Andrea Boggio

Ethical Norms and the International Governance of Genetic Databases and Biobanks: Findings from an International Study

This article highlights major results of a study into the ethical norms and rules governing biobanks. After describing the methodology, the findings regarding four topics are presented: (1) the ownership of human biological samples held in biobanks; (2) the regulation of researchers’ use of samples obtained from biobanks; (3) what constitutes “collective consent” to genetic research, and when it is needed; and (4) benefit sharing and remuneration of research participants. The paper then summarizes key lessons to be drawn from the findings and concludes by reflecting on the importance of such empirical research to inform future governance norms and practices.

Basic Research and Knowledge Production Modes A View from the Harvard Medical School

A robust body of literature analyzes the shift of academic science toward more business-oriented models. This paper presents the findings of an empirical study investigating basic scientists’ attitudes toward publicly funded basic research at the Harvard Medical School and affiliated institutions. The study finds that scientists at the Harvard Medical School construe publicly funded basic research as inquiries that, whether use oriented or not, must be governed by the cognitive and social norms of the traditional mode of knowledge production (mode 1 paradigm). They recognize that academic science is vulnerable to access by external capital but maintain that it remains distinct from research done in the private sector. Overall, the study demonstrates that important segments of academia have preserved a traditional approach to knowledge production, which is yet to be transformed by the entrepreneurial turn.

Countries’ Biomedical Publications and Attraction Scores. A PubMed-based assessment

Studying publication volumes at the country level is key to understanding and improving a country’s research system. PubMed is a public search engine of publications in all life sciences areas. Here, we show how this search engine can be used to assess the outputs of life science-related research by country. We have measured the numbers of publications during different time periods based on the country of affiliation of the first authors. Moreover, we have designed scores, which we have named Attraction Scores, to appraise the relative focus either toward particular types of studies, such as clinical trials or reviews, or toward specific research areas, such as public health and pharmacogenomics, or toward specific topics, for instance embryonic stem cells; we have also investigated a possible use of these Attraction Scores in connection with regulatory policies. We have weighed the statistics against general indicators such as country populations and gross domestic products (GDP). During the 5-year period 2008-2012, the United States was the country with the highest number of publications and Denmark the one with the highest number of publications per capita. Among the 40 countries with the highest GDPs, Israel had the highest publications-to-GDP ratio. Among the 20 countries with the most publications, Japan had the highest Attraction Score for induced pluripotent stem (iPS) cells and Italy the highest proportion of review publications. More than 50% of publications in English were from countries in which English is not the primary language. We show an assorted and extensive collection of rankings and charts that will inform scholars and policymakers in studying and improving the research systems both at the national and international level.

Regulating assisted reproduction in Italy: a 5-year assessment

In 2004, the Italian parliament comprehensively regulated medically assisted reproduction. Law 40/2004 has outlawed several techniques and tightly compressed the freedom of research in the area of human reproduction and regenerative medicine. This article analyses the post-2004 political, bioethical and legal debate on assisted reproduction in Italy. The analysis is grounded on empirical evidence on fertilisation outcomes released in 2007 and 2008 by the Italian government, on recent amendments related to the regulation of preimplantation genetic diagnosis and on the debates on the status of spare embryos as for their availability for scientific researches. The analysis shows that Law 40/2004 has failed to improve the access of infertile couples to assisted reproduction techniques and keeps supporting practices that the other jurisdictions have rejected because they are unwise from a clinical standpoint. Moreover, Law 40/2004 created severe limitations to scientific researches in the fields of medical embryology, gynaecology and regenerative medicine. With the political support of some Italian political parties and the Catholic Church, Law 40/2004 disregards the expectations of the majority of Italian citizens, international guidelines of good clinical practice, international codes of medical ethics, the interests of infertile couples and the social and economic relevance of biomedical research.

The Global Enforcement of Human Rights: The Unintended Consequences of Transnational Litigation

ABSTRACT In the last few years, a growing number of individuals whose basic rights are violated have filed transnational human rights claims in foreign countries. By placing the individual as a holder of basic rights at the core of the process of development, the capability approach, as put forward by Amartya Sen and Martha Nussbaum, provides a fertile theoretical framework to assess translational human rights litigation. The paper shows that transnational claims are problematic in two regards: 1) they undermine development by discouraging foreign companies from investing in countries that are sources of transnational claims and by weakening local governments and judiciaries; 2) the conflict resolution process is inadequate because financial and practical constraints prevent stakeholders from directly participating in the process, and because assessing damages and enforcing award judgments will most likely be unfair. The path to be taken involves developing a stronger rule of law, stronger local institutions and independent judiciaries in those developed countries where the violations of basic human rights take place.

Policies to increase the social value of science and the scientist satisfaction. An exploratory survey among Harvard bioscientists.

