertility outcomes of women who tried to conceive at least 2 years after fertility preservation (FP) for endometriosis. Summary answer To advise patients with endometriosis on the benefit of FP, particulary on the utilization rates of frozen oocytes and the actual chances of pregnancy What is known already Endometriosis is found in 25-40% of infertile patients. Due to the multiple and recurrent nature of lesions and the significant incidence of repeated ovarian surgery, endometriosis increase the risk of damaging the ovarian follicular stockpile. Since the revision of the French bioethics law (2014), women with endometriosis can be offered FP techniques. However, there is currently little data available in this population, limiting the possibility to establish formal recommendations Study design, size, duration A retrospective observational, bicentric cohort study conducted at Antoine Beclère and Jean Verdier University Hospitals.Inclusion criteria were: i) patients with confirmed endometriosis using imaging (pelvic MRI or ultrasound scan); ii) controlled ovarian hyperstimulation for FP between from July 1st 2013, and December 31st, 2019 (n = 200). The endpoint date was February 15, 2023, with data collected retrospectively. Participants/materials, setting, methods Cumulative incidences of pregnancy and live birth were calculated. Time to conception, time to utilization of oocytes, and predictive factors for pregnancy and live birth were assessed using logistic regression Cox models. Main results and the role of chance Among the 184 patients with available data after FP for endometriosis, 76 attempted to conceive (41%). The mean number of oocytes vitrified per patient were 14.7 ± 7.6 [8-20]. Patients attempting conception at least 2 years post-FP were more likely to have a partner at the first consultation (70.7% vs. 25.7%, p < 0.0001). Overall, 48 patients (43%) achieved a pregnancy, predominantly through spontaneous conception (50%), frozen-thawed oocytes (37.5%), or a new IVF attempt using fresh eggs (12.5%). Among those attempting conception, 31 (39%) reported a live birth. Cumulative chances of pregnancy at 4 years post-FP were estimated at 52% CI 95% [41% - 65%]. Utilization rates for frozen oocyteswere 7% CI 95% [4% - 12%] and 18% CI 95% [13% - 26%], respectively, 2 and 5 years post-freezing. Nulliparity was the only factor significantly associated with an increased probability of oocyte utilization (RR = 1.43 [1.0 - 2.06]). Limitations, reasons for caution The result should be interpreted with caution due to the small sample size of our study. Data were collected retrospectively and some information, concerning obstetrical and neonatal information where missing. Furthermore, the duration of the follow up time was too short to evaluate long-term fertility. Wider implications of the findings Despite endometriosis affecting fertility, our study revealed that half of pregnancies occurred spontaneously, irrespective of the endometriosis phenotype. These findings provide valuable insights into advising women on the utilization rates of frozen oocytes (7% to 18%) and the relatively high chances of natural conception after FP for endometriosis. Trial registration number NA

P-714 Prevalence of chromosomal abnormalities in oocyte donor candidates: a French survey of over 8200 karyotypes

