- Philosophy of Science, Philosophy Of Language, Epistemology, History of Science, Philosophy of Biology, Medical Ethics, and 22 moreApplied Ethics, History and Philosophy of Biology, History of Biology, Bioethics, Biolaw, Biobanks, Genetic Testing, Philosophy, Political Philosophy, Ethics, History of Medicine, Informed Consent, Public Understanding Of Science, History of Philosophy of Science, Research Ethics, Science and Technology Studies, Computer Networks, Databases, Software, Epigenetics, Philosophy of Medicine, and Political Ecologyedit
What happens to patients with cancer engaged in biomedical research when intellectual property regimes and ethical regimes intersect? This qualitative historical study addresses this question by situating the experiences, hopes, and... more
What happens to patients with cancer engaged in biomedical research when intellectual property regimes and ethical regimes intersect? This qualitative historical study addresses this question by situating the experiences, hopes, and reasons of patients to enter clinical trials within the historical trajectory of informed consent and monoclonal antibodies, the biotechnology underpinning many targeted drugs used in oncological clinical trials and biobank research. Based on fieldwork we undertook in a German university hospital where we interviewed patients and the medical personnel, a historical review, and an ethical analysis we inquire into the effects that financial, legal, and technological changes connected to the relevant pharmaceutical research and commerce have on cancer patients engaged in clinical trials and biobank research. We find that the controversial aspects of monoclonal antibodies, especially those related to the commercial interests at stake, enter the informed consent process mainly in the form of informative gaps. We highlight how a qualitative analysis of the clinic, especially when it is situated against the backdrop of the history of related technological advancements and patent regime, it can serve the purpose of giving voice to subjects who are silenced by regimes of an ethical, epistemic, and commercial kind while pointing to informed consent as an unhelpful device for addressing risks arising from the commercial purposes of biomedical products and infrastructure.
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Research Interests: Psychology, Ethics, Applied Ethics, Biomedicine, Bioethics, and 15 moreDepression, Philosophy of Medicine, Breast Cancer, Medical Ethics, Personalized Medicine, Medicine, Humans, Female, Anticancer Drugs, Clinical Sciences, Method Development and Validation of New Drugs, Bevacizumab, Precision Medicine, Antineoplastic Agents, and Breast Neoplasms
The industrialisation of food production over the past century has triggered a series of sanitary crises related to antibiotic resistance. In this article, I contend that to understand the radical transformation of animal farming and its... more
The industrialisation of food production over the past century has triggered a series of sanitary crises related to antibiotic resistance. In this article, I contend that to understand the radical transformation of animal farming and its effects on public health, we need to inquire into the historical development of the knowledge on microbes, especially with regard to the agricultural industry’s mobilisation and repression of microbial metabolism to scale up food production. Moreover, I conceive of the so-called Great Acceleration of the Anthropocene as a postcolonial mimetic trap through which actors who didn’t play an active role in the contemporary ecological collapse are subsumed into an indistinct “we”. To disentangle this alleged collective subject created from accounts of planetary health, I focus on the scientific, social, and institutional histories of antibiotic production and antibiotic use that materialised in the epidemiological issue of antibiotic resistance. Furthermore, I highlight how the history of antibiotic use and resistance is intertwined with the ecological, social, and geopolitical dynamics created by intense industrial production and international rivalries during the Cold War. This article calls for the re-evaluation and creation of counter-narratives of the planetary impact of industry on microbes, local communities, patients, medical personnel, and the global poor.
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The establishment of international sanitary institutions, which took place in the context of rivalry among the great European powers and their colonial expan-sion in Asia, allowed for the development of administrative systems of... more
The establishment of international sanitary institutions, which took place in the context of rivalry among the great European powers and their colonial expan-sion in Asia, allowed for the development of administrative systems of international epidemiological surveillance as a response to the cholera epidemics at the end of the nineteenth century. In this note, I reflect on how a historical analysis of the inception of international epidemiological surveillance and pandemic management helps us to understand what is happening in the COVID-19 pandemic today.
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Millions of people worldwide currently suffer from serious neurological diseases and injuries for which there are few, and often no, effective treatments. The paucity of effective interventions is, no doubt, due in large part to the... more
Millions of people worldwide currently suffer from serious neurological diseases and injuries for which there are few, and often no, effective treatments. The paucity of effective interventions is, no doubt, due in large part to the complexity of the disorders, as well as our currently limited understanding of their pathophysiology. The bleak picture for patients, however, is also attributable to avoidable impediments stemming from quality concerns in preclinical research that often escape detection by research regulation efforts. In our essay, we connect the dots between these concerns about the quality of preclinical research and their potential ethical impact on the patients who volunteer for early trials of interventions informed by it. We do so in hopes that a greater appreciation among preclinical researchers of these serious ethical consequences can lead to a greater commitment within the research community to adopt widely available tools and measures that can help to improve the quality of research.
