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

Ethical Imperialism’ and the Export of Research Ethics Regulation from the Global North to South Africa (Papers: Mark Israel | May 2017)0

Posted by Admin in on May 28, 2017

The global export of principlism forms part of broader international flows of capital, students and academics, as well as knowledge and ideology. The impact of global capital has had a long-standing effect on research ethics governance. Pharmaceutical companies have sought to open up new markets and take advantage of cheaper sites for multi-centre drug trials. Multinational research teams have looked to those countries with lower risks of litigation, low labour costs, pharmacologically ‘naive’ participants, weak ethics review and the absence of other regulatory processes. As a result, research in low- and middleincome countries has burgeoned. As developing countries struggle to keep pace, the Helsinki and UNESCO Declarations have created regulatory templates for those without the infrastructure to create their own, and a range of capacity-building initiatives in research ethics have encouraged researchers in many developing countries to follow these models. Increasing student and academic mobility and international research collaboration between the global North and South may also ease international transfer of a range of research and education policies that favour universalist approaches to research ethics. Contemporary regulations in countries such as South Africa have shadowed developments in the North and have extended biomedical regulation to all forms of research. However, in some parts of the global South and the Fourth World, there is an emerging distrust and a critique of the motivation for some of the funding for capacitybuilding in research ethics. For many, opposition to universalist claims is not simply targeted at insensitivity in application but draws on critical ethical traditions such as indigenous, postmodern and postcolonial ethics to challenge the universal basis for principlism, and calls for a deeper understanding of and engagement with how different societies, cultures, peoples and disciplines understand ethics, research and ethical research.

Israel, M (2017) ‘Ethical Imperialism’ and the Export of Research Ethics Regulation from the Global North to South Africa. AFSAAP Annual Conference Proceedings – Africa: Moving the Boundaries. ISBN 978-0-9942689-2-1.

Friday afternoon’s funny – Consent, insomnia and genuine understanding0

Posted by Admin in on May 26, 2017

Cartoon by Don Mayne

The length, complexity and sometimes the format of typical consent materials can test the patience/endurance of potential participants, but the vital question remains what do they understand and has it helped them make an informed decision?

Some Social Scientists Are Tired of Asking for Permission – The New York Times (Kate Murphy | May 2017)0

Posted by Admin in on May 25, 2017

Sometimes a change to national policy isn’t enough to alter institutional practice – especially when that practice has been entrenched for a few decades and is wrapped in institutional risk. This New York Times story highlights why there’s so much chatter around the change to the US ‘Common Rule’.

If you took Psychology 101 in college, you probably had to enroll in an experiment to fulfill a course requirement or to get extra credit. Students are the usual subjects in social science research — made to play games, fill out questionnaires, look at pictures and otherwise provide data points for their professors’ investigations into human behavior, cognition and perception.
But who gets to decide whether the experimental protocol — what subjects are asked to do and disclose — is appropriate and ethical? That question has been roiling the academic community since the Department of Health and Human Services’s Office for Human Research Protections revised its rules in January.
The revision exempts from oversight studies involving “benign behavioral interventions.” This was welcome news to economists, psychologists and sociologists who have long complained that they need not receive as much scrutiny as, say, a medical researcher.

Read the rest of this discussion piece

The hexamethonium asthma study and the death of a normal volunteer in research (Papers: Julian Savulescu & Merle Spriggs | July 2001)0

Posted by Admin in on May 20, 2017

On July 19, after investigating the death of a previously healthy volunteer, the United States Office for Human Research Protections (OHRP) suspended nearly all federally funded medical research involving human subjects at Johns Hopkins University. The death has been described as “particularly disturbing” because 24 year old Ellen Roche was a healthy volunteer who had nothing to gain by taking part in the study.1 Her death has revived debate about the adequacy of oversight of medical research that followed the death of 18 year old Jesse Gelsinger who volunteered for a gene therapy experiment.

Savulescu J, Spriggs M (2002) The hexamethonium asthma study and the death of a normal volunteer in research. Journal of Medical Ethics. 28:3-4.
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2001 New York Times story