Biomedical research ethics and policy

SARS-CoV-2 infects children far less frequently than adults and when infected, children experience no or benign symptoms. Children further do not transmit the virus in any meaningful way. Despite these facts, many public health authorities recommend that all children above the age of 12 get vaccinated to mitigate the spread of SARS-CoV-2. As a result, many schools, colleges, and universities require proof of vaccination for students to attend class, essentially coercing students to get the COVID-19 vaccine. The rationale presented by public health officials for recommending COVID-19 vaccination for children is threefold: a) To keep children from contracting COVID-19 and becoming seriously ill. b) To stop children from transmitting SARS-COV-2 to each other, teachers, parents and grandparents. c) It is needed to reach herd immunity. Consequently, this research investigates whether these hypotheses are correct and supported by the science and empirical data. If the principal points of departure are flawed, it follows that a policy to vaccinate children against COVID-19 would be irrational. The four main biomedical ethical principles, that is beneficence, non-maleficence, autonomy, and justice, are defined and explained to provide a universal, moral analytical framework that are that can aid public health policymakers in making morally and ethically sound decisions. The four main ethical principles are then applied to the policy and practice to coerce young people to get the COVID-19 vaccine.

Advances in regenerative nanomedicine raise a host of ethical, legal, and social questions that healthcare providers and scientists will need to consider. These questions and concerns include definitions, appropriate applications, dual use, potential risks, regulations, and access. In this chapter, we provide an overview of the questions and concerns and recommend proactive consideration and solutions.

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within 10 the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical 15 issues of its day, the field of research ethics involving human subjects may have outgrown it.

Escherichia coli (abbreviated as E. coli) is a common bacterium both in daily life and scientific researches. In order to demonstrate the biophysical properties of Escherichia coli, the 3D model and simulation of E. coli are built based on Blender, helping with the visualization. First, a brief introduction to Blender explains why it's chosen as the modelling software and demonstrates the advantages of Blender by comparison; next, the whole process of how the model is built through basic shapes and modifiers is provided step by step. Lastly, several C# scripts in Unity are written to make the model move as real Escherichia coli in a low Reynolds number environment to simulate the behaviour of the cell in line with a given motion mode. The final result manifests the above methods have a great performance in the construction and simulation of E. coli, which could offer ideas for further study of the simulation of the microorganism.

-----ÖZET: İnsanlar üzerinde gerek geçmişte Nazi Almanyası'nda yapılan deneyler, gerekse sonraki yıllarda gerçekleştirilen Tuskegee sifilis ve Guatemala CYBH araştırmaları ve de günümüzde de sürmekte olan klinik farmasötik deneyler sonucunda, insan deneklerin uğrayabileceği zararlar ve sömürü uzun zamandır ciddi bir sorun olarak tartışılagelmiştir. Özellikle Nazi bilim adamlarınca insanlar üzerinde yapılan deneylere dair Nürnberg'de gerçekleştirilen yargılamalar sırasında bu çalışmaları düzenleyici, uluslararası geçerlilikte bir kod olmadığı fark edilmiş ve bu eksikliği gidermek için Nürnberg Kodu oluşturularak ülkelerce kabul edilmiştir. Günümüzde in vivo farmasötik deneyler, in vitro prosedürler, kök hücre çalışmaları vb. ile, insanlar ve de insan doku ve hücreleri üzerinde tarihte daha önce hiç olmadığı kadar çeşitli ve karmaşık bilimsel araştırmalar gerçekleştirilmektedir. İnsan üzerindeki deneyler konusunda temel gerilim, bu deneyler sonucunda insan deneklerin uğrayabileceği zararlar ile bilim ve tüm insanlık için sağlanabilecek yararlar arasındadır. Bu yararlardan vazgeçmeden, ama söz konusu deneklere de zarar vermeden ilerleyebilmek için, birtakım bilimsel ve ahlaki kod ve kurallar geliştirilmiş, bunlar etik bildirgelerde ve hukuki mevzuatta ilan edilmiştir. Söz konusu deney ve araştırmalarda gerçekleşen değişikliklere paralel olarak, bu metinler de yeni gereksinimlere göre tadil edilmekte ya da bunlara yenileri eklenmektedir. Örneğin Helsinki Bildirgesi bugüne dek yedi kez revize edilmiştir. Sistematik bir derleme olan bu makale, insan denekli araştırmalarla ilgili ulusal ve uluslararası geçerlilikteki bu etikolegal metinleri bir yerde toplayan bir kaynak olmak amacındadır.

