Open Access. Powered by Scholars. Published by Universities.®
- Discipline
-
- Intellectual Property Law (290)
- Internet Law (287)
- Privacy Law (286)
- Computer Law (276)
- Health Law and Policy (24)
-
- Law and Society (23)
- Human Rights Law (17)
- Legislation (16)
- Law and Gender (15)
- Comparative and Foreign Law (14)
- Medical Jurisprudence (13)
- International Law (11)
- Food and Drug Law (9)
- Constitutional Law (8)
- Consumer Protection Law (8)
- Courts (7)
- Criminal Law (7)
- Law and Politics (7)
- Environmental Law (6)
- Contracts (5)
- Civil Rights and Discrimination (4)
- Jurisprudence (4)
- Law and Race (4)
- Legal Ethics and Professional Responsibility (4)
- Civil Procedure (3)
- Communications Law (3)
- Jurisdiction (3)
- Law and Economics (3)
- Keyword
-
- Copyright (22)
- PIPEDA (16)
- Canada (15)
- Privacy (14)
- Artificial intelligence (12)
-
- Book reviews (11)
- AI (9)
- E-commerce (9)
- Artificial Intelligence (8)
- Case comment (8)
- Intellectual property (8)
- Law (8)
- Section 8 (8)
- Freedom of expression (6)
- Machine Learning (6)
- Science (6)
- European Union (5)
- Human Rights (5)
- Right to Repair (5)
- Technology (5)
- Transparency (5)
- Admissibility (4)
- Biotechnology (4)
- Chilling Effects (4)
- Copyright Law (4)
- Data protection (4)
- Electronic surveillance (4)
- Ethics (4)
- Evidence (4)
- ICANN (4)
- Publication Year
- Publication
- Publication Type
Articles 91 - 120 of 375
Full-Text Articles in Science and Technology Law
Politics Of Adversarial Machine Learning, Kendra Albert, Jonathon Penney, Bruce Schneier, Ram Shankar Siva Kumar
Politics Of Adversarial Machine Learning, Kendra Albert, Jonathon Penney, Bruce Schneier, Ram Shankar Siva Kumar
Articles, Book Chapters, & Popular Press
In addition to their security properties, adversarial machine-learning attacks and defenses have political dimensions. They enable or foreclose certain options for both the subjects of the machine learning systems and for those who deploy them, creating risks for civil liberties and human rights. In this paper, we draw on insights from science and technology studies, anthropology, and human rights literature, to inform how defenses against adversarial attacks can be used to suppress dissent and limit attempts to investigate machine learning systems. To make this concrete, we use real-world examples of how attacks such as perturbation, model inversion, or membership inference …
Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens
Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens
Articles, Book Chapters, & Popular Press
Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …
Unscrewing The Future: The Right To Repair And The Circumvention Of Software Tpms In The Eu, Anthony D. Rosborough
Unscrewing The Future: The Right To Repair And The Circumvention Of Software Tpms In The Eu, Anthony D. Rosborough
Articles, Book Chapters, & Popular Press
This analysis examines the impact of software technological protection measures (“TPMs”) in the European Union which inhibit the repair and maintenance of products. Using John Deere tractors as a case study, this analysis addresses the growing number of products which incorporate computerisation and TPMprotected software into their design and function. In utilising software integration and TPMs, many product designs now allow manufacturers to retain considerable control over the manner of repair and choice of technician. In response, consumers and lawmakers are calling for legal reforms to make self-repair and servicing easier. Both the competition law and moral implications of this …
Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder
Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder
Articles, Book Chapters, & Popular Press
Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …
Implementing User Rights For Research In The Field Of Artificial Intelligence: A Call For International Action, Sean Flynn, Christophe Geiger, Joao Pedro Quintais, Thomas Margoni, Matthew Sag, Lucie Guibault, Michael W. Carroll
Implementing User Rights For Research In The Field Of Artificial Intelligence: A Call For International Action, Sean Flynn, Christophe Geiger, Joao Pedro Quintais, Thomas Margoni, Matthew Sag, Lucie Guibault, Michael W. Carroll
Articles, Book Chapters, & Popular Press
