How to face the future of embryonic science: can global regulatory agencies keep up?

Tech 2023-05-16 11:03:44 Source: Network

abstractDue to concerns about the speed of research, policymakers are looking for alternative methods to develop rules for genome editing and other technologies.Science is developing rapidly - but regulation often fails

abstract

Due to concerns about the speed of research, policymakers are looking for alternative methods to develop rules for genome editing and other technologies.

Science is developing rapidly - but regulation often fails. This is particularly true for embryonic science and genome editing. One way for policies to keep up with research is to design "primary" legislation that can be easily modified by "secondary" legislation. The 'regulatory sandbox' is a process developed by the financial sector that allows for experimentation in small-scale real-world environments. At the same time, soliciting opinions from the wider public should still be a crucial part of decision-making, even if the process is slow.

How to face future embryonic science

The study of human embryos is constrained by a series of guidelines and rules. Image source: Zernicka Goetz Laboratory/University of Cambridge/SPL

At the third human genome Editing International Summit, protesters held banners with the words "Stop designer baby" and "Never Eugenics", calling for the prohibition of human genome editing. This reminds people to pay attention to the ethical dilemmas that embryonic science and genome editing may bring.

At the meeting held at the Francisck Institute in London in March, it was evident that the scientific pace that sparked such concerns was accelerating. For example, scientists reported that they used eggs modified from male mouse 1 cell to cultivate mice. In the following month, Chinese researchers reported two cases of monkeys becoming pregnant after transplanting artificial embryos made from stem cells into the monkey's uterus, although the pregnancy did not progress to a very early stage.

The meeting also hosted a speech by a woman who successfully cured her sickle cell disease by editing the genetic code in her body's hematopoietic cells.

Regulatory agencies - whose responsibility is to determine allowable limits - are working hard to keep up. Peter Thompson, CEO of the Human Fertilization and embryology Authority (HFEA), said: "The speed of regulatory approval cannot keep pace with scientific development." The government agency is regarded as a pioneer in regulating this scientific and medical branch.

Five years ago, this problem was clearly proved. At the second human genome editing international summit held in Hong Kong, Chinese researcher He Jiankui announced that he had changed the genome of twin girls born through in vitro fertilization (IVF)The purpose is to make them resistant to HIV infection. His work was widely condemned by researchers as irresponsible, and he was sentenced to three years in prison after a Chinese court ruled that it involved "illegal medical practice".

The World Health Organization currently recommends against the use of heritable (or germline) human genome editing, but has no enforcement power - nor does any other international agency. Some national institutions, such as HFEA, can establish rules to manage research and its results, but this centralized supervision is relatively rare. Most scientists follow the guidelines developed by professional institutions such as the International Society for Stem Cell Research (ISSCR), but these principles have neither legal effect nor mandatory requirements from the wider society.

The ideal rulebook should be flexible, able to evolve with the development of science, and will include public and expert opinions. However, it is currently unclear whether the existing program can complete this work, so HFEA is considering changing its working methods to adapt to the pace of research. In February, it launched a public consultation on the idea of the "future oriented" Human Fertilization and embryology Act, the law governing embryo and fertility research in the UK.

But are these changes enough to keep up?

A subtle decision

The rules and laws governing embryonic science often emerge slowly and piecemeal. After the first in vitro fertilization (IVF) was born in the 1970s, the British government convened a panel of experts to consider how to regulate embryo research - for example, how long human embryos can be cultured and studied in the laboratory. In 1984, the group recommended limiting the fertilization time to 14 days, which eventually became law in the UK in 1990 and was adopted by several other countries. ISSCR also adopted this limitation in its guidelines - until 2021, it proposed relaxing the limitation in certain cases in response to researchers' newly discovered ability to cultivate embryos to their limits, taking into account the potential useful knowledge that can be collected beyond it.

Peter Thompson is director of the UK Human Fertilization and embryology Authority. Image source: HFEA

Meanwhile, ISSCR recommends not using CRISPR (a technique for cutting DNA sequences at specific points) or possibly more accurate "base" and "prime" editing techniques to alter the genome in human embryos until safety issues are better understood.

At the London Summit, most scientists seemed to agree that somatic cell editing will produce non heritable changes, and as long as it can prove its safety and effectiveness, it can cure sickle cell disease and other diseases.

The consensus is that lineage editing needs to be handled more cautiously, as these changes will be passed on to future generations. However, if some new precise editing methods are proven to be safe in human embryos, Crick developmental and stem cell biologist Robin Lovell Badge, who is one of the organizers of the summit, said that the entire field "may accelerate development" and the demand for lineage editing may increase.

