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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error (Papers: Ruth Macklin, Charles Natanson | January 2020)0

Posted by Admin in on January 7, 2020
 

Abstract
Comparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.

KEYWORDS:
Human subjects research; IRB (Institutional Review Board); informed consent; risk/benefit analysis

Macklin, R. & Natanson, C. (2019) Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error. Americaan Journal of Bioethics. 20(1):31-39. doi: 10.1080/15265161.2019.1687777.
Publisher: https://www.tandfonline.com/doi/full/10.1080/15265161.2019.1687777

Disaster-zone research needs a code of conduct – Nature (JC Gaillard & Lori Peek | November 2019)0

Posted by Admin in on December 10, 2019
 

Study the effects of earthquakes, floods and other natural hazards with sensitivity to ethical dilemmas and power imbalances.

A magnitude-7.0 earthquake rocked Anchorage, Alaska, in late November 2018. Roads buckled and chimneys tumbled from rooftops. Business operations were disrupted. Schools were damaged across the district. This was the largest earthquake to shake the region in a generation, and there was much to learn. What was the state of the infrastructure? Might further quakes occur? How did people respond? Teams of scientists and engineers from across the United States mobilized to conduct field reconnaissance in partnership with local researchers and practitioners. These efforts were coordinated through the clearing house set up by the Earthquake Engineering Research Institute in Oakland, California, which provided daily in-person and online briefings, as well as a web portal for sharing data.

This discussion is especially relevant at the moment given the bushfires/megafires raging in Australia (and California) and the volcano eruption on White Island, New Zealand.  Our sincere best wishes and hopes to anyone affected by these awful disasters.

But researchers are not always so welcome in disaster zones. After the deadly Indian Ocean earthquake and tsunami on 26 December 2004, hundreds of academics from countries including Japan, Russia, France and the United States rushed to the region to collect perishable data. This influx of foreign scientists angered and fatigued some locals; many declined researchers’ requests for interviews. The former governor of Aceh province, Indonesia, where more than 128,000 people died, described foreign researchers as “guerrillas applying hit-and-run tactics”1. Yet research on tsunami propagation and people’s response to the event has led to improved warnings and emergency-response plans.
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When, on 28 September 2018, an earthquake and tsunami hit the Indonesian island of Sulawesi, dozens of researchers found themselves unable to enter the country2. Indonesian law now requires foreign scientists to obtain a special visa before they can begin research. Data-collection protocols must be submitted to the government in advance and projects must have an Indonesian partner. Violators could face criminal charges and even prison.
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Authorship (NHMRC An Australian Code (2018) good practice guide | June 2019)0

Posted by Admin in on September 29, 2019
 

A guide supporting the Australian Code for the Responsible Conduct of Research

Contents

1. Introduction 1

2. Authorship criteria 1
2.1 What is a significant intellectual or scholarly contribution? 1
2.2 What does it mean to be accountable for the research output? 2

3. Responsibilities of institutions 2
… 3.1 Design and promote institutional policies 2
3.2 Provide training for researchers 3

4. Responsibilities of researchers 3
4.1 Ensure appropriate and fair attribution of authorship 3
4.2 Formalise authorship arrangements 4
4.3 Acknowledge contributions other than authorship 4
4.4 Be accountable for the research output 4
4.5 Approve research output 5
4.6 Engage in relevant training 5

5. Resolution of disputes 5

6. Breaches of the Code 6

7. Definitions 6

Additional resources 6

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Copyright the Card Game – Australian Edition (a game produced by Creative Commons Australia and the Australian Libraries Copyright Committee, in partnership with the Australian Digital Alliance | April 2019)0

Posted by Admin in on September 28, 2019
 

Copyright The Card Game – Australian Edition is an adaptation of Copyright The Card Game v3.0 by Chris Morrison and Jane Secker. This Edition and the original game are licensed for reuse under the terms of a Creative Common Attribution-Noncommercial-ShareAlike 4.0 International licence, http://creativecommons.org/licenses/by-nc-sa/4.0.

This Edition was adapted for Australia and Australian copyright law by Nerida Quatermass, Kate Makowiecka, Lisa Conti Phillipps, Elliott Bledsoe and Jessica Coates. It is proudly produced by Creative Commons Australia and the Australian Libraries Copyright Committee, in partnership with the Australian Digital Alliance.

Resources

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