Good practice in medicine and biology: scientific integrity needs global bioethics.

We consider scientific integrity to constitute a new theory of morality of science, in a very specific deontological sense. Indeed, at least in practice, scientific integrity extends beyond scientific concerns, seeking to develop specific moral duties and/or procedures based on general moral values and/or standards, leading to common moral frameworks for usual scientific practices. This is, of course, necessary. Contemporary history has shown us only too well that usual scientific practices need common moral frameworks, especially in medicine and biology. However, like scientific practices, and medical and biological practices in particular, the persistence of certain moral values and/or standards and the priority attributed to them, can change significantly, due to changes in society, people, the times and/or environments, and they may be under strong tension. We therefore believe that a new theory of ethics of science, in a very specific teleological sense, may be required in this case, particularly in medicine and biology, in addition to scientific integrity. This ethical theory, through research, professionals and structures in ethics of science also called medical ethics, research ethics or bioethics in the fields of medicine and biology, should seek to identify and find specific ethical solutions to these tensions, applicable at a particular place and time, based on common ethical purposes and/or consequences. As a result, these specific ethical solutions may, or may not, lead to an evolution of common moral frameworks, which may, or may not, be developed on the basis of scientific integrity. In the fields of medicine and biology, this ethical theory is closely related to another theory, global bioethics, but with a number of new conceptual and methodological developments.

Cancer and COVID-19: ethical issues concerning the use of telemedicine during the pandemic.

The lockdown imposed in France during the first wave of the COVID-19 pandemic wreaked havoc with access to healthcare. From March 2020 onwards, the oncologists of Foch Hospital, like many others at hospitals throughout the world, were obliged to adapt to the new conditions, including, in particular, the impossibility of seeing patients in classic consultations for the diagnosis and treatment of cancer. Patients with cancer are particularly susceptible to this new virus, due to their immune status, and this made it difficult to carry out standard hospital visits for these patients. Some patients refused to come to the hospital, whereas the doctors decided, for others, that consultation conditions at the hospital were not sufficiently safe, with sanitary measures that had yet to be precisely defined. Telemedicine was one of the adaptations adopted during this period. This mode of consultation was little used before the pandemic, for various reasons, and reimbursement was not automatic. This new approach proved to have limitations as well as advantages, as demonstrated by our empirical ethics research study, a retrospective qualitative survey of the doctors of the oncology and supportive care departments of Foch Hospital, performed during July 2021. The interview grid was based on the studies on telemedicine, oncology, COVID-19 and empirical ethics available at the time. Based on the experience gained in this domain during the first wave of the epidemic, which hit France between March and June 2020, we identified three eligibility criteria for consultations in telemedicine: the consultation concerned should not be the first consultation, the patient should be a known patient that the doctor trusts not to minimize the description of symptoms, and the results of the patient's evaluations and examinations must be good. It may be appropriate to continue the use of teleconsultation in the future, provided that these criteria are respected.

From a voluntary vaccination policy to mandatory vaccination against COVID-19 in cancer patients: an empirical and interdisciplinary study in bioethics.

BACKGROUND: At the start of 2021, oncologists lacked the necessary scientific knowledge to adapt their clinical practices optimally when faced with cancer patients refusing or reluctant to be vaccinated against COVID-19, despite the marked vulnerability of these patients to severe, and even fatal forms of this new viral infectious disease. Oncologists at Foch Hospital were confronted with this phenomenon, which was observed worldwide, in both the general population and the population of cancer patients. METHODS: Between April and November 2021, the Ethics and Oncology Departments of Foch Hospital decided to investigate this subject, through an empirical and interdisciplinary study in bioethics. Our scientific objective was to try to identify and resolve the principal bio-ethical issues, with a view to improving clinical practices in oncology during future major pandemics of this kind, from a highly specific bio-ethical standpoint (= quality of life/survival). We used a mainly qualitative methodological approach based on questionnaires and interviews. RESULTS: In April 2021, 29 cancer patients refused or were reluctant to be vaccinated (5.6%; 29/522). Seventeen of these patients said that making vaccination mandatory would have helped them to accept vaccination. In October 2021, only 10 cancer patients continued to maintain their refusal (1.9%; 10/522). One of the main reasons for the decrease in refusals was probably the introduction of the "pass sanitaire" (health pass) in July 2021, which rendered vaccination indispensable for many activities. However, even this was not sufficient to convince these 10 cancer patients. CONCLUSION: We identified a key bio-ethical issue, which we then tried to resolve: vaccination policy. We characterized a major tension between "the recommendation of anti-COVID-19 vaccination" (a new clinical practice) and "free will" (a moral value), and the duty to "protect each other" (a moral standard). Mandatory vaccination, at least in France, could resolve this tension, with positive effects on quality of life (i.e. happiness), or survival, in cancer patients initially refusing or reluctant to be vaccinated, but only if collective and individual scales are clearly distinguished.