Last year, before the onset of a global pandemic highlighted the critical and urgent need for technology-enabled scientific research, the World Intellectual Property Organization (WIPO) launched an inquiry into issues at the intersection of intellectual property (IP) and artificial intelligence (AI). We contributed comments to that inquiry, with a focus on the application of copyright to the use of text and data mining (TDM) technology. This article describes some of the most salient points of our submission and concludes by stressing the need for international leadership on this important topic. WIPO could help fill the current gap on international leadership, …
Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder
Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder
Articles, Book Chapters, & Popular Press
Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …
Editorial, Lucie Guibault
Editorial, Lucie Guibault
Articles, Book Chapters, & Popular Press
1 This issue marks the tenth month into the COVID-19 pandemic. Since March 2020, we have learned to live with the more or less strict public health measures put in place to ‘flatten the curve’ of infection from the virus. Words like ‘social distancing’, ‘mask wearing’, and ‘lockdowns’ have taken an entirely new meaning. In spite of these measures, the human toll is huge, most clearly among frontline workers and vulnerable people. While the curve is far from flat in most countries, the pandemic has brought to light the long time unacknowledged persistence of systemic inequalities: figures show that poorer, …
Introduction, Aldo Chircop, Floris Goerlandt, Claudio Aporta, Ronald Pelot
Introduction, Aldo Chircop, Floris Goerlandt, Claudio Aporta, Ronald Pelot
Articles, Book Chapters, & Popular Press
This chapter introduces a multidisciplinary collection of chapters addressing various aspects of governance of Arctic shipping written by leading international scholars. It investigates how ocean changes and anthropogenic impacts affect our understanding of risk, policy, management and regulation for safe navigation, environment protection, conflict management between ocean uses, and protection of Indigenous peoples’ interests in Canadian Arctic waters. The book is divided in three parts, together providing a multi-faceted and interdisciplinary view on governance of Arctic shipping. The first part addresses conceptual and empirical aspects of risk governance, management, and assessment in the Canadian Arctic. The second part focuses on …
Sustaining Canadian Marine Biodiversity: Policy And Statutory Progress, Jeffrey A. Hutchings, Julia K. Baum, Susanna D. Fuller, Josh Laughren, David Vanderzwaag
Sustaining Canadian Marine Biodiversity: Policy And Statutory Progress, Jeffrey A. Hutchings, Julia K. Baum, Susanna D. Fuller, Josh Laughren, David Vanderzwaag
Articles, Book Chapters, & Popular Press
A 2012 Expert Panel Report on marine biodiversity by the Royal Society of Canada (RSC) concluded that Canada faced significant challenges in achieving sustainable fisheries, regulating aquacul- ture, and accounting for climate change. Relative to many countries, progress by Canada in fulfilling international obligations to sustain biodiversity was deemed poor. To track progress by Canada since 2012, the RSC struck a committee to track policy and statutory developments on matters pertaining to marine biodiversity and to identify policy challenges, and leading options for implementation that lie ahead. The report by the Policy Briefing Committee is presented here. It concluded that …
Legal Risks Of Adversarial Machine Learning Research, Ram Shankar Siva Kumar, Jonathon Penney, Bruce Schneier, Kendra Albert
Legal Risks Of Adversarial Machine Learning Research, Ram Shankar Siva Kumar, Jonathon Penney, Bruce Schneier, Kendra Albert
Articles, Book Chapters, & Popular Press
Adversarial machine learning is the systematic study of how motivated adversaries can compromise the confidentiality, integrity, and availability of machine learning (ML) systems through targeted or blanket attacks. The problem of attacking ML systems is so prevalent that CERT, the federally funded research and development center tasked with studying attacks, issued a broad vulnerability note on how most ML classifiers are vulnerable to adversarial manipulation. Google, IBM, Facebook, and Microsoft have committed to investing in securing machine learning systems. The US and EU are likewise putting security and safety of AI systems as a top priority.
