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Accountability in Research

Carl Elliott
In the spring of 2015, 11 years after a mentally ill young man named Dan Markingson stabbed himself to death in an industry-sponsored drug study, officials at the University of Minnesota suspended recruitment of subjects into drug trials in its Department of Psychiatry. University officials agreed to act only after a scathing investigation by Minnesota Office of the Legislative Auditor found damning evidence of coerced recruitment, inadequate clinical care, superficial research oversight, a web of serious, disturbing conflicts of interest, and a pattern of misleading public statements by university officials aimed at deflecting scrutiny...
October 18, 2016: Accountability in Research
Sheldon Krimsky
No abstract text is available yet for this article.
October 7, 2016: Accountability in Research
Bart Penders
No abstract text is available yet for this article.
August 18, 2016: Accountability in Research
Zubin Master
Integrity in writing letters of recommendation is important to academic research because it is an influential criterion used pervasively in peer review. While research in the integrity of recommendation letters has concentrated on contents of the letter, bias, and reliability, few have questioned the process of letter writing. Here, I argue that letter writing should be a joint opportunity between mentor/supervisor/advisor and trainee. It results in more compelling letters, may prevent errors and the use of biased language, and serves as an excellent mentoring opportunity promoting self-reflection...
2017: Accountability in Research
David Shaw, Bernice Elger
No abstract text is available yet for this article.
June 30, 2016: Accountability in Research
Kristin Shrader-Frechette, Christopher ChoGlueck
Neurodevelopmental disorders such as autism affect one-eighth of all U.S. newborns. Yet scientists, accessing the same data and using Bradford-Hill guidelines, draw different conclusions about the causes of these disorders. They disagree about the pesticide-harm hypothesis, that typical U.S. prenatal pesticide exposure can cause neurodevelopmental damage. This article aims to discover whether apparent scientific disagreement about this hypothesis might be partly attributable to questionable interpretations of the Bradford-Hill causal guidelines...
June 27, 2016: Accountability in Research
David B Resnik
One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this paper, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process...
June 13, 2016: Accountability in Research
(no author information available yet)
No abstract text is available yet for this article.
2016: Accountability in Research
Jiin-Yu Chen
Programs in the responsible conduct of research (RCR) vary between institutions, demonstrated by disparate structures and goals. These variations may be attributed to the absence of grounding frameworks within which to examine research and RCR education programs. This article examines research as a practice and a profession, using these frames to draw out defining features of research and the moral obligations entailed. Situating research within virtue ethics can clarify how researchers might cultivate the virtues necessary for meeting its obligations and aims...
2016: Accountability in Research
Logan M Steele, Tyler J Mulhearn, Kelsey E Medeiros, Logan L Watts, Shane Connelly, Michael D Mumford
Training is a costly investment. As such, it is of great interest to know the extent to which that investment is yielding a positive return. Recent meta-analytic efforts have observed that ethics training programs are, indeed, having a positive effect, leading to the conclusion that the programs are working. However, they have also uncovered considerable variability in the effectiveness of ethics training programs, which leads to the purpose of the present study-to review current practices in ethics training evaluation...
2016: Accountability in Research
Alison L Antes, John T Chibnall, Kari A Baldwin, Raymond C Tait, Jillon S Vander Wal, James M DuBois
The professional decision-making in research (PDR) measure was administered to 400 National Institutes of Health (NIH)-funded and industry-funded investigators, along with measures of cynicism, moral disengagement, compliance disengagement, impulsivity, work stressors, knowledge of responsible conduct of research (RCR), and socially desirable response tendencies. Negative associations were found for the PDR and measures of cynicism, moral disengagement, and compliance disengagement, while positive associations were found for the PDR and RCR knowledge and positive urgency, an impulsivity subscale...
2016: Accountability in Research
Nuria Homedes, Antonio Ugalde
Readers' trust on the medical literature has been eroded, and journal editors and some editorial boards are taking measures to ensure that authors fully and accurately report research findings and disclose conflicts of interest. This article describes a case study in which the papers editor of the World Health Organization (WHO) Bulletin influenced the content of an article that had been approved by the external reviewers. The editor objected to the publication of the large price differentials of the new molecular entities (NMEs) across the Latin American countries where they had been tested and the limited added therapeutic value of the NMEs that had been assessed by independent drug bulletins...
2016: Accountability in Research
Lisa Cosgrove, Steven Vannoy, Barbara Mintzes, Allen F Shaughnessy
The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines...
2016: Accountability in Research
Abdulghani Muthanna
As combating plagiarism is a shared responsibility of all, this article focuses on presenting the current situation of higher education in Yemen. The critical review of four implementable policy documents and interviews revealed the absence of research ethics code, research misconduct policy, and institutional policies in the country. This led to the presence of several acts of research dishonesty. The article concludes with an initiative for necessary future actions in the nation.
2016: Accountability in Research
Iekuni Ichikawa, Ellen Wright Clayton
No abstract text is available yet for this article.
2016: Accountability in Research
Viroj Wiwanitkit
No abstract text is available yet for this article.
2016: Accountability in Research
Mohamed El-Shinawi, Karim Osama Mohamed, Yousef Ahmed Fouad, Yara Mohamed Fahmy, Hadeel Abdulwahed Asar, Mohamed Gomaa Khalil, Lida Anestidou, Samer S El-Kamary, Mona Mostafa Mohamed
This is a quasi-experimental pre-post assessment study utilizing an anonymous self-administered questionnaire to assess Egyptian medical students' awareness about responsible conduct of research (RCR) and research ethics. Students' were assessed before and after an RCR awareness campaign. Our results showed that most of the pre-campaign respondents were not familiar with the basic principles and terms of RCR. An increase in the awareness about RCR across all discussed topics was noted following the campaign...
2016: Accountability in Research
Khaled Moustafa
Multiple inherent biases related to different citation practices (for e.g., self-citations, negative citations, wrong citations, multi-authorship-biased citations, honorary citations, circumstantial citations, discriminatory citations, selective and arbitrary citations, etc.) make citation-based bibliometrics strongly flawed and defective measures. A paper can be highly cited for a while (for e.g., under circumstantial or transitional knowledge), but years later it may appear that its findings, paradigms, or theories were untrue or invalid anymore...
2016: Accountability in Research
Chandrashekar Janakiram, Ramanarayanan Venkitachalam, Joe Joseph
OBJECTIVES: To assess the existence, structure, and functioning of Institutional Ethics Committees (IECs) in dental teaching institutions in Kerala. METHODOLOGY: A cross-sectional questionnaire-based survey was conducted by personally approaching Heads of Institutions/Ethics Committee (EC) in-charge of all dental colleges (23) in Kerala. The validated questionnaire consisted of two parts. The first part pertained to details of institutions, and the second part assessed the structure and functioning of the IEC...
2016: Accountability in Research
N Cheaib
In view of the MENA increasing participation in multinational trials and the increasing number of national/regional trials, this article explores potential areas of pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Regulatory silence on expedited reporting requirements creates confusion for local sites that are part of multinational trials. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review...
2016: Accountability in Research
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