As both a researcher and a research administrator in healthcare, one of the more vexing issues that I have to deal with on an almost daily basis is how to manage what are termed quality assurance, quality improvement and audit activities. In its 2014 publication entitled “Ethical Considerations in Quality Assurance and Evaluation Activities”, the NHMRC (NHMRC QA guidance) suggests that these can be loosely gathered together under an umbrella term of Quality Assurance (QA) and/or evaluation. I believe this construct is wrong and reinforces a longstanding approach to ethics review that relies on the category of an investigative activity to determine the level of review that is used. This approach is problematic and leads to some significant unintended consequences.
In this post, Gary, Mark and Kim refect on the draft update to Section 5 of the Australia’s National Statement.
“In recent years in Australia, we have seen some painful cases where research ethics review delegated to a non-HREC review body has failed to guard against projects that proved to be embarrassing for their host institution (see, for example, the ‘Racist bus driver’ and ‘Laughing at the disabled’ projects)….”
Katherine Christian, Carolyn Johnstone, Jo-ann Larkins, Wendy Wright and Michael Doran Katherine Christian, Federation University Australia Carolyn Johnstone, Federation University
Elle Loughran Student, Trinity College Dublin Elle Loughran is a Laidlaw scholar studying genetics at Trinity College Dublin in Ireland
Prof. Colin Thomson AM AHRECS Senior Consultant We at AHRECS, like all our friends, colleagues and clients, are becoming more
JC Gaillard School of Environment, The University of Auckland, New Zealand Unit for Environmental Sciences and Management, North-West University, South
Mark Israel (AHRECS and Murdoch University) and Farida Fozdar (The University of Western Australia). There is considerable momentum behind the
Dr Ann-Maree Vallence and Dr Hakuei Fujiyama College of Science, Health, Engineering and Education, Murdoch University, Perth, Australia http://profiles.murdoch.edu.au/myprofile/ann-maree-vallence/ http://profiles.murdoch.edu.au/myprofile/hakuei-fujiyama/
Dr Gary Allen, Senior Consultants AHRECS Prof. Mark Israel Prof. Colin Thomson AM . Reflecting on
Dr Amanda Fernie, Manager Research Ethics & Integrity, Griffith University Dr Gary Allen, Senior
In this thought-provoking post, Nik Zeps (a consultant with AHRECS and a partner at Chrysalis) discusses the serious harm (in terms of reputation and career, as well as lost useful lines of inquiry) when there are complaints that allege ethical problems with clinical research.
These relate to situations where the clinical research is evaluating different kinds of intervention, where the evidence for the ‘accepted’ treatment might not be clear.
A misunderstanding of such research designs and a visceral reaction to apparent breaches aren’t helpful.
When such allegations are made, the researchers are rarely afforded an opportunity to respond and explain. If they were, one assumes that the manner could be easily cleared up.
We are embarrassed to admit in our own reporting of the cited case we really didn’t grasp the realities of what occurred or called out the very emotive reaction.
Dr Jo-Anne Kelder, Senior Lecturer, Curriculum Innovation and Development, University of Tasmania, https://www.linkedin.com/in/jokelder/ Professor