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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

The Next Phase of Human Gene-Therapy Oversight – The New England Journal of Medicine (Francis S. Collins and Scott Gottlieb | August 2018)0

Posted by Admin in on October 18, 2018
 

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have played key roles in the emergence of safe and effective human gene therapies. Now, we are proposing new efforts to encourage further advances in this rapidly evolving field.

The potential to alter human genes directly was first recognized nearly 50 years ago, around the same time as initial groundbreaking advances were being made in recombinant DNA technology. After intense discussions regarding the ethical, legal, and social implications of this technology, conversations were initiated at the NIH that led to the establishment of the Recombinant DNA Advisory Committee (RAC) in 1974. The RAC’s mission was to advise the NIH director on research that used emerging technologies involving manipulation of nucleic acids — a mission that was eventually expanded to encompass the review and discussion of protocols for gene therapy in humans. In 1990, the FDA oversaw the first U.S. human gene-therapy trial, which involved pediatric patients with adenosine deaminase deficiency and was conducted at the NIH Clinical Center in Bethesda, Maryland.

Although no major safety concerns were initially reported, over the course of the 1990s it became evident that many questions regarding the safety and efficacy of gene therapy remained unanswered. These unknowns were brought into sharp focus in 1999 when Jesse Gelsinger died of a massive immune response during a safety trial of gene therapy for ornithine transcarbamylase deficiency.1 This tragic death led to closer scrutiny of the field, including a greater focus on open dialogue and increased regulatory oversight.

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