Abstract Study question Is karyotyping worth considering for fertile and childless oocyte donor candidates? Summary answer Karyotyping reduces the genetic risk of utilizing oocytes with balanced structural chromosomal rearrangements for recipient couples. What is known already While some countries including France consistently advocate for karyotype to be routinely performed, others suggest it as optional, specifically advising it for donors with a medical history indicating chromosomal rearrangements. Ravel et al. have demonstrated a higher incidence of balanced structural chromosomal rearrangements among 1196 french fertile oocyte donor candidates (FODC) compared to unselected newborns, raising the question whether oocyte donor recruitment could be biased towards chromosomally at-risk women. In 2016, France authorized childless oocyte donor candidates (CODC) to enhance recruitment, yet as of now, there is no reported study on their genetic status. Study design, size, duration A retrospective observational multicentric study conducted from January 2005 to October 2021. Participants/materials, setting, methods ODC were recruited within the French CECOS (Centre d’Etude et de Conservation des Œufs et du Sperme humain) network. Both FODC and CODC were compared to a control group composed of female newborns from literature. Quantitative and qualitative data were expressed as the median [25%–75%] or n (‰), respectively. Non-parametric Mann-Whitney tests were employed for quantitative parameters, while Chi-square tests or Fisher’s exact tests were used, as appropriate, to compare frequencies between groups. Main results and the role of chance A total of 8229 ODC from 22 CECOS centers were included in this study. FODC (n = 6339) and CODC (n = 1890) were compared to 8102 control female newborns. In total, 65 chromosomal abnormalities (7.9‰) were identified, leading to the exclusion of the ODC. This outcome was comparable to the 53 abnormalities observed in the control group (6.54‰, p = 0.3059). The occurrence of balanced structural chromosomal rearrangements was increased in ODC population (4.8‰) compared to controls (2.34‰, p = 0.0086). The occurance of reciprocal translocations was increased 5-fold in CODC (3.70‰) compared to the control group (0.74‰, p = 0.013). The number of gonosomal mosaics was notably increased in FOCD, with 17 cases (2.68‰) compared to the control group with six cases (0.74‰, p = 0.0052). Among chromosomal aberration carriers only two childless women (one reciprocal translocation and one gonosomal mosaïc) had fertility issues in their medical history with a diagnosis of premature ovarian failure. Limitations, reasons for caution This retrospective study was designed to examine ODC within the framework of French bioethics laws. ODC should adhered to specific criteria: being volunteers, anonymous, aged 18 to 38, and without any financial compensation. Since 2016, donors were permitted to retain around 50% of their gametes for personal oocyte cryopreservation. Wider implications of the findings Karyotyping is a straightforward and cost-effective approach to identify structurally balanced chromosomal abnormalities. Thus, chromosomal analysis limits genetic risks whithout resorting to the ethically debated expanded genetic screening in the ODC population. Nevertheless, it is crucial to communicate to gamete recipients the inherent genetic risks associated with any conception. Trial registration number not applicable

Expectations and Vietnam’s responses during COVID-19: potential human rights violations and related propositions

Background It appears that underneath many propositions or actions, there might have been certain expectations. The reality of the complexity of human beings and interactions within a society yields expectations which, in turn, further interact with each other. Methods This paper offers the first in-depth study on ‘expectations’ in bioethical and health law studies, taking Vietnam’s responses to coronavirus disease (COVID-19) as an illustration. Results It defines ‘expectations’ as normative imaginaries that can induce or guide actions and inactions at individual and collective levels. Conclusions It argues that violations of human rights and certain related propositions within the Vietnamese context can be understood in terms of expectations. Within such contexts as Vietnam, expectations account for behaviours, including human rights violations. It suggests that ‘expectations’ is a fruitful concept for bioethical and health law studies. Studying expectations thus has implications for governance and future research agendas.

Chapter 9. Return to the revision of the bioethics law regarding the use of artificial intelligence in the field of medical imaging.

On the occasion of the sixth AI international Summit (November 22-24, 2023), Professor Daniel Rueckert (Technical University of Munich) replies to our questions on ethical issues raised by the use of artificial intelligence in medical imaging.

Conceptualizing expectations - Vietnam’s responses during COVID-19 as an illustration

Background A key part of the complexity of actual social life lies in the fact that it operates on a large web of not only prescribed norms and rules, but also explicit and especially implicit expectations which constantly interact with each other. Methods This paper offers the first in-depth study on ‘expectations’ in bioethical and health law studies, taking Vietnam’s responses to coronavirus disease (COVID-19) as an illustration. Results It defines ‘expectations’ as normative imaginaries that can induce or guide actions and inactions at individual and collective levels. Conclusions It suggests that ‘expectations’ is a fruitful concept for bioethical and health law studies because it helps better understand the complexity of interactions in society and patterns of thinking and acting of actors in real-world contexts. Studying expectations has implications for governance and future research agendas.

