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 not permitted' and 'Category 3B Prohibited research activities' in the 2021 guidelines and (2) the move of heritable human genome editing research out of the 'prohibited' category and into the 'currently not permitted' category. These changes are noteworthy because of the absence of a clear demarcation line between the two categories insofar as, by definition, that which is 'prohibited' is 'currently not permitted', and vice versa. Permanence is not part of the definition of 'prohibition'. In principle, a prohibition can be rescinded at any time. This begs the question 'Why make a policy change that has no apparent practical effect?' One hypothesis is that the recategorisation of specific 'prohibited' research activities as 'currently not permitted' is meant to seed intuitions about which prohibited research activities should 'soon' be permitted subject to specialised scientific and ethics review and approval.
Pregnant women, their fetuses, and infants are at increased risk of severe disease and death from many vaccine-preventable diseases, including COVID-19.1,2 However, they are typically excluded from pre-implementation vaccine research aimed at generating robust data in support of evidence-informed decision making. This was initially the case with COVID-19 vaccines. In 2019, the PREVENT Working Group published 22 recommendations on how to include pregnant and breastfeeding women in vaccine research and implementation for emerging infections.
In “Crossing Species Boundaries” (Robert and Baylis 2003), the authors explored the history, ethics, and prospective future of stem cell research involving chimeras made in part from human cells. They dismissed the various then-extant ethical objections to the creation of such chimeras, finding them all inadequate. In their stead, they sketched (but did not elaborate or defend) an alternative response—namely, that their creation would create a kind of inexorable moral confusion. Since then, a variety of alternative objections to—as well as justifications for—this research have emerged, alongside advances in the technologies for introducing genetic and cellular material across putative species boundaries. In this chapter, the authors revisit the notion of inexorable moral confusion, further specifying and elaborating the original concept in light of recent scientific and technical developments and ethical insights.
In September 2020, a detailed report on Heritable Human Genome Editing was published. The report offers a translational pathway for the limited approval of germline editing under limited circumstances and assuming various criteria have been met. In this perspective, some three dozen experts from the fields of genome editing, medicine, bioethics, law, and related fields offer their candid reactions to the National Academies/Royal Society report, highlighting areas of support, omissions, disagreements, and priorities moving forward.
Abstract The two panelists will elaborate on 'four practical problems and six ethical objections', which add up to one very bad idea, i.e., the 'immunity passport'. Such an idea is equal to restricting movement on the basis of biology threatens freedom, fairness and public health. Lessons from previous pandemics will be examined in the context of current measures being deployed, assessing practical and ethical aspects. For example, false negatives in people with few antibodies leading to immune individuals being incorrectly labelled as not immune or not having access to testing to demonstrate immunity. Additionally, the case of healthcare workers will be examined considering feasibility of testing, but also in terms of discrimination and stigma. Another aspect to be explored in detail is monitoring and how it erodes privacy, with the main aim of immunity passport controlling movement. Documentation systems are already presenting a serious risk to privacy, with China announcing the QR-code tracking systems is likely to stay in place after the pandemic ends. Access issues to testing can contribute to further discrimination, whereas labelling people on their basis of their COVID19 status would create a new measure of dividing the society to 'immunoprivileged and immonodeprived' people. A labelling particularly disconcerting in the absence of a free, universally available vaccine. Furthermore, Social and financial inequities would be amplified, whereas divisions between nations could be fueled. Already people with HIV are subjected to restrictions on entering, living and working in certain countries with laws that impinge on the rights of those from sexual and gender minorities. Governments should instead invest on pandemic damage limitation - test, trace and isolate, and apps that empower individuals to make safe choices about their own movements should be prioritized. Also, the development, production and global distribution of a vaccine for SARS-CoV-is key. Universal, timely, free access to a vaccination becomes possible could allow for ethical recording of vaccination status in the context of certain activities. Threats to freedom, fairness and public health are inherent to any platform that is designed to segregate society on the basis of biological data. All policies and practices must be guided by a commitment to social justice.
