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).     

Using Surplus Embryos and Research Embryos in Stem Cell Research: Ethical Viewpoints of Buddhist,Hindu and Catholic Leaders in Malaysia on the Permissibility of Research

The sources of embryos for Embryonic Stem Cell Research (ESCR) include surplus embryos from infertility treatments, and research embryos which are created solely for an ESCR purpose. The latter raises more ethical concerns. In a multi-religious country like Malaysia, ethical discussions on the permissibility of ESCR with regard to the use surplus and research embryos are diversified. Malaysia has formulated guidelines influenced by the national fatwa ruling which allows the use of surplus embryos in ESCR. Input from other main religions is yet to be documented. In light of this, this study addresses (i) the ethical viewpoints of Buddhist, Hindu and Catholic leaders on the permissibility of using surplus and research embryos; and (ii) the moral standpoints of religious leaders towards attaining a consensus on the practice of ESCR in Malaysia. Responses from the religious leaders were obtained via semi-structured, face-to-face interviews. The findings show that generally the Buddhist and Hindu leaders approve the use of surplus embryos. Their responses on the creation of research embryos for ESCR are varied. Meanwhile, the Catholic leaders distinctively objected to ESCR regardless of the embryo sources, referring to it as the destruction of life. Taking into account the diverse views, this study explores the response of the religious leaders for a general consensus wherever possible. The ethical discourse surrounding ESCR in a multi-religious setting offers new perspective, which needs to be explored in a broader global community.     

Mentoring for Responsible Research: The Creation of a Curriculum for Faculty to Teach RCR in the Research Environment

Despite more than 25 years of a requirement for training in the responsible conduct of research (RCR), there is still little consensus about what such training should include, how it should be delivered, nor what constitutes “effectiveness” of such training. This lack of consensus on content, approaches and outcomes is evident in recent data showing high variability in the development and implementation of RCR instruction across universities and programs. If we accept that one of the primary aims of instruction in RCR/research ethics is “to foster a community of social responsibility” (Antes et al. 2009: 398), then it makes sense to consider the research environment itself—where learning one’s science happens where one also engages in social interaction around that science. In order to take the best advantage of that already existing/naturally occurring research environment, the authors, through a deliberative, collaborative, and integrative process, crafted a workshop curriculum meant to arm research faculty with concrete and specific tools to effectively introduce research ethics in the context of the research environment.     

Respecting Context to Protect Privacy: Why Meaning Matters

In February 2012, the Obama White House endorsed a Privacy Bill of Rights, comprising seven principles. The third, “Respect for Context,” is explained as the expectation that “companies will collect, use, and disclose personal data in ways that are consistent with the context in which consumers provide the data.” One can anticipate the contested interpretations of this principle as parties representing diverse interests vie to make theirs the authoritative one. In the paper I will discuss three possibilities and explain why each does not take us far beyond the status quo, which, regulators in the United States, Europe, and beyond have found problematic. I will argue that contextual integrity offers the best way forward for protecting privacy in a world where information increasingly mediates our significant activities and relationships. Although an important goal is to influence policy, this paper aims less to stipulate explicit rules than to present an underlying justificatory, or normative rationale. Along the way, it will review key ideas in the theory of contextual integrity, its differences from existing approaches, and its harmony with basic intuition about information sharing practices and norms.     

Surveillance,Self and Smartphones: Tracking Practices in the Nightlife

This paper is the result of the EMERGING ICT FOR CITIZEN VEILLANCE-workshop organized by the JRC, Ispra, Italy, March 2014. The aim of this paper is to explore how the subject participates in surveillance situations with a particular focus on how users experience everyday tracking technologies and practices. Its theoretical points of departure stem from Surveillance Studies in general and notions of participatory surveillance (Albrechtslund 2008) and empowering exhibitionism (Koskela in Surveill Soc 2(2/3):199–215, 2004) in particular. We apply these theoretical notions on smartphones and its users to investigate the combination of participation and surveillance. Empirically, the paper uses interviews held with urban nightlife visitors to uncover practices of smartphone use. This qualitative and explorative study contributes to the concept of participatory surveillance by discussing to what extent smartphone-users’ actions and motivations can be seen as forms of surveillance and how that influences these actors in a (nightly) public space. We finish by setting out directions for studying mobile technologies of the self.     

Why Frankenstein is a Stigma Among Scientists

As one of the best known science narratives about the consequences of creating life, Mary Shelley’s Frankenstein; or, The Modern Prometheus (1818) is an enduring tale that people know and understand with an almost instinctive familiarity. It has become a myth reflecting people’s ambivalent feelings about emerging science: they are curious about science, but they are also afraid of what science can do to them. In this essay, we argue that the Frankenstein myth has evolved into a stigma attached to scientists that focalizes the public’s as well as the scientific community’s negative reactions towards certain sciences and scientific practices. This stigma produces ambivalent reactions towards scientific artifacts and it leads to negative connotations because it implies that some sciences are dangerous and harmful. We argue that understanding the Frankenstein stigma can empower scientists by helping them revisit their own biases as well as responding effectively to people’s expectations for, and attitudes towards, scientists and scientific artifacts. Debunking the Frankenstein stigma could also allow scientists to reshape their professional identities so they can better show the public what ethical and moral values guide their research enterprises.     

