Rules on reporting trials must be better enforced, say health integrity groups

BMJ 2017; 359: j5786
Author: Deborah Cohen
“Unregulated reporting of clinical trials opens the door to fraud and corruption, undermining medical advances and public health objectives, a report has warned. The report, by a consortium of “health integrity organisations,” urges governments to enforce current rules to ensure that patients, doctors, and scientists can access the full results of all clinical trials.”
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Ethical issues in Alzheimer’s disease research involving human subjects

Journal of Medical Ethics 2017;43:852-856.
Author: Dena S Davis
“As we aggressively pursue research to cure and prevent Alzheimer’s disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others.”
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Designing Ethical Trials of Germline Gene Editing

N Engl J Med 2017; 377:1911-1913
Author: Bryan Cwik
“Much of the biomedical ethics literature on gene editing has focused on broad social issues related to how it should be done, such as questions about using it for enhancing human cognitive abilities. Comparatively little has dealt with more ground-floor ethical issues about the design of clinical trials and use of gene editing in reproductive medicine. The time for that discussion has now come: foreseeable use of gene editing in reproductive medicine is no longer science fiction, and it’s important to consider seriously what would be required for the conduct of ethically sound clinical trials of this new technology.”
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“Hyped” papers by disgraced Karolinska surgeon should be retracted, says ethics board

BMJ 2017; 359:j5060
Author: Nigel Hawkes
“Sweden’s top ethical review board has called for six papers published by the disgraced surgeon Paolo Macchiarini to be retracted. They include a key 2011 paper published in the Lancet in which Macchiarini and colleagues claimed success in transplanting an artificial trachea seeded with the patient’s own cells into a 36 year old man. The operation took place at the Karolinska University Hospital in Stockholm.”
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Misdirections in Informed Consent — Impediments to Health Care Innovation

N Engl J Med 2017; 377:1412-1414
Authors: David A. Asch, Tracy A. Ziolek, Shivan J. Mehta
“A large literature on research consent aims to prevent these problems, offering ethical analyses that are more forgiving of waivers of consent than what many investigators hear from their IRBs. Indeed, so many ethicists may have weighed in on this issue not because the ethics are disputed, but because overgeneralizations of research conventions persist despite the published literature. The QRS plan is instructive in part because it seems so obviously acceptable; yet IRBs are left to define “practicability” and “adverse effects on rights and welfare.” In doing so, they are susceptible to predictable sources of misdirection. Trials of substantially greater consequence — for example, those focused on critically ill patients — face greater obstacles.”
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Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011

JAMA Intern Med. 2017; 177(10): 1-8.
Authors: Peter Doshi, Peter Hur, Mark Jones, et al
“Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.”
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China vows to clamp down on academic fraud amid medical journal scandal

BMJ 2017; 357: j2970
Author: Jane Parry
“China’s Ministry of Science and Technology has said that it is investigating the case of 107 papers from China retracted by the journal Tumor Biology in April this year and that it has “zero tolerance” for academic fraud. The papers were retracted after the journal’s publisher, Springer, conducted a manual screening that showed that the authors had submitted papers with fake email addresses for reviewers.”
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Not Just About Consent: The Ethical Dimensions of Research Methodology Knowledge in IRBs

JME Blog, 15 June 2017
Author: Sarah Wieten
“The recent article, “Some Social Scientists Are Tired of Asking for Permission” in the New York Times inspired a great deal of debate about the role of institutional research ethics board (IRB) oversight in social science, which some argue is in most cases unlikely to involve significant harm to participants.”
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Development of a consensus operational definition of child assent for research

BMC Medical Ethics 2017 18:41
Authors: Alan R Tait, Michael E Geisser
“While research participation for most children requires the permission of parent(s)/guardian(s), the bioethical principle of “respect for persons” requires that children also provide their assent to participate to the degree that they are deemed “capable of providing it,” taking into account the child’s “age, maturity, and psychological state”. While this regulatory framework is designed to allow children to express their burgeoning autonomy, foster moral growth, and develop decision-making skills, it provides absolutely no practical guidance with respect to what actually constitutes assent and which children are capable of providing it.”
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