On Dolly and the scandalous nature of life sciences and Where bioethics really begins.

25 years ago, Dolly the sheep and the cloning issue stood in the focus of widespread and heated societal and ethical discussions that, for the bigger part, were not rational. In the aftermath of Dolly, in Europe bioethics was established as a discipline that is hyper-sceptical critic of science. Bioethics seen from the point of view of science is nebulous to many researchers, such as Lewis Wolpert, who called bioethics "a gross load of nonsense". It appears that the image of science in bioethics and society has as much suffered and moved away from the factual truth, as the image of bioethics and society has suffered in science since the Dolly event. It is time to return to a reasonable view of science, bioethics and society - and of Dolly the sheep.

A conceptual model for students' satisfaction with team-based learning using partial least squares structural equation modelling in a faculty of life sciences, in the United Kingdom.

PURPOSE: Students' satisfaction is an essential element in higher education. This study aimed to identify paths and predictive power of students' satisfaction during team-based learning (TBL) activities in the faculty of life sciences using partial least squares structural equation modelling (PLS-SEM). METHODS: In 2018-2019, at the University of Sussex (Falmer, UK), 180 life science students exposed to TBL were invited to participate in the study. Team-Based-Learning-Student-Assessment-Instrument was used. A conceptual model was developed for testing six hypotheses. H1: What was the effect of TBL on student satisfaction? H2: What was the effect of lectures on student satisfaction? H3: What was the effect of TBL on accountability? H4: What was the effect of lectures on accountability? H5: What was the effect of accountability on student satisfaction? H6: What were the in-sample and out-of-sample predictive power of the model? The analysis was conducted using the PLS-SEM approach. RESULTS: Ninety-nine students participated in the study giving a 55% response rate. Confirmatory tetrad analysis suggested a reflective model. Construct reliability, validity, average extracted variance, and discriminant validity were confirmed. All path coefficients were positive, and 5 were statistically significant (H1: ß=0.587, P<0:001; H2: ß=0.262, P<0.001; H3: ß=0.532, P<0.001; H4: ß=0.063, P=0.546; H5: ß=0.200, P=0.002). The in-sample predictive power was weak for Accountability, (R2=0.303; 95% confidence interval [CI], 0.117-0.428; P<0.001) and substantial for Student Satisfaction (R2=0.678; 95% CI, 0.498-0.777; P<0.001). The out-of-sample predictive power was moderate. CONCLUSION: The results have demonstrated the possibility of developing and testing a TBL conceptual model using PLS-SEM for the evaluation of path coefficients and predictive power relative to students' satisfaction.

Research misconduct in health and life sciences research: A systematic review of retracted literature from Brazilian institutions.

BACKGROUND: Measures to ensure research integrity have been widely discussed due to the social, economic and scientific impact of research integrity. In the past few years, financial support for health research in emerging countries has steadily increased, resulting in a growing number of scientific publications. These achievements, however, have been accompanied by a rise in retracted publications followed by concerns about the quality and reliability of such publications. OBJECTIVE: This systematic review aimed to investigate the profile of medical and life sciences research retractions from authors affiliated with Brazilian academic institutions. The chronological trend between publication and retraction date, reasons for the retraction, citation of the article after the retraction, study design, and the number of retracted publications by author and affiliation were assessed. Additionally, the quality, availability and accessibility of data regarding retracted papers from the publishers are described. METHODS: Two independent reviewers searched for articles that had been retracted since 2004 via PubMed, Web of Science, Biblioteca Virtual em Saúde (BVS) and Google Scholar databases. Indexed keywords from Medical Subject Headings (MeSH) and Descritores em Ciências da Saúde (DeCS) in Portuguese, English or Spanish were used. Data were also collected from the Retraction Watch website (www.retractionwatch.com). This study was registered with the PROSPERO systematic review database (CRD42017071647). RESULTS: A final sample of 65 articles was retrieved from 55 different journals with reported impact factors ranging from 0 to 32.86, with a median value of 4.40 and a mean of 4.69. The types of documents found were erratum (1), retracted articles (3), retracted articles with a retraction notice (5), retraction notices with erratum (3), and retraction notices (45). The assessment of the Retraction Watch website added 8 articles that were not identified by the search strategy using the bibliographic databases. The retracted publications covered a wide range of study designs. Experimental studies (40) and literature reviews (15) accounted for 84.6% of the retracted articles. Within the field of health and life sciences, medical science was the field with the largest number of retractions (34), followed by biological sciences (17). Some articles were retracted for at least two distinct reasons (13). Among the retrieved articles, plagiarism was the main reason for retraction (60%). Missing data were found in 57% of the retraction notices, which was a limitation to this review. In addition, 63% of the articles were cited after their retraction. CONCLUSION: Publications are not retracted solely for research misconduct but also for honest error. Nevertheless, considering authors affiliated with Brazilian institutions, this review concluded that most of the retracted health and life sciences publications were retracted due to research misconduct. Because the number of publications is the most valued indicator of scientific productivity for funding and career progression purposes, a systematic effort from the national research councils, funding agencies, universities and scientific journals is needed to avoid an escalating trend of research misconduct. More investigations are needed to comprehend the underlying factors of research misconduct and its increasing manifestation.