Now, research on adversarial …
Ethical Testing In The Real World: Evaluating Physical Testing Of Adversarial Machine Learning, Kendra Albert, Maggie Delano, Jonathon Penney, Afsaneh Ragot, Ram Shankar Siva Kumar
Ethical Testing In The Real World: Evaluating Physical Testing Of Adversarial Machine Learning, Kendra Albert, Maggie Delano, Jonathon Penney, Afsaneh Ragot, Ram Shankar Siva Kumar
Articles, Book Chapters, & Popular Press
This paper critically assesses the adequacy and representativeness of physical domain testing for various adversarial machine learning (ML) attacks against computer vision systems involving human subjects. Many papers that deploy such attacks characterize themselves as “real world.” Despite this framing, however, we found the physical or real-world testing conducted was minimal, provided few details about testing subjects and was often conducted as an afterthought or demonstration. Adversarial ML research without representative trials or testing is an ethical, scientific, and health/safety issue that can cause real harms. We introduce the problem and our methodology, and then critique the physical domain testing …
Technology-Facilitated Gender-Based Violence: An Overview, Suzie Dunn
Technology-Facilitated Gender-Based Violence: An Overview, Suzie Dunn
Articles, Book Chapters, & Popular Press
Technology facilitated gender-based violence (TFGBV) is a complex worldwide phenomenon with devastating results. Research to date shows that victim-survivors of intimate partner violence are tracked by their abusive partners who use technology to monitor their movements and communication. Many women journalists, human rights defenders and politicians face daily death threats and rape threats for speaking out about equality issues or for simply being a woman in a leadership role. Those with intersecting marginalized identities are at specific risk, with Black, Indigenous, and people of colour, LGBTQ+ people, and people with disabilities facing higher rates of attacks and concerted attacks that …
Subverting Democracy To Save Democracy: Canada’S Extra-Constitutional Approaches To Battling “Fake News”, Michael Karanicolas
Subverting Democracy To Save Democracy: Canada’S Extra-Constitutional Approaches To Battling “Fake News”, Michael Karanicolas
Canadian Journal of Law and Technology
Nearly a decade after the first Twitter and Facebook revolutions, the early narratives pointing to social media as a great agent of democratization1 have given way to a more nuanced understanding of the impact of the Internet on our political discourse. While there is no question that Internet access provides tremendous expressive benefits, scholars are increasingly questioning whether this information diet is ultimately healthy for society. An analogy to sugars, fats and salts has emerged, where just as an appetite for rich foods served our species well when resources were scarce, but have become a liability in an age of …
Flying Under The Radar: Two Decades Of Dna Testing At Ircc, Ida Ngueng Feze, Gabriel Marrocco, Miriam Pinkesz, Jacqueline Lacey, Yann Joly
Flying Under The Radar: Two Decades Of Dna Testing At Ircc, Ida Ngueng Feze, Gabriel Marrocco, Miriam Pinkesz, Jacqueline Lacey, Yann Joly
Canadian Journal of Law and Technology
Since the early 1990s, Immigration, Refugees and Citizenship Canada (formerly Citizenship and Immigration Canada) began using DNA testing technology in the processing of family reunification applications. Over the years, Canadian citizens, permanent residents, and family members living abroad have been increasingly suggested, or required to undergo DNA testing to either facilitate or enable them to reunite in Canada, under the family reunification procedure. This practice, although said to be rare, has since grown in popularity, and is used more extensively for applications coming from certain regions, including Africa, Asia, and the Caribbean. Through analysis of recent case law, this paper …
Privacy Law Issues In Public Blockchains: An Analysis Of Blockchain, Pipeda, The Gdpr, And Proposals For Compliance, Noah Walters
Privacy Law Issues In Public Blockchains: An Analysis Of Blockchain, Pipeda, The Gdpr, And Proposals For Compliance, Noah Walters
Canadian Journal of Law and Technology
Proponents of blockchain proclaim that the technology’s greatest innovation is trust. Blockchain create trust by serving as an indispensable ledger (a central point of truth), for all stakeholders to a transaction. Instead of companies managing and reconciling records of the same transaction in privately held databases, both sides of a transaction are recorded simultaneously on a shared ledger — the blockchain. As a result, the crypto economic environment is characterized by the decentralized coordination of business processes and transactions. Proponents of crypto-economics regard decentralized coordination as an opportunity for new forms of economic innovation, forms designed to increase value for …
Developing A Privacy Code Of Practice For Connected And Automated Vehicles, Rajen Akula
Developing A Privacy Code Of Practice For Connected And Automated Vehicles, Rajen Akula
Canadian Journal of Law and Technology
Connected and autonomous vehicles (‘‘CAVs”) can collect, store, process and transmit vast amounts of data. Understanding the use (and potential misuse) of this data, particularly when that data is about an identifiable individual within the meaning of data protection law, is regarded critical to the success of this new mode of transportation. However, what constitutes personal information in relation to coneccted and automated vehicle data on a case-by-case basic. This presents a policy challenge for the government and creates uncertainty for businesses wishing to make use of this data.