Predatory Journals Spamming for Publications: What Should Researchers Do?

In the internet era spam has become a big problem. Researchers are troubled with unsolicited or bulk spam emails inviting them to publish. However, this strategy has helped predatory journals hunt their prey and earn money. These journals have grown tremendously during the past few years despite serious efforts by researchers and scholarly organizations to hinder their growth. Predatory journals and publishers are often based in developing countries, and they potentially target researchers from these counties by using different tactics identified in previous research. In response to the spread of predatory publishing, scientists are trying to develop criteria and guidelines to help avoid them—for example, the recently reported “predatory rate”. This article attempts to (a) highlight the strategies used by predatory journals to convince researchers to publish with them, (b) report their article processing charges, (c) note their presence in Jeffrey Beall’s List of Predatory Publishers, (d) rank them based on the predatory rate, and (e) put forward suggestions for junior researchers (especially in developing counties), who are the most likely targets of predatory journals.     

Scientists Still Behaving Badly? A Survey Within Industry and Universities

Little is known about research misconduct within industry and how it compares to universities, even though a lot of biomedical research is performed by–or in collaboration with–commercial entities. Therefore, we sent an e-mail invitation to participate in an anonymous computer-based survey to all university researchers having received a biomedical research grant or scholarship from one of the two national academic research funders of Belgium between 2010 and 2014, and to researchers working in large biomedical companies or spin-offs in Belgium. The validated survey included questions about various types of research misconduct committed by respondents themselves and observed among their colleagues in the last three years. Prevalences of misconduct were compared between university and industry respondents using binary logistic regression models, with adjustments for relevant personal characteristics, and with significance being accepted for p < 0.01. The survey was sent to 1766 people within universities and an estimated 255 people from industry. Response rates were 43 (767/1766) and 48% (123/255), and usable information was available for 617 and 100 respondents, respectively. In general, research misconduct was less likely to be reported by industry respondents compared to university respondents. Significant differences were apparent for one admitted action (gift authorship) and three observed actions (plagiarism, gift authorship, and circumventing animal-subjects research requirements), always with lower prevalences for industry compared to universities, except for plagiarism. This survey, based on anonymous self-report, shows that research misconduct occurs to a substantial degree among biomedical researchers from both industry and universities.     

Differing Perceptions Concerning Research Integrity Between Universities and Industry: A Qualitative Study

Despite the ever increasing collaboration between industry and universities, the previous empirical studies on research integrity and misconduct excluded participants of biomedical industry. Hence, there is a lack of empirical data on how research managers and biomedical researchers active in industry perceive the issues of research integrity and misconduct, and whether or not their perspectives differ from those of researchers and research managers active in universities. If various standards concerning research integrity and misconduct are upheld between industry and universities, this might undermine research collaborations. Therefore we performed a qualitative study by conducting 22 semi-structured interviews in order to investigate and compare the perspectives and attitudes concerning the issues of research integrity and misconduct of research managers and biomedical researchers active in industry and universities. Our study showed clear discrepancies between both groups. Diverse strategies in order to manage research misconduct and to stimulate research integrity were observed. Different definitions of research misconduct were given, indicating that similar actions are judged heterogeneously. There were also differences at an individual level, whether the interviewees were active in industry or universities. Overall, the management of research integrity proves to be a difficult exercise, due to many diverse perspectives on several essential elements connected to research integrity and misconduct. A management policy that is not in line with the vision of the biomedical researchers and research managers is at risk of being inefficient.     

Conflict of Interest and the CREATE-X Trial in the New England Journal of Medicine

There is an increasing emphasis on clear disclosure of conflict of interest in medical communities, following repeated scientific frauds in clinical trials. However, incomplete COI statements continue to be prevalent in the medical community, as appears to have occurred in the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial, which was recently published in the New England Journal of Medicine. The authors of the article did not clearly report the roles of the Japan Breast Cancer Research Group, a sponsor and funder of the study, although a majority of the Japanese authors served in important positions in the organization. Furthermore, the conflict of interest related to Chugai Pharmaceutical Company, a Japanese distributor of capecitabine, was not correctly disclosed. More transparent statements of conflict of interest and clarification of sponsors and funders’ roles, as well as rigorous review by academic journals are required to fairly interpret the findings of clinical trials, including and beyond the single case of the CREATE-X trial.