Françoise Baylis

• PhD
• Distinguished Research Professor at Dalhousie University

The Guidelines for Stem Cell Research and Clinical Translation, recently issued by the International Society for Stem Cell Research (ISSCR), include a number of substantive revisions. Significant changes include: (1) the bifurcation of ‘Category 3 Prohibited research activities’ in the 2016 Guidelines into ‘Category 3A Research activities currently...

Discussions and debates about the governance of human germline and heritable genome editing should be informed by a clear and accurate understanding of the global policy landscape. This policy survey of 106 countries yields significant new data. A large majority of countries (96 out of 106) surveyed have policy documents-legislation, regulations, g...

The 18-member HHGE commission was co-chaired by two eminent human geneticists, Dame Kay E. Davies (University of Oxford) and Richard P. Lifton (Rockefel-ler University), and compiled the report over more than a year of meetings and deliberations. It offers a transla-tional pathway for the limited approval of HHGE under very particular circumstances...

Restricting movement on the basis of biology threatens freedom, fairness and public health. Restricting movement on the basis of biology threatens freedom, fairness and public health.

As public interest advocates, policy experts, bioethicists, and scientists, we call for a course correction in public discussions about heritable human genome editing. Clarifying misrepresentations, centering societal consequences and concerns, and fostering public empowerment will support robust, global public engagement and meaningful deliberatio...

As public interest advocates, policy experts, bioethicists, and scientists, we call for a course correction in public discussions about heritable human genome editing. Clarifying misrepresentations, centering societal consequences and concerns, and fostering public empowerment will support robust, global public engagement and meaningful deliberatio...

Eric Lander, Françoise Baylis, Feng Zhang, Emmanuelle Charpentier, Paul Berg and specialists from seven countries call for an international governance framework. Eric Lander, Françoise Baylis, Feng Zhang, Emmanuelle Charpentier, Paul Berg and specialists from seven countries call for an international governance framework. Embryo culture dish used f...

Despite opprobrium from the scientific community, the creation of the first CRISPR babies by germline genome editing has led to a debate more about execution than intent. We need public education, engagement and empowerment to reach ‘broad societal consensus’ on whether, not how, to pursue heritable genome editing, argues Françoise Baylis.

A new infrastructure is urgently needed at the global level to facilitate exchange on key issues concerning genome editing. We advocate the establishment of a global observatory to serve as a center for international, interdisciplinary, and cosmopolitan reflection. This article is the first of a two-part series.

A new infrastructure is urgently needed at the global level to facilitate exchange on key issues concerning genome editing. We advocate the establishment of a global observatory to serve as a center for international, interdisciplinary, and cosmopolitan reflection. This article is the second of a two-part series.

Guilia Cavaliere and César Palacios-Gonzalez argue that lesbian couples should have access to human nuclear genome transfer (so-called mitochondrial replacement) so that both members of the couple can have a genetic link to the child they intend to parent. Their argument is grounded in an appeal to reproductive freedom. In this Response, I address...

A prospective first-in-human Phase 1 CRISPR gene editing trial in the United States for pa-tients with melanoma, synovial sarcoma, and multiple myeloma offers hope that gene editing tools may usefully treat human disease. An overarching ethical challenge with first-in-human Phase 1 clinical trials, however, is knowing when it is ethically acceptabl...

In this article, I argue that there is no compelling therapeutic ‘need’ for human nuclear genome transfer (so-called mitochondrial replacement) to prevent mitochondrial diseases caused by mtDNA mutations. At most there is a strong interest in (i.e. ‘want’ for) this technology on the part of some women and couples at risk of having children with mit...

This article interrogates the nature of editorial privilege and authorial integrity in peer-reviewed academic journals. Focusing on the authors’ experience with publishing a letter critiquing high-profile authors in a high-profile journal, the article identifies key concerns with (i) the time it took to complete the peer-review process, (ii) the fa...

