Ethics teaching in medical school: the perception of medical students.

BACKGROUND: In times of a pandemic, morals and ethics take center stage. Due to the challenges of the pandemic and ongoing discussions about the end of life, student teaching demands might have changed. This study aimed to evaluate teaching ethics, law, and decision-making skills in medical education via a survey to customize the curriculum to the students' needs. Furthermore, gender differences were examined to determine gender equality in medical education. METHODS: The medical students at the Medical University of Vienna were requested to complete an anonymous online survey, providing feedback on the teaching of ethics, law, and decision-making skills. RESULTS: Our study showed the students' strong demand for more teaching of ethics, law, and decision-making skills. Moreover, we found that students were afraid to encounter ethical and moral dilemmas. Gender differences could be found, with female students assessing their knowledge and the teaching as being more insufficient, resulting in greater fear of encountering ethical and moral dilemmas. CONCLUSION: The fear of encountering ethical and moral dilemmas might be linked to medical students' self-perceived insufficient legal knowledge. The education should guarantee gender equality in medical training and be customized to the students to provide the future doctors with the ethical and legal expertise to preserve the patient's rights and protect their mental health.

Volunteers for clinical trials: from the history of abuses and exploitation to the inclusion movement, and to an income resource / Voluntários para ensaios clínicos: de uma de história de abusos e exploração até o movimento de inclusão e fonte de renda / Voluntarios para ensayos clínicos: de una historia de abusos y explotación hasta el movimiento de inclusión y fuente de renta

Medical research is essential to develop new and better therapies, increase social standards and a better life for all of us. Scientific curiosity has helped to achieve many successful innovations, but history also demonstrates that research can lead to abuses of individuals neglecting autonomy and integrity of the human being. Since the 1960ies we have witnessed a continuous development of international regulations and ethics guidelines (soft law) in medical research, leading to a higher quality of scientific results. An important focus lies on recognizing human vulnerability and a therefore adapted informed consent procedure. Our modern clinical trials structure requires the inclusion of healthy volunteers in the first phases of the development of a new medicinal product, leading to new ethical questions and challenges. The Corona-Pandemic has accelerated vaccine development in a successful way also leading to a new importance of healthy volunteers in the medical research landscape.

A pesquisa médica é essencial para desenvolver novas e melhores terapias, aumentar os padrões sociais e uma vida melhor para todos nós. A curiosidade científica ajudou a alcançar muitas inovações bem-sucedidas, mas a história também demonstra que a pesquisa pode conduzira abusos de indivíduos, negligenciando a autonomia e a integridade do ser humano. Desde a década de 1960, temos testemunhado um desenvolvimento contínuo de regulamentos internacionais e de diretrizes éticas (soft law) em pesquisa médica, levando a resultados científicos de maior qualidade. Um foco importante está no reconhecimento da vulnerabilidade humana e, consequentemente, num procedimento de consentimento informado adaptado. A nossa estrutura moderna de ensaios clínicos requer a inclusão de voluntários saudáveis nas primeiras fases do desenvolvimento de um novo medicamento, suscitando novas questões e desafios éticos. A pandemia de coronavírus acelerou o desenvolvimento de vacinas de uma forma bem-sucedida, contribuindo também para uma maior importância de voluntários saudáveis no cenário da pesquisa médica.

La investigación médica es esencial para desarrollarterapias nuevas y mejores, aumentar los estándares sociales y una vida mejor para todos nosotros. La curiosidad científica ha ayudado a lograr muchas innovaciones exitosas, pero la historia también demuestra que la investigación puede conducir a abusos deindividuos que descuidan la autonomía y la integridad del ser humano.Desde la década de 1960 hemos sido testigos de un desarrollo continuo de las regulaciones internacionales y de las directriceséticas(soft law) en la investigación médica, lo que ha llevado a una mayor calidad de los resultados científicos. Un enfoque importante radica en el reconocimiento de la vulnerabilidad humana y, por lo tanto, en un procedimiento de consentimiento informado adaptado.Nuestra moderna estructura de ensayos clínicos requiere la inclusión de voluntarios sanos en las primeras fases del desarrollo de un nuevo medicamento, lo que genera nuevas cuestiones y desafíos éticos. La pandemia de coronavirus ha acelerado el desarrollo de vacunas de una manera exitosa, lo que también ha dado lugar a una nueva importancia de los voluntarios sanos en el panorama de la investigación médica.

Targeted COVID-19 Vaccination (TAV-COVID) Considering Limited Vaccination Capacities-An Agent-Based Modeling Evaluation.

