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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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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Research with former refugees: Moving towards an ethics in practice (Nisha Thapliyal and Sally Baker | September 2018)0

Posted by Admin in on October 14, 2018
 

Abstract:
Research into issues relating to people from refugee backgrounds has proliferated in line with the explosion in the numbers of people seeking refuge globally. In this think piece, we reflect on what it means to research with former refugees in contexts of resettlement in an academic and social climate dominated by audit culture and austerity politics. Drawing on an interdisciplinary literature and existing institutional ethics standards, we discuss key, often unaddressed, ethical issues which manifest throughout research processes of recruitment, data collection and dissemination. Specifically, we problematise static and decontextualised approaches to engaging with issues of vulnerability, fair selection, informed consent and the burdens and benefits of participation, and point towards the benefits of taking an ethics in practice approach. In doing so, we hope to make a useful contribution to our collective strategic repertoires to carry out ethical research in practice with former refugees.

Thapliyal, Nisha and Baker, Sally. (2018) Research with former refugees: Moving towards an ethics in practice [online]. The Australian Universities’ Review, Vol. 60, No. 2, Sep 2018: 49-56. ISSN: 0818-8068
https://search.informit.com.au/documentSummary;dn=818725514655109;res=IELHSS 

The Limits of Dual Use – Issues in Science & Technology (Tara Mahfoud, et al | September 2018)0

Posted by Admin in on October 12, 2018
 

Distinguishing between military and civilian applications of scientific research and technology development has become increasingly difficult. A more nuanced framework is needed to guide research.

Research and technologies designed to generate benefits for civilians that can also be used for military purposes are termed “dual use.” The concept of dual use frames and informs debates about how such research and technologies should be understood and regulated. But the emergence of neuroscience-based technologies, combined with the dissolution of any simple distinction between civilian and military domains, requires us to reconsider this binary concept.

Not only has neuroscience research contributed to the development and use of technology and weapons for national security, but a variety of factors have blurred the very issue of whether a technological application is military or civilian. These factors include the rise of asymmetric warfare, the erosion of clear differentiation between states of war abroad and defense against threats “at home,” and the use of military forces for homeland security. It is increasingly difficult to disentangle the relative contributions made by researchers undertaking basic studies in traditional universities from those made by researchers working in projects specifically organized or funded by military or defense sources. Amid such complexity, the binary world implied by “dual use” can often obscure rather than clarify which particular uses of science and technology are potentially problematic or objectionable.

To help in clarifying matters, we argue that policy makers and regulators need to identify and focus on specific harmful or undesirable uses in the following four domains: political, security, intelligence, and military (PSIM). We consider the ways that research justified in terms of socially constructive applications—in the European Human Brain Project, the US BRAIN initiative, and other brain projects and related areas of neuroscience—can also provide knowledge, information, products, or technologies that could be applied in these four domains. If those who fund, develop, or regulate research and development (R&D) in neuroscience, neurotechnology, and neurorobotics fail to move away from the dual-use framework, they may be unable to govern its diffusion.

Mahfoud, Tara, Christine Aicardi, Saheli Datta, and Nikolas Rose. “The Limits of Dual Use.” Issues in Science and Technology 34, no. 4 (Summer 2018).
http://issues.org/34-4/the-limits-of-dual-use/

Practical, Epistemological, and Ethical Challenges of Participatory Action Research: A Cross-Disciplinary Review of the Literature (Papers: Danielle Lake and Joel Wendland | 2018)0

Posted by Admin in on October 9, 2018
 

Abstract
This article extends recent discussions on the practical, epistemological, and ethical challenges of participatory action research (PAR) for community-engaged scholars through a cross-disciplinary literature review. It focuses on how practitioners across fields define power, engage with conventional research approval processes, and manage risk. The review demonstrates that PAR can be a valuable research approach for community-engaged scholars, but problematic practices and disparities must be addressed. For instance, although PAR practitioners consistently articulate a commitment to empowering the community and shifting structures of oppression, contradictions around how to define and respond to power, engage with standard IRB practices, and cope with high levels of risk are prevalent. We conclude by offering a set of recommendations, highlighting the need for more transparent and self-reflexive methods; transdisciplinary practices; metrics designed to assess risk, inclusion, and power-sharing; ongoing dialogues across disciplinary and institutional divides; and inclusive authorship and open-access publishing practices.

Keywords: participatory action research, ethical challenges, interdisciplinarity, institutional

LAKE, Danielle; WENDLAND, Joel. Practical, Epistemological, and Ethical Challenges of Participatory Action Research: A Cross-Disciplinary Review of the Literature. Journal of Higher Education Outreach and Engagement, [S.l.], v. 22, n. 3, p. 11-42, sep. 2018. ISSN 2164-8212. Available at: http://openjournals.libs.uga.edu/index.php/jheoe/article/view/2093>.

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