Hiring Algorithms In The Canadian Private Sector: Examining The Promise Of Greater Workplace Equality, Connor Bildfell
Hiring Algorithms In The Canadian Private Sector: Examining The Promise Of Greater Workplace Equality, Connor Bildfell
Canadian Journal of Law and Technology
Private-sector employers are increasingly using hiring algorithms as a tool for screening job applicants, comparing qualifications, and ultimately determining which candidates should be selected. Within this context, hiring algorithms make no small promise: a hiring process that is not only more efficient and effective, but also more supportive of workplace equality. This promise rests largely on the notion that traditional human-driven models of hiring are beset by subjective biases and prejudices, whereas hiring algorithms, which are driven by hard data and objective evidence, can eliminate certain human biases and prejudices, thereby promoting workplace equality. But can hiring algorithms deliver on …
Technology, The Changing Nature Of Disputes, And The Future Of Equitable Principles In Canadian Contract Law, Conrad Flaczyk
Technology, The Changing Nature Of Disputes, And The Future Of Equitable Principles In Canadian Contract Law, Conrad Flaczyk
Canadian Journal of Law and Technology
There are a number of legitimate reasons to be excited about the application of new technologies to make contracting more efficient. Unfortunately, each of those reasons is associated with certain risks for both contractors and contractees. In this article, I argue that an ‘‘equitable” approach to modern contract law — understood by the likes of Larry DiMatteo and others ‘‘not merely as a system of rules, but of rules tempered by standards and principles” — is particularly well suited for counterbalancing some of the undesirable contractual risks introduced by new technologies like blockchain, artificial intelligence, and smart contracts. A historical …
Ethical Hacking By Alana Maurushat, Laura Ellyson
Ethical Hacking By Alana Maurushat, Laura Ellyson
Canadian Journal of Law and Technology
Book Review of Ethical Hacking by Alana Maurushat (Ottawa: University of Ottawa Press, 2019).
La Saisie De Données Situées Dans Le Nuage En Droit Criminel Canadien, Laura Ellyson
La Saisie De Données Situées Dans Le Nuage En Droit Criminel Canadien, Laura Ellyson
Canadian Journal of Law and Technology
L’article 8 de la Charte canadienne des droits et libertés prévoit que « chacun a droit à la protection contre les fouilles, les perquisitions ou les saisies abusives ». Cette disposition a fait couler beaucoup d’encre depuis son adoption, mais aussi plus récemment en raison de son application aux nouvelles technologies. En effet, dans les 20 dernières années, la Cour suprême du Canada a adapté les principes généraux découlant des fouilles, saisies et perquisitions aux réalités informatiques nouvelles, notamment l’ordinateur et le cellulaire. Toutefois, l’émergence de nouvelles technologies est un phénomène qui ne cesse jamais. L’essor de l’infonuagique, ce modèle …
Privacy And Connected Objects, Nicolas Karsenti
Privacy And Connected Objects, Nicolas Karsenti
Canadian Journal of Law and Technology
Our society perennially seeks to multiply its connectivity in the name of greater efficiency. Over the past few years, several devices that had previously been quite basic have been made ‘‘smarter” in order to facilitate a consumer’s life. A recent study highlights that some of the most common reasons for using ‘‘smart” objects are home automation and remote control. Thus, convenience is driving companies, particularly appliance makers, to connect their devices to the internet in order to make them ‘‘smart”. These range from intelligent thermostats, smart fridges, connected pacemakers, smart watches and personal assistants (PAs) such as Alexa, Siri or …
Hardship And Hard Drives: Artificial Intelligence, Judicial Decision-Making, And The Discharge Of Student Loan Debt, Forrest Finn
Hardship And Hard Drives: Artificial Intelligence, Judicial Decision-Making, And The Discharge Of Student Loan Debt, Forrest Finn
Canadian Journal of Law and Technology
Section 178(1.1) of the Bankruptcy and Insolvency Act allows individuals to apply for discretionary relief from the non-dischargeable nature of student loan debts. Subparagraph (b) of this relief establishes a ‘‘hardship” requirement. The elements for this hardship requirement have been developed and applied by judges in the form of standards. The issue addressed in this paper is whether these standards are applied predictably. Using both statistical analysis and machine learning algorithms, this paper demonstrates that judicial decision-making on the hardship requirement is predictable. This predictability has significant implications. Most importantly it suggests that predictive software could be created for s. …