[Precariousness, access to care and home support, a coordination support system]. / Maintien à domicile, un dispositif d'appui à la coordination.

In their daily practice, professionals are called upon to meet older people who are more in distress than others. In order to best meet their needs, it is necessary first to define these difficulties and then to consider the mechanisms that can provide assistance adapted to the requirements and needs of the people. Access to hospital health care services and coordination support mechanisms, as defined by the law of 26 July 2019, can contribute to this assistance, without criteria limiting access to care. Examples of prevention and coordination actions carried out by the Access to Health Care, Rights and Education Network.

French-style genetics v. 2.0: The "e-CohortE" project.

In the digital age, a genetics cohort has become much more than a simple means of determining the cause of a disease. Two-sided markets, of which 23andMe, Ancestry DNA and MyHeritage are the best known, have showed this perfectly over the last few years: a cohort has become a means of producing massive amounts of data for medical, scientific and commercial exploitation, and for genetic use in particular. French law does not currently allow these foreign private companies to develop on French national territory and also forbids the creation of similar entities in France. However, at least in theory, this same law does not preclude the creation of new types of cohorts in France inspired by the success of two-sided markets but retaining features specific to the French healthcare management system. We propose an optimal solution for France, for genomic studies associated with multi-subject questionnaires, still purely theoretical for the moment: the development, with no need for any change in the law, of France's own version of "Genetics v.2.0": "e-CohortE."

Genetic Data, Two-Sided Markets and Dynamic Consent: United States Versus France.

Networks for the exchange and/or sharing of genetic data are developing in many countries. We focus here on the situations in the US and France. We highlight some recent and remarkable differences between these two countries concerning the mode of access to, and the storage and use of genetic data, particularly as concerns two-sided markets and dynamic consent or dynamic electronic informed consent (e-IC). This brief overview suggests that, even though the organization and function of these two-sided markets remain open to criticism, dynamic e-IC should be more widely used, especially in France, if only to determine its real effectiveness.

Innovation in Surgery: Qualitative Analysis of the Decision-Making Process and Ethical Concerns.

BACKGROUND: Surgical innovation from surgeon's standpoint has never been scrutinized as it may lead to understand and improve surgical innovation, potentially to refine the IDEAL (Idea, Development, Exploration, Assessment, Long-term Follow-up) recommendations. METHODS: A qualitative analysis was designed. A purposive expert sampling was then performed in organ transplant as it was chosen as the ideal model of surgical innovation. Interviews were designed, and main themes included the following: definition of surgical innovation, the decision-making process of surgical innovation, and ethical dilemmas. A semistructured design was designed to analyze the decision-making process, using the Forces Interaction Model. An in-depth design with open-ended questions was chosen to define surgical innovation and ethical dilemmas. RESULTS: Interviews were performed in 2014. Participants were 7 professors of surgery: 3 in liver transplant, 2 in heart transplant, and 2 in face transplant. Saturation was reached. They demonstrated an intuitive understanding of surgical innovation. Using the Forces Interaction Model, decision leading to contemporary innovation results mainly from collegiality, when the surgeon was previously the main factor. The patient is seemingly lesser in the decision. A perfect innovative surgeon was described (with resiliency, legitimacy, and no technical restriction). Ethical conflicts were related to risk assessment and doubts regarding methodology when most participants (4/7) described ethical dilemma as being irrelevant. CONCLUSIONS: Innovation in surgery is teamwork. Therefore, it should be performed in specific specialized centers. Those centers should include Ethics and Laws department in order to integrate these concepts to innovative process. This study enables to improve the IDEAL recommendations and is a major asset in surgery.

Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine.

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with "genomic medicine" nor with "precision medicine", but with "data medicine" (DM) (big data, data mining). The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The "transformation" of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision of care. Molecular tumor boards (MTB) are one response to these changes and are now providing better access to next-generation sequencing (NGS) and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent (IC) documents at all academic medical centers and to introduce dynamic and electronic informed consent (e-IC).

Ethical reflections on the principle of patient autonomy.

