Even in the United States, the most productive country in terms of basic genome editing research,41 there are several legal limits to HGGE. These limitations are part of what has been described as a „complex regulatory and statutory network dealing with human embryo research in general and human germline modification in particular”.42 Although HGGE is not officially banned, several mechanisms taken together currently effectively impede the clinical adoption of this technology. First, the National Institutes of Health, which is responsible for funding research in the United States, has stated that it „will not fund the use of gene-editing technologies in human embryos.”43 Second, the U.S. Food and Drug Administration, which has the authority to regulate products and drugs involving gene editing, including human gene editing, has so far impeded the use of HGGE for reproductive purposes. and probably won`t be their policy in the near future. Since December 2015, the U.S. Congress has regularly added an amendment to the FDA funding law, known as the „bill rider,” that prevents the FDA from reviewing an application that „involves research that intentionally creates or modifies a human embryo to include an inherited genetic modification.”44 Without FDA approval, the implantation of a genetically modified human embryo is illegal in the United States. However, genetic modification of human embryos for research purposes is allowed, although such experiments still cannot be publicly funded.45 The possibilities offered by gene editing are undoubtedly very promising for the future. Gene editing may involve modification of somatic or reproductive cells. In the first case, the change is not hereditary.

The second type of modification concerns not only the performance of a particular unit, but also the possible transfer of this modification to subsequent generations (Sykora, 2018). In this article, I look at the changes that are currently taking place in the discussion of human rights and HGGE. I argue that many of the calls to lift or reconsider existing bans and restrictions on HGGE are rooted in a new but impoverished understanding of the importance of human rights in this issue. In support of this assertion, I compare the understanding of human rights underlying these recent proposals with human rights approaches to HGGE as found in existing legal frameworks in this area, such as the UNESCO Universal Declaration on the Human Genome and Human Rights (1997) and the Council of Europe Convention on Human Rights and Biomedicine (1997). However, assisted reproduction procedures and genetic modification of human reproductive cells have shown that it is possible to cause damage that becomes visible only after the birth of the child and does not harm the mother. This problem is not only related to genetic modification, but also occurs in relation to errors in the in vitro procedure, for example in situations where implantation of a non-maternal embryo takes place (Krekora-ZajÄ c W Åwietle¦ 2015a, 2015b). Germline gene editing is prohibited in the United States by acts of Congress, although there is no federal legislation imposing protocols or restrictions regarding human genetic engineering. There are federal controls on the allocation of public funds to research projects, the manipulation of human embryos, and the conduct of gene therapy clinical trials. There are no germline gene therapy products in the United States. The Food and Drug Administration`s position on gene editing, according to the government`s website: In general, laboratory work is subject to local oversight by institutional biosafety committees (IBCs) that focus on safety and, in many cases, also to federal quality assurance oversight under the Clinical Laboratory Improvement Amendments.4 In some cases, laboratory work with cells from identifiable living donors is also subject to review by institutional audit committees (IRBs). which focuses on protecting donors from the effects of identification and obtaining adequate informed consent.

Laboratory work with human embryos is not the responsibility of the IRB unless the precursor donors are identifiable, but may be supervised by voluntary oversight bodies, for example: B. Embryonic Stem Cell Research Oversight Committees (OCSCs) established in accordance with NAS/IOM recommendations (IOM, 2005) or Embryo Research Oversight Committees (EMRO) recently proposed by the International Society for Stem Cell Research (ICSS). 2016a). Preclinical work involving animals is subject to regulation and oversight by institutional animal care and use committees in accordance with the Animal Welfare Act. Clinical trials may be subject to discussion and review of the advisory protocol by the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), but require IRB and FDA approval. This issue is all the more important as we have been observing for years the expansion of human health protection at early stages of development, both in Poland and in other European countries. (Kmieciak, 2015). Across Europe, we are struggling with declining birth rates and a significant number of miscarriages caused by various fetal abnormalities, including genetic mutations (Araki & Ishii, 2014). It must therefore be assumed that once geneticists and biotechnologists have allowed the elimination of these mutations and given parents the chance to give birth to healthy children, legislators will also be forced to work towards legalizing such therapy (Simonstein, 2017). On closer inspection, there are some key differences between PGD and human germline editing that suggest that it is problematic to apply the PGD model to germline editing without reservation. First, the risk of a slippery slope at HGGE is much greater.

Unlike PGD, HGGE breaks with the principle of reproduction by genetic recombination. As a result, the number of possible choices increases exponentially. For example, as mentioned earlier, Chinese genetically modified twins have a new variation of the CCR5 gene that has never been seen before in humans. In addition, it is theoretically possible to introduce not only non-parental DNA, but also non-human DNA. The Nuffield Council offers an interesting list of several opportunities opened up by CRISPR, including the creation of „supersenses or supercapacitances” and „tolerance to adverse environmental conditions (such as those that might be considered as a result of climate change or space travel).” As the Nuffield Council explains, „These opportunities pave the way for a shift from a vision focused on achieving a limited goal – which may have stimulated initial research and innovation – to one inspired by the use of technology to ensure maximum benefits from its use.” 123 As a result, it can be said that the eugenic potential of HGGE exceeds that of PGD several times.124 The creators of the CRISPR-Cas9 method have reached out to the global community, including lawyers, to have a public debate about the effects it can have.