ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Authorship inflation and author gender in pulmonology research (Blake Umberham, et al | October 2018)0

Posted by Admin in on July 12, 2019
 

Abstract

Introduction
Honorary authorship and equal gender representation are two pressing matters in scientific research. Honorary authorship is the inclusion of authors who do not meet the criteria established by the International Committee of Medical Journal Editors (ICMJE) authorship guidelines. The inclusion of honorary authors in the medical literature has led to an increase of the number of authors on studies and a decrease in single author studies in various fields.

Methods
Our primary objective was to assess authorship trends in two major pulmonology journals (selected on the basis of Google Scholar rankings): Thorax and American Journal of Respiratory and Critical Care Medicine. We reviewed all articles published in both journals in the years 1994, 2004, and 2014 using Web of Science and extracted data such as number of authors and gender of the first and last authors.

Results
The total number of authors steadily increased from 1994 to 2014. The median number of authors grew from about four in 1994 to nearly seven in 2014, which is approximately a 75% increase. When we compiled all the data, we found the percentage of female authors from both journals had increased from 17% to 29.9% during the study period.

Discussion
We found an increase in the average number of authors on pulmonology publications between 1994 and 2014 as well as an increase in the number of females with a lead or main author position. This may be due to a variety of factors, such as increased team science. However, our data in conjunction with data from other areas of medicine, indicate that honorary authorship may be contributing to the trends we identified.

Umberham, B., et al. (2018). “Authorship inflation and author gender in pulmonology research.” bioRxiv. doi: https://doi.org/10.1101/446385
Publisher (Open Access): https://www.biorxiv.org/content/10.1101/446385v1.full

Pragmatic trials without informed consent? – The Ethics Blog (Pär Segerdahl | April 2019)0

Posted by Admin in on July 9, 2019
 

Randomized controlled trials (RCTs) are considered to be the gold standard for determining a causal effect of medical interventions. To achieve this aim, possible confounding factors must be avoided. This implies excluding many patients from participating in the trial, for example, patients with concomitant conditions. A negative consequence of these exclusions, however, is limited generalizability. Studying the artificially uniform participant group, you will be able to determine a causal effect, but you will know much less about real-life treatment outcomes in the population where the intervention actually will be used.

This radical and controversial idea isn’t currently permissible in many jurisdictions (including Australia), but that doesn’t mean it isn’t worth serious discussion.

Further artificiality is created by the written informed consent procedure, which excludes even further patients from participating in the trial. Moreover, because they know they participate in a clinical trial, participants may change their behavior.

All this points to the importance of so-called pragmatic randomized controlled trials. In such trials, the effectiveness of two approved and routinely prescribed medicines are compared in normal clinical practice. This avoids most of the artificiality of RCTs and significantly improves generalizability and practical clinical relevance. Randomization is still required for scientific purposes, however, and written informed consent is an ethical obligation.

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Not Reporting Results of a Clinical Trial Is Academic Misconduct – ACP (Editorial | Joshua D. Wallach, MS, PhD; Harlan M. Krumholz, MD, SM | May 2019)0

Posted by Admin in on July 3, 2019
 

Failure to report the results of clinical trials threatens the public’s trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers “have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports” (1). When participants volunteer to take part in clinical trials, and expose themselves to interventions with unknown safety and efficacy profiles, they have a tacit assumption, based on trust, that the evidence generated will inform clinical science (2). Health care providers and medical societies, who are responsible for evaluating and synthesizing evidence and filling the gap between research and practice, need for investigators to fully report their results in a timely manner. The utility of the diligent search for truth in the medical literature depends on its completeness. However, when research findings are not consistently disseminated, the literature provides a skewed view of the science, which may bias reviews of the evidence.

During the past 2 decades, efforts have been increasing to promote the reporting of clinical trial results. After the creation of ClinicalTrials.gov, a public registration database, the United States moved to establish consequences of not reporting clinical trial results. In particular, the U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007 created legal requirements for certain intervention studies of FDA-regulated…

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Infecting healthy people in vaccine research can be ethical and necessary – The Conversation (Michael Selgelid & Euzebiusz Jamrozik | June 2019)0

Posted by Admin in on July 1, 2019
 

Medical experiments involving intentionally infecting people with bacteria, viruses, and parasites are surprisingly common. And they are becoming more common worldwide, particularly in developing countries.

The ultimate aim of these “human challenge studies” is usually to test potential new vaccines.

However, because of the risks involved, this kind of research raises difficult ethical questions. For example, who should be infected? And which pathogens would be too dangerous to use?

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