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Amid ethics outcry, should journals publish the ‘CRISPR babies’ paper? – STAT (Adam Marcus | December 2018)0

Posted by Admin in on December 31, 2018

Like researchers everywhere, He Jiankui — the scientist in China who claims to have used CRISPR to edit embryos to create babies protected from HIV — is eager to publish scientific papers. It is, after all, a publish-or-perish world — although in He’s case, his fate at home may rest more with what the Chinese government thinks of his behavior than what a peer reviewer says about his work.

Part of the dilemma for a journal editor will be which ethical standard to apply, whether that standard provides any guidance with regard to research on an unborn fetus, the genetic manipulation of humans, risk management and consent. A journal faces a pretty stark dilemma that the edition the paper appears in will attract huge attention, be highly cited (though probably not positively) and the journal title will suddenly be on everyone’s lips. But the reputation of the publication, publisher and editor is likely to take a massive hit. Would you publish?  We doubt we would.

As STAT reported Monday, He shopped around a manuscript earlier this fall about using CRISPR to edit genes for a different purpose — to prevent an inherited condition that causes sky-high cholesterol levels — but it was rejected because of ethical and scientific shortcomings. And two weeks ago, in the face of withering criticism over his lack of transparency, He told the International Summit on Human Genome Editing in Hong Kong that he had submitted a paper on the “CRISPR babies” work to a journal.

Given the maelstrom surrounding He’s claims, however, should any journals even consider papers from him? And if they do, what should they keep in mind?

Jeremy Berg, editor of Science, told STAT that while he could not comment on whether the paper had been submitted to his journal, “given the numerous ethical issues with this situation as presented, we would be extremely unlikely to consider it.”

Howard Bauchner, the editor of the Journal of the American Medical Association, wouldn’t comment on the possibility of a submission by He either, but said, “I believe articles should be reviewed and not judged based upon what is written in the media.”.

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The Ethical Governance of German Physicians, 1890-1939: Are There Lessons from History? (Papers: Robert Dingwall & Vienna Rozelle | 2011)0

Posted by Admin in on December 20, 2018

The limitations of the traditional historiography of the ethical regulation of biomedical research are becoming increasingly well recognized. A simplistic history has been used to justify a simplistic policy, in the elaboration of regulatory instruments associated with a bureaucracy of administration and enforcement that has acquired its own material interests in self-perpetuation and jurisdictional expansion. The official history of institutionalized ethical regulation sees a clear and self-evident line of descent from the Nazi experiments of World War II to the various legal and quasi-legal instruments that now govern most scientific and, increasingly, social scientific practice. Without regulatory interventions, it is claimed, researchers will revert to barbarism.

Many of us point to the Nuremberg Code as the first formal attempt to govern the ethical conduct of human research.  While the atrocities committed by the Nazi scientists are no less horrific, this paper by Robert Dingwall and Vienna Rozelle paints quite a different picture of the early evolution of the governance of ethics in bio-medicine. The lessons and implications should cause us pause. Perhaps regulation is not a safeguard against ethically compromised research and we need to stop referring to the inhuman acts of the Nazis to justify our current human research ethics arrangements.

This version of the “rise of bioethics” tends to place considerable emphasis on the Nuremberg Doctors Trial, and the Nuremberg Code promulgated at its conclusion, and to use these as an “origin myth” that legitimizes its professional project. As a narrative, it says little, for example, about the lengthy gap between the conclusion of the Nuremberg trial in 1948 and the development of regulatory interventions for medical research in the victor countries during the 1960s. It tends not to acknowledge the evidence, from writers like Henry Beecher in the United States and Maurice Pappworth in the United Kingdom, that ethically questionable experiments continued in the victor countries well after World War II, a phenomenon explored further by Tal Bolton in a recent PhD. thesis and her article in this journal issue. However, it also tends to equate an absence of regulation with an absence of ethical concern, despite the evidence from Susan Lederer and Sydney Halpern about the effective operation of informal social controls in the United States before World War II. Most crucially, it neglects Jenny Hazelgroves exploration of the difficulty that the prosecutors faced in framing charges against the Nuremberg defendants because they were unable to point to any clear set of regulations or standards in any country other than Germany that could be said to have been violated.

The publication of further analyses of the pre-World War II German experience provides an additional resource for the critical examination of the claims being made about the importance of formal regulation in the maintenance of ethical standards in biomedical research. This body of work has documented the rise of attempts at ethical research governance in Germany from the late nineteenth century through to the 1930s. In so doing, it may seem to provide us with an opportunity to explore the limits of regulation. Why did it fail to protect the victims of the Nazi medical experiments? Why did it seemingly attract so little international interest, despite Germany’s leading role in science and biomedicine over much of this period? However, as a number of influential historians of late nineteenth- and early twentieth- century Germany have observed, the study of this period has suffered from the imposition of narrative arcs, influenced by sociology or political science, that see it only as the precursor to the disaster of the Nazi regime. No actor at the time consciously sought this end for their actions: even the Nazi leadership sought power rather than defeat. Accounts that find a logic in the events from the late nineteenth century to the end of World War II may overlook the unintended consequences of actors dealing with contingent events on the basis of partial information interpreted according to what were contemporaneously considered valid knowledge or theories. It is important, then, to avoid constructing an equally simplistic counter-narrative about the general ineffectiveness of regulation.

Dingwall, R and Rozelle, V (2011) The ethical governance of German physicians, 1890–1939: Are there Lessons from History? Journal of Policy History 23(1): 29-52.

Respect for Human Vulnerability: The Emergence of a New Principle in Bioethics (Papers: Henk ten Have | 2015)0

Posted by Admin in on November 30, 2018

Vulnerability has become a popular though controversial topic in bioethics, notably since 2000. As a result, a common body of knowledge has emerged (1) distinguishing between different types of vulnerability, (2) criticizing the categorization of populations as vulnerable, and (3) questioning the practical implications. It is argued that two perspectives on vulnerability, i.e., the philosophical and political, pose challenges to contemporary bioethics discourse: they re-examine the significance of human agency, the primacy of the individual person, and the negativity of vulnerability. As a phenomenon of globalization, vulnerability can only be properly addressed in a global bioethics that takes the social dimension of human existence seriously.

Global bioethics, Globalization, Vulnerability, Research ethics, Philosophy of medicine

ten Have, H. Respect for Human Vulnerability: The Emergence of a New Principle in Bioethics. Bioethical Inquiry (2015) 12: 395.

Patients find misleading information on the internet – The Ethics Blog (Pär Segerdahl | October 2018)0

Posted by Admin in on November 25, 2018

In phase 1 clinical studies of substances that might possibly be used to treat cancer in the future, cancer patients are recruited as research participants. These patients almost always have advanced cancer that no longer responds to the standard treatment.

That research participation would affect the cancer is unlikely. The purpose of a phase 1 study is to determine safe dosage range and to investigate side effects and other safety issues. This will then enable proceeding to investigating the effectiveness of the substance on specific forms of cancer, but with other research participants.

Given that patients often seek online information on clinical trials, Tove Godskesen, Josepine Fernow and Stefan Eriksson wanted to investigate the quality of the information that currently is available on the internet about phase 1 clinical cancer trials in Sweden, Denmark and Norway.

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