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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Children in Social Research: Do Higher Payments Encourage Participation in Riskier Studies? (Stephanie Taplin, et al | February 2019)0

Posted by Admin in on February 18, 2019
 

Abstract

Full disclosure, columns on the advisory panel for this work, But this is a great paper with disciplinary application.

The MESSI (Managing Ethical Studies on Sensitive Issues) study used hypothetical scenarios, presented via a brief online survey, to explore whether payment amounts influenced Australian children and young people to participate in social research of different sensitivity. They were more likely to participate in the lower sensitivity study than in the higher at all payment levels (A$200 prize draw, no payment, $30, or $100). Offering payments to children and young people increased the likelihood that they would agree to participate in the studies and, in general, the higher the payments, the higher the likelihood of their participating. No evidence of undue influence was detected: payments can be used to increase the participation of children and young people in research without concerns of undue influence on their behavior in the face of relatively risky research. When considering the level of payment, however, the overriding consideration should be the level of risk to the children and young people.
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Keywords
children and adolescent, pediatrics, justice, participant selection, inclusion, recruitment, payment for research participation, research ethics, risks, benefits, and burdens of research, beneficence and nonmaleficence, vignette studies, decision-making capacity, surrogate decision makers, parental consent, child assent, voluntariness, coercion
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Taplin, S., Chalmers, J., Hoban, B., McArthur, M., Moore, T. and Graham, A. (2019) Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols. Journal of Empirical Research on Human Research Ethics.
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American scientist played more active role in ‘CRISPR babies’ project than previously known – STAT (Jane Qiu | January 2019)0

Posted by Admin in on February 11, 2019
 

BEIJING — An American scientist at Rice University was far more involved in the widely condemned “CRISPR babies” experiment than has previously been disclosed. Most notably, STAT has learned that Rice biophysicist Michael Deem was named as the senior author on a paper about the work that was submitted to Nature in late November.

Deem’s prominent authorship indicates that a respected American researcher played an instrumental role in the controversial project, which sparked a worldwide furor. His involvement could have encouraged volunteers to join the experiment and lent credibility to He Jiankui, the Chinese scientist who led the work.

Emails provided to STAT show that Deem was listed as the last author — which, in the life sciences, is typically reserved for the senior researcher who oversees a study. The paper, titled “Birth of twins after genome editing for HIV resistance,” has another nine contributors, including He as the first author, where the person who makes the most hands-on contribution is credited.

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(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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