Basic research in the biomedical field generates both knowledge that has a value per se regardless of its possible practical outcome and knowledge that has the potential to produce more practical benefits. Policies can increase the benefit potential to society of basic biomedical research by offering various kinds of incentives to basic researchers. In this paper we argue that soft incentives or “nudges” are particularly promising. However, to be well designed, these incentives must take into account the motivations, goals and views of the basic scientists. In the paper we present the results of an investigation that involved more than 300 scientists at Harvard Medical School and affiliated institutes. The results of this study suggest that some soft incentives could be valuable tools to increase the transformative value of fundamental investigations without affecting the spirit of the basic research and scientists’ work satisfaction. After discussing the findings, we discuss a few examples of nudges for basic researchers in the biomedical fields.

Biobanks and the ‘well-being’ of humanity: integrating consent to research with the capability approach

Among the important ethical challenges that biobanks raise, the shortcoming of the traditional acceptation of informed consent is one of the most debated. The protection of research participants’ autonomy is a central theme in current ethical reasoning on biomedical research. In this article, I argue that moral philosophy offers the opportunity to broaden the debate raised by the shortcomings of the established doctrine of informed consent when applied to biobanking activities. The capability approach and deliberative democracy theories are particularly interesting in analyzing biobanks and informed consent because they shift the focus from the relationships patient/physician and participants in research/investigator–the bioethics focus–to the well-being of research participants and their ability to self-determination understood as a mean by which individuals participate in the societal arrangements that underscore biobanks’ regulation, thus fostering the democratic deliberative process. My claim is that many ethical issues raised are better understood and eventually solved if a broader definition of the notion of autonomy as put forth by moral and political theory is integrated in the discourse of biobanking and informed consent. Philosophy is like this: eternally unsettled and only occasionally disturbed by new facts Matt Ridley, Nature via Nurture, p.23

Biomedical publications on Ebola and the 2014 outbreak

In this research note we examine the biomedical publication output about Ebola in 2014. We show that the volume of publications has dramatically increased in the past year. The rise reflects an impressive growth starting in the month of August, concomitant with or following the surge in infections, deaths and coverage in news and social media. Though non-research articles have been the major contributors to this growth, there has been a substantial increase in original research articles too, including many papers of basic science. The United States has been the country with the highest number of research articles, followed by Canada and the United Kingdom. We present a comprehensive set of charts and facts that, by describing the volumes and nature of publications in 2014, show how the scientific community has responded to the Ebola outbreak and how it might respond to future similar global threats and media events. This information will assist scholars and policymakers in their efforts to improve scientific research policies with the goal of maximizing both public health and knowledge advancement.

Publications in PubMed on Ebola and the 2014 outbreak

In this research note we examine the biomedical publication output about Ebola in 2014. We show that the volume of publications has dramatically increased in the past year. In 2014 there have been over 888 publications with ‘ebola’ or ‘ebolavirus’ in the title, approximately 13 times the volume of publication of 2013. The rise reflects an impressive growth starting in the month of August, concomitant with or following the surge in infections, deaths and coverage in news and social media. Though non-research articles have been the major contributors to this growth, there has been a substantial increase in original research articles too, including many papers of basic science. The United States has been the country with the highest number of research articles, followed by Canada and the United Kingdom. We present a comprehensive set of charts and facts that, by describing the volumes and nature of publications in 2014, show how the scientific community has responded to the Ebola outbreak and how it might respond to future similar global threats and media events. This information will assist scholars and policymakers in their efforts to improve scientific research policies with the goal of maximizing both public health and knowledge advancement.

Countries’ Biomedical Publications and Attraction Scores

Studying publication volumes at the country level is key to understanding and improving a countrys research system. PubMed is a public search engine of publications in all life sciences areas. Here, we show how this search engine can be used to assess the outputs of life science-related research by country. We have measured the numbers of publications during different time periods based on the country of affiliation of the first authors. Moreover, we have designed scores, which we have named Attraction Scores, to assess the relative focus either toward particular types of studies, such as clinical trials or reviews, or toward specific research areas, such as public health and pharmacogenomics, or toward specific topics, for instance embryonic stem cells; we have also investigated a possible use of these Attraction Scores through a correlation analysis with regulatory policies. We have weighed the statistics against general indicators such as country populations and gross domestic products (GDP). During the 5-year period 2008-2012, the United States was the country with the highest number of publications and Denmark the one with the highest number of publications per capita. Among the 40 countries with the highest GDPs, Israel had the highest publications-to-GDP ratio. Among the 20 countries with the most publications, Japan had the highest Attraction Score for induced pluripotent stem (iPS) cells and Italy the highest proportion of review publications. More than 50% of publications in English were from countries in which English is not the primary language. We show an assorted and extensive collection of rankings and charts that will inform scholars and policymakers in studying and improving the research systems both at the national and international level.