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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Millions of dollars’ worth of research in limbo at NIH

The Washington Post, 4 June 2017
Author: Lenny Bernstein
“The leadership at the National Institute on Deafness and Other Communication Disorders has banned the use of data collected over 25 years from more than 1,000 volunteers in the lab of neurologist Allen R. Braun, citing “serious and widespread” record-keeping errors, all of them clerical matters related to forms used for matters such as screening volunteers or logging physical exams.”
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Junior doctor is struck off over false research claims

BMJ 2017; 357: j2637
Author: Clare Dyer
“A junior doctor who was suspended for dishonesty in 2011 has been struck off after making false claims in an abstract for a conference presentation. Harman Mattu, who qualified at the University of London in 2006, told “blatant lies” in an abstract for presentation at an Imperial College clinical education conference, a medical practitioners tribunal heard.”
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The Ethics of Clinical Trials Research in Severe Mood Disorders

Bioethics. May 2017. doi:10.1111/bioe.12349
Authors: Nugent, A. C., Miller, F. G., Henter, I. D. and Zarate, C. A.
“Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research.”
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Some Social Scientists Are Tired of Asking for Permission

NYT, 22 May 2017
Author: Kate Murphy
“Who gets to decide whether the experimental protocol — what subjects are asked to do and disclose — is appropriate and ethical? That question has been roiling the academic community since the Department of Health and Human Services’s Office for Human Research Protections revised its rules in January.”
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