Heritable human genome editing is 'currently not permitted', but it is no longer 'prohibited': so says the ISSCR.

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 In principle, a prohibition can be rescinded at any time.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.

'No' to lesbian motherhood using human nuclear genome transfer.

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.

Human Nuclear Genome Transfer (So-Called Mitochondrial Replacement): Clearing the Underbrush.

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 mitochondrial disease, and perhaps also a 'want' on the part of some researchers who see the technology as a useful precedent - one that provides them with 'a quiet way station' in which to refine the micromanipulations techniques essential for other human germline interventions and human cloning. In advance of this argument, I review basic information about mitochondrial disease and novel genetic strategies to prevent the transmission of mutated mitochondria. Next, I address common features of contemporary debates and discussions about so-called mitochondrial replacement. First, I contest the cliché that science-and-(bio)technology is fast outpacing ethics. Second, I dispute the accuracy of the term 'mitochondrial replacement'. Third, I provide a sustained critique of the purported 'need' for genetically-related children. In closing, I call into question the mainly liberal defense of human nuclear genome transfer. I suggest an alternative frame of reference that pays particular attention to issues of social justice. I conclude that our limited resources (time, talent, human eggs, and money) should be carefully expended in pursuit of the common good, which does not include pandering to acquired desires (i.e., wants).

A Review of Consent Documents From Canadian IVF Clinics, 1991 to 2014.

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 contacted all Canadian IVF clinics in operation in 1991 (17 clinics), 2004 (24 clinics), and 2014 (35 clinics) by mail and requested blank copies of their IVF consent documents. Documents received were reviewed for the inclusion of information about the nature of IVF, the potential benefits of IVF, the potential harms and inconveniences of IVF, confidentiality, voluntariness, and options for the use or discarding of embryos not transferred in the original stimulated cycle (sometimes referred to as supernumerary, excess, or spare embryos). RESULTS: We received responses from 11 of 17 clinics operating in 1991 (response rate 65%), 14 of 24 clinics operating in 2004 (response rate 58%), and 11 of 35 clinics operating in 2014 (response rate 31%). In general, comparisons of the 1991, 2004, and 2014 data sets showed a long-term decrease in documented disclosure of information that should be provided to patients in accordance with minimum ethical standards. The only cases in which this trend appeared to be reversed was with disclosure about the probability of supernumerary embryos, long-term risks of treatment, the right to revoke consent to the use or discarding of supernumerary embryos, and some of the options for the use of supernumerary embryos. In these few instances, there was a notable improvement in the disclosure of relevant information between 1991 and 2014. CONCLUSION: The disclosure of information relevant to the interests of those undergoing IVF and those who are born as a result of IVF appears to be decreasing. Furthermore, the information that increasingly is being disclosed in consent documents appears to be directing the orientation and content of these documents away from the primary interests of the relevant women, couples, and children. These two trends are inconsistent with the goal of informed consent.

Human embryos and eggs: from long-term storage to biobanking.

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 nature of genetic information has clear implications for informed consent, and the identifying nature of biological samples and information has clear implications for promises of confidentiality. Next, with regard to the special case of biobanking human embryos and eggs, we consider issues arising from: first, the type of tissues being stored; second, the use to which these tissues are put; and third, how this plays out given the shared and identifying nature of these tissues. Specifically, we examine the differences between human bodily tissues and human reproductive tissues focusing on the assumed potential of the reproductive tissues and on the possible greater emotional attachment to these tissues because of their real and imagined kinship. For some donors there may be a sense of family connection with embryos and eggs they once thought of as 'children-in-waiting'. Finally, we conclude by considering the implications for ethical practice.

Fake it till you make it: Policymaking and assisted human reproduction in Canada.

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 later, Health Canada still has not drafted the regulations governing reimbursement. Section 12 is therefore still not in force. Health Canada and others have asserted that there is a Health Canada policy on reimbursement and that reimbursement with receipts is legally permissible. We dispute the existence of such a policy and its legitimacy (if it exists). We also challenge the decision by Health Canada not to produce regulations and thereby make it possible for Parliament to bring s.12 into force. This intentional lack of action is worrisome on at least two fronts. First, it sidesteps the processes required for regulations and thereby ducks the Parliamentary oversight very deliberately built into the AHR Act. Second, it leaves Canadians who provide and who access assisted human reproduction uncertain about what is and is not permitted, and therefore fearful of, or at risk of, prosecution. We conclude that Health Canada should take the steps necessary to put regulations in front of Parliament so that Parliament will then be able to pass regulations and bring s.12 into force. Canadians should demand no less.

La Loi sur la procréation assistée (LPA) est entrée en vigueur en 2004. L'article 12 de la LPA stipule qu'il est interdit de rembourser les frais supportés par un donneur pour le don d'un ovule ou d'un spermatozoïde, par quiconque pour l'entretien ou le transport d'un embryon in vitro ou par une mère porteuse pour agir à ce titre, sauf en conformité avec les règlements (avec reçus). Dix ans plus tard, Santé Canada n'a toujours pas formulé de règlements régissant le remboursement. L'article 12 n'est donc toujours pas en vigueur. Santé Canada et d'autres intervenants ont soutenu qu'il existe une politique de Santé Canada sur le remboursement et que le remboursement sur présentation de reçus est permis au plan légal. Nous contestons l'existence d'une telle politique et sa légitimité (le cas échéant). Nous contestons également la décision de Santé Canada de ne pas formuler de règlements et d'empêcher ainsi l'entrée en vigueur de l'article 12. Cette inaction délibérée est troublante pour au moins deux raisons. Premièrement, elle contourne les processus requis pour ce qui est des règlements et se soustrait donc à la surveillance parlementaire qui a été intégrée à la LPA de façon très délibérée. Deuxièmement, elle expose les Canadiens qui offrent et qui utilisent des services de procréation assistée à de l'incertitude quant à ce qui est et à ce qui n'est pas permis, ce qui fait en sorte qu'ils ne savent donc pas s'ils s'exposent ou non à des poursuites. Nous en venons à la conclusion que Santé Canada devrait prendre les mesures nécessaires pour soumettre des règlements au Parlement, de façon à ce que ce dernier soit en mesure de les promulguer et d'assurer l'entrée en vigueur de l'article 12. Les Canadiens devraient l'exiger.

The ethics of creating children with three genetic parents.

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; (ii) harms to potential offspring and future generations; (iii) harms to specific interest groups; and (iv) harms to society. Taken together, these ethical objections are cause for serious concern and yet the development and future use of mitochondrial replacement technology is likely inevitable.

Ill-informed consent? A content analysis of physical risk disclosure in school-based HPV vaccine programs.

OBJECTIVES: 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. DESIGN AND SAMPLE: We conducted an online search for program related HPV vaccine risk/benefit documents for all 13 Canadian jurisdictions between July 2008 and May 2009 including follow-up by e-mail and telephone requests for relevant documents from the respective Ministries or Departments of Health. The physical risks listed in the documents were compared across jurisdictions and against documents prepared by the vaccine manufacturer (Merck Frosst Canada), the National Advisory Committee on Immunization (NACI), the Society of Obstetricians and Gynecologists of Canada (SOGC), and a 2007 article in Maclean's Magazine. RESULTS: No jurisdiction provided the same list of vaccine related physical risks as any other jurisdiction. Major discrepancies were identified. CONCLUSIONS: Inaccurate, incomplete, and inconsistent information can threaten the validity of consent/authorization and potentially undermine trust in the vaccine program and the vaccine itself. Efforts are needed to improve the quality, clarity, and standardization of the content of written documents used in school-based HPV vaccine programs across Canada.