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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

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

An Australian university cleared a cancer researcher of misconduct. He’s now retracted six papers – Retraction Watch (Ivan Oransky – January 2019)0

Posted by Admin in on January 19, 2019
 

Khachigian’s research is a long and winding tale.

One place to start would be in October 2009, when a paper co-authored by Khachigian — whose work at the University of New South Wales (UNSW) has been funded by millions of dollars in funding from the Australian government, and has led to clinical trials, although more on that later — was retracted from Biochemical and Biophysical Research Communications. The “corresponding author published the paper without the full consent or acknowledgement of all the researchers and would like to apologize for this error,” according to that notice.

Three more papers, all from the Journal of Biological Chemistry (JBC), were retracted the following July, saying only that “This article has been withdrawn by the authors,” as was typical for the JBC for many years.

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