AbbVie cancer drug fails two late-stage trials

Reuters, 19 April 2017
Authors: Divya Grover, Savio D’Souza, Bill Rigby
“AbbVie Inc experimental cancer drug, veliparib, failed to meet the main goals of two late-stage studies. The trials evaluated the effect of veliparib, in combination with a chemotherapy regimen, on patients with non-small cell lung cancer (NSCLC) and triple-negative breast cancer. In one trial, the combination treatment failed to improve the overall survival of NSCLC patients. In another trial, the drug did not achieve the complete pathologic response.”
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Swedish stem cell “pioneers” are found guilty of research misconduct

BMJ 2017;357:j1808
Author: Owen Dyer
“Two Swedish professors, hailed as pioneers in the field of stem cell transplantation, have been found guilty of misconduct by their employer, Gothenburg University, after they falsely claimed to have obtained ethics approval for unproven operations that they carried out on three children.”
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A critique of the regulation of data science in healthcare research in the European Union

BMC Medical Ethics 2017 18:27
Authors: John M. M. Rumbold, Barbara K. Pierscionek
“The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification.”
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Independent board needed to promote research integrity, US panel says

BMJ 2017; 357:j1879
Author: Michael McCarthy
“A new US report calls for the creation of an independent advisory board to help scientists, scientific institutions, journals, and other participants tackle research misconduct and reduce questionable practices, which, while they might not represent misconduct, harm research enterprise.”
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Inconsistent state laws may complicate medical decision-making

EurekAlert, 12 April 2017
Source: University of Chicago Medical Center
“A patchwork of state laws creates a labyrinth that can make it confusing to navigate incapacitated patients’ medical wishes. Without clear national standards, the problem may worsen as the nation’s 75 million baby boomers continue to age, according to medical ethics research published in the New England Journal of Medicine. On average, 40 percent of hospitalized adults can’t make their own medical decisions. In some intensive care units, that figure skyrockets to 90 percent.”
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Smithfield makes move on market for pig-human transplants

Reuters, 12 April 2017
Authors: Julie Steenhuysen, Michael Hirtzer
“Smithfield Foods, the world’s largest pork producer, has established a separate bioscience unit to expand its role in supplying pig parts for medical uses, with the ultimate goal of selling pig organs for transplantation into humans. Recent scientific advances for using pigs as a supply of replacement parts for sick or injured people, makes it an attractive new market. Transplants from animals could help close a critical gap to help those in need.”
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How consent requirements may shape teen mental health research

Reuters, 6 April 2017
Author: Lisa Rapaport
“Requiring teens to get permission from their parents to participate in studies about behavioral health may make it harder to understand adolescent psychology – especially when drugs and alcohol are involved. “Requiring parental consent may introduce a systematic bias that excludes certain segments of our population,” said lead study author Chao Liu of Oklahoma State University in Stillwater. In the U.S., minors under age 18 generally need permission from their parents to get medical treatment or participate in research.”
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How ethical is sexual assault research?

The Conversation, 5 April 2017
Author: Bianca Fileborn
“Thirty-nine Australian universities will now individually release the findings of a national research project on sexual assault and harassment on campus. This announcement follows intense criticism from student bodies and sexual assault activists after it was initially announced that the findings for individual universities would not be made public. Clearly, this case raises some substantial questions about what constitutes “ethical” research on sexual assault.”
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Ethics complicate clinical interpretation & reporting of human genome sequence results

EurekAlert, 3 April 2017
Author: Mary Ann Liebert
“Medical use of a patient’s genomic sequence information can improve diagnostic capabilities and enable personalized therapies, but technical and practical barriers to understanding the clinical implications of sequence data and interpreting them for patients are contributing to ongoing ethical concerns. In the article entitled “From Sequence Data to Returnable Results: Ethical Issues in Variant Calling and Interpretation,” the authors discuss the potential harm that can be caused by overstating a result or reporting a false-positive finding.”
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A qualitative study of participants’ views on re-consent in a longitudinal biobank

BMC Medical Ethics 2017 18:22
Authors: Mary Dixon-Woods, David Kocman, Liz Brewster, Janet Willars, Graeme Laurie, Carolyn Tarrant
“Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or ‘biobanks’ over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank.”
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