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Biobanks, which contain human biological samples and/or data, provide a crucial contribution to the progress of biomedical research. However, the effective and efficient use of biobank resources depends on their accessibility. In fact,... more
Biobanks, which contain human biological samples and/or data, provide a crucial contribution to the progress of biomedical research. However, the effective and efficient use of biobank resources depends on their accessibility. In fact, making bio-resources promptly accessible to everybody may increase the benefits for society. Furthermore, optimizing their use and ensuring their quality will promote scientific creativity and, in general, contribute to the progress of bio-medical research. Although this has become a rather common belief, several laboratories are still secretive and continue to withhold samples and data. In this study, we conducted a questionnaire-
based survey in order to investigate sample and data accessibility in research biobanks operating all over the world. The survey involved a total of 46 biobanks. Most of them gave permission to access their samples (95.7%) and data (85.4%), but free and
unconditioned accessibility seemed not to be common practice. The analysis of the guidelines regarding the accessibility to resources of the biobanks that responded to the survey highlights three issues: (i) the request for applicants to explain what they would like to do with the resources requested; (ii) the role of funding, public or private, in the establishment of fruitful collaborations between biobanks and research labs; (iii)
the request of co-authorship in order to give access to their data. These results suggest that economic and academic aspects are involved in determining the extent of sample and data sharing stored in biobanks. As a second step of this study, we investigated
the reasons behind the high diversity of requirements to access biobank resources. The analysis of informative answers suggested that the different modalities of resource accessibility seem to be largely influenced by both social context and legislation of the countries where the biobanks operate.
based survey in order to investigate sample and data accessibility in research biobanks operating all over the world. The survey involved a total of 46 biobanks. Most of them gave permission to access their samples (95.7%) and data (85.4%), but free and
unconditioned accessibility seemed not to be common practice. The analysis of the guidelines regarding the accessibility to resources of the biobanks that responded to the survey highlights three issues: (i) the request for applicants to explain what they would like to do with the resources requested; (ii) the role of funding, public or private, in the establishment of fruitful collaborations between biobanks and research labs; (iii)
the request of co-authorship in order to give access to their data. These results suggest that economic and academic aspects are involved in determining the extent of sample and data sharing stored in biobanks. As a second step of this study, we investigated
the reasons behind the high diversity of requirements to access biobank resources. The analysis of informative answers suggested that the different modalities of resource accessibility seem to be largely influenced by both social context and legislation of the countries where the biobanks operate.
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In biobank research, one of the main obstacles for full applicability of Open Access to biomedical resources is the researchers’ reluctance to make immediately and freely available these materials before having adequately exploited their... more
In biobank research, one of the main obstacles for full applicability of Open Access to biomedical resources is the researchers’ reluctance to make immediately and freely available these materials before having adequately exploited their potential. To analyse this issue from a wider perspective, we need to consider the role of research biobanks as main repositories in which human biological samples are stored, with or without accompanying them with genetic or clinical data (Haga and Beskow 2008). If withholding of biobanks’ resources drastically reduces their full value, their wide sharing is not simple to put into practice. The first and most complex barrier hindering Open Access is the lack of common standards, guidelines and legal frameworks due to socio-cultural differences of countries where biobanks operate (see Capocasa et al 2015 https://peerj.com/preprints/1212/). Developing harmonised standards is a challenge that primarily needs to foster international norms for donors’ p...
Background Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather... more
Background
Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent.
Methods
Review question: Which empirical data are available on research participants’ perceptions and views regarding information and elicitation of consent for biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially relevant full text articles by two authors independently. As categories for content analysis we defined (i) understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research participants’ concerns.
Results
The search in Pubmed yielded 337 abstracts of which 10 articles were included in this study. Approaches to information and consent varied considerably across the selected studies. The majority of research participants opted for some version of limited consent when being informed about such possibility. Among the factors influencing the type of preferred consent were information about sponsoring of biobank research by pharmaceutical industry and participants’ trade-off between privacy and perceived utility. Studies investigating research participants’ understanding and recall regarding the consent procedure indicated considerable lack of both aspects. Research participants’ perceptions of benefits and harms differ across those studies.
Conclusion
The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved.
Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent.
