Beyond platitudes: a qualitative study of Australian Aboriginal people's perspectives on biobanking.

BACKGROUND: Biobanks are vital resources for genetics and genomics, and it is broadly recognised that for maximal benefit it is essential that they include samples and data from diverse ancestral groups. The inclusion of First Nations people, in particular, is important to prevent biobanking research from exacerbating existing health inequities, and to ensure that these communities share in the benefits arising from research. AIMS: To explore the perspectives of Australian Aboriginal people whose tissue - or that of their family members - has been stored in the biobank of the National Centre for Indigenous Genomics (NCIG). METHODS: Semi-structured interviews with 42 Aboriginal people from the Titjikala, Galiwinku, Tiwi Islands, Yarrabah, Fitzroy Crossing, Derby, One Arm Point and Mulan communities, as well as a formal discussion with A. Hermes, an Indigenous Community Engagement Coordinator at the NCIG who had conducted the interviews. The interviews and the structured discussion were double coded using a procedure informed by Charmaz's outline of grounded theory analysis and Morse's outline of the cognitive basis of qualitative research. RESULTS: In this article, we report on A. Hermes' interviews with members from the above Aboriginal communities, as well as on her personal views, experiences, and interpretations of the interviews she conducted with other community members. We found that participation in the NCIG biobank raised issues around broken trust, grief and loss, but also - somewhat unexpectedly - was perceived as a source of empowerment, hope and reconnection. CONCLUSIONS: This research reminds us (again) of the need to engage deeply with communities in order to respond appropriately with respect for their cultural values and norms, and to develop culturally relevant policies and processes that enhance the benefits of biobank participation and minimise potential harms.

Are my religious beliefs anyone's business? A framework for declarations in health and biomedicine.

Conflicts of interests (COI) are typically divided into those that are financial and those that are not. While there is general agreement that financial COIs have a significant impact on decisions and need to be declared and managed, the status of non-financial COIs continues to be disputed. In a recent BMJ feature article it was proposed that religious beliefs should be routinely declared as an interest. The article generated over 41 responses from the medical community and health researchers, which put forward diverse and opposing views. In this paper, we analyse the discourse to shed further light on the reasons put forward for and against declaring religious beliefs. We argue for a middle path in which only material beliefs should be declared, and then only when there are no extenuating circumstances. To this end, we present a framework to help evaluate the materiality of interests that can be used for both financial and non-financial interests.

Transvaginal mesh, gender and the ethics of clinical innovation.

On 10 October 2018, Australian Health Minister Greg Hunt issued a national apology to the Australian women who experienced 'horrific outcomes' following surgery using transvaginal mesh-acknowledging the 'historic agony and pain that has come from mesh implantation'. This apology followed many decades of 'innovative' use of transvaginal mesh for the treatment of pelvic organ prolapse. We use the case of transvaginal mesh to explore how clinical innovation may not only harm patients, but also entrench vulnerability and exacerbate existing inequities-in this case, those relating to gender.

Public trust and global biobank networks.

BACKGROUND: Biobanks provide an important foundation for genomic and personalised medicine. In order to enhance their scientific power and scope, they are increasingly becoming part of national or international networks. Public trust is essential in fostering public engagement, encouraging donation to, and facilitating public funding for biobanks. Globalisation and networking of biobanking may challenge this trust. METHODS: We report the results of an Australian study examining public attitudes to the networking and globalisation of biobanks. The study used quantitative and qualitative methods in conjunction with bioethical analysis in order to determine factors that may contribute to, and threaten, trust. RESULTS: Our results indicate a generally high level of trust in biobanks and in medical research more broadly. Key factors that can reduce perceived trustworthiness of biobanks are commercialisation and involvement in global networking. CONCLUSIONS: We conclude that robust ethical oversight and governance standards can both promote trust in global biobanking and ensure that this trust is warranted.

'Treat them into the grave': cancer physicians' attitudes towards the use of high-cost cancer medicines at the end of life.

The prescribing of high-cost cancer medicines at the end of life has become a focus of criticism, due primarily to concerns about the safety, efficacy and cost-effectiveness of these medicines in this clinical context. In response to these concerns, a number of interventions have been proposed - frequently focused on improving physician-patient communication at the end of life. Underpinning these strategies is the assumption that the prescribing of high-cost cancer medicines at the end of life is primarily the result of poor communication on the part of cancer physicians. In this paper, we explore the factors perceived by cancer physicians to be driving the use of high-cost cancer medicines at the end of life. Drawing on semi-structured interviews with 16 Australian oncologists and haematologists, we demonstrate that these physicians believe that the use of high-cost medicines at the end of life is driven by multiple factors - including individual, interpersonal, socio-cultural and public policy influences. We conclude that these factors, and their interactions, need to be taken into account in the development of public policy and clinical interventions to address the use of high-cost medicines at the end of life.

Dangers of neglecting non-financial conflicts of interest in health and medicine.