In 2004, the Assisted Human Reproduction Act was passed by the Parliament of Canada. Fully in force by 2007, the act was intended to safeguard the health and safety of Canadians. However, a 2010 Supreme Court of Canada decision ruled that key parts of the act were invalid. Regulating Creation is a collection of essays built around the 2010 ruling....

Currently, a new revolutionary genome-editing tool is opening new avenues for gene engineering. It is known as the clustered regularly interspaced short palindromic repeats (CRISPR)11 and the CRISPR-associated (Cas) 9 system. In general, the CRISPR-Cas system has been evolved in archaea and bacteria as part of their adaptive immune mechanisms. Mec...

In Canada, research involving human embryos is circumscribed by law and research guidelines. This chapter describes the development of these policy instruments over the past 25+ years and analyses this history using a typology of modes of public consultation developed by Eric Montpetit (2003). Over time, the degree to which the views of Canadians o...

The matter of ‘abandoned embryos’ arises when surplus embryos left over after IVF are frozen and stored for later use. If the fertility clinic or storage facility in question does not have clear direction about what to do with the embryos, and/or payment for storage ceases, and/or the embryo providers cannot be reached, the embryos raise an ethical...

Objective: We reviewed the content of IVF consent documents (i.e., consent forms and accompanying information sheets) used by Canadian IVF clinics in 1991, 2004, and 2014, paying particular attention to the inclusion of information that should be provided to patients in accordance with minimum ethical standards for disclosure. Methods: We contac...

Pregnant women deserve more from clinical research. Justice requires a research agenda that adequately addresses the health needs of pregnant women, and fair inclusion criteria that support the safe and responsible participation of pregnant women in relevant research. In recent years, there have been successful global efforts to expand paediatric c...

A direct consequence of the routine exclusion of pregnant women from clinical trials is pregnant women using over-the-counter and prescription medications in the absence of population-specific clinical trial data about the potential benefits and harms of these medications for themselves, their foetuses, and their future children. In our view, pregn...

This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to...

Genetic relatedness poses significant challenges to traditional practices of medical ethics as concerns the biobanking of human biological samples. In this paper, we first outline the ethical challenges to informed consent and confidentiality as these apply to human biobanks, irrespective of the type of tissue being stored. We argue that the shared...

Identity is a concept of pivotal importance in neuroethics, especially in relation to recent and emerging advances in neuroscience that promise to effectively treat a wide range of motor and psychological disorders. A persistent worry is that modern neurotechnologies (including electroconvulsive therapy, psychosurgery, neural stimulation, psycho-ph...

The dominant approach to conscience in contemporary bioethics presumes that conscience functions to promote personal moral integrity, and therefore presumes that the relevant values are inherently personal. This approach fails to demonstrate when and why claims of conscience should be taken seriously by others. I draw on Hannah Arendt's deliberativ...

Infertility is a difficult reality for individuals and couples who would like to have a family that includes children (and, for some, preferably children with whom they have a genetic link). This article provides a summary overview of the multiple meanings of infertility along with information about the prevalence, causes, and consequences of unwan...

To avoid the commercialization of reproduction, the Canadian Assisted Human Reproduction Act (AHR Act 2004) prohibits the purchase of human eggs. We endorse this legal prohibition and moreover believe that this facet of the law should not be allowed to have as an unintended consequence an increase in transnational trade in human eggs. In an effort...

To avoid the commercialization of reproduction, the Canadian Assisted Human Reproduction Act (AHR Act 2004) prohibits the purchase of human eggs. We endorse this legal prohibition and moreover believe that this facet of the law should not be allowed to have as an unintended consequence an increase in transnational trade in human eggs. In an effort...

This book concerns the ethics of making or expanding families through adoption or technologically assisted reproduction. For many people, these methods are separate and distinct; they can choose either adoption or assisted reproduction. But for others, these options blend together. For example, in some jurisdictions, the path of assisted reproducti...

