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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Why We Need Guidelines for Brain Scan Data – Wired (Evan D. Morris | September 2019)0

Posted by Admin in on September 18, 2019
 

Your brain is a lot like your DNA. It is, arguably, everything that makes you uniquely you. Some types of brain scans are a lot like DNA tests. They may reveal what diseases you have (Parkinson’s, certainly; depression-possibly), what happened in your past (drug abuse, probably; trauma, maybe), or even what your future may hold (Alzheimer’s, likely; response to treatment, hopefully). Many people are aware—and properly protective—of the vast stores of information contained in their DNA. When DNA samples were collected in New York without consent, some went to great lengths to have their DNA expunged from databases being amassed by the police.

Fewer people are aware of the similarly vast amounts of information in a brain scan, and even fewer are taking steps to protect it. My colleagues and I are scientists who use brain imaging (PET and fMRI) to study neuropsychiatric diseases. Based on our knowledge of the technologies we probably ought to be concerned. And yet, it is rare that we discuss the ethical implications of brain imaging. Nevertheless, by looking closely, we can observe parallel trends in science and science policy that are refining the quality of information that can be extracted from a brain scan, and expanding who will have access to it. There may be good and bad reasons to use a brain scan to make personalized predictions. Good or bad, wise or unwise, the research is already being conducted and the brain scans are piling up.

PET (Positron Emission Tomography) is commonly used, clinically, to identify sites of altered metabolism (e.g., tumors). In research, it can be used to identify molecular targets for treatment. A recent PET study of brain metabolism in patients with mild cognitive impairment predicted who would develop Alzheimer’s disease. In our work at Yale, we have used PET images of a medication that targets an opioid receptor to predict which problem drinkers would reduce their drinking while on the medication.

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European universities dismal at reporting results of clinical trials – Nature (Nic Fleming | April 2019)0

Posted by Admin in on September 11, 2019
 

Analysis of 30 leading institutions found that just 17% of study results had been posted online as required by EU rules.

Failing to post the results of a clinical trial is not only a technical breach, it is a waste of resources, places an unwarranted burden on volunteers, is a waste of resources and is a public health issue.  Does your institution follow-up to check if results have been reported?  Is action taken if it hasn’t?

Many of Europe’s major research universities are ignoring rules that require them to make public the results of clinical trials.

A report published on 30 April found that the results of only 162 of 940 clinical trials (17%) that were due to be published by 1 April had been posted on the European Union’s trials register. The 30 universities surveyed are those that sponsor the most clinical trials in the EU. Fourteen of these institutions had failed to publish a single results summary.

If three high-performing UK universities are excluded from the figures, the results of just 7% of the trials were made public on time. Campaigners say the resulting lack of transparency harms patients by undermining the efforts of doctors and health authorities to provide the best treatments, slows medical progress and wastes public funds.

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Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation? (Papers: Dara Hallinan & Michael Friedewald | 2015)0

Posted by Admin in on August 22, 2019
 

Abstract
This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Hallinan, D. and M. Friedewald (2015). “Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation?” Life Sciences, Society and Policy 11(1): 1.
Publisher (Open Access): https://lsspjournal.biomedcentral.com/articles/10.1186/s40504-014-0020-9

Journals retract more than a dozen studies from China that may have used executed prisoners’ organs – Retraction Watch (Ivan Oransky | August 2017)0

Posted by Admin in on August 15, 2019
 

In the past month, PLOS ONE and Transplantation have retracted fifteen studies by authors in China because of suspicions that the authors may have used organs from executed prisoners.

All of the original studies — seven in Transplantation, and eight in PLOS ONE — were published between 2008 and 2014. Two involved kidney transplants, and the rest involved liver transplants. Two other journals, the Clinical Journal of the American Society of Nephrology and Kidney International, have recently issued expressions of concern for the same reason.

In an editorial explaining the seven retractions from its journal, the editors of Transplantation write:

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