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

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – Medical devices0

Posted by Admin in on September 8, 2017
 

Cartoon by Don Mayne www.researchcartoons.com

The issue we are most familiar with is when it comes to the end of a clinical trial will participants still have access to the trialled drug when the trial concludes (I know well a heart-wrenching story of a family who lost access to a life saving treatment). Device-based trials raise completely different questions: Can it/should it be removed? If so, what are the risks and who pays? But if not, who monitors and services the device? And who pays for that?

Disaster ethics: issues for researchers and participants (Papers: Dónal O’Mathúna | 2017)0

Posted by Admin in on September 7, 2017
 

Disaster responders need evidence to help guide their decisions as they plan for and implement responses. The need for evidence creates an ethical imperative to conduct some research on and in disasters. Some of that research involves human participants and raises another ethical imperative to protect participants. This presentation will provide an overview of some ethical challenges arising in balancing the dual imperatives in disaster research: to produce high-quality research findings and to engage with participants ethically and respectfully. Such issues have been highlighted by the inclusion of disaster research within the 2016 revision of the Council for International Organizations of Medical Sciences (CIOMS) ethics guidelines for health-related research involving humans.

An ethics in practice symposium was held in Auckland at the Auckland University of Technology South campus on June 28. 2017 and repeated in Wellington at the Massey University campus on July 7 as a continuation of an ethics in practice conference held at Otago University in 2015. The symposium was intended to bring social science researchers together with ethics committee members to discuss common concerns and to learn more about innovations in the field of disaster research ethics and ethics administration in Australia. The symposiums were funded by a Marsden grant (U00-088) from the Royal Society of New Zealand.

Debate exists over whether disaster research ethics is particularly unique. Regardless, the confluence of challenging ethical issues and the multiple vulnerabilities to which participants are exposed has the potential to create a perfect ethical storm. These issues will be examined through the lens of one set of benchmarks for ethical research in low-income settings, with examples from intervention research and qualitative research in humanitarian crises. Disaster research challenges current approaches to research ethics approval procedures. The current weight of research ethics An argument will be presented that research ethics is currently unbalanced with its focus on ethical approval and needs to refocus on facilitating ethical research. Virtue ethics for researchers needs to be developed because in the field, all that researchers may have to rely on are their conscience, virtues and personal integrity.
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Dónal O’Mathúna is Associate Professor of ethics at Dublin City University, Ireland and at The Ohio State University, USA. He is the Director of the Center for Disaster & Humanitarian Ethics (http://www.ge2p2.org/new-blog/) and was Chair of the EU-funded COST Action on Disaster Bioethics, 2012-2016 (http://disasterbioethics.eu/). He has written and presented widely on disaster ethics, including a recent comment in The Lancet (DOI: 10.1016/S0140-6736(17)31276-X).
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Download the presentation as a PDF

Ethics in the scholarship of teaching and learning: Key principles and strategies for ethical practice. Taylor Institute for Teaching and Learning Guide Series0

Posted by Admin in on September 5, 2017
 

“This new Taylor Institute Guide takes the researcher through the essentials of the Canadian standards for ethical practice in the scholarship of teaching and learning (SoTL). Because of the unique challenges of SoTL, where the human participants that are the subject of the research are also typically the researcher’s students, this Guide translates the comprehensive TCPS2 (2014) for the researcher conducting SoTL research.” Access this particular guide here.

Fedoruk, L. (2017). Ethics in the scholarship of teaching and learning: Key principles and strategies for ethical practice. Taylor Institute for Teaching and Learning Guide Series. Calgary, AB: Taylor Institute for Teaching and Learning at the University of Calgary. www.ucalgary.ca/taylorinstitute/guides

Covers key issues in research ethics and tracks TCPS2 well (the Canadian national statement on research ethics). Limited reference to research ethics literature and it would have been good to see the Scholarship of Teaching and Learning community model more imaginative pedagogy in research ethics.

Also see
SoTL resource booklets produced by AHRECS

NIH Blood Transfusion Trial’s Ethics Questioned – MedPage Today (Larry Husten | August 2017)0

Posted by Admin in on September 3, 2017
 

Public Citizen demands halt to study comparing transfusion strategies after MI

Public Citizen is calling for the immediate suspension of a large NIH-sponsored trial comparing blood transfusion strategies after heart attacks. The Myocardial Ischemia and Transfusion (MINT) trial should be halted “because of potentially serious ethical violations,” said the consumer advocacy group in a letter sent to the Office for Human Research Protections and the VA’s Office of Research Oversight.

The MINT trial started earlier this year in April and is expected to be completed in 2021. The trial plan calls for 3,500 hospital patients with acute MI who have blood counts below 10 g/dL to be randomized to either a liberal or restrictive transfusion strategy with red blood cells. The primary endpoint is the composite outcome of all-cause mortality or nonfatal MI at 30 days.

Read the rest of this discussion piece

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