-----ABSTRACT: Due to the human experimentation conducted in the Nazi Germany in the past, the subsequent Tuskegee syphilis and Guatemala STD studies, and the ongoing clinical pharmaceutical trials, potential harms to and exploitation of human subjects have long been discussed as a serious problem. Especially during the trials held in Nuremberg regarding the human experimentation that had been conducted by Nazi scientists the important lack of an internationally binding regulatory code was recognized, and the Nuremberg Code was created and adopted by countries to fill this gap. Given the ongoing in vivo pharmaceutical trials, in vitro procedures, stem cell research, etc., more various and complicated scientific research than ever before is conducted today on humans and human cells and tissues. The main tension in the field of human experimentation is between potential harms to the human subjects and potential benefits for science and humanity. A variety of scientific and ethical codes and rules have been developed and declared both in ethical declarations and in legal regulations in order to proceed to achieve these benefits without harming the subjects. In parallel with changes in these trials and research, these texts have also been either modified or supplemented by new texts. The Helsinki Declaration , for instance, has been revised for seven times up to the present. This systematic review aims to provide a source that gathers these nationally and internationally binding ethicolegal texts concerning human experimentation.

Increasingly, a range of 'things' (e.g. infrastructure, data, knowledge, bodies, etc.) are configured and/or reconfigured as assets, or capitalized property. Accumulation strategies have changed as a result of this assetization process, which characterizes a particular form of technoscientific capitalism. Rather than entrepreneurial strategies based on commodity production, technoscientific capitalism is increasingly underpinned by rentiership, or the appropriation of value through ownership rights (e.g. intellectual property), monopoly conditions, and regulatory or market devices and practices (e.g. investment dispute courts, exclusivity agreements, etc.). While rentiership and rent-seeking are often presented as negative phenomena (e.g. distorting markets, unearned income) in both neoclassical and Marxist literatures – and much in-between – it is my intention in this paper to unpack rentiership as an increasingly constitutive political-economic process underpinning technoscientific capitalism. Rather than being framed as a problematic 'side-effect' of capitalism, I argue that rentiership can help us to understand how different forms of value extraction are constituted by and come to constitute different forms of technoscience. This has significant analytical, political, and normative implications for understanding the relationship between science, innovation, and business (e.g. how do rentier rationales configure research agendas, how does innovation enable rentiership, what are the consequences for social equity, etc.).

The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines.