More flexible rulemaking

Science is developing rapidly - but regulation often fails. For HFEA, changing regulations usually requires amending the law. Thompson said, "The problem is the inevitable mismatch between a fixed legal framework (slow change) and the continuous development of science

Thompson said that one way to address this issue is to design 'primary' legislation to make it easier for it to be modified by 'secondary' legislation, which does not require the same level of parliamentary review or approval. In 2016, HFEA successfully approved a technology called mitochondrial replacement therapy using this method.

Another method being explored by HFEA is the 'regulatory sandbox': a controlled experiment in which new ways of doing things are tested in small-scale real-world environments. This process was initially developed in the financial sector to test new and unproven investment vehicles. The latest public consultation from HFEA is the first step in measuring people's interest in such methods.

Some scientific innovations may still be in cracks. Take the embryonic model as an example: synthetic structure, usually made of embryonic stem cells or stem cells derived from adult somatic cell cells, is called induced pluripotent stem cells (iPS cells), which can summarize embryonic development. There is currently no consensus on whether they should be considered as true embryonic organisms or tissue culture types.The researchers are already in vitroCultivated such embryonic models until organ development began, and the latest monkey research shows that scientists can implant them and begin pregnancy. However, this situation occurs without clear regulations on what is allowed: they are "completely unregulated," Lovell Badge said.

HFEA has clear legal authority over some of these technologies, but in other countries/regions, regulatory development is more organic. In the United States, the government cannot regulate solely on moral grounds, but it effectively prohibits research that creates or destroys human embryos by restricting federal funding. The editing of the pedigree human genome was also blocked by an indirect bureaucratic strategy: clinical trials could not be conducted without the approval of the US Food and Drug Administration (FDA), but FDA was even prohibited from considering such requests.

At the same time, each state in the United States can control research and medical procedures through its own legislation, thus creating a patchwork situation. But Alta Charo, a bioethicist at the University of Wisconsin Madison, believes that this temporary system has its advantages. We have a 'state laboratory', "she said. It is very chaotic and inefficient, but it allows for exploring various options

In Japan, biological ethicist Tetsuya Ishii from Hokkaido University stated that such technologies are mainly limited by guidelines that are "to some extent effective" but not legally enforceable, especially for therapies using adult stem cells. In contrast, research and therapy based on iPS cells or embryonic stem cells "are subject to a lot of supervision and regulation in Japan", said Cantas Alev, a developmental biologist at Kyoto University.

public opinion

Bartha Knoppers, an expert in genomics and biotechnology ethics and law at McGill University in Montreal, Canada, said that when science develops rapidly, policymakers may respond. She said that this mindset may overly limit the science that may be beneficial to health. Asking those who may benefit should be a crucial part of decision-making. However, "whether patients think the regulation goes too fast or not depends on your condition," said Bettina Ryll, founder of the European Network of melanoma Patients, who spoke at the Genome Editing Summit. She said that people with severe and progressive diseases are more willing to accept risks.

public opinion[]

However, some researchers question why time should be the most important. Sheila Jasanoff of Harvard University in Cambridge, Massachusetts is an expert on the impact of science and technology on society and policy. She opposes the idea of changing regulations to keep up with rapidly developing fields. Why is a slow and thoughtful process always considered problematic? "She asked. Adhering to this philosophy, she and biological ethicist Benjamin Hurlbut of Arizona State University in Tempe launched the Global Genome Editing Observatory in 2020, aiming to promote dialogue between different populations on this and related biotechnology developments.

Regardless of the regulatory stance, it is worthwhile to understand the upcoming developments. Some international and national organizations have already conducted this "horizon scanning" of rapidly developing technologies - although it is not yet clear whether any organization has considered embryonic science. For example, the Organization for Economic Cooperation and Development (OECD) has established a Public Sector Innovation Observatory, aimed at developing guidelines for governments and the public sector on the opportunities and risks of emerging technologies such as artificial intelligence (another area of the organization), which progress exceeds regulation.

Hank Greeley, who studies the legality of bioethics at Stanford University in California, calls for the establishment of such field of vision scanning teams more widely, as well as audit institutions to monitor compliance with regulations and compliance with purpose 4. He added that the problem is who will fund and supervise these projects; Industry, government, and research institutions may all be seen as having vested interests.

Finally, ensuring timely and effective regulation of rapidly developing science is to maintain a stable social contract between science and society. Do we constantly ask ourselves, is this the place we want to go? Who will it serve? "Knoppers said. This is about staying vigilant

Nature six hundred and seventeen,242-243(2023)

doi: https://doi.org/10.1038/d41586-023-01550-8

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