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.
The right to liberty in a pandemic McWhirter, Rebekah
University of Queensland law journal,
12/2021, Volume:
40, Issue:
2
Journal Article
Peer reviewed
Open access
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.
Biobanks will be essential to facilitate the translation of genomic research into real improvements to healthcare. Biobanking is a long-term commitment, requiring public support as well as ...appropriate regulatory, social and ethical guidelines to realize this promise. There is a growing body of research that explores the necessary conditions to ensure public trust in biomedical research, particularly in the context of biobanking. Trust is, however, a complex relationship. More analysis of public perceptions, attitudes and reactions is required to understand the primary triggers that influence gain and loss of trust. Further, the outcomes of these analyses require detailed consideration to determine how to promote trustworthy institutions and practices.
This article uses national survey data, combined with the results of a community consultation that took place in Tasmania, Australia in 2013, to analyze the specific issue of public reactions to commercialization of biobanks and their outputs. This research will enhance the ability of biobanks to respond preemptively to public concerns about commercialization by establishing and maintaining governance frameworks that are responsive to those concerns. The results reveal that it is possible to counter the ‘natural prejudice’ that many people have against commercialization through independent governance of biobank resources and transparency with regard to commercial involvement. Indeed, most participants agreed that they would rather have a biobank with commercial involvement than none at all. This analysis provides nuanced conclusions about public reactions towards commercialization and equips researchers and biobank operators with data on which to base policies and make governance decisions in order to tackle participant concerns respectfully and responsively.
•An understanding of public perceptions is needed to appropriately govern biobanks.•Public trust is vital to biobank participation and commercialization is concerning.•Prejudice against commercialization can be countered with good governance.•Key commercialization concerns relate to benefit sharing, profit making and control.
In 'Vavricka' v 'Czech Republic', the European Court of Human Rights held that the Czech Republic's childhood vaccination policy did not contravene the Article 8 right to private life. This note ...presents a rhetorical and contextual analysis of the Court's engagement with questions of expertise. The majority's application of a wide margin of appreciation avoided grappling with the details of scientific and medical authority, as much as the political challenges raised by the application. We conclude by considering the wider context and limits of rights-based approaches to global public health.
Doctrine of informed consent – duty to warn of risks of procedure – whether the duty could encompass a disclosure of the doctors skill and experience – role of performance data in relation to ...surgeons and surgical outcomes – statutory obligations and case law on the duty to warn – policy considerations.
Identifying public expectations of genetic biobanks Critchley, Christine; Nicol, Dianne; McWhirter, Rebekah
Public understanding of science (Bristol, England),
08/2017, Volume:
26, Issue:
6
Journal Article
Peer reviewed
Understanding public priorities for biobanks is vital for maximising utility and efficiency of genetic research and maintaining respect for donors. This research directly assessed the relative ...importance the public place on different expectations of biobanks. Quantitative and qualitative results from a national sample of 800 Australians revealed that the majority attributed more importance to protecting privacy and ethical conduct than maximising new healthcare benefits, which was in turn viewed as more important than obtaining specific consent, benefit sharing, collaborating and sharing data. A latent class analysis identified two distinct classes displaying different patterns of expectations. One placed higher priority on behaviours that respect the donor (n = 623), the other on accelerating science (n = 278). Additional expectations derived from qualitative data included the need for biobanks to be transparent and to prioritise their research focus, educate the public and address commercialisation.
Understanding public attitudes to genomic data sharing is widely seen as key in shaping effective governance. However, empirical research in this area often fails to capture the contextual nuances of ...diverse sharing practices and regulatory concerns encountered in real-world genomic data sharing. This study aimed to investigate factors affecting public attitudes to data sharing through responses to diverse genomic data sharing scenarios.
