Is Mitochondrial Donation Germ-Line Gene Therapy? Classifications and Ethical Implications

The classification of techniques used in mitochondrial donation, including their role as purported germ‐line gene therapies, is far from clear. These techniques exhibit characteristics typical of a variety of classifications that have been used in both scientific and bioethics scholarship. This raises two connected questions, which we address in this paper: (i) how should we classify mitochondrial donation techniques?; and (ii) what ethical implications surround such a classification? First, we outline how methods of genetic intervention, such as germ‐line gene therapy, are typically defined or classified. We then consider whether techniques of mitochondrial donation fit into these, whether they might do so with some refinement of these categories, or whether they require some other approach to classification. To answer the second question, we discuss the relationship between classification and several key ethical issues arising from mitochondrial donation. We conclude that the properties characteristic of mitochondrial inheritance mean that most mitochondrial donation techniques belong to a new sub‐class of genetic modification, which we call ‘conditionally inheritable genomic modification’ (CIGM)

Enrolling Children in Clinical Trials for Genetic Neurodevelopmental Conditions: Ethics, Parental Decisions, and Children's Identities.

Knowledge of genetic mechanisms contributing to neurodevelopmental conditions is advancing. This is informing development of new drugs to treat or ameliorate these conditions, through targeting underlying genetic pathways. Drugs are tested in clinical trials, necessitating parents to engage with decisions about whether to enroll their child. In this article, we consider important ethical issues to anticipate as clinical research opportunities in genetic neurodevelopmental conditions arise. For example, genetic pathways targeted by the drugs may interact with valued character and personality traits. It is essential that recruitment and consent processes are optimized for families who will grapple with whether these novel drug treatments interact with their child's personality and authentic identity. We call for focused social science research and further normative analysis so that parents are better supported to make informed choices. Additionally, clinical research regulators should have a sound understanding of the contextual experiences regarding how this population of parents engages with decisions

Is Mitochondrial Donation Germ-Line Gene Therapy? Classifications and Ethical Implications

The classification of techniques used in mitochondrial donation, including their role as purported germ-line gene therapies, is far from clear. These techniques exhibit characteristics typical of a variety of classifications that have been used in both scientific and bioethics scholarship. This raises two connected questions, which we address in this paper: (i) how should we classify mitochondrial donation techniques?; and (ii) what ethical implications surround such a classification? First, we outline how methods of genetic intervention, such as germ-line gene therapy, are typically defined or classified. We then consider whether techniques of mitochondrial donation fit into these, whether they might do so with some refinement of these categories, or whether they require some other approach to classification. To answer the second question, we discuss the relationship between classification and several key ethical issues arising from mitochondrial donation. We conclude that the properties characteristic of mitochondrial inheritance mean that most mitochondrial donation techniques belong to a new sub-class of genetic modification, which we call ‘conditionally inheritable genomic modification’ (CIGM)

Genetic Modification

Genetic modification in humans, non-human animals, and plants gives rise to a range of philosophical and ethical issues. There are a range of techniques and applications for genetic modification, but all are intended to change the genome within the cells of an organism. This poses problems to do with interfering with the natural, safety and risk considerations, impacts upon welfare and social justice, and determining whether genetic modification is needed or merely wanted. Within these broad areas, there are also particular issues regarding definitions of health and disease, employing a precautionary stance, and determining which perspectives are over- or under-estimated in debates

Using voluntary agreements to exclude stock from waterways: an evaluation of project success and persistence

Agriculture is one of the major drivers of ecological degradation in river basins. Excluding stock (cows and sheep) from grazing riverbanks and accessing rivers is one of the most common river restoration activities. To be effective, stock exclusion must be maintained indefinitely. In Australia, and elsewhere, stock exclusion projects are most commonly implemented by establishing voluntary agreements between landholders and government agencies. This study examined the extent to which landholders in 3 catchment management authority (CMA) regions in southeast Australia maintain stock exclusion from waterways, whether vegetation on riverbanks recovered, and the effectiveness of assessment methods. It was found that nearly half of landholders continue to graze stock on the riverbank. There has been some success with improving the condition of riparian vegetation. Sites with full stock exclusion contain the pre-European abundance of juvenile trees, and sites with continued grazing contain significantly lower abundance of juvenile trees. Establishing the effectiveness of management was made more difficult by the inconsistent methods used by the different CMAs. Stock exclusion projects implemented with voluntary agreements have the potential to succeed if oversight is improved between government agencies and CMAs and between CMAs and landholders. Projects will be easier to assess if regional authorities use consistent methods of assessment. Voluntary agreements are only suitable for environmental management if projects are monitored, maintained, and assessed appropriately

The PiGeOn project: Protocol of a longitudinal study examining psychosocial and ethical issues and outcomes in germline genomic sequencing for cancer

© 2018 The Author(s). Background: Advances in genomics offer promise for earlier detection or prevention of cancer, by personalisation of medical care tailored to an individual's genomic risk status. However genome sequencing can generate an unprecedented volume of results for the patient to process with potential implications for their families and reproductive choices. This paper describes a protocol for a study (PiGeOn) that aims to explore how patients and their blood relatives experience germline genomic sequencing, to help guide the appropriate future implementation of genome sequencing into routine clinical practice. Methods: We have designed a mixed-methods, prospective, cohort sub-study of a germline genomic sequencing study that targets adults with cancer suggestive of a genetic aetiology. One thousand probands and 2000 of their blood relatives will undergo germline genomic sequencing as part of the parent study in Sydney, Australia between 2016 and 2020. Test results are expected within12-15 months of recruitment. For the PiGeOn sub-study, participants will be invited to complete surveys at baseline, three months and twelve months after baseline using self-administered questionnaires, to assess the experience of long waits for results (despite being informed that results may not be returned) and expectations of receiving them. Subsets of both probands and blood relatives will be purposively sampled and invited to participate in three semi-structured qualitative interviews (at baseline and each follow-up) to triangulate the data. Ethical themes identified in the data will be used to inform critical revisions of normative ethical concepts or frameworks. Discussion: This will be one of the first studies internationally to follow the psychosocial impact on probands and their blood relatives who undergo germline genome sequencing, over time. Study results will inform ongoing ethical debates on issues such as informed consent for genomic sequencing, and informing participants and their relatives of specific results. The study will also provide important outcome data concerning the psychological impact of prolonged waiting for germline genomic sequencing. These data are needed to ensure that when germline genomic sequencing is introduced into standard clinical settings, ethical concepts are embedded, and patients and their relatives are adequately prepared and supported during and after the testing process