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result(s) for
"Bioengineering - legislation "
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Regulate gene editing in wild animals
2015
Altering wild animal populations using gene drive aims to rapidly disrupt a particular trait, such as the ability of Anopheles mosquitoes to transmit malaria. From the standpoint of ethics, it is not clear why trait modification is by definition a bad thing.
Journal Article
Patents in synthetic biology
by
Chan, Sarah
,
Sulston, John
in
Bioengineering - legislation & jurisprudence
,
Communication
,
Genetic engineering
2010
May hinder future research and restrict access to innovation
Journal Article
Synthetic Biology in the FDA Realm
by
Hall, Ralph F.
,
Fatehi, Leili
in
Bioengineering - legislation & jurisprudence
,
EMERGING ISSUES AND NEW FRONTIERS FOR FDA REGULATION An FDLI Symposium in Partnership with Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
,
Government Regulation
2015
Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve “thinking ahead” to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time. These new approaches constitute a marked departure from the status quo, and their development and implementation will require considerable time, resources, and reallocation of responsibilities. Furthermore, in order to develop an appropriate oversight response, adaptive or otherwise, there is first a need to identify the specific types and natures of applications, uncertainties, and regulatory issues that are likely to pose oversight challenges.
This article presents our vision for a Productive Oversight Assessment (POA) approach in which the abilities and deficits of an oversight system are evaluated with the aim of enabling productive decisions (i.e., timely, feasible, effective for achieving desired policy outcomes) about oversight while also building capacity to facilitate broader governance efforts. The value of POA is two-fold. First, it will advance the development of a generalizable approach for making productive planning and decision-making about the oversight of any given new technology that presents challenges and uncertainties for any given oversight system whose policy goals are implicated by that technology. Second, this effort can enhance the very processes advocated under anticipatory and adaptive approaches by laying the groundwork for and providing valuable data to support future normative deliberations about the governance of emerging technologies.
Journal Article
Four ethical priorities for neurotechnologies and AI
by
Fins, Joseph J.
,
Rubel, Alan
,
Teicher, Mina
in
Alzheimer Disease - diagnosis
,
Animals
,
Artificial intelligence
2017
Current BCI technology is mainly focused on therapeutic outcomes, such as helping people with spinal-cord injuries. It might take years or even decades until BCI and other neurotechnologies are part of our daily lives. Such advances could revolutionize the treatment of many conditions, from brain injury and paralysis to epilepsy and schizophrenia, and transform human experience for the better. But the technology could also exacerbate social inequalities and offer corporations, hackers, governments or anyone else new ways to exploit and manipulate people.
Journal Article
Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine
by
Gilbert, Frederic
,
Dodds, Susan
,
Mladenovska, Tajanka
in
3-D printers
,
Bioengineering
,
Bioethics
2018
Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.
Journal Article
Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date
by
Islam, Jiaul
,
Robinson, Kye J.
,
Corrie, Simon R.
in
Biochemistry
,
Biomedical and Life Sciences
,
Biomedical Engineering and Bioengineering
2016
ABSTRACT
In this review we provide an up to date snapshot of nanomedicines either currently approved by the US FDA, or in the FDA clinical trials process. We define nanomedicines as therapeutic or imaging agents which comprise a nanoparticle in order to control the biodistribution, enhance the efficacy, or otherwise reduce toxicity of a drug or biologic. We identified 51 FDA-approved nanomedicines that met this definition and 77 products in clinical trials, with ~40% of trials listed in clinicaltrials.gov started in 2014 or 2015. While FDA approved materials are heavily weighted to polymeric, liposomal, and nanocrystal formulations, there is a trend towards the development of more complex materials comprising micelles, protein-based NPs, and also the emergence of a variety of inorganic and metallic particles in clinical trials. We then provide an overview of the different material categories represented in our search, highlighting nanomedicines that have either been recently approved, or are already in clinical trials. We conclude with some comments on future perspectives for nanomedicines, which we expect to include more actively-targeted materials, multi-functional materials (“theranostics”) and more complicated materials that blur the boundaries of traditional material categories. A key challenge for researchers, industry, and regulators is how to classify new materials and what additional testing (e.g. safety and toxicity) is required before products become available.
Journal Article
Artificial Intelligence Crime: An Interdisciplinary Analysis of Foreseeable Threats and Solutions
by
Taddeo, Mariarosaria
,
Floridi, Luciano
,
Aggarwal, Nikita
in
Artificial intelligence
,
Artificial Intelligence - trends
,
Biomedical Engineering and Bioengineering
2020
Artificial intelligence (AI) research and regulation seek to balance the benefits of innovation against any potential harms and disruption. However, one unintended consequence of the recent surge in AI research is the potential re-orientation of AI technologies to facilitate criminal acts, term in this article AI-Crime (AIC). AIC is theoretically feasible thanks to published experiments in automating fraud targeted at social media users, as well as demonstrations of AI-driven manipulation of simulated markets. However, because AIC is still a relatively young and inherently interdisciplinary area—spanning socio-legal studies to formal science—there is little certainty of what an AIC future might look like. This article offers the first systematic, interdisciplinary literature analysis of the foreseeable threats of AIC, providing ethicists, policy-makers, and law enforcement organisations with a synthesis of the current problems, and a possible solution space.
Journal Article
Artificial Intelligence and the ‘Good Society’: the US, EU, and UK approach
by
Cath, Corinne
,
Mittelstadt, Brent
,
Wachter, Sandra
in
Artificial intelligence
,
Development strategies
,
Ethics
2018
In October 2016, the White House, the European Parliament, and the UK House of Commons each issued a report outlining their visions on how to prepare society for the widespread use of artificial intelligence (AI). In this article, we provide a comparative assessment of these three reports in order to facilitate the design of policies favourable to the development of a ‘good AI society’. To do so, we examine how each report addresses the following three topics: (a) the development of a ‘good AI society’; (b) the role and responsibility of the government, the private sector, and the research community (including academia) in pursuing such a development; and (c) where the recommendations to support such a development may be in need of improvement. Our analysis concludes that the reports address adequately various ethical, social, and economic topics, but come short of providing an overarching political vision and long-term strategy for the development of a ‘good AI society’. In order to contribute to fill this gap, in the conclusion we suggest a two-pronged approach.
Journal Article