A set of seven empirically validated genomic data sharing scenarios reflecting a range of current practices in Australia was used in an open-ended survey of a diverse sample of the Australian public (n = 243). Qualitative responses were obtained for each of the scenarios. Respondents were each allocated one scenario and asked five questions on: whether (and why/not) they would share data; what sharing would depend on; benefits and risks of sharing; risks they were willing to accept if sharing was certain to result in benefits; and what could increase their comfort about sharing and any potential risk. A thematic analysis was used to examine responses, coded and validated by two blinded coders.
Participants indicated an overall high willingness to share genomic information, although this willingness varied considerably between different scenarios. A strong perception of benefits was reported as the foremost explanation for willingness to share across all scenarios. The high degree of convergence in the perception of benefits and the types of benefits identified by participants across all the scenarios suggests that the differentiation in intention to share may lie in perceptions of risk, which showed distinct patterns within and between the different scenarios. Some concerns were shared strongly across all scenarios, particularly benefit sharing, future use, and privacy.
Qualitative responses provide insight into popular assumptions regarding existing protections, conceptions of privacy, and which trade-offs are generally acceptable. Our results indicate that public attitudes and concerns are heterogeneous and influenced by the context in which sharing takes place. The convergence of key themes such as benefits and future uses point to core concerns that must be centred in regulatory responses to genomic data sharing.
Guidelines for cardiovascular disease (CVD) prevention recommend assessment of absolute CVD risk to guide clinical management. Despite this, use among general practitioners (GPs) remains limited.
...Pathology services may provide an appropriate setting to assess and report absolute CVD risk in patients attending for cholesterol measurement. This study aimed to explore GPs perceptions of such a service.
A focus group and semi-structured interviews were conducted with GPs (n = 18) in Tasmania, Australia, to identify perceptions of assessment and reporting of absolute CVD risk via pathology services. An example pathology report including absolute CVD risk was provided and discussed. Audio-recordings were transcribed and thematically coded by two researchers.
Almost all GPs identified that absolute CVD risk assessed and reported via pathology services could address deficits in practice. First, by reducing the number of appointments required to collect risk factors. Second, by providing a systematic (rather than opportunistic) approach for assessment of absolute CVD risk. Third, by reducing misclassification of patient CVD risk caused by overreliance on clinical intuition. All GPs reported they would order absolute CVD risk when issuing a cholesterol referral if such a service was offered. GPs recommended improving the service by providing information on methods used to measure risk factors on the pathology report.
Absolute CVD risk assessed and reported via pathology services may address challenges of screening CVD risk experienced by GPs in practice and encourage dedicated follow-up care for CVD prevention.
Human research ethics committees (HRECs) are evaluating increasing quantities of genomic research applications with complex ethical considerations. Genomic confidence is reportedly low amongst many ...non-genetics-experts; however, no studies have evaluated genomic confidence levels in HREC members specifically. This study used online surveys to explore genomic confidence levels, predictors of confidence, and genomics resource needs of members from 185 HRECs across Australia. Surveys were fully or partially completed by 145 members. All reported having postgraduate 94 (86%) and/or bachelor 15 (14%) degrees. Participants consisted mainly of researchers (n = 45, 33%) and lay members (n = 41, 30%), affiliated with either public health services (n = 73, 51%) or public universities (n = 31, 22%). Over half had served their HREC Formula: see text3 years. Fifty (44%) reviewed genomic studies Formula: see text3 times annually. Seventy (60%) had undertaken some form of genomic education. While most (94/103, 91%) had high genomic literacy based on familiarity with genomic terms, average genomic confidence scores (GCS) were moderate (5.7/10, n = 119). Simple linear regression showed that GCS was positively associated with years of HREC service, frequency of reviewing genomic applications, undertaking self-reported genomic education, and familiarity with genomic terms (p < 0.05 for all). Conversely, lay members and/or those relying on others when reviewing genomic studies had lower GCSs (p < 0.05 for both). Most members (n = 83, 76%) agreed further resources would be valuable when reviewing genomic research applications, and online courses and printed materials were preferred. In conclusion, even well-educated HREC members familiar with genomic terms lack genomic confidence, which could be enhanced with additional genomic education and/or resources.
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