Dans son dernier dialogue, Platon définit la famille comme une communauté d’individus liés par deux types de relation : le sang et les rites religieux, l’un relevant de « l’être » et l’autre du « faire », pour reprendre la terminologie usitée par l’anthropologue américain David Schneider. Tels sont les mots de l’Étranger d’Athènes : « Quelqu’un qui honore et révère la famille (sungeneian) et la communauté de tous ceux qui ont les mêmes dieux et dans les veines de qui coule le même sang (aimatos) peut raisonnablement compter sur la bienveillance des dieux qui président à la famille pour la procréation de ses propres enfants » (PLATON, Lois, 729c). Cet extrait des Lois sera le point de départ d’une interrogation globale sur le rôle du sang, haima, dans les conceptions de la parenté que Platon et Aristote ont élaborées dans leurs différentes œuvres, autant médicales que philosophico-politiques. Platon n’a pas suivi une ligne théorique unique et la famille célèbre de la République est celle de la performativité des rôles parentaux, dépouillés de leur substrat biologique. En apparence seulement car Platon élabore, parallèlement à la communauté classificatoire des parents et des enfants, une politique foncièrement eugéniste, qui suppose l’acceptation de la transmission naturelle des caractères d’une génération à l’autre. Face au volet performatif de la refondation familiale et utopique de la République, Aristote a répondu à son maître par un pamphlet essentialiste qui, dans la Politique, réaffirme la primauté des liens du sang, connus des individus, pour assurer l’efficacité de la philia intrafamiliale et le respect entre parents. À la consanguinité nominale Aristote substitue la consanguinité biologique. La pensée aristotélicienne semble cohérente : l’analyse des positions du Stagirite sur l’embryogénèse montre son attachement à la théorie de l’hématogénèse, où le sang est le principe originel des semences, hypothèse que ne valide pas Platon. Et, dans les Éthiques à Nicomaque et à Eudème, Aristote confirme l’idée que le partage du sang est à la base d’une hiérarchie complexe de l’amour entre parents et enfants. Platon et Aristote posent ainsi des questions aux résonances très contemporaines, quand il s’agit de la famille déchirée entre nature et culture, du contrôle qualitatif des grossesses et de la détection de défaillance génétique, ou encore de la compréhension de l’inceste. Autant de sujets d’études qui interrogent le lien entre la famille et le sang.

El presente trabajo reflexiona sobre la interacción entre regulación tecnológica y valores sociales desde un estudio del caso farmacéutico. Partiendo de las distinciones entre riesgo material y riesgo social propuestas por Tula Molina, indaga acerca de las regulaciones vigentes sobre los medicamentos. En primer término, se analizan los valores de calidad, seguridad y eficacia, consensuados internacionalmente como parámetros técnicos para la evaluación de un fármaco. En segundo, se abordan dos cuestiones que se inscriben claramente en la discusión sobre los riesgos sociales del desarrollo tecnológico: el valor terapéutico de las innovaciones y el acceso a medicamentos esenciales. Finalmente, se propone que las regulaciones técnicas hagan mención explícita de las circunstancias sociales en las que serán implementadas.

Palabras-clave: Riesgo tecnológico. Evaluación de tecnologías. Regulación tecnológica. Medicamentos. Productos farmacéuticos. Filosofía de la tecnología.

The concept of distributed moral responsibility (DMR) has a long history. When it is understood as being entirely reducible to the sum of (some) human, individual, and already morally loaded actions, then the allocation of DMR, and hence of praise and reward or blame and punishment, may be pragmatically difficult, but not conceptually problematic. However, in distributed environments it is increasingly possible that a network of agents, some human, some artificial (e.g. a program) and some hybrid (e.g. a group of people working as a team thanks to a software platform) may cause distributed moral actions (DMAs). These are morally good or evil (i.e., morally loaded) actions caused by local interactions that are in themselves neither good nor evil (morally neutral). In this article, I analyse DMRs that are due to DMAs and argue in favour of the allocation, by default and overridably, of full moral responsibility (faultless responsibility) to all the nodes/agents in the network causally relevant for bringing about the DMA in question, independently of intentionality. The mechanism proposed is inspired by, and adapts, three concepts: back propagation from network theory, strict liability from jurisprudence, and common knowledge from epistemic logic.

Catholic Servant (February 2021): 3 (due to the layout I made a two-page pdf). In this Q & A column: I note the morally problematic nature of the current Covid vaccines; briefly explain the traditional categories governing cooperation with evil for Catholics; explain why it is not intrinsically immoral to take the vaccines but also not morally obligatory; and finally note several valid reasons why people would abstain from taking them.

Social Science relies heavily on the use of ethnographic and other forms of qualitative study, research that may place the researcher as well as their subjects at significant ethical risk. In Canada, Research Ethics Boards are responsible for protecting research participants during these studies. But how much ethical oversight ought the Research Ethics Boards be entitled to? Are they repressing valuable qualitative studies or are the Social Sciences simply rebelling against new, but appropriate, control mechanisms not formerly applied to them? This paper evaluates how well the changes made in the TCPS 2 respond to the concerns of Social Scientists as presented in the literature.