The Assisted Human Reproduction Act (AHR Act) came into effect in 2004. The AHR Act stipulates in s.12 that no reimbursement of expenditures incurred in the course of donating gametes, maintaining or transporting in vitro embryos, or providing surrogacy services is permitted, except in accordance with the regulations and with receipts. Ten years la...

In this chapter, Jason Robert and Francoise Baylis critically examine the morality of crossing species boundaries in the context of research that involves combining human and nonhuman animals at the genetic or cellular level. They begin by discussing the notion of species identity, with a focus on the presumed fixity of species boundaries, as well...

This article explores the notion of the dislocated self following deep brain stimulation (DBS) and concludes that when personal identity is understood in dynamic, narrative, and relational terms, the claim that DBS is a threat to personal identity is deeply problematic. While DBS may result in profound changes in behaviour, mood and cognition (char...

To the Editor: We are a group of physicians, bioethicists, and scholars in allied fields who agree with the Office for Human Research Protections (OHRP) that the informed-consent documents that were used in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) were seriously inadequate.(1) The aims of the SUPPORT study were...

This article on mitochondrial replacement technology briefly explains and defends the legitimacy of such terms as 'three-parent embryos', 'three-parent babies' and 'three-person IVF'. Next, it reviews select ethical objections to mitochondrial replacement technology that fall into four, sometimes overlapping, categories: (i) harms to egg providers;...

In Canada (as elsewhere) there is a growing demand for human eggs for reproductive purposes and currently demand exceeds supply. This is not surprising, as egg production and retrieval is onerous. It requires considerable time, effort, and energy and carries with it significant physical and psychological risks. In very general terms, one cycle of e...

Au printemps 2012, l’Agence canadienne de contrôle de la procréation assistée (ACCPA)—l’organisme fédéral devant surveiller la procréation assistée au Canada—a été abolie lorsqu’on a adopté la loi omnibus sur le budget. Cette fin ignominieuse était en partie une réaction au renvoi de la Cour suprême du Canada relatif à la Loi sur la procréation ass...

Three reasons are given for the pursuit of human stem cell research: to increase understanding of normal cell development; to screen new drugs in vitro; and to provide tissue for cell-based regenerative medicine. Not surprisingly, public enthusiasm for human stem cell research centers on the promise of regenerative medicine where there is the prosp...

In humans, the term “embryo” technically applies after implantation of the organism is complete (approximately 14 days after fertilization) until eight weeks of development, at which time the developing organism is referred to as a fetus. Prior to implantation, the scientific terms for the product of conception at different developmental stages are...

Pregnant women and their fetuses deserve timely access to safe, effective, evidence-based care. To this end, pregnant women should be included in clinical trials of drugs and vaccines, except when there is a compelling scientific or ethical reason not to do so. This article examines the benefits and limitations of two different starting points for...

In this article, we critically examine the arguments for and against the exceptional status given human pluripotent stem cell research in Canada (through the latest [December 2010] revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), and conclude that this exceptionalism is unwarranted and ethically unsound....

Infertility is a difficult reality for individuals and couples who would like to have a family that includes children and, for some, preferably children with whom they have a genetic link. This article provides an overview of the prevalence, consequences, and causes of infertility. It then briefly examines some of the options for dealing with infer...

This study examines the accuracy, completeness, and consistency of human papilloma virus (HPV) vaccine related physical risks disclosed in documents available to parents, legal guardians, and girls in Canadian jurisdictions with school-based HPV vaccine programs. We conducted an online search for program related HPV vaccine risk/benefit documents f...

This article is the second in a two-part review of policy design for human embryo research in Canada. In the first article in 6(1) of the JBI, we explain how this area of research is circumscribed by law promulgated by the federal Parliament and by guidelines adopted by the Tri-Agencies, and we provide a chronological description of relevant policy...

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns...

A comment in response to the article 'Withdrawal of clinical trials policy by Canadian research institute is a “lost opportunity for increased transparency”' (BMJ 2011;342:d2570).

