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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) ‘Three Identical Strangers’: The high cost of experimentation without ethics – The Washington Post (Barron H. Lerner | January 2019)0

Posted by Admin in on February 10, 2019
 

On Sunday night, CNN will air “Three Identical Strangers,” a documentary about an experiment in which adopted twins and triplets were secretly separated. Viewers will probably be appalled as they learn about the emotional damage these individuals experienced as a result of their forced separation. But this medical experiment was not exceptional: It was just one of many unethical studies in the 1950s and 1960s that used subjects as means to an end.

Another shocking research project from the US (1955-70) that demonstrates the Nuremberg war trials and publication of the Nuremberg Code didn’t end egregious ethical lapses. We have added links to some related items.

Injunctions against unethical research go back at least to the mid-19th century, when the French scientist Claude Bernard admonished his fellow investigators never to do an experiment that might harm a single person, even if the result would be highly advantageous to science and the health of others. Yet despite Bernard’s admonition, the next century was replete with experiments that put orphans, prisoners, minorities and other vulnerable populations at risk for the sake of scientific discovery. Medical progress often came at too high a human cost, something the CNN documentary exposes.
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Human experimentation surged during World War II as American scientists raced to find treatments for diseases encountered on the battlefield. This experimental enthusiasm continued into the Cold War years, as the United States competed with the Soviet Union for scientific knowledge. In both eras, a utilitarian mind-set trumped concerns about research subjects.
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Ask the patients about the benefits and the risks – The Ethics Blog (Pär Segerdah | January 2019)0

Posted by Admin in on January 31, 2019
 

Almost no medications are without risks of side effects. When new drugs are approved, decision makers must balance risks and benefits. To make the balancing, they use results from clinical trials where the drugs are tested on patients to determine (among other things) efficacy and side effects.

‘Consumer/community’ involvement in research and clinical decision-making is a big thing for us. For example, Gary is the lead investigator on a Hopkins Centre seed-grant project that hopefully will create some resources on this for disability research. Consequently, we’re fans of the idea patients should have a key role in evaluating the seriousness of treatment side-effects and the importance of their benefits

But how do you balance risks and benefits? Is the balancing completely objective, so that all that is needed is results from clinical trials? Or can risks and benefits be valued differently?
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It has been noted that decision makers can value risks and benefits differently from patients. Therefore, results merely from clinical trials do not suffice. Decision makers also need to understand how the patients themselves value the risks and the benefits associated with treatments of their disease. The patients need to be asked about their preferences.
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Karin Schölin Bywall is a PhD student at CRB. She plans to carry out preference studies with patients suffering from rheumatoid arthritis. The task is complex, since risks and benefits are multidimensional. Rheumatoid arthritis is a chronic disease with several symptoms, such as pain, stiffness, fatigue, fever, weakness, deformity, malaise, weight loss and depression. Medications can be variously effective on different symptoms, while they can have a range of side effects. Which positive effect on which symptom is sufficiently important for the patients to outweigh a certain level of one of the side effects?
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Research ethics: How to Treat People who Participate in Research – NIH (Ezekiel Emanuel, et al | nd)0

Posted by Admin in on January 23, 2019
 

Excerpt from a commentary written by Gary Allen and Mark Israel.

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Finding a free and polished human research ethics resource from a highly reputable source should be cause for celebration and so its inclusion in an institutional resource library might seem to be a foregone conclusion.
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But…
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In this case, AHRECS also suggests caution. We think that, like many international sources of advice, it calls for some local commentary, so the brochure does not have an unexpected negative impact. There is nothing egregious about this document; it may be a really good source of advice for medical research in the United States. Our concern is about the uncritical adoption of such work across disciplines, methodologies and countries.
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The full commentary is available to USD1/month AHRECS patrons.

Introduction
In Alabama from the 1930s to 1970s, researchers recruited black men to participate in a study of syphilis – a terrible disease that can cause disability and death. The researchers told the men participating that they were getting medical treatment, even though they were not. in fact, when the study began syphilis was untreatable. the researchers instead wanted to study what syphilis does to the body over time. after World War ii, when a treatment – penicillin – was available for syphilis, the researchers kept the men from receiving it because they wanted to study what happened as the disease got worse. What makes this study – the Tuskegee Syphilis Study – unethical? What is wrong with the way the researchers acted?
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A human exercise experiment or class survey designed by a student for a science fair seems very different from the tuskegee syphilis study. however, is there anything about student studies that might raise ethical concerns?
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Human subjects research is exactly what it sounds like. it is research that uses people as the subjects of experiments or studies. it can include giving people new drugs, doing tests on their blood, even having them take surveys. Researchers have a duty to treat the people they study ethically and respectfully. in particular, it is important to make sure that researchers do not exploit their subjects. Exploitation is addressed further on page 9. unfortunately, as the Tuskegee Syphilis Study shows, some people were treated.
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Unfortunately, as the Tuskegee Syphilis Study shows, some people were treated horribly during research studies in the past. German and Japanese researchers, for instance, conducted terrible experiments on prisoners during World War ii. Many other incidents took place before the 1970s, when some u.s. doctors experimented on hospital patients without telling them or failed to provide medicines that would have treated potentially deadly diseases. Today, there are ethical principles for research to help ensure that people who participate are not harmed and that the scandals of the past do not occur again.these principles even apply to student research projects with humans, and they are important for you to think about as you design experiments.

Access  the brochure

TABLE OF CONTENTS

Introduction 3
Introduction to the 7 Principles 4
Other Important Concepts and Issues 8
Applying the Principles 10
Further Reading

Emanuel, E, Abodler, E. and Stunkel, L. (nd) Research ethics: How to Treat People who Participate in Research. US National Institutes of Health.
https://bioethics.nih.gov/education/FNIH_BioethicsBrochure_WEB.PDF

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.”.

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