The European Medical Information Framework (EMIF) project, funded through the IMI programme (Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115372), has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice (ECoP) to ensure the privacy protection of data subjects, protect the interests of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board (EAB), to provide feedback on its approach, platform, and the Eco...

Scholars and lawmakers expend much effort determining optimal incentives to innovate, but almost entirely neglect the regulation of knowledge-producing activities themselves. This Article critically examines that regulatory framework, adopted by more than one dozen federal agencies in the U.S. and many other countries, which governs the vast majority of those knowledge-producing activities that have the greatest potential to affect human welfare: research involving human beings, or “human subjects research” (HSR). It focuses on the primary actors in the regulation of HSR — licensing committees called Institutional Review Boards (IRBs) which, before each study may proceed, must find that its risks to participants are “reasonable in relation to” its expected benefits for both participants and society. It argues for a particular interpretation of this risk-benefit standard and, drawing on scholarship in psychology, economics, neuroscience and other fields, argues that participant heterogeneity prevents IRBs from carrying out their regulatory duty. Instead, the regulatory system implicitly responds to the heterogeneity problem with risk aversion that is costly not only to researchers and society but, critically, to would-be research participants. The Article concludes by laying out the policy options that remain in the wake of the heterogeneity problem’s intractability: continuing the legal fiction of risk-benefit analysis, honestly embracing the heterogeneity problem and its costs, or jettisoning IRB risk-benefit analysis. A companion Article develops the possibility of the third option.

The New Zealand Cervical Cancer Inquiry established that patients with carcinoma-in-situ were left untreated in order to observe the natural history of their disease. Many patients developed invasive carcinoma unnecessarily and some died. The Inquiry found the research to have been unethical in that: the risk of progression to invasive carcinoma was known; the subjects had not consented to the study; and it was poorly designed and conducted. The Inquiry was critical of the lack of proper review and the failure of responsible doctors and administrators to intervene in the interests of the patients. This article considers reasons for this failure and background issues of ethics and law. It is concluded that there is no cause for complacency in Australia in that provisions that are designed to protect patients may be ineffective. The NZ recommendations for changes in communication with patients, in the treatment of patients, in reviews of research, and in the training of doctors should be examined for their possible adoption in Australia. We have the same range of human weaknesses on this side of the Tasman. As the Chelmsford Hospital case illustrates, we have the same institutional and professional resistance to examining accusations of unethical treatment. The NZ cervical-cancer study should not be dismissed lightly. The recommendations of the Cervical Cancer Inquiry go further to protect patients than do most of the equivalent provisions in Australia. They should be examined closely for their relevance and possible adoption.

This paper argues that data-driven medicine gives rise to a particular normative challenge. Against the backdrop of a distinction between the good and the right, harnessing personal health data towards the development and refinement of data-driven medicine is to be welcomed from the perspective of the good. Enacting solidarity drives progress in research and clinical practice. At the same time, such acts of sharing could-especially considering current developments in big data and artificial intelligence-compromise the right by leading to injustices and affecting concrete modes of individual self-determination. In order to address this potential tension, two key elements for ethical reflection on data-driven medicine are proposed: the controllability of information flows, including technical infrastructures that are conducive towards controllability, and a paradigm shift towards output-orientation in governance and policy.

Tetracycline belongs to one of the extracellular pr oduced polyketide antibiotics having hydrophilic properties. Statistical based optimization, Plac kett–Burman design (PBD) and response surface methodology (RSM) were occupied to screen and optimize the medium co nditions for the production of tetracycline from Streptomyces aur eofaciens NCIM 2417, using solid state fermenta tion. pineapple peel waste was used as both the cur ious solid support and carbon and nitrogen sourc es and inorganic salts for the growth of Streptomyces aureofaciens NCIM 2417. Based on the positive influence of the half normal plot obtained from PBD on tetracycline production, three medium conditions – peanut meal, incubation period and s oluble starch were screened. Central composite design (CCD) was occupied using these three medium conditions at five levels, for advance optimization, and the second order polynomial equation was derived, based on the experiment al data. Response surface methodology showed ...