Non-financial interests, and the conflicts of interest that may result from them, are frequently overlooked in biomedicine. This is partly due to the complex and varied nature of these interests, and the limited evidence available regarding their prevalence and impact on biomedical research and clinical practice. We suggest that there are no meaningful conceptual distinctions, and few practical differences, between financial and non-financial conflicts of interest, and accordingly, that both require careful consideration. Further, a better understanding of the complexities of non-financial conflicts of interest, and their entanglement with financial conflicts of interest, may assist in the development of a more sophisticated approach to all forms of conflicts of interest.

Perspectives on non-financial conflicts of interest in health-related journals: A scoping review.

The objective of this scoping review was to systematically review the literature on how non-financial conflicts of interest (nfCOI) are defined and evaluated, and the strategies suggested for their management in health-related and biomedical journals. PubMed, Embase, Scopus and Web of Science were searched for peer reviewed studies published in English between 1970 and December 2023 that addressed at least one of the following: the definition, evaluation, or management of non-financial conflicts of interest. From 658 studies, 190 studies were included in the review. nfCOI were discussed most commonly in empirical (22%; 42/190), theoretical (15%; 29/190) and "other" studies (18%; 34/190) - including commentary, perspective, and opinion articles. nfCOI were addressed frequently in the research domain (36%; 68/190), publication domain (29%; 55/190) and clinical practice domain (17%; 32/190). Attitudes toward nfCOI and their management were divided into two distinct groups. The first larger group claimed that nfCOI were problematic and required some form of management, whereas the second group argued that nfCOI were not problematic, and therefore, did not require management. Despite ongoing debates about the nature, definition, and management of nfCOI, many articles included in this review agreed that serious consideration needs to be given to the prevalence, impact and optimal mitigation of non-financial COI.

Clinical innovation ethics frameworks: A systematic narrative review.

BACKGROUND: It is common for doctors to engage in clinical innovation-i.e. to use novel interventions that differ from standard practice, and that have not yet been shown to be safe or effective according to the usual standards of evidence-based medicine-in the belief that this will benefit their patients. Clinical innovation is currently poorly defined and lacks cohesive oversight mechanisms. METHODS: A systematic narrative review, with the aim of identifying areas of similarity and divergence in innovation ethics frameworks developed across different medical specialties. RESULTS: 47 articles were included in the review. Few ethical issues raised by the ethics frameworks appear to be unique to distinct areas of practice. While variations exist in the oversight mechanisms suggested, these are again not specific to areas of practice, but rather reflect either cautious or more permissive attitudes towards clinical innovation. CONCLUSIONS: There is considerable overlap amongst ethics frameworks developed for use in diverse areas of practice. This reflects a tendency to treat innovative interventions in each area of practice as "exceptional" and a failure to develop "higher order" frameworks such as those that have been developed for research. Those involved in the oversight of clinical innovation need to aim for a balance between exceptionalism and harmonisation.

Situating commercialization of assisted reproduction in its socio-political context: a critical interpretive synthesis.

BACKGROUND: In many countries, ART service provision is a commercial enterprise. This has benefits, for example, creating efficiencies and economies of scale, but there are also concerns that financial imperatives can negatively impact patient care. The commercialization of ART is often conceptualized as being driven solely by the financial interests of companies and clinicians, but there are in fact many complex and intersecting socio-political demands for ART that have led to, sustain and shape the industry. OBJECTIVE AND RATIONALE: To use the academic and policy discourse on the commercialization of ART to build a theoretical model of factors that influence demand for ART services in high-income countries in order to inform potential policy responses. SEARCH METHODS: We searched electronic databases for journal articles (including Web of Science, Scopus, PubMed) and websites for grey literature, carried out reference chaining and searched key journals (including Human Reproduction, Fertility and Sterility). The terms used to guide these searches were 'assisted reproductive technology' OR 'in vitro fertilization' AND 'commerce' OR 'commercialisation' OR 'industry' OR 'market'. The search was limited to the English language and included articles published between 2010 and 2020. We used an established method of critical interpretive synthesis (CIS) to build a theoretical model of factors that influence demand for ART services in high-income countries. We developed initial themes from a broad review of the literature followed by iterative theoretical sampling of academic and grey literatures to further refine these themes. OUTCOMES: According to contemporary academic and broader socio-political discourse, the demand for ART has arisen, expanded and evolved in response to a number of intersecting forces. Economic imperatives to create sustainable national workforces, changing gender roles and concerns about the preservation of genetic, national/ethnic and role-related identities have all created demand for ART in both public and private sectors. The prominence given to reproductive autonomy and patient-centred care has created opportunities to (re)define what constitutes appropriate care and, therefore, what services should be offered. All of this is happening in the context of technological developments that provide an increasing range of reproductive choices and entrench the framing of infertility as a disease requiring medical intervention. These socio-political drivers of demand for ART can be broadly organized into four theoretical categories, namely security, identity, individualization and technocratization. LIMITATIONS REASONS FOR CAUTION: The primary limitation is that the interpretive process is ultimately subjective, and so alternative interpretations of the data are possible. WIDER IMPLICATIONS: Development of policy related to commercial activity in ART needs to account for the broad range of factors influencing demand for ART, to which commercial ART clinics are responding and within which they are embedded. STUDY FUNDING/COMPETING INTERESTS: This work was supported by a National Health and Medical Research Council Ideas Grant (APP1181401). All authors declare that they have no conflict of interest in relation to this work.

