Is the concept of clinical equipoise still relevant to research?
Spencer Hey, Alex John London, and Charles Weijer argue that there is no better framework for justifying patient participation in research. But Annette Rid and Franklin Miller say that it is a mistake to require clinical research ethics to align with the norms of clinical practice
A collusion of interests: Hope, hype and science and the shaping of patient’s expectations of treatment (Powerpoint)
PDF - 1.01 MB
Presented at COSA 2017
By Professor Ian Kerridge
Haematology Department, RNSH
Sydney Health Ethics, University of Sydney
13th November 2017
The Power of Patterns in Big Data - How and when can data be repurposed? (Powerpoint)
Presented at AAMRI
By Malcolm Crompton AM
Lead Privacy Advisor for Information Integrity Solutions Pty Ltd (IIS), a global consultancy specialising in data protection and privacy strategies.
6th December 2017
Don't let genetic discrimination condemn the genetic revolution: Nik Zeps at TEDxPerth
Genetic research might be key to a massive leap in our ability to cure disease. Yet regulations that are aimed at protecting privacy are also impacting our ability to research this powerful branch of science. In this talk, Dr. Nik Zeps argues that the fundamental reason why regulations should exist is not to protect information - but instead to prevent discrimination based on genetics. He argues that rather than stifling our ability to research, we should instead focus attention on overcoming all forms of discrimination based upon genetics.
The autobiography of a species in 23 chapters
Extract: This is not a book about the Human Genome Project — about mapping and sequencing techniques - but a book about what that project has found. Some time in the year 2000, we shall probably have a rough first draft of the complete human genome. In just a few short years we will have moved from knowing almost nothing about our genes to knowing everything.
The best interests of the child and the return of results in genetic research: international comparative perspectives
This comparative analysis reveals that policy-makers and legislators have responded to the above challenges in different ways. Nevertheless, in Europe as well as in Canada, there is an emerging trend towards making the return of certain results mandatory in the paediatric context, should this course of action prove to be in the best interests of the child.
Genomics in research and health care with Aboriginal and Torres Strait Islander peoples
Genomics is increasingly becoming an integral component of health research and clinical care. The perceived difficulties associated with genetic research involving Aboriginal and Torres Strait Islander people mean that they have largely been excluded as research participants. This limits the applicability of research findings for Aboriginal and Torres Strait Islander patients. Emergent use of genomic technologies and personalised medicine therefore risk contributing to an increase in existing health disparities unless urgent action is taken. To allow the potential benefits of genomics to be more equitably distributed, and minimise potential harms, we recommend five actions: (1) ensure diversity of participants by implementing appropriate protocols at the study design stage; (2) target diseases that disproportionately affect disadvantaged groups; (3) prioritise capacity building to promote Indigenous leadership across research professions; (4) develop resources for consenting patients or participants from different cultural and linguistic backgrounds; and (5) integrate awareness of issues relating to Indigenous people into the governance structures, formal reviews, data collection protocols and analytical pipelines of health services and research projects.
Ethical issues in human genomics research in developing countries
Many ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects.
Return of Genomic Results to Research Participants: The Floor, the Ceiling, and the Choices In Between
As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that pathogenic mutations in 56 specified genes should be returned in the clinical setting has raised the question of whether comparable recommendations should be considered in research settings. The Clinical Sequencing Exploratory Research (CSER) Consortium and the Electronic Medical Records and Genomics (eMERGE) Network are multisite research programs that aim to develop practical strategies for addressing questions concerning the return of results in genomic research. CSER and eMERGE committees have identified areas of consensus regarding the return of genomic results to research participants. In most circumstances, if results meet an actionability threshold for return and the research participant has consented to return, genomic results, along with referral for appropriate clinical follow-up, should be offered to participants. However, participants have a right to decline the receipt of genomic results, even when doing so might be viewed as a threat to the participants’ health. Research investigators should be prepared to return research results and incidental findings discovered in the course of their research and meeting an actionability threshold, but they have no ethical obligation to actively search for such results. These positions are consistent with the recognition that clinical research is distinct from medical care in both its aims and its guiding moral principles.
To tell or not to tell? A systematic review of ethical reflections on incidental findings arising in genetics contexts
Any test that produces visual images or digital or genetic sequences will tend to produce incidental findings because more will be visible than what was originally sought. We conducted a systematic review of the ethical reasons presented in the literature for and against the disclosure of incidental findings arising in clinical and research genetics contexts. A search of electronic databases resulted in 13 articles included for systematic review. Articles presented reasons for and against disclosure, and reasons for proceeding with caution when making decisions about disclosure. One major recommendation of the reviewed articles is in favor of qualified disclosure: incidental findings with confirmed clinical utility where there is the possibility of treatment or prevention should be disclosed, with exceptions. A second type of recommendation is that disclosure should proceed with caution, especially in the context of new genetic technologies and genetic testing involving minors. It is also recommended that the number of possible incidental findings be limited even before genetic testing is carried out. Such a policy, which we advocate, would show preference for non-disclosure.