A single, open access journal may prevent the primary publishing problems in the life sciences.

Herein, we discuss a novel way to knit current life sciences publishing structures together under the scope of a single life science journal that would countermand many of the issues faced in current publishing paradigms. Such issues include, but are not limited to, publication fees, subscription fees, impact factor, and publishing in more "glamorous" journals for career health. We envision a process flow involving (i) a single, overall, life sciences journal, (ii) divided into sections headed by learned societies, (iii) to whom all scientific papers are submitted for peer review, and (iv) all accepted scientific literature would be published open access and without author publication fees. With such a structure, journal fees, the merit system of science, and unethical aspects of open access would be reformed for the better. Importantly, such a journal could leverage existing online platforms; that is to say, it is conceptually feasible. We conclude that wholly inclusive publishing paradigms can be possible. A single, open access, online, life sciences journal could solve the myriad problems associated with current publishing paradigms and would be feasible to implement.

Perspective: Sistas In Science - Cracking the Glass Ceiling.

In this perspective, we describe our experience as women of color scientists from diverse backgrounds and similar struggles embarking upon the National Heart, Lung and Blood Institute-funded program called PRIDE (Programs to Increase Diversity among Underrepresented Minorities Engaged in Health-Related Research). Under the leadership of our mentor and friend, Betty Pace, MD, a renowned and successful African American physician-scientist, the PRIDE Program was designed to address the difficulties experienced by junior-level minority investigators in establishing independent research programs and negotiating tenure and full professor status at academic institutions. The strength of PRIDE's innovative formula was pairing us with external senior mentors and, importantly, allowing us to serve as peer mentors to each other. We believe this "Sister's Keeper" paradigm is one solution for women to overcome their limitations and extend understandings and best practices worldwide for science, medicine, and global health.

Derechos fundamentales y ciencias biomédicas: el Ararteko ante los desafíos de la 4ª generación de derechos humanos / Fundamental rights and biomedical sciences: the Ombudsman facing the challenges of the 4th generation of human rights

La división de los derechos humanos en tres generaciones fue inicialmente propuesta por el jurista Karel VASAK en el Instituto Internacional de Derechos Humanos, en Estrasburgo, en 1979. Su división tenía la vocación de seguir las nociones centrales de las tres frases que fueron la divisa de la revolución francesa: Libertad, Igualdad y Fraternidad, que son, a su vez, valores profundamente europeos. Sin embargo, la evolución de la sociedad y la aparición de nuevos problemas complejos que afectan a las personas en su diversidad y los estados han hecho emerger una nueva generación de derechos humanos, llamada la cuarta generación, en pro de dar cabida a las necesidades de protección de esos nuevos derechos derivados de dicha evolución; generación ligada al mundo de la tecnología y también de la bioética, en toda su amplitud y diversidad. El autor, en su condición de actual Ararteko (Defensor del Pueblo del País Vasco) afronta los proyectos e iniciativas frente a esta cuarta generación de derechos humanos. Así, la institución que representa no es ajena a esta realidad y su evolución así como a la progresiva configuración y formalización de los distintos rangos de derechos humanos, que afronta como retos dentro de su rol como Alto Comisionado del Parlamento Vasco para la defensa de los derechos de las personas, en relación con las actuaciones y políticas públicas de la Comunidad Autónoma del País Vasco

