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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) Google and the University of Chicago Are Sued Over Data Sharing – New York Times (Daisuke Wakabayashi | June 2019)0

Posted by Admin in on October 17, 2019
 

SAN FRANCISCO — When the University of Chicago Medical Center announced a partnership to share patient data with Google in 2017, the alliance was promoted as a way to unlock information trapped in electronic health records and improve predictive analysis in medicine.

On Wednesday, the University of Chicago, the medical center and Google were sued in a potential class-action lawsuit accusing the hospital of sharing hundreds of thousands of patients’ records with the technology giant without stripping identifiable date stamps or doctor’s notes.

The suit, filed in United States District Court for the Northern District of Illinois, demonstrates the difficulties technology companies face in handling health data as they forge ahead into one of the most promising — and potentially lucrative — areas of artificial intelligence: diagnosing medical problems.

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Work of renowned UK psychologist Hans Eysenck ruled ‘unsafe’ – The Guardian (Sarah Boseley | October 2019)0

Posted by Admin in on October 14, 2019
 

Eysenck’s ‘cancer-prone’ personality theory had come under criticism for decades

The work of one of the most famous and influential British psychologists of all time, Hans Eysenck, is under a cloud following an investigation by King’s College London, which has found 26 of his published papers “unsafe”.

King’s says the results and conclusions of the papers “were not considered scientifically rigorous” by its committee of inquiry. Prof Sir Robert Lechler, the provost at King’s, has contacted the editors of the 11 journals where the papers appeared, recommending they should be retracted.

Eysenck, who died in 1997, published prolifically and wrote many well-known books, holding controversial views on a number of subjects, including race and IQ. The investigation centred on research that claimed personality played a bigger part in people’s chances of dying from cancer or heart disease than smoking.

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Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight – JAMA Network (Holly Fernandez Lynch, et al | September 2019)0

Posted by Admin in on October 2, 2019
 

Faced with the prospect of death or debilitating disease, patients and their families may be willing to try almost any treatment. A number of systems exist to help prevent this understandable desperation from resulting in serious harm, including standards of medical professionalism, requirements for product approval by the US Food and Drug Administration (FDA), and oversight of research by institutional review boards (IRBs). There are gaps in this safety net, however, that become particularly evident in the context of clinical trials that require patients to pay to participate. Although these trials may sometimes satisfy the standards of ethical research, the research oversight system in the United States is not sufficiently robust to ensure that this will always be the case.

Pay-to-Participate Trials
Clinical research is typically funded by governments, charitable foundations, and private companies. Built into this traditional funding system are review mechanisms intended to select for high-priority, high-quality studies. These mechanisms can often prevent the initiation of low-value studies, but they may also limit innovation by prioritizing incremental progress over bold ideas or deprioritizing research with little commercial promise. Inevitably, limited resources may force funders to forgo important studies.

One response is to seek out alternative funding sources, including study participants. Short of fraud protections, there is no legal prohibition against asking patients to pay to participate in research. The FDA explicitly permits charging for investigational products under certain circumstances, while regulations governing research consent simply call for disclosure of any “additional costs” that may result from participation.

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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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