Methods
Review question: Which empirical data are available on research participants’ perceptions and views regarding information and elicitation of consent for biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially relevant full text articles by two authors independently. As categories for content analysis we defined (i) understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research participants’ concerns.
Results
The search in Pubmed yielded 337 abstracts of which 10 articles were included in this study. Approaches to information and consent varied considerably across the selected studies. The majority of research participants opted for some version of limited consent when being informed about such possibility. Among the factors influencing the type of preferred consent were information about sponsoring of biobank research by pharmaceutical industry and participants’ trade-off between privacy and perceived utility. Studies investigating research participants’ understanding and recall regarding the consent procedure indicated considerable lack of both aspects. Research participants’ perceptions of benefits and harms differ across those studies.
Conclusion
The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved.
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1. Breve storia del consenso informato Prime spinte verso il consenso informato La dichiarazione di Helsinki La convenzione di Oviedo Il consenso informato nella regolamentazione italiana Per riassumere 2. Breve introduzione... more
1. Breve storia del consenso informato
Prime spinte verso il consenso informato
La dichiarazione di Helsinki
La convenzione di Oviedo
Il consenso informato nella regolamentazione italiana
Per riassumere
2. Breve introduzione all’evoluzione bioetica del consenso informato
La medicina paternalistica e il principio di beneficità
Il principio di autodeterminazione, lo shared decision making, e l’empowerment del paziente
La trasparenza nel rapporto medico/paziente
Per riassumere
3. Dal consenso informato alla decisione autonoma e informata
Il consenso informato tra efficacia terapeutica ed equità
Equità, giustizia sociale e medicina difensiva
Per riassumere
Conclusioni
Riferimenti Bibliografici
Prime spinte verso il consenso informato
La dichiarazione di Helsinki
La convenzione di Oviedo
Il consenso informato nella regolamentazione italiana
Per riassumere
2. Breve introduzione all’evoluzione bioetica del consenso informato
La medicina paternalistica e il principio di beneficità
Il principio di autodeterminazione, lo shared decision making, e l’empowerment del paziente
La trasparenza nel rapporto medico/paziente
Per riassumere
3. Dal consenso informato alla decisione autonoma e informata
Il consenso informato tra efficacia terapeutica ed equità
Equità, giustizia sociale e medicina difensiva
Per riassumere
Conclusioni
Riferimenti Bibliografici
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With the rise of -omics disciplines and biobank research, personal data and biosamples crossing national borders pose new ethical questions. In this article, informed consent, as originally conceived, is shown as not being sufficient to... more
With the rise of -omics disciplines and biobank research, personal data and biosamples crossing national borders pose new ethical questions. In this article, informed consent, as originally conceived, is shown as not being sufficient to address aims of research and interests of patients any more. Therefore the author has, after having scrutinised issues in biobanking, sketched a model of dynamic consent and a manner of scrutinising ethical issues through empirical data.
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The phenomenon of high cancer mortality has been the key factor in driving drug approval processes and health-care policies. In this paper, we discuss the inconsistencies of the genetic model of cancer as applied in the case of colorectal... more
The phenomenon of high cancer mortality has been the key factor in driving drug approval processes and health-care policies. In this paper, we discuss the inconsistencies of the genetic model of cancer as applied in the case of colorectal cancer (CRC). The result of relying on a genetic model of CRC is the approval of cancer drugs based on the inhibition of the epidermal growth factor receptor. The poor clinical performance of these drugs has prompted the use of a molecular biomarker to find the respondent patients. Due to the complexity of the cancer cell biological pathways, even the use of a molecular biomarker has not improved the clinical response of treated patients. Within the clinical uncertainty derived from the limited predictive value of a cancer molecular biomarker, we analyse the patient-doctor relationship. Beyond the challenge of communicating the medical uncertainty, many influences coming from the health-care system make the medical decisions biased. We analyse the ethical justification in using drugs that, at best, extend the patients’ survival for a few weeks, then we proceed to highlight the excessive cost of these drugs that create a problem for the allocation of resources for the whole society. We hold that a sensitive evaluation before the use of costly drugs for metastatic cancers must enter into the physician-patient relationship balancing the ethical concerns of the oncologist community and the need for the development of preventive policies.
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The first part of the thesis is a critical analysis of the proceedings of the conferences" Towards a Theoretical Biology" founded by the Rockefeller Foundation and leaded by Conrad H. Waddington. The second part is an... more
The first part of the thesis is a critical analysis of the proceedings of the conferences" Towards a Theoretical Biology" founded by the Rockefeller Foundation and leaded by Conrad H. Waddington. The second part is an epistemological and sociological analysis ...
