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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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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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(US) Rounding up the Belmont Report Retrospectives – Amp@sand (May 2019)0

Posted by Admin in on June 27, 2019
 

Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report.

Safeguards for human studies can’t cope with big data
Nature
This provocative piece explores the ways in which the Belmont Report is insufficient for dealing with revolutionary digital technologies, arguing that “data science overlooks risks to human participants by default” and that it is “past time for a Belmont 2.0.” That new summit, the author argues, would need to engage with the currently “poorly understood risks and harms” that big data researches poses to humans.

A Belmont Report for Health Data (abstract available)
The New England Journal of Medicine
HIPAA offers robust protection of a limited range of data, but in 2019, the demands on humans’ health data come from far more directions than the 1996 legislation could anticipate. The authors of this NEJM piece call for a coordinated expansion of the scope of ethical review of the gathering, use, and manipulation of health data to account for sources such as “social-media platforms, health and wellness apps, smartphones [and] life insurers,” citing concerns about reidentification of deidentified data, discrimination, health profiling, and more.

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