Big Brother Riding Shotgun: Internal Surveillance Of Semi-Autonomous Vehicles And Its Effects On The Reasonable Expectation Of Privacy, Tunca Bolca
Canadian Journal of Law and Technology
The makers of autonomous vehicles (AVs) claim that their vehicles will reduce traffic accidents by 90 per cent and save millions of lives. Although this is yet to be proven, even if these new generation cars are made to be everything that the carmakers claim, accidents will still happen. Now, as the technology is progressing, governments and scholars are trying to come up with solutions to many legal, ethical and sociological problems the AVs will bring along.
Moving On From The Ombuds Model For Data Protection In Canada, Teresa Scassa
Moving On From The Ombuds Model For Data Protection In Canada, Teresa Scassa
Canadian Journal of Law and Technology
Both the Personal Information Protection and Electronic Documents Act (PIPEDA) and the Privacy Act adopt an ombuds model when it comes to addressing complaints by members of the public. This model is also present in other data protection laws, including public sector data protection laws at the provincial level, as well as personal health information protection legislation. The focus of this short paper is the model adopted in PIPEDA and its ongoing suitability. PIPEDA was designed to apply across the full range of private sector actors and is increasingly under strain in the big data society. These factors may make …
Can We Trust Artificial Intelligence In Criminal Law Enforcement?, Sara M. Smyth
Can We Trust Artificial Intelligence In Criminal Law Enforcement?, Sara M. Smyth
Canadian Journal of Law and Technology
With the rapid advances made by AI in the last few years, yet with so much of it happening behind the scenes, it’s no wonder that most people are both baffled and awestruck by the capacity for these systems to render humans obsolete. Until recently, much of what the general public knew about AI, robotics, and their superhuman capabilities came from Hollywood blockbuster films like Minority Report. While it’s true that these films, in fact, provided a surprisingly realistic portrait of the capabilities that AI can now deliver, there is still a real lack of understanding on the part of …
Law And The “Sharing Economy”: Regulating Online Market Platforms By Derek Mckee, Finn Makela & Teresa Scassa, John D. Gregory
Law And The “Sharing Economy”: Regulating Online Market Platforms By Derek Mckee, Finn Makela & Teresa Scassa, John D. Gregory
Canadian Journal of Law and Technology
No abstract provided.
Digital Evidence: A Practitioner’S Handbook By Gerald Chan & Susan Magotiaux, Robert J. Currie
Digital Evidence: A Practitioner’S Handbook By Gerald Chan & Susan Magotiaux, Robert J. Currie
Canadian Journal of Law and Technology
No abstract provided.
Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder
Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder
Articles, Book Chapters, & Popular Press
Policy Points
- The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
- Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
- Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …
Privacy And Legal Automation: The Dmca As A Case Study, Jonathon Penney
Privacy And Legal Automation: The Dmca As A Case Study, Jonathon Penney
Articles, Book Chapters, & Popular Press
Advances in artificial intelligence, machine learning, computing capacity, and big data analytics are creating exciting new possibilities for legal automation. At the same time, these changes pose serious risks for civil liberties and other societal interests. Yet, existing scholarship is narrow, leaving uncertainty on a range of issues, including a glaring lack of systematic empirical work as to how legal automation may impact people’s privacy and freedom. This article addresses this gap with an original empirical analysis of the Digital Millennium Copyright Act (DMCA), which today sits at the forefront of algorithmic law due to its automated enforcement of copyright …
Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group
Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group
Articles, Book Chapters, & Popular Press
Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.
Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.
Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) …