In a world open to the movement of people, medical ethics is today associated with the area of loyal behavior of the practitioner and oriented in the patient's interest and accountability of each. The universal vision of respect for the dignity of the sick person progresses. Yet, many behaviours are sometimes illegitimate, but not in principle legally reprehensible. One of the main principles marking the observance of patient consent is based on the autonomy given to the patient to decide for himself what appears to be adapted to his or her care. The patient must be the one who makes the final decision on issues concerning them and doctors must act to respect it. Therefore, they must accept that the patient has a different value system.

Partnering with patients in translational oncology research: ethical approach.

BACKGROUND: The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. METHODS: Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. RESULTS: The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. CONCLUSIONS: Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses the concept of translational ethics as a way to handle the main remaining gap between combining care and research activities in the medical pathway and the existing framework.

Supportive Care Organization in France: a national in-depth survey among patients and oncologists.

PURPOSE: Medical doctors' (MDs), but not patients', perception of supportive care in cancer (SCC) in France has been previously assessed in a national survey. This study evaluated MDs and patients' perceptions of the SCC organization and implementation in France. METHODS: The French SCC Association conducted two observational studies: study 1 (S1), containing a 30-point questionnaire sent to 2263 MDs, and study 2 (S2), containing a 40-point questionnaire sent to 2000 patients. RESULTS: Overall, 711 MDs completed S1 and 1562 patients completed S2. In S1, 81% of MDs reported relying on a SCC organization and 76% attended SCC multidisciplinary discussions. MDs considered palliative (98%), psychological (98%), and social care (98%) as the top 3 SCC areas of importance for patients. In contrast, patients' priorities were psychology (61%), nutrition (55%) and organization of intake consultations (55%). The concept of SCC was familiar to 34% of patients; according to MDs, this concept was introduced mainly by MDs (78%) and admission nurses (41%). Outpatients identified as professional resources for SCC information general practitioners (84%), nurses (58%), and pharmacists (52%). Patients reported supportive treatment being prescribed in 63% of cases, with 64% receiving information on the negative side-effects. Among MDs, 87% reported proposing palliative and 41% adjuvant SCC treatment. Furthermore, 72% of MDs recommended SCC treatment at the metastatic stage, and 36% immediately following diagnosis. DISCUSSION: Oncologists play a vital role in enhancing SCC efficacy. This can be increased by implementing a multidisciplinary integrated approach or by assuring the availability of patient information.

Could Ethical Tensions in Oral Healthcare Management Revealed by Adults with Intellectual Disabilities and Caregivers Explain Unmet Oral Health Needs? Participatory Research with Focus Groups.

BACKGROUND: Cognitively impaired patients often present poor oral health status that may be explained by ethical tensions in oral healthcare management. This participatory study explored such tensions among adults with intellectual disabilities and with caregivers. The second objective was to specify, with caregivers, the points that should be developed in a future study among dentists. MATERIALS AND METHODS: Three focus groups involving adults with intellectual disabilities, family caregivers and professional caregivers were organized in France in 2013. RESULTS: The thematic content analysis identified discrepancies between experiences and expectations, which were particularly marked for the dentist's competence and attitudes, the dentist's role in decisions, the dental care management and the French socio-political context. CONCLUSIONS: These discrepancies could partly explain multiple attempts to find the 'right' dentist or the fact that care was abandoned, and could at least contribute to oral health needs being unmet.

[An example of a network supporting elderly people]. / Un exemple de réseau au service des personnes âgées.

One of a health network's main missions is to favour access to care and to decompartmentalise the management of patients' treatment. With regard to the coordination of the pathways of elderly people, the 'Access to Care, Access to Rights, Health Education' network operating in the Hauts-de-Seine region aims to support health professionals in establishing and coordinating the health pathway of people in complex situations. It is a question of trust, cooperation, multi-professionality and exchanges.

23andMe: a new two-sided data-banking market model.

BACKGROUND: Since 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals (90% participating in research), through a direct-to-consumer (DTC) online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration (FDA) halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States (US). However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. Furthermore, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status, and, more recently, to provide consumers with "carrier status" information for 35 genes known (with high levels of confidence) to cause disease. DISCUSSION: In this Debate, we highlight the likelihood that the primary objective of the company was probably two-fold: promoting itself within the market for predictive testing for human genetic diseases and ancestry at a low cost to consumers, and establishing a high-value database/biobank for research (one of the largest biobanks of human deoxyribonucleic acid (DNA) and personal information). By dint of this marketing approach, a two-sided market has been established between the consumer and the research laboratories, involving the establishment of a database/DNA biobank for scientific and financial gain. We describe here the profound ethical issues raised by this setup.