Clinical trials routinely exclude expectant mothers. This is unethical and unscientific, and regulators must mandate change, says Françoise Baylis, in the second of three related pieces on gender bias in biomedicine.

International medical travel occurs when patients cross national borders to purchase medical goods and services. On occasion, physicians in home countries will be the last point of domestic contact for patients seeking healthcare information before they travel abroad for care. When this is the case, physicians have a unique opportunity to inform pa...

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) was first issued in 1998. At that time, the inappropriate exclusion of women from clinical trials was a serious problem. Currently, the TCPS is undergoing a comprehensive review and it is expected that new research guidelines will be issued in 2010. One of the pr...

Canada is in the forefront of thinking about the unique and complex issues of contemporary public health ethics. However, an inordinate focus on the urgent issues of emergency preparedness in pandemic and reliance on bioethical analysis steeped in the autonomy and individual rights tradition of health care and research do not serve adequately as th...

In April 2007, as part of its public consultation initiative, the Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom published Hybrids and chimeras: A consultation on the ethical and social implications of creating human/ animal embryos in research. This HFEA document identifies a number of possible arguments against the crea...

In 2004 and 2005, Woo-Suk Hwang achieved international stardom with publications in Science reporting on successful research involving the creation of stem cells from cloned human embryos. The wonder and success all began to unravel, however, when serious ethical concerns were raised about the source of the eggs for this research. When the egg scan...

In April 2007, as part of its public consultation initiative, the Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom published Hybrids and chimeras: A consultation on the ethical and social implications of creating human/animal embryos in research. This HFEA document identifies a number of possible arguments against the creat...

In September 2007, the Human Fertilisation and Embryology Authority (HFEA) in the United Kingdom concluded that "there is no fundamental reason to prevent cytoplasmic hybrid research ... this area of research can, with caution and careful scrutiny, be permitted." Later, in January 2008, HFEA issued two research licenses to create humanesque cytopla...

This article is the first in a two-part review of policy design for human embryo research in Canada. In this article we explain how this area of research is circumscribed by law promulgated by the federal Parliament (the Assisted Human Reproduction Act) and by guidelines issued by the Tri-Agencies (the Tri-Council Policy Statement: Ethical Conduct...

In this article, we critically examine some of the ethical challenges and interpretive difficulties with possible future non-clinical applications of pediatric fMRI with a particular focus on applications in the classroom and the courtroom - two domains in which children come directly in contact with the state. We begin with a general overview of a...

From the time that James Thomson and colleagues (1998) fi rst announced the successful derivation of human embryonic stem cell (hESC) lines, there has been a heated debate about the ethical acceptability of hESC research because this research entails the destruction of human embryos (see Prainsack et al., 2008a). In an effort to quell this debate,...

In January 2008, the Human Fertilisation and Embryology Authority (HFEA) (London, UK) issued two 1-year licenses for cytoplasmic hybrid embryo research. This article situates the HFEA's decision in its wider scientific and political context in which, until quite recently, the debate about human embryonic stem cell research has focused narrowly on t...

The potential public health benefits of genetic engineering are considerable, but so too are the potential harms. Genetic engineering may help to promote health and prevent illness by increasing the quality and quantity of food, by cleaning up toxic environments, and by alleviating human health problems for existing and subsequent generations. Gene...

Recently, there has been a growing interest in public health and public health ethics. Much of this interest has been tied to efforts to draw up national and international plans to deal with a global pandemic. It is common for these plans to state the importance of drawing upon a well-developed ethics framework and we argue that this framework shou...

Cognitive performance tools are evolving and their application is expanding rapidly. Although these tools promise significant advantages, they also raise a number of significant ethical and social concerns. This paper first provides an overview of various cognitive performance tools. Subsequently, there is a dialogue between Viirre on the one hand...

Medicine and health care generate many bioethical problems and dilemmas that are of great academic, professional and public interest. This comprehensive resource is designed as a succinct yet authoritative text and reference for clinicians, bioethicists, and advanced students seeking a better understanding of ethics problems in the clinical setting...