The division of human rights into three generations was initially proposed by the jurist Karel VASAK at the International Institute of Human Rights in Strasbourg in 1979. His division had the vocation to follow the central notions of the three phrases that were the motto of the revolution French: Freedom, Equality and Fraternity, which are, in turn, deeply European values. However, the evolution of society and the emergence of new complex problems that affect people in their diversity and states have led to the emergence of a new generation of human rights, called the fourth generation, in order to accommodate the needs of protection of these new rights derived from said evolution; generation linked to the world of technology and also of bioethics, in all its breadth and diversity. The author, current Ararteko (Ombudsman of the Basque Country) faces the projects and initiatives in front of this fourth generation of human rights. Thus, this institution is not alien to this reality and its evolution, as well as to the progressive configuration and formalization of the different ranges of human rights, which it faces as challenges within its role as High Commissioner of the Basque Parliament for the defense of the rights of people in relation to the actions and public policies of the Autonomous Community of the Basque Country

Between Scylla and Charybdis: reconciling competing data management demands in the life sciences.

BACKGROUND: The widespread sharing of biologicaConcluding Comments: Teaching Responsible Datal and biomedical data is recognised as a key element in facilitating translation of scientific discoveries into novel clinical applications and services. At the same time, twenty-first century states are increasingly concerned that this data could also be used for purposes of bioterrorism. There is thus a tension between the desire to promote the sharing of data, as encapsulated by the Open Data movement, and the desire to prevent this data from 'falling into the wrong hands' as represented by 'dual use' policies. Both frameworks posit a moral duty for life sciences researchers with respect to how they should make their data available. However, Open data and dual use concerns are rarely discussed in concert and their implementation can present scientists with potentially conflicting ethical requirements. DISCUSSION: Both dual use and Open data policies frame scientific data and data dissemination in particular, though different, ways. As such they contain implicit models for how data is translated. Both approaches are limited by a focus on abstract conceptions of data and data sharing. This works to impede consensus-building between the two ethical frameworks. As an alternative, this paper proposes that an ethics of responsible management of scientific data should be based on a more nuanced understanding of the everyday data practices of life scientists. Responsibility for these 'micromovements' of data must consider the needs and duties of scientists as individuals and as collectively-organised groups. Researchers in the life sciences are faced with conflicting ethical responsibilities to share data as widely as possible, but prevent it being used for bioterrorist purposes. In order to reconcile the responsibilities posed by the Open Data and dual use frameworks, approaches should focus more on the everyday practices of laboratory scientists and less on abstract conceptions of data.

Incidence of Data Duplications in a Randomly Selected Pool of Life Science Publications.

Since the solution to many public health problems depends on research, it is critical for the progress and well-being for the patients that we can trust the scientific literature. Misconduct and poor laboratory practice in science threatens the scientific progress, leads to loss of productivity and increased healthcare costs, and endangers lives of patients. Data duplication may represent one of challenges related to these problems. In order to estimate the frequency of data duplication in life science literature, a systematic screen through 120 original scientific articles published in three different cancer related journals [journal impact factor (IF) <5, 5-10 and >20] was completed. The study revealed a surprisingly high proportion of articles containing data duplication. For the IF < 5 and IF > 20 journals, 25% of the articles were found to contain data duplications. The IF 5-10 journal showed a comparable proportion (22.5%). The proportion of articles containing duplicated data was comparable between the three journals and no significant correlation to journal IF was found. The editorial offices representing the journals included in this study and the individual authors of the detected articles were contacted to clarify the individual cases. The editorial offices did not reply and only 1 out of 29 cases were apparently clarified by the authors, although no supporting data was supplied. This study questions the reliability of life science literature, it illustrates that data duplications are widespread and independent of journal impact factor and call for a reform of the current peer review and retraction process of scientific publishing.

The Acid Test for Biological Science: STAP Cells, Trust, and Replication.

In January 2014, a letter and original research article were published in Nature describing a process whereby somatic mouse cells could be converted into stem cells by subjecting them to stress. These "stimulus-triggered acquisition of pluripotency" (STAP) cells were shown to be capable of contributing to all cell types of a developing embryo, and extra-embryonic tissues. The lead author of the publications, Haruko Obokata, became an overnight celebrity in Japan, where she was dubbed the new face of Japanese science. However, in the weeks that followed publication of the research, issues arose. Other laboratories and researchers (including authors on the original papers) found that they were unable to replicate Obokata et al.'s work. Closer scrutiny of the papers by the scientific community also suggested that there was manipulation of images that had been published, and Obokata was accused of misconduct. Those who should have been supervising her work (also her co-authors on the publications) were also heavily criticised. The STAP cell saga of 2014 is used as an example to highlight the importance of trust and replication in twenty-first century biological science. The role of trust in the scientific community is highlighted, and the effects on interactions between science and the public examined. Similarly, this essay aims to highlight the importance of replication, and how this is understood by researchers, the media, and the public. The expected behaviour of scientists in the twenty-first century is now more closely scrutinised.

