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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Doctor who participated in fake chocolate study fined for violating code of conduct – Retraction Watch (Hinnerk Feldwisch-Drentrup | September 2016)0

Posted by Admin in on January 30, 2019
 

A German district attorney has fined a doctor who participated in a bogus study showing chocolate helps weight loss, designed to illustrate how shady science can make the news, arguing it was unethical to ask people to participate unknowingly in such a scam.

This item generated considerable discussion on the Retraction Watch website, including the doctor disputing some of the observations.

As soon as the study was published, critics raised questions over whether it was appropriate to include volunteers in a bogus clinical trial, which included giving blood. Recently, a German district attorney for professional conduct of physicians ruled that it was not.
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In an anonymized version of a decision from the district attorney – who investigates on possible violations of the physicians’ professional law – he fined the doctor who participated in a bogus study about the health benefits of chocolate 500 Euros for not obtaining proper consent from the people who volunteered to participate, and for not involving an ethics committee.
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Read the rest of this discussion piece

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

Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight (Papers: Holly Fernandez Lynch, et al | December 2018)0

Posted by Admin in on January 13, 2019
 

Abstract

Is your research ethics committee effective? Even deciding what effective means in this context isn’t easy. If effectiveness means research being conducted more ethically, how do judge that? This great paper should be seen as a springboard into an important discussion.

There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs “work” requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs.

Keywords
Institutional Review Board, research ethics oversight, effectiveness, quality, empirical evaluation

Lynch, H. F., Nicholls, S., Meyer, M. N., & Taylor, H. A. (2018). Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264618812625
Publisher: https://journals.sagepub.com/doi/abs/10.1177/1556264618812625#articleCitationDownloadContainer

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