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(US) ER patients given ketamine, other powerful drugs in clinical trials without their consent, FDA finds – STAT (Sharon Begley | October 2018)0

Posted by Admin in on November 15, 2018
 

Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.

Based on those findings, a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a letter to the Food and Drug Administration and the Department of Health and Human Services office that protects human research subjects, Public Citizen also called for regulators to immediately launch an investigation into the conduct and oversight of the studies and “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies” at Minneapolis’s Hennepin County Medical Center.

The hospital committee that green-lighted the studies, called an institutional review board (IRB), “appears incapable of doing its job,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, who organized the letter. It acted unethically and placed patients in danger, he said, “including by waiving the requirement for informed consent in situations where that is not allowed.”

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Research ethics, informed consent and the disempowerment of First Nation peoples (Papers: Juan M Tauri | 2017)0

Posted by Admin in on November 14, 2018
 

Abstract
Recently, Indigenous commentators have begun to analyse the way in which institutional Research Ethics Boards (REBs) engage with Indigenous researchers and participants, respond to Indigenous peoples’ concerns with academic research activities, and scrutinise the ethics proposals of Indigenous scholars. Of particular concern for Indigenous commentators is that the work of REBs often results in the marginalisation of Indigenous approaches to knowledge construction and dissemination, especially in relation to the vexed issue of informed consent. Based on analysis of the results of research with Indigenous researchers and research participants, this paper argues that institutionalised REBs’ preference for ‘universal’ and ‘individualised’ approaches for determining ethical research conduct marginalises Indigenous approaches to ethical research conduct. The paper concludes by calling for a decolonisation of REB processes through recognition of the validity of communal processes for attaining the informed consent of Indigenous research participants.

Keywords First Nations, research ethics boards, informed consent, decolonisation

Tauri, J. M. (2018). Research ethics, informed consent and the disempowerment of First Nation peoples. Research Ethics, 14(3), 1–14. https://doi.org/10.1177/1747016117739935
Publisher (Open Access): https://journals.sagepub.com/doi/full/10.1177/1747016117739935

(Egypt) Debate over misconduct stalls Egyptian clinical trials law – Sci Dev Net (Hazem Badr | October 2018)0

Posted by Admin in on November 11, 2018
 

[Cairo] Egypt’s president Abdel Fattah El-Sisi has declined to sign the country’s clinical trials law into action, after objecting to parts that, he said, might violate the human body.

Despite the delays with the Egyptian new clinical trials law, with its legal penalties for failure to meet human research ethics and research integrity standards there are indications and commentary that suggest the delay reflects a political engagement many of us would like to see in our own countries.

According to researchers following the law’s creation, Sisi returned seven amendments to the law, which could delay its creation. For example, articles 28, 29 and 32 of the law have been amended to reduce the severity of proposed prison terms for misconduct, such as using human samples without informed consent.
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But the scientists following the law’s creation are positive about the president’s response, saying that his amendments show he is engaging with the matter and keen to see the law signed into life. “The president’s comments address the complex equation of respecting the sacredness of the human body and, at the same time, endorsing scientific research,” said Mahmoud Sakr, the director of Egypt’s Academy of Scientific Research and Technology.
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“The text [as it stands] contradicts our goal of motivating universities to pursue joint research and hinders the exploration of samples using advanced equipment that might not be available locally,”
……Abdel Fattah El-Sisi, Egypt’s president
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The ‘problem’ of undesigned relationality: Ethnographic fieldwork, dual roles and research ethics (Papers: Kirsten Bell | 2018)0

Posted by Admin in on October 28, 2018
 

Abstract

This October 2018 paper reflects on an area of research which continues to be a source of tension between at least some researchers* and research ethics reviewers: Is it a problem, or an advantage or in fact sometimes a necessity that there be an existing connection between participant and researcher. *Especially for ethnographers and anthropologists who might feel they are being held to a biomedical standard that is irrelevant and useless for their work. We have included links to a trove of related items in the Resource Library.

Perhaps the most unique feature of ethnographic fieldwork is the distinctive form of relationality it entails, where the ethnographer’s identity as a researcher is not fixed in the way typical of most other forms of research. In this paper, I explore how this ‘undesigned relationality’ is understood, both in procedural ethics frameworks and by the different disciplines that have come to claim a stake in the ‘method’ itself. Demonstrating that the ethical issues it entails are primarily conceptualized via the lens of the ‘dual role’, I use this as a means of exploring the ideal relationship between researcher and subject that procedural ethics frameworks are premised upon. I go on to explore the epistemological differences in ways that ethnographers themselves understand and respond to the multiple forms of relationality that characterize fieldwork and the challenge this poses to the possibility of a pan-disciplinary consensus on ethnographic research ethics.
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Keywords
ethnography, research ethics, dual roles, disciplinarity, relationality
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Bell, K. (2018). The ‘problem’ of undesigned relationality: Ethnographic fieldwork, dual roles and research ethics. Ethnography. https://doi.org/10.1177/1466138118807236

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