Could research on human embryos aged 16-19 days provide insight into the ban on research on human embryos after 14 days?

This is an important document, not only for the reasons given in the discussion, but because of its potential (which the authors do not discuss) to help shape future regulations on the use of human embryos. and simbryos (the class of self-constructed stem cell structures used or proposed as models for early development).

Some readers will likely be baffled by the fact that the human embryo used in the research had reached 16-19 days of development. Is this legally possible? Isn’t there a hard 14 day limitation? Well the answer is, of course there is a 14 day limit, but the research did fit well within the applicable regulatory framework. The legal significance of the article does not lie in the fact that the research was undertaken on a human embryo after 14 days, but in the results of the research itself. These findings can inform the review of existing limitations and decisions of ethics boards.

First, we need to be clear that the regulatory activity took place in England. The affected embryo was provided via the Human Developmental Biology Resource and fully consented to the research for which there was ethical approval (see Methods). Second, the embryo was not “live”. It is this fact, rather than that the embryo was not the product of in vitro fertilization, which prevents the prohibition provided for in Article 3 of the Human Fertilization and Embryology Act 1990 (HFE law) in force. Instead, the embryo is governed by a different UK law, the Human Tissue Act, 2004 (HT Act), which applies to fetuses and non-fetal conception products (such as amniotic fluid, umbilical cord, placenta and membranes). In other words, not only the embryo, but everything that derives from the trophectoderm, provided it comes from the mother’s body, is hypertension. For all these reasons, the famous 14-day rule Not Applicable. The research fit well within the regulatory framework.

The material involved, a single perfectly preserved Carnegie stage 7 embryo, is highly unlikely to be available often, especially given the ban on cloning human embryos. However if, hypothetically, aborted embryos were maintained ”liveIn a culture dish, an authorization from the HFEA would be required, although no research is possible after the appearance of the primitive sequence (at 14 days) without a modification of the law. This therefore clarifies the why and how of the regulations concerning this type of research. But this is truly an exceptional study, not only because virgin, natural human embryos at such an early stage of development are extraordinarily difficult to find, nor because of the exquisite techniques applied to map the gene expression of all. the cells of the embryo. , but because of the importance of the actual discoveries made. It provides a genomic map for human and comparative anatomy, taken shortly after the formation of the structure that will develop into a human body. This will no doubt help researchers triangulate studies involving a range of simbryo species and models exposing developmental discrepancies to further investigation.

Having ruled out any apparent legal complications, I would now like to suggest that the research has legal significance, as a dataset to inform any revision of the HFE law. Indeed, the 14-day limit established by this law was the creation of a pre-genomic age in which the ethical status of the embryo was largely determined by morphological and religious considerations. Studies such as Srinivas et al provide the opportunity to assess the ethical significance of particular genes activated at particular points in development. The authors note, for example, that “Our characterization reveals that the embryo at [16-19 days] already had [primordial germ cells and red blood cells, but had not yet initiated neural specification”. [Para 2, Discussion]. Depending on the ethical weight given to these aspects, future legislators could use this data as a point of reference to reconsider a breakthrough on the current limits of research on the human embryo. It will certainly be a touchstone for ethics bodies in jurisdictions looking to the 2021 guidance of the ISSRB, with respect to both human embryos and simbryos. Although there is no proposed reform of the HFE law, the Authority may recommend that the Secretary of State take it into account in any revision of the law. Of course, pressures for change are intensifying, more recently on the period of consent to the use of gametes, but also on the modalities of hereditary editing of the human genome and, as here, on the period during which embryos can be cultivated.

Some readers will likely be baffled by the fact that the human embryo used in the research had reached 16-19 days of development. Is this legally possible?

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