Strategy, Morality, Courage: Bioethics and Health Law after Dobbs.

Our paper examines what is required to protect and promote effective public discussion and policy development in the current climate of divisive disagreement about many public policy questions. We use abortion as a case example precisely because it is morally fraught. We first consider the changes made by Dobbs, as well as those which led up to the Dobbs decision, accompany it, and follow from it.

Charity Scott, Bioethics, and Health Law.

As Steve Kaminshine said in his comments at the symposium honoring Charity Scott, I was recruited to come to Georgia State University as a "Law and Bioethics" scholar who had spent more than sixteen years shuttling between an office in a hospital and another in a law school. But when I first visited Georgia State Law, I did not know that more than ten years earlier Charity Scott had spent the better part of an academic year living and breathing clinical ethics at Grady Memorial Hospital.1 Because of her usual habit of immersion in all learning experiences, in that year Charity gained more insight into how hospitals work and how physicians behave when they are knee deep in their professional milieu of life and death decision-making than many full-time bioethics academics do in a career. For the rest of her career Charity kept one foot well planted in the medical context, as an advisor in problems of research ethics, as a teacher in her own medical-legal partnership structured around real-life clinical problems, and as an ethical analyst who could never be accused of mouthing a mantra of phrases, the "vacuous incantation of abstract principles"2 that might pass for bioethics discourse in some circles.

Conscience of Science: Ethical Imperatives in Zoological Research

Zoological science is an intricate field which requires intimate considerations and guidelines to make sure that limits and boundaries are set for the ethical and humane conduction of research. A number of bioethical laws and international conventions have been designed by bioethical and committees and review boards that serve as moral compass steering towards responsible and humane scientific research. Animal Welfare Act (AWA) sets standards for the responsible treatment of animals in research, transport, exhibition and animal dealers, handling and research protocols, Guide for the Care and Use of Laboratory Animals that is published by National research Council of Unites States provides a framework for the proper use and optimal care of animals for in vivo research in laboratory experiments [1]. Similarly, European Union Directive 2010/63/EU is a directive which outlines the standards for the animal protection used for research purposes in the Europe. It states 3Rs of animal testing i.e., Refinement, Reduction and Replacement, and necessitates that researchers consider alternatives before resorting to the animal experiments. An elaborate directive, Declaration of Helsinki, primarily focuses on human research ethics but has principle related o animal research ethics as well [2]. Likewise, another Convention on International Trade in Endangered Species of Wild Fauna and Flora also called as CITES, deals with the trade of endangered animals ensuring that any research which involves endangered species is conducted ethically with proper permits and prevents illegal and unethical exploitation of animals [3]. Last but not the least, the ARRIVE guidelines provide a checklist of essential information which must be included while publishing the research data which describes animal experiments, promotes transparency and improve the quality of reporting in the animal research. The current global conditions necessitate ethical consciousness in zoological research. These considerations extend beyond laboratory settings and encompass wildlife conservation and the prevention of zoonotic diseases such as COVID-19. Innovations in non-invasive research methods, genetic analyses, and data-driven insights pave the way for more ethical and efficient scientific practices. Ethical consciousness aligning with the pursuit of knowledge nurtures a landscape where wonder of discovery and the ethical treatment of animals walk hand in hand.

The revision of the Bioethics Act, two years on: major principles and consequences for practice in the reproductive biology laboratory

Since 1994, in France, bioethics law has set the regulatory framework for Medically Assisted Reproduction (MAR). The latest revision of the law of August 2, 2021, is characterized by major upheavals in the field of MAR and intervenes in several areas: the purpose and conditions to access to MAR, access to origins in the case of gamete or embryo donation, and gametes cryopreservation without medical indication. Indeed, the law authorizes, because of a strong societal demand, the extension of sperm donation to couples of women and unmarried women, as well as the possibility for any person to preserve his/her gametes if he/she meets the age criteria defined by decree. Finally, the law opens the possibility for people born following gamete or embryo donation to have access, from their 18th anniversary, to identifying and/or non-identifying data. These new measures have led to a very important number of MAR requests to fertility and donation centers, and have required the implementation of new circuits in order to harmonize care, without discrimination or prioritization.