Biobank networking and globalisation: perspectives and practices of Australian biobanks.

Objective This study examined the practices and attitudes of Australian biobanks regarding access to samples and data, as well as local and global networking with other biobanks. Methods This was a mixed-methods study, including an online survey of Australian biobank administrators and qualitative interviews with survey participants. The survey examined the criteria applied when considering requests to share or network. The interviews explored attitudes and practices regarding sharing and networking. Results Most (90.9%; 30/33) biobanks offered access to their samples and data to others, principally for research (90.6%; 29/32). The most common criteria used to evaluate access requests included ethical oversight (84.8%; 28/33), scientific merit (84.8%; 28/33) and intended use (81.8%; 27/33). Just over two-thirds (69.7%; 23/33) of biobanks participated in Australian networks, and 39.1% (9/23) participated in global networks. Networking took the form of both sharing standardised operating procedures and policies (60.9%) and sharing samples and data (43.5%). Thirteen of the 16 interviewees participated in networks. Motivations for sharing included scientific necessity, sharing expertise and standardising operations and governance. Significant barriers to networking remain, including insufficient resources, inconsistent regulations and procedures, and cultural and political issues to do with the conduct of research. Conclusions Many Australian biobanks are already active participants in various types of global biobanking. If biobanks are to expand and make the most of their involvement in global networks, then important barriers need to be overcome. What is known about the topic? Biobanks that store human tissue and associated data are increasingly forming local, national and global networks. These networks create opportunities for enhancing the utility and sustainability of biobanks, but also raise considerable technical, legal and ethical challenges. What does this paper add? This paper reports findings from a mixed-methods study of Australian biobanks and reveals contemporary practices and perspectives concerning sample and data sharing, as well as local and global networking. It found most Australian biobanks currently take part in these activities. What are the implications for practitioners? Many Australian biobanks are networking in various ways across regional and national borders. A better understanding of current practices and views on significant and emerging issues is relevant to the diverse range of biobank stakeholders involved in any agenda to expand biobank networking, including patients, consumers, clinicians, scientists, policy makers and regulators.

Status, Respect, and Stigma: A Qualitative Study of Non-financial Interests in Medicine.

Conflicts of interest (COI) in health and medicine have been the source of considerable public and professional debate. Much of this debate has focused on financial, rather than non-financial COI, which is a significant lacuna because non-financial COI can be just as influential as financial COI. In an effort to explore the nature and effects of non-financial, as well as financial COI, we conducted semi-structured interviews with eleven Australian medical professionals regarding their experiences of, and attitudes towards, COI. We found that this group of medical professionals saw non-financial interests-most notably the pursuit of status and respect and the avoidance of stigma-as potentially conflicting with other important interests (such as patient care).

Examining diversity in public willingness to participate in offshore human biobanking: An Australian mixed methods study.

To ensure their sustainability and scientific utility, human biobanks are networking internationally. Sharing biospecimens and associated data across jurisdictions raise a number of practical, ethical, legal and social challenges that could reduce the publics' willingness to donate their much needed tissue for research purposes. This research aims to identify the impact of biobank location on willingness to donate through a national quantitative survey (n = 750) and 16 in-depth interviews. A latent class analysis in combination with qualitative results suggests that a large proportion of Australians are willing to donate and/or allow their tissue to be stored offshore to help others, but others are reluctant due to uncertainty around foreign ethical and regulatory standards and the loss of potential local benefits. The results highlight for the first time the diversity of public views, and provide important guidance for policy makers and science communicators eager to tailor strategies for specific publics.

"Some sort of fantasy land": A qualitative investigation of appropriate prescribing in cancer care.

RATIONALE, AIMS, AND OBJECTIVES: Increasing the appropriateness of prescribing has long been a focus of government, non-government, and professional organizations. Progress towards this is made difficult by the fact appropriate prescribing remains inconsistently defined and is the subject of ongoing intense disagreement. In this study, we attempted to understand why this is the case within the context of oncology and haematology. METHODS: We performed a qualitative empirical analysis of semi-structured interviews with 16 Australian oncologists and haematologists. RESULTS: We found that oncologists framed appropriate prescribing in terms of the following inter-related, and at times opposed, values: civic mindedness, hope and compassion, realism, and virtue in motivation. CONCLUSIONS: These values cannot be ranked a priori, and therefore, any definition of appropriate prescribing must be aligned with what communities want from their health system. When one value is privileged over another in any specific context, a compelling argument must be provided to justify the choice. In an era of shared decision making, patient rights, and high-cost medicines, we need to reassess what we mean by appropriate prescribing in cancer care.