(1) Background: The Austrian supply of COVID-19 vaccine is limited for now. We aim to provide evidence-based guidance to the authorities in order to minimize COVID-19-related hospitalizations and deaths in Austria. (2) Methods: We used a dynamic agent-based population model to compare different vaccination strategies targeted to the elderly (65 ≥ years), middle aged (45-64 years), younger (15-44 years), vulnerable (risk of severe disease due to comorbidities), and healthcare workers (HCW). First, outcomes were optimized for an initially available vaccine batch for 200,000 individuals. Second, stepwise optimization was performed deriving a prioritization sequence for 2.45 million individuals, maximizing the reduction in total hospitalizations and deaths compared to no vaccination. We considered sterilizing and non-sterilizing immunity, assuming a 70% effectiveness. (3) Results: Maximum reduction of hospitalizations and deaths was achieved by starting vaccination with the elderly and vulnerable followed by middle-aged, HCW, and younger individuals. Optimizations for vaccinating 2.45 million individuals yielded the same prioritization and avoided approximately one third of deaths and hospitalizations. Starting vaccination with HCW leads to slightly smaller reductions but maximizes occupational safety. (4) Conclusion: To minimize COVID-19-related hospitalizations and deaths, our study shows that elderly and vulnerable persons should be prioritized for vaccination until further vaccines are available.

From scientific exploitation to individual memorialization: Evolving attitudes towards research on Nazi victims' bodies.

During the Third Reich, state-sponsored violence was linked to scientific research on many levels. Prisoners were used as involuntary subjects for medical experiments, and body parts from victims were used in anatomy and neuropathology on a massive scale. In many cases, such specimens remained in scientific collections and were used until long after the war. International bioethics, for a long time, had little to say on the issue. Since the late 1980s, with a renewed interest in the Holocaust and other Nazi crimes, a consensus has increasingly taken hold that research on human tissues and body parts from the Nazi era is inadmissible, and that such specimens should be removed from scientific collections and buried. The question of what to do with scientific data obtained from these sources has not received adequate attention, however, and remains unsolved. This paper traces the history of debates about the ethical implications of using human tissue or body parts from the Nazi period for scientific purposes, primarily in the fields of anatomy and neuropathology. It also examines how this issue, from after the war until today, influenced the establishment of legal and bioethical norms on the use of human remains from morally tainted sources, with a particular emphasis on Germany and Austria. It is argued that the use of such specimens and of data derived from them is unethical not only because of potential harms to posthumous rights of the victims, but also because such use constitutes a moral harm to society at large.

The Medical University of Vienna and the legacy of Pernkopf's anatomical atlas: Elsevier's donation of the original drawings to the Josephinum.

Eduard Pernkopf (1888-1955) became head of the Second Anatomical Institute in 1933, dean of the medical faculty in 1938 with the Annexation of Austria into Nazi Germany, and rector of the University of Vienna in 1943. He gained worldwide recognition with his anatomical atlas, which many consider unequaled to this day. In the decades that followed, suspicion arose that the drawings were made using corpses of people who had been victims of Nazi persecution and, following international inquiries and critique, the University of Vienna appointed a historical commission to the matter. The commission published its results in 1998, concluding that anatomical specimens used for the illustrations in Pernkopf's atlas had in all likelihood been made using corpses of victims of the Nazi judicial system. In total, the Anatomical Institute received the corpses of at least 1377 executed people, including many members of the anti-Nazi resistance. Through the acquisition of Pernkopf's original publisher Urban & Schwarzenberg in 2003, the original drawings and the publishing rights went to Elsevier. While existing copies of Pernkopf's Anatomy remain in use, printing or licensing of the atlas or its illustrations were stopped in 1994, inducing an effective ban on publishing the illustrations in other contexts, for example in works dealing with history and ethics of anatomy. In December 2019, Elsevier donated the remaining original drawings and proofs to the Medical University of Vienna, ensuring that these returned to the institution where they originated. They are now part of the university's historical collections held at the Josephinum. Moreover, the transfer of the originals to Vienna ensures appropriate archiving and conservation, cataloging and digitization, as well as access to the illustrations for historical and related research.

Development of sustainable research excellence with a global perspective on infectious diseases: Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon.

Medical research in sub-Saharan Africa is of high priority for societies to respond adequately to local health needs. Often enough it remains a challenge to build up capacity in infrastructure and human resources to highest international standards and to sustain this over mid-term to long-term periods due to difficulties in obtaining long-term institutional core funding, attracting highly qualified scientists for medical research and coping with ever changing structural and political environments. The Centre de Recherches Médicales de Lambaréné (CERMEL) serves as model for how to overcome such challenges and to continuously increase its impact on medical care in Central Africa and beyond. Starting off as a research annex to the Albert Schweitzer Hospital in Lambaréné, Gabon, it has since then expanded its activities to academic and regulatory clinical trials for drugs, vaccines and diagnostics in the field of malaria, tuberculosis, and a wide range of poverty related and neglected tropical infectious diseases. Advancing bioethics in medical research in Africa and steadily improving its global networks and infrastructures, CERMEL serves as a reference centre for several international consortia. In close collaboration with national authorities, CERMEL has become one of the main training hubs for medical research in Central Africa. It is hoped that CERMEL and its leitmotiv "to improve medical care for local populations" will serve as an inspiration to other institutions in sub-Saharan Africa to further increase African capacity to advance medicine.