To suggest that modern technology is creating a world where we will one day all be borne via a petri dish is more than a little over the top. It was not too long ago that we were told that the condom would be the downfall of society and bring about The Rapture. In fact as we now know the condom is potentially saving the world from the rapturous embrace of HIV and AIDS. In all the discussions on the impact of modern technology upon our sexual and reproductive lives there is a moral and ethical undertone, some in favour, many more against. This essay shall look at both these sides of the argument and shall attempt to put them into context, especially in light of the recent revelation of the bench-top Ion Proton™ Sequencer and the fresh uproar it has caused. We shall begin by looking at the latest in technology, the bench-top Ion Proton™ Sequencer and analysing whether it should be welcomed or feared. We shall study John A. Robertsons extensive research in this area and discuss the legal and moral implications of genome sequencing and its potential impact on those with disabilities. We shall then follow this by studying the pre-implantation tests which are currently available in an attempt to see if the IP Sequencer will have a positive or negative impact on them. We shall also look at the abortion statistics which are available in regards to both Irish women and women in the UK who seek terminations specifically for the purpose of eradicating a foetus with a disability. The purpose of doing this is to fully understand whether pre-implantation might in fact be a way of preventing a greater harm to a foetus, instead of a lesser harm to an embryo. We shall see if the fear of eugenics is justified or whether Robertson is correct in his stance in relation to this matter, for he suggests that to assume that IVF would eventually ‘trump’ sex is more than a slight exaggeration. When we rationalise our thinking and look at the facts, especially in the case of ‘saviour siblings’ which many feared would lead to an abuse or the technology in order to create ‘designer babies’ or a ‘superior’ child, we begin to see that many of these fears are completely unfounded and created by scaremongering. We shall then look at current twin studies and epigentics in an attempt to rationalise our potential fears in the area of genetics before we analyse our own human moral values. We shall discuss how the changes in our moral understanding have impacted positively upon our sexual and reproductive health.

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,16,17 ✉ and The International AIDS Society (IAS) Global Scientific Strategy working group* Despite the success of antiretroviral therapy (ART) for people living with HIV, lifelong treatment is required and there is no cure. HIV can integrate in the host genome and persist for the life span of the infected cell. These latently infected cells are not recognized as foreign because they are largely transcriptionally silent, but contain replication-competent virus that drives resurgence of the infection once ART is stopped. With a combination of immune activators, neutralizing antibodies, and therapeutic vaccines, some nonhuman primate models have been cured, providing optimism for these approaches now being evaluated in human clinical trials. In vivo delivery of gene-editing tools to either target the virus, boost immunity or protect cells from infection, also holds promise for future HIV cure strategies. In this Review, we discuss advances related to HIV cure in the last 5 years, highlight remaining knowledge gaps and identify priority areas for research for the next 5 years.

Pētniecības biobankas ir bioloģisko paraugu un datu krātuves, kurām ir būtiska nozīme mūsdienīgas zinātnes infrastruktūras izveidē. To darbība ne vien dod iespēju veikt nozīmīgus pētījumus bioloģijā un medicīnā, bet arī rada virkni ētisku problēmu, kas saistītas ar biobanku donoru piekrišanas iegūšanu, personas datu aizsardzību, biobanku darbības caurskatāmību un risku un ieguvumu samēra izvērtēšanu. Tādēļ ļoti svarīgi ir nodrošināt ētiski un sociāli atbildīgu biobanku pārvaldību, lai aizsargātu biobanku donoru tiesības, veidotu ētikas vadlīnijas, risinātu problēmsituācijas un izstrādātu visu iesaistīto pušu vajadzībām atbilstošas rīcībpolitikas. Raksta mērķis ir, balstoties uz empīriskiem datiem, identificēt galvenās jomas sociāli un ētiski atbildīgas pētniecības biobanku pārvaldības nodrošināšanai Latvijā. Raksts ir balstīts uz projekta rezultātiem, kura ietvaros pētnieku grupa veica sabiedrības, biobanku donoru un zinātnieku aptaujas, kā arī 40 kvalitatīvas intervijas ar biobanku donoriem un zinātniekiem.

