Human Germ Line and Heritable Genome Editing: The Global Policy Landscape.

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, guidelines, codes, and international treaties-relevant to the use of genome editing to modify early-stage human embryos, gametes, or their precursor cells. Most of these 96 countries do not have policies that specifically address the use of genetically modified in vitro embryos in laboratory research (germline genome editing); of those that do, 23 prohibit this research and 11 explicitly permit it. Seventy-five of the 96 countries prohibit the use of genetically modified in vitro embryos to initiate a pregnancy (heritable genome editing). Five of these 75 countries provide exceptions to their prohibitions. No country explicitly permits heritable human genome editing. These data contrast markedly with previously reported findings.

Conflicts of interest in e-cigarette research: A public good and public interest perspective.

The tobacco industry's involvement in the electronic cigarette research that informs public health policy is controversial. On the one hand, some are concerned that their involvement presents conflicts of interest that bias research outputs and invalidate the policies that use them. On the other hand, some have argued that the tobacco industry may support valid research and contribute to the goals of public health, for instance, if the interests of the e-cigarette industry could be part of a tobacco smoking cessation policy. We approach this debate from the ethical perspective of the public interest and the public good, considering how legitimate researchers can square their expert opinion with validating tobacco industry-funded research, given the perfidy of the tobacco industry and paucity of robust, conclusive evidence on the public health impacts of liberalizing e-cigarette use.

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.

The extreme male brain theory of autism and the potential adverse effects for boys and girls with autism.

Autism, typically described as a spectrum neurodevelopmental disorder characterized by impairments in verbal ability and social reciprocity as well as obsessive or repetitious behaviours, is currently thought to markedly affect more males than females. Not surprisingly, this encourages a gendered understanding of the Autism Spectrum. Simon Baron-Cohen, a prominent authority in the field of autism research, characterizes the male brain type as biased toward systemizing. In contrast, the female brain type is understood to be biased toward empathizing. Since persons with autism are characterized as hyper-systemizers and hypo-empathizers, Baron-Cohen suggests that, whether they are male or female, most possess an "extreme male brain profile." We argue that Baron-Cohen is misled by an unpersuasive gendering of certain capacities or aptitudes in the human population. Moreover, we suggest that this may inadvertently favour boys in diagnosing children with Autism Spectrum Disorders. If this is correct, it could also have rather serious consequences for treatment and services for girls (and women) on the Autism Spectrum.

Who cares about consent requirements for sourcing human embryonic stem cells? Are errors in the past really errors of the past?

Through an Access to Information Act request, we have obtained the consent forms used by the providers of every human embryonic stem cell (hESC) line approved for use by the Canadian Institutes of Health Research (CIHR), and examined them to verify whether or not they meet the consent requirements established by Canadian law and regulations. Our findings show that at least seven out of ten consent forms studied did not satisfy these minimum requirements. We then outline various options for responding to this situation in terms of: (i) remedial measures for dealing with executive problems with regulatory oversight procedures; and (ii) remedial measures for dealing with the impugned lines.