Decision-making by Human Research Ethics Committees ('HRECs') is subject to significant criticisms, many of which relate to the extent to which decisions are made within their authority or to the ...provision of reasons for such decisions. This suggests that judicial review of decisions made by HRECs may contribute to improving adherence to administrative law norms and the quality of decision-making processes. This article assesses this proposition by examining current opportunities for review and then assessing the extent to which expanding the role of judicial review might better hold HRECs to account. It argues that only some types of HREC decisions are currently open to judicial review, and that the purported benefits of enhanced decision-making processes arising from judicial review are less than the risks of impairment to efficient administration. Alternative mechanisms are suggested. Decisions that are neither clearly within or outside the scope of judicial review provide useful case studies for interrogating both the purpose of judicial review and the extent to which it achieves its aims.
Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic ...diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.
Indigenous populations, in common with all populations, stand to benefit from the potential of genetic research to lead to improvements in diagnostic and therapeutic tools for a wide range of complex ...diseases. However, many Indigenous communities, especially ones that are isolated, are not included in genetic research efforts. This situation is largely a consequence of the challenges of ethically conducting genetic research in Indigenous communities and compounded by Indigenous peoples’ negative past experiences with genetic issues. To examine ways of addressing these challenges, we review one investigation of a cancer cluster in remote Aboriginal communities in Arnhem Land, Australia. Our experiences demonstrate that genetic research can be both ethically and successfully conducted with Indigenous communities by respecting the authority of the community, involving community members, and including regular community review throughout the research process.
ObjectiveObtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy and may fail to achieve the desired ...participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of self-directed multimedia delivery of participant consent.DesignIt is a single-centre, randomised, prospective study to determine the efficacy, usability and acceptability of a self-directed multimedia consent process (intervention) compared with the traditional paper-based approach (control). The intervention was free of research staff, with computer-based finger-signed consent.SettingPathology blood collection services in Tasmania, Australia.Participants298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152).Outcome measuresEfficacy, usability and acceptability of the allocated consent process were assessed by a questionnaire.ResultsAll participants successfully completed the allocated interventions. Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all). Intervention participants were more likely to engage with the study information and spend more time on the consent process (p=<0.001 and p=0.006, respectively). Both groups reported similar levels of acceptability, although more control participants reported that the study information was too long (24% vs 14%; p=0.020).ConclusionA self-directed multimedia consent process is effective for achieving participant understanding and obtaining consent free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs and achieve informed consent in clinical research.
The right to liberty in a pandemic Rebekah McWhirter
University of Queensland law journal,
12/2021, Volume:
40, Issue:
2
Journal Article
Peer reviewed
The 'European Convention on Human Rights' has given rise to the most extensive and influential case law of any human rights jurisdiction, and the inclusion of an express infectious diseases exception ...to the right to liberty suggests that its jurisprudence is likely to provide the best available guidance to states on the circumstances in which such measures may be justifiable and lawful. However, this article argues that the principles developed to date are limited in their applicability to the current crisis, and are insufficient for determining the appropriate balance between public health and the right to liberty when seeking to control the spread of a large-scale, highly infectious disease.
The right to liberty in a pandemic Rebekah McWhirter
University of Queensland law journal,
12/2021, Volume:
40, Issue:
2
Journal Article
Peer reviewed
The 'European Convention on Human Rights' has given rise to the most extensive and influential case law of any human rights jurisdiction, and the inclusion of an express infectious diseases exception ...to the right to liberty suggests that its jurisprudence is likely to provide the best available guidance to states on the circumstances in which such measures may be justifiable and lawful. However, this article argues that the principles developed to date are limited in their applicability to the current crisis, and are insufficient for determining the appropriate balance between public health and the right to liberty when seeking to control the spread of a large-scale, highly infectious disease.
The right to liberty in a pandemic Rebekah McWhirter
University of Queensland law journal,
12/2021, Volume:
40, Issue:
2
Journal Article
Peer reviewed
The 'European Convention on Human Rights' has given rise to the most extensive and influential case law of any human rights jurisdiction, and the inclusion of an express infectious diseases exception ...to the right to liberty suggests that its jurisprudence is likely to provide the best available guidance to states on the circumstances in which such measures may be justifiable and lawful. However, this article argues that the principles developed to date are limited in their applicability to the current crisis, and are insufficient for determining the appropriate balance between public health and the right to liberty when seeking to control the spread of a large-scale, highly infectious disease.
There is strong evidence for both genetic and environmental risk factors comprising the aetiology of multiple sclerosis (MS). While much progress has been made in recent years in identifying common ...genetic variants using genome-wide association studies, alternative approaches have remained relatively neglected. The prevalence of MS in Orkney and Shetland is among the highest in the world. Previous studies have suggested that a higher degree of parental relatedness in these isolated communities may contribute to the high rates of MS, indicating that recessive effects have an important role in MS aetiology. The Northern Isles Multiple Sclerosis (NIMS) study investigated the potential role of genome-wide homozygosity in MS risk by genotyping 88 MS patients, 89 controls matched by age, sex and ancestry, and a further 89 controls matched for sex and ancestry, but passed the majority of lifetime risk of developing MS (>70 years of age). Three participants were removed on the basis of pedigree-genomic anomalies (n=263). Three measures of genome-wide homozygosity were generated for each individual, and association with MS was assessed using logistic regression models. No effect of genome-wide homozygosity was detected, indicating that inbreeding and consanguinity are not risk factors for MS in this population.
Abstract Objective A cluster of vulvar cancer exists in young Aboriginal women living in remote communities in Arnhem Land, Australia. A genetic case–control study was undertaken involving 30 cases ...of invasive vulvar cancer and its precursor lesion, high-grade vulvar intraepithelial neoplasia (VIN), and 61 controls, matched for age and community of residence. It was hypothesized that this small, isolated population may exhibit increased autozygosity, implicating recessive effects as a possible mechanism for increased susceptibility to vulvar cancer. Methods Genotyping data from saliva samples were used to identify runs of homozygosity (ROH) in order to calculate estimates of genome-wide homozygosity. Results No evidence of an effect of genome-wide homozygosity on vulvar cancer and VIN in East Arnhem women was found, nor was any individual ROH found to be significantly associated with case status. This study found further evidence supporting an association between previous diagnosis of CIN and diagnosis of vulvar cancer or VIN, but found no association with any other medical history variable. Conclusions These findings do not eliminate the possibility of genetic risk factors being involved in this cancer cluster, but rather suggest that alternative analytical strategies and genetic models should be explored.
Australian midwives are regulated under the National Registration and Accreditation Scheme. Unregistered birth workers may provide midwifery services at homebirths without any regulatory oversight. ...To address this issue, several states have passed legislation enabling prohibition orders to be made (negative licensing) against unregistered health practitioners who fail to comply with a statutory code of conduct developed for those not covered by the National Scheme.
To explore the consequences for the availability of birth choices for women that arise from the introduction of negative licensing.
An analysis of the regulatory framework and recent cases of unregistered birth workers attending homebirths reveals problems with equitable access to homebirth support, arising from issues with professional indemnity insurance, geography, and poor integration with hospitals and the wider healthcare system. These problems contribute to women choosing to employ the services of unregistered birth workers.
Negative licensing provides a useful additional tool for improving the safety of homebirths for mothers and babies, but it does not address the issues leading expectant parents to choose an unregistered birth worker to attend their births, and may contribute to an increase in high-risk behaviours, such as freebirthing.
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