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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(UK) Crackdown on unreported trials is good news for researchers – *Research (Till Bruckner | November 2018)0

Posted by Admin in on January 27, 2019
 

With MPs, funders and regulators on the case, universities’ poor record on transparency is going to have to change, says Till Bruckner.

On 30 October, the House of Commons Science and Technology Committee issued its long-expected report on clinical trials transparency. The report notes that even today, around half of all clinical trials in the UK still fail to post their results onto registries.

As official documents go, the report is remarkably candid—the word “disappointed” leaps off the pages again and again. The parliamentarians’ ire may have been heightened by the fact that five years earlier, a similar report from the same committee called for decisive government action, evidently to little effect.

The latest report singles out universities and NHS trusts for particular criticism, citing data from the recently launched EU Clinical Trials Tracker, an online transparency tool. The tracker paints an unflattering picture of academic institutions’ performance. Across Europe, only 11 per cent of university-sponsored trials have posted their results. In contrast, many pharmaceutical companies boast reporting rates of close to 100 per cent.

Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform (Papers: Nola M. Ries, et al | 2017)0

Posted by Admin in on January 24, 2019
 

Abstract
Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decisionmaking principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives.

Keywords
Research ethics, Law. Dementia, Consent, Substitute decision-making, Advance directives

Ries, N. M., Thompson KA., & Lowe M. (2017) Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform. Journal of Bioethical Inquiry 14(3): 359-374.
https://link.springer.com/article/10.1007%2Fs11673-017-9794-9

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.
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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?
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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.”
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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.”.

Read the rest of this discussion piece

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.
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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. http://irep.ntu.ac.uk/id/eprint/16649/1/205167_7323%20Dingwall%20Publisher.pdf

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