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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Vulnerable patients – easy targets for companies willing to sacrifice ethics for profits – The Hill (Jody Lyneé Madeira | May 2018)0

Posted by Admin in on August 5, 2018
 

A small medical device has just become embroiled in a large controversy, suggesting violations of fundamental ethical norms and settled principles of scientific research.

Stories like this highlight why people living with a chronic medical condition (and their families) need to be discerning and cautious when it comes to glowing media reports about amazing new treatments.

At first glance, the Bridge — a neuro-modulation device that attaches behind the ear — resembles a hearing aid with wires. The Bridge received Food and Drug Administration (FDA) clearance in November 2017 for easing opioid withdrawal symptoms during detoxification; before, it was approved only for acupuncture.
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This device is supposed to help patients get through the difficult opioid withdrawal process. It’s used in pilot programs in several states, available in at least one major Indiana hospital chain, and is starting to be covered by insurance.
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(US) FDA’s revolving door: Companies often hire agency staffers who managed their successful drug reviews – Science (Charles Piller | July 2018)0

Posted by Admin in on August 4, 2018
 

The Food and Drug Administration (FDA) says its rules, along with federal laws, stop employees from improperly cashing in on their government service. But how adequate are those revolving door controls? Science has found that much like outside advisers, regular employees at the agency, headquartered in Silver Spring, Maryland, often reap later rewards—jobs or consulting work—from the makers of the drugs they previously regulated.

FDA staffers play a pivotal role in drug approvals, presenting evidence to the agency’s advisory panels and influencing or making approval decisions. They are free to move to jobs in pharma, and many do; in a 2016 study in The BMJ, researchers examined the job histories of 55 FDA staff who had conducted drug reviews over a 9-year period in the hematologyoncology field. They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry.

FDA’s safeguards are supposed to keep the prospect of industry employment from affecting employees’ decisions while at the agency, and to discourage them from exploiting relationships with former colleagues after they depart. For example, former high-level employees can’t appear before the agency on the precise issues they regulated—sometimes permanently, in other cases for a year or two.

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Genome editing and human reproduction (Nuffield Council on Bioethics | July 2018)0

Posted by Admin in on July 19, 2018
 

Foreword
The capacity to select the traits of our future children has long been a central theme in science fiction writing, often solemnly warning of the moral dangers associated with doing so, even when undertaken with the best of intentions. The discovery of DNA, the so-called ‘code of life’, pointed the way towards the scientific avenue through which deliberate intervention to select for desired human traits of future children might be brought about. Yet even after DNA was discovered, the prospect of doing so has remained purely speculative: we simply lacked the scientific knowledge and tools to attempt such a feat. However, as the Council’s 2016 report Genome editing: an ethical review observes, the development of genome editing techniques has been game changing for research across the biosciences, particularly since the emergence of the CRISPR-Cas9 system in 2012, which enabled precisely targeted alterations to DNA sequences in living cells. As a result, deliberately intervening in the human genome for the purposes of selecting traits of future children has now become a real and distinct possibility. The central question which this Report sets out to address is whether such interventions would be ethically acceptable. Our conclusion is that interventions of this kind to influence the characteristics of future generations could be ethically acceptable, provided if, and only if, two principles are satisfied: first, that such interventions are intended to secure, and are consistent with, the welfare of a person who may be born as a consequence, and second, that any such interventions would uphold principles of social justice and solidarity – by this we mean that such interventions should not produce or exacerbate social division, ormarginalise or disadvantage groups in society.

While this document isn’t specifically about human research ethics/research ethics review we thought the report could be of interest to research ethics reviewers and researchers.

