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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Wake-up call from Hong Kong – Science (Victor J. Dzau, et al | December 2018)0

Posted by Admin in on February 12, 2019

The Second International Summit on Human Genome Editing, held in Hong Kong last month, was rocked by the revelation from a researcher from Shenzhen that twins were born whose healthy embryonic genomes had been edited to confer resistance to HIV. Despite widespread condemnation by the summit organizing committee, world scientific academies, and prominent scientific leaders that such research was “deeply disturbing” and “irresponsible,” and the launch of an investigation in China into the researcher’s actions, it is apparent that the ability to use CRISPR-Cas9 to edit the human genome has outpaced nascent efforts by the scientific and medical communities to confront the complex ethical and governance issues that they raise. The current guidelines and principles on human germline genome editing are based on sound scientific and ethical principles. However, this case highlights the urgent need to accelerate efforts to reach international agreement upon more specific criteria and standards that have to be met before human germline editing would be deemed permissible.

“We need…broad agreement on…criteria for human germline genome editing research…”

Together, we call upon international academies to quickly convene international experts and stakeholders to produce an expedited report that will inform the development of these criteria and standards to which all genome editing in human embryos for reproductive purposes must conform, and to engage scientific bodies around the world in this effort. The United States National Academies are willing to lead in this endeavor. Academies are well-positioned to convene needed international expertise and to help foster broad scientific consensus on the responsible pursuit of human genome editing research and clinical applications. We strongly believe that international consensus on such standards is important to avoid the potential for researchers to rationalize the justification or seek out convenient locales for conducting dangerous and unethical experimentation. The establishment of international scientific standards is not intended to substitute for national regulation but could inform such regulation.

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Are scientists’ reactions to ‘CRISPR babies’ about ethics or self-governance? – STAT (Nina Frahm and Tess Doezema | January 2019)0

Posted by Admin in on February 12, 2019

It’s been two months since Chinese scientist He Jiankui shocked the world with the announcement that his lab had created the first genetically edited babies. Since then, much of the public furor surrounding the news has died down, even as He has been fired by the Southern University of Science and Technology. There is one important takeaway from the controversy that seems to have gone overlooked in the CRISPR ethics discussion: defining the ethics of editing human life should not be left to scientists alone.

The research community widely agreed that He and his colleagues crossed an ethical line with the first inheritable genetic modification of human beings. Gene-editing experts as well as bioethicists described the transgression as being conducted by a “rogue” individual. But when leading voices such as NIH Director Francis Collins assert that He’s work “represents a deeply disturbing willingness by Dr. He and his team to flout international ethical norms,” what are they actually expressing concern about? Who determines what are the ethics of altering human life?

We believe that the alarm being sounded by the scientific community isn’t really about ethics. It’s about protecting a particular form of scientific self-governance, which the “ethics” discourse supports. What are currently treated as matters of research ethics are in fact political and social questions of fundamental human importance.

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American scientist played more active role in ‘CRISPR babies’ project than previously known – STAT (Jane Qiu | January 2019)0

Posted by Admin in on February 11, 2019

BEIJING — An American scientist at Rice University was far more involved in the widely condemned “CRISPR babies” experiment than has previously been disclosed. Most notably, STAT has learned that Rice biophysicist Michael Deem was named as the senior author on a paper about the work that was submitted to Nature in late November.

Deem’s prominent authorship indicates that a respected American researcher played an instrumental role in the controversial project, which sparked a worldwide furor. His involvement could have encouraged volunteers to join the experiment and lent credibility to He Jiankui, the Chinese scientist who led the work.

Emails provided to STAT show that Deem was listed as the last author — which, in the life sciences, is typically reserved for the senior researcher who oversees a study. The paper, titled “Birth of twins after genome editing for HIV resistance,” has another nine contributors, including He as the first author, where the person who makes the most hands-on contribution is credited.

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Political Research and Human Research Ethics Committees (Papers: Anthony J. Langlois | 2011)0

Posted by Admin in on February 5, 2019

Human Research Ethics Committees have become an established part of the institutional structure of research in the humanities and social sciences over the last two decades in Australia, a development which many in the political disciplines have regarded with ambiguity or outright hostility. My purpose is to consider some of the particular problems which arise for the political disciplines from the form of research ethics review which has become institutionalised in Australia, and to suggest some reforms which would significantly ameliorate these problems.

My argument is that the conceptual framework on which research ethics review is built, and consequently the institutional model by which ethical review is applied within Australian universities is not appropriate to some forms of political research, with serious detrimental consequences. These consequences may include, but are not limited to: research findings being potentially skewed; research going underground or being undertaken in ways which diverge from what has been approved by committees; self censorship; disengagement with institutional research governance procedures; the generation of risk for researchers who are operating outside institutional approvals because they feel they “have to”; the construction of unnecessary prejudice against the legitimate aims of research ethics review procedures; and, finally, and most disturbingly, important and legitimate research not being undertaken.

Raise the issue of research ethics with a politics researcher in the hallways of any Australian university, and you are likely to meet with a litany of complaints which match in some measure or another my list above. Being a politics academic and – until recently -­‐ the chair of a university wide human research ethics committee, has been an interesting experience; one which has led me to offer the following analysis and suggestions for reform.

Anthony J. Langlois (2011) Political Research and Human Research Ethics Committees. Australian Journal of Political Science, 46:1, 141-156, DOI: 10.1080/10361146.2010.544287