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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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Debriefing for ego threat may require more than we thought – Psychology & More (Dana C. Leighton, Ph.D. | July 2019)0

Posted by Admin in on July 7, 2019
 

When social psychologists manipulate a participant’s attitudes or beliefs, we have an ethical obligation to undo that manipulation. I explain it to my students as “putting the participant back the way we found them.” We frequently use a debriefing procedure, in the form of a written and/or (as in the case of my lab) verbal notice something to the effect of “yuk yuk, gosh, ya know what? we were just kidding. the thing you (read/did) was fake, we made it up, and it doesn’t mean anything.” Here is an example from the verbal debriefing script I used in a study several years ago that presented participants with a fake newspaper article about vandalism by University of Texas students.

I want to thank you for your participation here today and for your contribution to this project. We really appreciate your help with this work. Let me tell you a little bit about what we are trying to study.

First, we want to assure you that the incident you read about never happened on the campus. We created a fake newspaper article about it in order to better understand how people respond to these kinds of situations. To our knowledge, no University of Texas students have ever been involved in such an incident.

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The full article is behind a paywall, but here’s the reference:
Miketta, S., & Friese, M. (2019). Debriefed but still troubled? About the (in)effectiveness of postexperimental debriefings after ego threat. Journal of Personality and Social Psychology. Advance online publication.
http://dx.doi.org/10.1037/pspa0000155

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

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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