Frequency and Type of Conflicts of Interest in the Peer Review of Basic Biomedical Research Funding Applications: Self-Reporting Versus Manual Detection.

Despite the presumed frequency of conflicts of interest in scientific peer review, there is a paucity of data in the literature reporting on the frequency and type of conflicts that occur, particularly with regard to the peer review of basic science applications. To address this gap, the American Institute of Biological Sciences (AIBS) conducted a retrospective analysis of conflict of interest data from the peer review of 282 biomedical research applications via several onsite review panels. The overall conflicted-ness of these panels was significantly lower than that reported for regulatory review. In addition, the majority of identified conflicts were institutional or collaborative in nature. No direct financial conflicts were identified, although this is likely due to the relatively basic science nature of the research. It was also found that 65 % of identified conflicts were manually detected by AIBS staff searching reviewer CVs and application documents, with the remaining 35 % resulting from self-reporting. The lack of self-reporting may be in part attributed to a lack of perceived risk of the conflict. This result indicates that many potential conflicts go unreported in peer review, underscoring the importance of improving detection methods and standardizing the reporting of reviewer and applicant conflict of interest information.

Engineering Values Into Genetic Engineering: A Proposed Analytic Framework for Scientific Social Responsibility.

Recent experiments have been used to "edit" genomes of various plant, animal and other species, including humans, with unprecedented precision. Furthermore, editing the Cas9 endonuclease gene with a gene encoding the desired guide RNA into an organism, adjacent to an altered gene, could create a "gene drive" that could spread a trait through an entire population of organisms. These experiments represent advances along a spectrum of technological abilities that genetic engineers have been working on since the advent of recombinant DNA techniques. The scientific and bioethics communities have built substantial literatures about the ethical and policy implications of genetic engineering, especially in the age of bioterrorism. However, recent CRISPr/Cas experiments have triggered a rehashing of previous policy discussions, suggesting that the scientific community requires guidance on how to think about social responsibility. We propose a framework to enable analysis of social responsibility, using two examples of genetic engineering experiments.

An Evaluation of Research Ethics in Undergraduate Health Science Research Methodology Programs at a South African University.

The amended research ethics policy at a South African University required the ethics review of undergraduate research projects, prompting the need to explore the content and teaching approach of research ethics education in health science undergraduate programs. Two qualitative data collection strategies were used: document analysis (syllabi and study guides) and semi-structured interviews with research methodology coordinators. Five main themes emerged: (a) timing of research ethics courses, (b) research ethics course content, (c) sub-optimal use of creative classroom activities to facilitate research ethics lectures, (d) understanding the need for undergraduate project research ethics review, and (e) research ethics capacity training for research methodology lecturers and undergraduate project supervisors.

The ethics of biosafety considerations in gain-of-function research resulting in the creation of potential pandemic pathogens.

This paper proposes an ethical framework for evaluating biosafety risks of gain-of-function (GOF) experiments that create novel strains of influenza expected to be virulent and transmissible in humans, so-called potential pandemic pathogens (PPPs). Such research raises ethical concerns because of the risk that accidental release from a laboratory could lead to extensive or even global spread of a virulent pathogen. Biomedical research ethics has focused largely on human subjects research, while biosafety concerns about accidental infections, seen largely as a problem of occupational health, have been ignored. GOF/PPP research is an example of a small but important class of research where biosafety risks threaten public health, well beyond the small number of persons conducting the research.We argue that bioethical principles that ordinarily apply only to human subjects research should also apply to research that threatens public health, even if, as in GOF/PPP studies, the research involves no human subjects. Specifically we highlight the Nuremberg Code's requirements of 'fruitful results for the good of society, unprocurable by other methods', and proportionality of risk and humanitarian benefit, as broad ethical principles that recur in later documents on research ethics and should also apply to certain types of research not involving human subjects. We address several potential objections to this view, and conclude with recommendations for bringing these ethical considerations into policy development.