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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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Forced Migration Review – Issue 61 (Papers: Marion Couldrey and Jenny Peebles Editors | June 2019)0

Posted by Admin in on July 2, 2019
 

the ETHICS issue
exploring ethical questions that confront us in our work

We each live according to our own personal code of ethics but what moral principles guide our work? The 19 feature theme articles in this issue debate many of the ethical questions that confront us in programming, research, safeguarding and volunteering, and in our use of data, new technologies, messaging and images. Prepare to be enlightened, unsettled and challenged. This issue is being published in tribute to Barbara Harrell-Bond, founder of the Refugee Studies Centre and FMR, who died in July 2018.

Forced Migration Review issue 61 www.fmreview.org/ethics
PDF copy of this edition

Contents

  • 4 Big data, little ethics: confidentiality and consent Nicole Behnam and Kristy Crabtree
  • 7 New technologies in migration: human rights impacts Petra Molnar
  • 9 Social media screening: Norway’s asylum system Jan-Paul Brekke and Anne Balke Staver
  • 12 Developing ethical guidelines for research Christina Clark-Kazak
  • 15 ‘Over-researched’ and ‘under-researched’ refugees Naohiko Omata
  • 18 Research fatigue among Rwandan refugees in Uganda Cleophas Karooma
  • 20 Over-researching migration ‘hotspots’? Ethical issues from the Carteret Islands Johannes M Lutz
  • 23 Ethics and accountability in researching sexual violence against men and boys Sarah Chynoweth and Sarah Martin
  • 26 Ethics and consent in settlement service delivery Carla Nayton and Sally Baker
  • 28 Ethical primary research by humanitarian actors Prisca Benelli and Tamara Low
  • 30 EU migration strategy: compromising principled humanitarian action Anaïs Faure Atger
  • 33 A humanitarian approach to travel medicine? Marta Aleksandra Balinska
  • 36 Principled humanitarian assistance and non-State armed groups Ruta Nimkar, Viren Falcao, Matthew Tebbutt and Emily Savage
  • 39 Ethical dilemmas posed by unethical behaviour by persons of concern Anna Turus
  • 41 Ethical quandaries in volunteering Ashley Witcher
  • 44 The ethical use of images and messaging Dualta Roughneen
  • 47 Representing refugees in advocacy campaigns Natalie Slade
  • 49 Putting safeguarding commitments into practice Agnes Olusese and Catherine Hingley
  • 52 Safeguarding in conflict and crisis Sarah Blakemore and Rosa Freedman Tribute to Barbara Harrell-Bond
  • 55 A Life Not Ordinary: our colleague Barbara Harrell-Bond Matthew Gibney, Dawn Chatty and Roger Zetter
  • 56 A lifelong commitment to justice HRH Prince El Hassan bin Talal of Jordan
  • 58 A refugee-centred perspective Anita H Fábos
  • 60 Building expert witness reports: Barbara’s legacy Maja Grundler
  • 62 The helpfulness of Imposing Aid: a tribute from the Refugee Law Project Chris Dolan
  • 65 Barbara’s ethics of antagonism Joshua Craze
  • 67 AMERA: delivering a refugee-centred approach to protection Sarah Elliott and Megan Denise Smith
  • 69 From a critique of camps to better forms of aid Alyoscia D’Onofrio
  • 72 Resist injustice Olivier Rukundo

Make reports of research misconduct public – Nature (C. K. Gunsalus | June 2019)0

Posted by Admin in on June 30, 2019
 

Confronted with bad behaviour, institutions will keep asking the wrong questions until they have to show their working, says C. K. Gunsalus.

During decades as a research-integrity officer, expert witness for misconduct investigations and consultant, I have been inspired — and I have seen inexcusable conduct. Even when investigations are exemplary and findings clear, universities rarely report them publicly. That secrecy perpetuates misbehaviour and breeds mistrust — as evidenced by the ongoing revelations of universities that failed to respond appropriately, sometimes for years, to allegations of sexual misconduct.

Science is fast becoming more transparent. So, too, should institutional practice. Open misconduct reports would create a virtuous circle. Institutions would learn from their own and others’ investigations. Leaders would be more likely to pay attention to reports that are subject to scrutiny. Honest researchers could see that although groundbreaking science is often uncertain, it is qualitatively different from the conduct that leads to misconduct reviews.

We are already seeing such a shift in health care. Last month, a study showed that mortality is lower in UK hospitals in which medical professionals feel that they can talk openly about problems without worrying about repercussions to their careers (V. Toffolutti and D. Stuckler Health Affair. http://doi.org/c6df; 2019). I often find that institutional investigators ask the wrong questions, such as: ‘We don’t have to report this, do we?’, ‘How could anyone think Dr X would do such a thing?’ or (to whistle-blowers) ‘Why would you want to cause trouble for your own research project?’ Investigators pin all the blame on one actor without examining the contributions of co-authors or supervisors of the flawed work. An investigation might stop abruptly if the subject of it resigns. A 2019 paper examining investigations by institutions after the retraction of 12 clinical-trial papers by one research group stated that although investigations lasted for between 8 and 17 months, they did not examine preclinical papers from this group even after receiving detailed, serious concerns about them (A. Grey et al. Res. Integr. Peer Rev. 4, 3; 2019).

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Fake news about the past is a crime against history – University World News (Antoon De Baets | May 2019)0

Posted by Admin in on June 29, 2019
 

Historians observing the current debate on fake news are tempted to make comments from a long-term perspective. First, fake news, as a type of lie that constitutes disinformation, has an ancient pedigree.

Indeed, among the plethora of primary sources used by historians to study the past, some are forged, many distorted and all are biased. To filter truth from such sources, historians have developed a severe method of source criticism over the ages, first in East Asia and Europe.

Although an old phenomenon, fake news in its recent guises also has some strikingly new features because it spreads on the internet nowadays, mainly via social media platforms.

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