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In the article some remarks are made on the birth and development of genetics and epigenetics, and in respect of their relationship with environmental factors. If Johannsen’s genotype concept is a reprise of Woltereck’s Norm of Reaction,... more
In the article some remarks are made on the birth and development of genetics and epigenetics, and in respect of their relationship with environmental factors. If Johannsen’s genotype concept is a reprise of Woltereck’s Norm of Reaction, is also true that the former excluded the important role of environmental factors considered by the latter. Then, I describe some operational concepts taken from Woltereck’s Norm of Reaction and that through the work of Krafka and Hersch were transferred to Conrad Waddington in the contemporary biological debate. In the light of the role that epigenetics confers to the interaction between environmental factors and organisms’ development, the importance of the genetic code is questioned.
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ll volume introduce il lettore all’epigenetica, lo studio biologico della continuità tra organismi e ambienti, attraverso la sua storia e le sue attuali applicazioni nella salute pubblica e nella ricerca scientifica. Sulla scia della... more
ll volume introduce il lettore all’epigenetica, lo studio biologico della continuità tra organismi e ambienti, attraverso la sua storia e le sue attuali applicazioni nella salute pubblica e nella ricerca scientifica. Sulla scia della divisione del mondo nei blocchi delineati durante la guerra fredda, l’epigenetica venne osteggiata dalle più importanti istituzioni scientifiche occidentali di inizio Novecento e dimenticata fino alla fine degli anni sessanta. Uno dei motivi di questo ostracismo da parte degli ambienti accademici risiedeva nel carattere di forte interdisciplinarità della sua genesi – prerogativa propria della scienza sovietica – mentre nell’assetto scientifico del blocco occidentale la specializzazione disciplinare e il conseguente ruolo degli esperti nelle istituzioni democratiche iniziava a prendere piede. Dopo aver percorso le tappe storiche dello sviluppo dell’epigenetica, vengono analizzati casi di studio in cui questa disciplina interagisce con la zoologia, la botanica e la sfera della salute pubblica per le generazioni presenti e future, nonché le linee di ricerca più recenti che aprono al ripensamento dei cardini culturali e scientifici delle nostre stesse società.
Research Interests: Bioethics, History of Medicine, Molecular Biology, Environmental Studies, History of Science, and 14 morePhilosophy of Medicine, Medical Ethics, History of Biology, Biopolitics, Social Studies Of Science, Epigenetics, History and philosophy of science (History), History of genetics, Biopower and Biopolitics, Evolutionism, Political Epistemology, History and Philosophy of Science, Science and Technology Studies, and History of Epigenetics
In this article I recognise three major historical phases of epigenetics, the first initiated by Child, Needham and Waddington during the first half of last century, focused on a dialectical analysis of biological processes between the... more
In this article I recognise three major historical phases of epigenetics, the first initiated by Child, Needham and Waddington during the first half of last century, focused on a dialectical analysis of biological processes between the organisms and their environments. The second phase started with the Bellagio conferences organised by Waddington where general principles derived from quantum physics were used to establishing a global order underpinned by scientific, objective facts beyond ethical and moral judgments. In the third phase, started with the failure of the Human Genome Project, there isn’t any consensus on the operative and philosophical notion of nature – i.e. the environmental context. Then, I highlight the necessity to reunify knowledge and moral within epigenetics.
Research Interests: Genetics, Philosophy of Science, Molecular Biology, History of Science, History and Philosophy of Biology, and 9 moreHistory of Biology, Epigenetics, History of genetics, Research Policy, Science and Society, Political Epistemology, Social Values, Epistemic Values, and Science and Technology Studies
Il volume presenta il consenso informato alla luce del dibattitto filosofico e antropologico e nel suo sviluppo storico e legale. Pensato inizialmente per proteggere i soggetti di ricerca dagli abusi dei medici, il consenso informato si è... more
Il volume presenta il consenso informato alla luce del dibattitto filosofico e antropologico e nel suo sviluppo storico e legale. Pensato inizialmente per proteggere i soggetti di ricerca dagli abusi dei medici, il consenso informato si è poi trasformato in dispositivo ideologico–liberale per contrastare il paternalismo medico e promuovere il diritto individuale all’autodeterminazione dei pazienti. L’opera mette in evidenza gli aspetti più deboli di un dispositivo etico–giuridico oramai centenario, ad esempio il suo uso in medicina difensiva, per stimolare riflessioni utili a ricontestualizzarlo con appropriatezza nell’ambito della cura dei pazienti e nello scenario più ampio dei diritti sociali.