Bioethics and human rights: international legal regulation and the role of international organizations

The article deals with general debatable issues in the field of bioethics and bioethical law, discusses the guidelines of international organizations on the appointment, principles of organization and functioning of ethical committees on bioethics of various types. Short research includes a legal analysis of the activities of international organizations on issues of protection of human rights in the field of biomedical research. Analyzed and proposed сclassification of bioethics ethics committees according to the level at which they operate, according to the tasks to be solved, according to the level of coverage (national, regional, local), the degree of development of bioethics ethics committees in the Republic of Moldova. The role of international non-governmental organizations in the regulation of bioethical issues.

Assisted reproductive technology in France: The reproductive rights of LGBT people

BackgroundIn 2021, France authorized ART with sperm donor for female couples and single women. ObjectivesWe summarize here the possibilities of ART among LGBT people in France to date, pointing out the main restrictions for LGBT reproductive rights, requiring future legislative changes. ResultsDespite the latest modification of the French bioethics laws which notably opens ART to female couples, French legislation still excludes most LGBT people from parenthood through ART, especially gay men and transgender people in most cases. Surrogacy, ROPA, co-parenting and directed sperm donation are banned. ConclusionsLegalize ROPA and overcome gender issues for trans people are necessary. A French model of surrogacy is to be considered.

Conclusions et ouverture : dialogue intergénérationnel

As the bioethics law has just been voted, several actors during this academic conference have examined the paradigm shift introduced by this resolutely liberal law from their respective perspectives. Using a reading grid inherited from Pascal’s orders, the different dimensions of moral, political, legal, and scientific discourse are used as a reference to evaluate an often highly contrasting discourse. The evolution of the paradigm from bioethics law to zoethics law, in search of social legitimacy and of a response to individual desires, constitutes a turning point in the revision of bioethics laws. Under these conditions, does bioethics law does not lose its universal purpose?

Chapitre 2. La loi de bioéthique : un enjeu de démocratie sanitaire

The law of bioethics defines the judicial framework for governing medical practices and research involving the human body and the embryo. Does any scientific or technologic innovation warrant a modification of the law? To respond to this question, a preliminary reflection is necessary so as to define new equilibria which respect ethical principles, the promotion of solidarity with respect for the autonomy of each person.The CCNE is charged with organizing public debate, in the form of a general assembly of bioethics, with the support of regional spaces of ethical reflection. This extensive experience took place from January to June 2018 and lead to several lessons, notably the strong expression of a need for information and a critical vision of the notion of medical progress.Then, the parliamentary instruction and hearings that accompanied it, from 24 July 2019 to 2 August 2021, contributed developments to the initial bill. Thus, the periodic review of the law of bioethics is now based on citizen participation in the construction of legislative arbitration, demonstrating the French way of social participation.

Chapitre 5. Réalité et ambitions de la démocratisation des lois bioéthiques

Bioethics laws have many particularities because of the technicity and sensitivity of the questions tackled. First, their revision is planned to be made within seven years. Second, since 2011, this revision must be preceded by a public debate called “États généraux de la bioéthique” which aims to involve all part of the society, from experts to uninitiated.The law regarding bioethics enacted on the 2nd of august 2021, is relevant on this point in two ways. First, it is the first law made after the requirements of 2011. It is therefore possible to assess the mild impact of public debate on law-making and decisions. Second, the changes made by the law enacted in 2021 allow us to identity the means mobilized to reinforce and perpetuate public participation in the field of bioethics.