In order to arrive at this conclusion, our approach begins by asking: what is the societal challenge for which deliberate attempts to edit the human genome in the context of reproduction might respond? Put differently, we ask (somewhat more crudely), why might heritable human genome editing be understood as a valuable and worthwhile response to a societal problem? The answer offered in this report centres on the reproductive choices of prospective parents and the preferences they may express for their future child. In the most obvious cases, this may be to take steps that will reduce the prospect of their future child inheriting a genetic disorder. But there is potential for genome editing to be used in a wider variety of more common circumstances, and for a wider range of purposes that may be unrelated to the avoidance of medical diseases or disorders. Our view is that the two guiding principles that condition the ethical acceptability of genome editing in the context of reproduction should orient ethical evaluation and are applicable to the full range of potential motivations for wishing to undertake such interventions. In the UK, genome editing for reproductive purposes is currently unlawful. We make several recommendations concerning how deliberate interventions into the human genome should be governed, including recommendations concerning what we think is needed prior to any move to amend UK legislation to permit heritable genome editing. In particular, we conclude that no such change should be broached without consideration of whether it can be ensured that any proposed use would conform to these two ethical principles: the principle of the welfare of the future person and the principle of social justice and solidarity. Although the prospect of such a move remains a very long way off and, indeed, might never arrive, we nevertheless emphasise the need for broad, inclusive societal debate concerning the desirability of such interventions to take placesooner rather than later, in order to produce an understanding of the public interest, and for engagement with other countries and international organisations to help develop international norms for the law and governance of genome editing.
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When I was asked to take on the role of Chair in the summer of 2016, my initial instinct was to decline the invitation. Because the moral acceptability of intervening in the human germ line with the aim of affecting the traits of future children is highly contested, often engaging deeply held views, I was acutely aware that, whatever conclusions the working party arrived at, some people were bound to oppose and even abhor them. In other words, I recognised that by taking up the role, I would be taking up something of a poisoned chalice. At the same time, I had not arrived at my own personal view about the ethical acceptability or otherwise of heritable genome editing, particularly in light of my own experience of the unique and extraordinary role of being, and the process of becoming, a parent of children created within my body to whom I had given birth. My reluctance to take up the role of Chair was partly, perhaps, a product of recognising that, in order to arrive at a position, one must inevitably confront some intractable and insoluble questions including, among other things, questions concerning the significance and sanctity of what it means to be human, and how properly to comprehend the unique character of the parent-child relationship. Accordingly, intentional attempts to intervene in thehuman germ line might affect our responses to those questions, and to that meaning and character, for good or for ill. Nevertheless, I overcame my initial reluctance to accept the role of Chair, recognising – as I have often counselled my students – that the difficulty, complexity and contestability surrounding a set of questions are not good reasons to shy away from attempting to grapple with them. This is all the more so when the questions are real, important and can have tangible and profound consequences for the lives of individuals and for society more generally.
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Access the report web page
Download a PDF copy of the report

National Statement on Ethical Conduct in Human Research (2007) – Updated July 20180

Posted by Admin in on July 12, 2018
 

National Statement 2018 coverThe National Statement is the Australian national reference for human research. It was issued by the NHMRC and has been endorsed by the ARC and UA. The document articulates the four core principles of merit and integrity, beneficence, justice and respect for persons. Specific advice is provided with regard to benefits and risk, informed consent, privacy, methodologies and potential participant populations. Guidance is also provided with regard to the appointment and operation of human research ethics committees, the conduct of ethical reviews, and the responsibilities of institutions. Even though the document has not been enacted compliance with the National Statement is a strict condition of NHMRC and ARC funding.

Since 2014 a joint working group (including appointees from AHEC, the ARC and UA) have been conducting a rolling review of the National Statement. Dr Allen is involved in this rolling review.

In 2015-17 a joint drafting committee (including appointees from AHEC, the ARC and UA) drafted changes and addition to the chapters in Section 3 of the National Statement, as well as corresponding changes to Section 5 and the glossary Dr Allen, Prof Israel and Prof Thomson are involved in this rolling review.

Access – the PDF copy | the NS page

National Health and Medical Research Council, Australia (2007, updated 2018) National Statement on Ethical Conduct in Human Research. Available at: https://www.nhmrc.gov.au/_files_nhmrc/file/publications/national-statement-2018.pdf

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