Life and Learning XXIX: Proceedings of the 2019 University Faculty for Life Conference (2019): 263-72. ABSTRACT: Mary Shelley’s Frankenstein depicts the dangers of a scientific ethos in which technological control over life is seized, even with partially good motivations. This essay explores the motivations of Victor Frankenstein and the dysfunction seen in his physically superior creature. It notes the similarities between Victor’s own intention and that of the founder of IVF, as well as the similarities in the experiences between Victor’s creature and children conceived through IVF, as witnessed to in the report My Daddy’s Name is Donor (2010) and the ongoing surveys done at the website “We Are Donor Conceived.” It then draws some lessons about the dangers in bringing children into the world outside of the normal and natural biological way.

Advances in regenerative nanomedicine raise a host of ethical, legal, and social questions that healthcare providers and scientists will need to consider. These questions and concerns include definitions, appropriate applications, dual use, potential risks, regulations, and access. In this chapter, we provide an overview of the questions and concerns and recommend proactive consideration and solutions.

This thesis focuses on the history of embryonic stem cell research, spanning in particular the nineteenth and twentieth centuries. As yet, there has not been a comprehensive history of embryonic stem cell research carried out, which is a particular aim of this thesis. The first two chapters consider the conceptualisation of the stem cell, and the development and diversity of relevant disciplines and their establishment in the twentieth century; in particular, this covers heredity, genetics,embryology and development. This is illustrated through the use of experimental embryology, or ‘fantastical experiments’, that were proposed in the nineteenth century, and carried out in the twentieth. The third chapter considers the theoretical and practical links between cancer and embryonic cells. The fourth and fifth chapters explore the isolation and culture of murine and human embryonic stem cells, focusing on the social, political, and economic factors affecting stem cell research, and the motivations behind the isolation of embryonic stem cells in the 1980s and 1990s. The
sixth chapter queries whether the history presented suggests that a new stem cell concept is emerging.
There are three questions that this thesis aims to answer. Firstly, what are the (historical) social and political influences that affect (embryonic) stem cell research? Evidence presented suggests that this has occurred from the nineteenth century, and continues today. Secondly, this thesis queries the importance of cell fate, and cell fate studies, to embryonic stem cell research. Since one of the two abilities of stem cells is the ability to differentiate, cell fate and studies of cell fate are central to developing a stem cell concept, and may also be influential in changing that concept in the future. Lastly, this thesis asks which paradigms have affected embryonic stem cell research throughout its history. In particular, the genetic paradigm is shown to be influential from the early twentieth century onwards. More recently, it has been proposed that stem cell research needs to undergo a paradigm shift, from the stem cell entity view, to the stem cell state view. This is also explored through the thesis, with the aim of generating a better understanding of stem cells for future researchers.

This is a post published by the American Philosophical Association on their online blog: http://blog.apaonline.org/

http://blog.apaonline.org/2017/03/23/psychiatry-and-the-humanities-postgraduate-course-in-the-faculty-of-medicine-university-of-montreal/

In 2012 a new biobanking law came into effect in Finland which, according to some, is one of the most com- prehensive and broad national biobanking legislations in the world to date. The law covers both clinical and research collections and provides institutions with great flexibility in terms of transferring existing collections into a biobank. The law also includes provisions for individuals whose samples are stored in the biobank to request information regarding the studies in which the sample has been used. However, this provision also compels biobanks to provide an account of the significance of the research findings to their individual health. This legal provision has created tension between policy and practice in that most biobanks will struggle to interpret and apply this provision in practice. The relationship between the rights and needs to conduct research using biobank material and individual rights of access is sometimes unclear and fraught with interpretational challenges. The derivation of national interpretations of European Directives and Conventions gives rise to what I call interpretive regulatory dissonance. This is expected to be a challenge for harmonizing European and global biobanking activities in the future.