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Gm Ethics Essay

Leading UK research funders are calling for an urgent national debate on the ethics of genetically modifying human embryos and other tissues to prevent serious diseases.

The plea has been prompted by scientists’ rapid progress in developing a powerful tool called genome editing, which has the potential to transform the treatment of genetic conditions by rewriting the DNA code of affected cells.

Genome editing: how to modify genetic faults – and the human germline

Although UK law bans genetic modification of embryos for clinical uses, it is permitted in research laboratories under licence from the fertility regulator, the Human Fertilisation and Embryology Authority (HFEA) – provided the embryos are destroyed after 14 days.

In a position statement published on Wednesday, five leading biomedical funders declare support for genome-editing research and certain therapies that might follow, such as infusions of modified immune cells that are tailor-made to attack patients’ tumours.

Scientists genetically modify human embryos in controversial world first

But they add that altering the DNA of human sperm and eggs, known as “germ cells”, and human embryos should become the focus of a broad ethical debate that fully explores the potential benefits and pitfalls of the procedure.

The prospect of modifying human embryos is deeply controversial because the DNA changes, and any unintended potentially harmful effects, would be passed on from generation to generation. The risks of altering the human germ line, as it is called, has troubled ethicists for decades. Without proper regulation, the procedure also raises the spectre of “designer babies”, where embryos are genetically modified to enhance them in the eyes of their parents.

“We believe that genome-editing technologies may hold significant potential for clinical applications in the future, and we would be open to supporting the development of new therapeutic approaches should the evidence from research advance sufficiently to justify their use,” the statement says.

It adds: “There may be future potential to apply genome editing in a clinical context using human germ cells or embryos, though we understand this is unlikely to be permissible in European jurisdictions at present. This raises important ethical and regulatory questions which need to be anticipated and explored.”

The statement is signed by the Wellcome Trust, the Medical Research Council, the Academy of Medical Sciences, the Association of Medical Research Charities and the Biotechnology and Biological Sciences Research Council.

In laboratory studies, scientists have used genome editing – known technically as Crispr-Cas9 – to correct mutations that cause metabolic disorders, to create cells that attack tumours and to make others that are resistant to HIV infection.

The most controversial study emerged in April when Chinese researchers took faulty IVF embryos that would otherwise have been discarded and edited the DNA to fix an aberrant gene that causes a life-threatening blood disorder.

Shortly before the Chinese study was published, a group of US scientists led by Edward Lanphier, chairman of the Alliance for Regenerative Medicine in Washington DC, called for a global moratorium on modifying human reproductive cells and embryos, even for basic research.

“Such research could be exploited for non-therapeutic modifications. We are concerned that a public outcry about such an ethical breach could hinder a promising area of therapeutic development,” the group wrote in the journal Nature.

Crispr: is it a good idea to ‘upgrade’ our DNA?

Michael Werner, executive director of the Alliance for Regenerative Medicine, said it agreed “to the need for a robust discussion about this important topic”.

Similar concerns were voiced in the US journal Science by a group that included one of the inventors of Crispr-Cas9, Jennifer Doudna, from the University of California, Berkeley. Unlike the UK, the US has no law banning the creation of genetically modified embryos for clinical uses.

Katherine Littler, senior policy adviser at the Wellcome Trust, said: “We think it’s important to look at the issues in relation to human cells, and particularly the germ line, in clinical applications. It’s a long way off, but we think it’s very important that these issues are looked at.

“Let’s have some well thought-through debates. A moratorium is the wrong starting point. We want an open dialogue. We want people to have an open mind about the issues rather than respond straight away.

“Are there specific diseases, are there areas where this would be the most efficient and effective way to do to it, where this would be acceptable? That’s part of the debate that has to be had.

“You can’t predict where the public or even the science community will take this debate, but hopefully it will be informed by good science and good ethics and not hyped fears.”

Public must have their say on genome editing | Letter from Professor Jonathan Montgomery of the Nuffield Council on Bioethics

The issues raised by genome editing are due to be explored by the US National Academy of Sciences, the Nuffield Council on Bioethics, and the Hinxton Group, an international organisation that brings scientists and policymakers together.

“It’s really important that these bodies do this to frame the issues and work out what the key ethical questions are, rather than it being overtaken by people who already have a particular stance,” Littler added.

Peter Mills, from the Nuffield Council on Bioethics, said: “They [the funders of the research] are clearly conscious of the broad public-interest questions that go beyond the scientific risks involved in germline editing, and they are keen to get that debate moving.

“The possibility of germline editing has come into view and they want to move forward with a debate on this before we arrive at that point.”

  • This article was amended on 4 September 2015. An earlier version said “potentially unintended harmful effects” where “unintended potentially harmful effects” was meant.

Ethical Culture and Legal Liability: The GM Switch Crisis and Lessons in Governance

51 PagesPosted: 17 Nov 2015Last revised: 16 Sep 2016

Date Written: December 14, 2015

Abstract

During 2014 news stories emerged that eventually revealed and caused General Motors (GM) to admit that the corporation took more than ten years to recall millions of vehicles because of an elaborate cover-up related to defects in its engine ignition switches. Beyond the tragedy of at least 100 deaths attributed to the ignition switch failures, there is the company’s internal failure to address and timely disclose what was a material event evident in the earliest stages of the use of the switch and clear evidence of the company’s awareness of the defects. Within the past fifteen years there have been significant examples of ethical lapses, all with the common factor that the evolution of the lapses within the companies took place over a period of time with many in the organization aware of the growing problems. The ignition switch problem at GM follows the same pattern. The purpose of this article is to examine the GM ignition switch debacle in light of its culture and past practices and search for insights to aid other companies in how to detect these material events and decisions in their early stages. First, we discuss what went wrong at GM, including findings from the report conducted by attorney Anton Valukas at the request of GM’s board. Second, we explore GM’s several appearances before Congress due to this ignition switch safety issue. Third, we look at what GM is reported to have done so far. Fourth, we provide thoughts about what GM needs to do. Next, we discuss lessons learned from this ethical crisis. Finally, we conclude and offer advice. We believe this paper offers a recital of the facts surrounding an egregious lapse in U.S. corporate ethical conduct as it provides constructive thoughts about future prevention of the causal management conduct, failure of corporate governance and regulatory oversight. The GM experience offers many lessons about the importance of organizational integrity, “truth telling” at all levels within large corporations, and the costs and issues that result when there are failures in corporate governance.

Keywords: Audit Committee, Automobile Safety, BP, Clawbacks, Code of Ethics, Congressional Oversight, Corporate Governance, Cover-up, Criminal Probe, Crisis, Culture, Ethics, Executive Compensation, General Motors, Ignition Switch, Risk, Valukas Report, Volkswagen

JEL Classification: F13, F23, G38, K13, K14, K22, K32, L62, M14, O33

Suggested Citation:Suggested Citation

Jennings, Marianne M. and Trautman, Lawrence J., Ethical Culture and Legal Liability: The GM Switch Crisis and Lessons in Governance (December 14, 2015). 22 Boston University Journal of Science and Technology Law (2016). Available at SSRN: https://ssrn.com/abstract=2691536 or http://dx.doi.org/10.2139/ssrn.2691536

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