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.
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.
And we should all have a say in how the technology is governed.
“The Parliament of Canada recognizes and declares that … trade in the reproductive capabilities of women and men and the exploitation of children, women and men for commercial ends raise health and ethical concerns that justify their prohibition.” 1 Assisted Human Reproduction Act (S.C. 2004, c.2) http://laws-lois.justice.gc.ca/eng/acts/a-13.4/Date: 2018 Google Scholar This clear and powerful statement is among the guiding principles of the Assisted Human Reproduction Act and informs the sections of the Act that prohibit payment for surrogacy, for arranging the services of a surrogate mother, and for eggs and sperm.
Giulia Cavaliere and César Palacios-González 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 number of concerns with their argument. These concerns relate to nomenclature, treating like cases alike, genetic-relatedness and the limits of reproductive rights. On this last point, I insist that we should not mistake ‘wants’ for ‘needs’ or ‘rights’. I maintain that there is no right to biological parenthood, there is no compelling need for human nuclear genome transfer to satisfy a so-called need for genetically-related children, and we ought not to pander to an acquired desire (ie, want) for genetic filiation.
Should human genome editing be limited to somatic cells, or should germline genome editing also be permitted? Should (apparently) permissible human genome editing be limited to therapeutic purposes, or should enhancement purposes also be permitted? Who decides, and on what basis?
Beverly Beckham (2008) writes in the Boston Globe in praise of Lisa Genova’s (2007) Still Alice: ‘‘You have to get this book. . . . I couldn’t put it down. . . .’’ After I read Still Alice, a book of fiction about an accomplished Harvard professor with early-onset Alzheimer’s disease, I too wanted to tell everyone to get this book, but not because ‘‘I couldn’t put it down.’’ The first time I read it, I put it down several times to cry. It was too painful to read in one stretch. Years back, my mother, Gloria Baylis,1 had been diagnosed with vascular dementia, and recently there had been findings suggestive of an atypical presentation of Alzheimer’s disease. The story of Alice Howland, the Alice of Still Alice, was both too familiar (because of what I already knew), and too revealing (because of what I did not yet know). Beckham refers to Alzheimer’s as ‘‘the monster breaking down the door’’ and says ‘‘there’s no place to run because there is no place to hide.’’ One can try ‘‘to tame it and outrun and outwit it. . . . But the monster at the door does not go away.’’ As these comments illustrate, Alzheimer’s is, for many, a special kind of horror story from which there is no escape. Notably, the monster that is Alzheimer’s is not only perceived as a threat to the person with the disease and a threat to all those who care about that person, but it is also perceived as
Conscientious refusal to provide insured health care services is a significant point of controversy in Canada, especially in reproductive medicine and end-of-life care. Some provincial and territorial legislatures have developed legislation or regulations, and some professional regulatory bodies have developed policies or guidelines, to better reconcile tensions between health care professionals’ conscience and patients’ access to health care services. As other groups attempt to draft standards and as challenges to existing standards head to court, the fact that the meaning of “freedom of conscience” under the Canadian Charter of Rights and Freedoms is not yet settled will become ever more problematic. In this paper, we review the case law and legislative history relating to freedom of conscience. Having shown that the nature and scope of the freedom of conscience provision cannot be settled by either review, we turn to philosophy for insights with respect to the contemporary purpose of protecting freedom of conscience. On this basis, we offer a substantive test for freedom of conscience under the Charter. We do so for two reasons. First, we seek to assist those responsible for regulating the conduct of health care professionals in designing and implementing laws and policies that protect and promote the health needs and interests of patients without unjustifiably limiting the Charter conscience rights of health care professionals. Second, we seek to inform the analysis of future freedom of conscience Charter cases in response to the decriminalization of medical assistance in dying and the licensing of the drugs used for medical abortion.