What Should Be Done with Pernkopf's Anatomical Illustrations?: A Commentary from the Medical University of Vienna.

Thanks to a recent donation by Elsevier, the Medical University of Vienna now holds in its collections the known existing original paintings for Eduard Pernkopf's Atlas of Topographical and Applied Human Anatomy. The work is widely considered a pinnacle of the art of anatomical illustration. However, it is severely tainted by its historical origins. Pernkopf was a high-ranking National Socialist and co-responsible for the expulsion of hundreds of Jewish scientists and students from the university. Also, the Vienna Institute of Anatomy, which Pernkopf headed, received during the war the bodies of at least 1377 people executed by the regime, many for their political views or acts of resistance, including at least seven Jewish victims. Although it is impossible to individually identify the people used for the atlas, it is to be assumed that a considerable number of the paintings produced during and after the war are based on the bodies of these victims. Against this background, and out of respect for the victims, use of Pernkopf's atlas and its illustrations in medical teaching, training and practice should be - wherever possible without compromising medical outcomes - reduced to a minimum. Given the high variability of human anatomy, even the most detailed anatomical illustrations cannot replace teaching and training in the dissection room. As the experience at the Medical University of Vienna and elsewhere demonstrates, Pernkopf's atlas is far from irreplaceable. In keeping with the stipulations of the contract of donation, the Medical University of Vienna considers the Pernkopf originals primarily as historical artifacts, which will support the investigation, teaching and commemoration of this dark chapter of the history of medicine in Austria, out of a sense of responsibility towards the victims.

COVID-19 and ethical preparedness?

Mankind has to prepare for a pandemic with respect to medical and practical aspects, but also with respect to ethical issues. There are various ethical guidelines for managing infectious disease outbreaks, but they do not apply to the specific aspects of the COVID-19 pandemic, since they were formulated after the different kinds of outbreaks of avian influenza and Ebola. Today we are confronted with completely new issues endangering our fundamental human rights. As COVID-19 is spreading all over the world, we are in a desperate situation to find treatment solutions; however, despite the urgency, scientific rules have to be applied as bad science is unethical since it might be harmful for patients. Fake news and alternative facts might not be easily recognized and are also threatening scientific values. Pandemics might be leading to a meltdown of the health system if no measures are being taken constraining fundamental human rights. Tracking of persons is violating human rights as well if not accepted on a voluntary basis. A failure to have safeguards for times of crisis leads to a scarcity of medicinal products and goods resulting in a nationalistic approach and ignorance of international solidarity. And last but not least selective measures and triage in intensive care have to be taught to young physicians and nursing staff in medical schools in order to be prepared in times of an infectious disease outbreak and scarcity of resources.

Correction to: White paper: statement on conflicts of interest.

The original version of this article unfortunately contained a mistake.

White paper: statement on conflicts of interest.

INTRODUCTION: Conflicts of interest are a normal part of human social intercourse. They become problematic when there is a power differential between participants in the setting of relationships requiring a high degree of trust, as in healthcare. In this white paper we consider how these conflicts may be detected and mitigated. METHODS: Following Medline search and reference chaining, we undertook a narrative review of the literature with iterative discussion. RESULTS: Conflicts of interest may be financial, professional or personal, and may operate at the level of the individual or the organisation. Unmanaged, they become a source of bias which places the interests of the professional or the organisation before those of the patient. Reported with increasing frequency, conflicts damage trust, harm patients, and defraud the health system. We make 15 recommendations for minimising conflicts of interest. CONCLUSIONS: Nationally funded open-access registries should be established to permit complete disclosure of financial, professional, and personal relationships with the potential for driving bias in research, clinical practice, or health management. Governance of disclosure should be the responsibility of employing organisations through annual staff appraisals, audited by national research integrity committees. Research fraud should incur suspension of the license to practice. Organisations should monitor staff perceptions of ethical climate to enhance awareness of staff behaviours and the potential for misconduct driven by academic pressures. Clear separation of advisory and voting roles is needed in best practice guideline panels. Professional societies and scientific journals should display conflict of interest policies for their own staff and officers as well as for speakers and authors. Undergraduates should not be exposed to pharmaceutical promotions masquerading as education. Undergraduate and postgraduate training programmes should include teaching about managing conflicts of interest and identifying research misconduct.

Sharing and reuse of individual participant data from clinical trials: principles and recommendations.

OBJECTIVES: We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. DESIGN AND METHODS: This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. OUTCOME: We developed principles and practical recommendations on how to share data from clinical trials. RESULTS: The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata. CONCLUSIONS: The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.

Fostering responsible research with genome editing technologies: a European perspective.

In this consensus paper resulting from a meeting that involved representatives from more than 20 European partners, we recommend the foundation of an expert group (European Steering Committee) to assess the potential benefits and draw-backs of genome editing (off-targets, mosaicisms, etc.), and to design risk matrices and scenarios for a responsible use of this promising technology. In addition, this European steering committee will contribute in promoting an open debate on societal aspects prior to a translation into national and international legislation.