Global Public Perceptions of Genomic Data Sharing: What Shapes the Willingness to Donate DNA and Health Data?

Analyzing genomic data across populations is central to understanding the role of genetic factors in health and disease. Successful data sharing relies on public support, which requires attention to whether people around the world are willing to donate their data that are then subsequently shared with others for research. However, studies of such public perceptions are geographically limited and do not enable comparison. This paper presents results from a very large public survey on attitudes toward genomic data sharing. Data from 36,268 individuals across 22 countries (gathered in 15 languages) are presented. In general, publics across the world do not appear to be aware of, nor familiar with, the concepts of DNA, genetics, and genomics. Willingness to donate one's DNA and health data for research is relatively low, and trust in the process of data's being shared with multiple users (e.g., doctors, researchers, governments) is also low. Participants were most willing to donate DNA or health information for research when the recipient was specified as a medical doctor and least willing to donate when the recipient was a for-profit researcher. Those who were familiar with genetics and who were trusting of the users asking for data were more likely to be willing to donate. However, less than half of participants trusted more than one potential user of data, although this varied across countries. Genetic information was not uniformly seen as different from other forms of health information, but there was an association between seeing genetic information as special in some way compared to other health data and increased willingness to donate. The global perspective provided by our "Your DNA, Your Say" study is valuable for informing the development of international policy and practice for sharing genomic data. It highlights that the research community not only needs to be worthy of trust by the public, but also urgent steps need to be taken to authentically communicate why genomic research is necessary and how data donation, and subsequent sharing, is integral to this.

Death determination, organ donation and the importance of the Dead Donor Rule following withdrawal of life-sustaining treatment: a survey of community opinions.

BACKGROUND: Background: Organ donation (OD) following circulatory determination of death (DCDD) is an increasing source of transplant organs but little is known about community opinions on treatment withdrawal, determination of death and acceptance of OD in DCDD. AIMS: To determine attitudes on death determination in DCDD, the importance of patient choice in treatment withdrawal and OD agreement, and the importance of the 'Dead Donor Rule'. METHODS: Scenario-based online survey of 1017 members of the Australian general public. Mean levels of agreement across respondent's responses to statements were compared by repeated measures ANOVA. RESULTS: 54% (548) of respondents agreed that a DCDD scenario patient could be declared dead 2 minutes after circulatory standstill, however over 80% nonetheless agreed OD would be appropriate, including 77% (136/176) of those disagreeing with a 2-minute death declaration. 48% (484) supported OD even if it caused the patient's death. 75% (766) would accept relatively benign ante-mortem treatments administered to improve transplant outcomes. Over 70% supported a high quadriplegic patient's request to be allowed to die, with 61% (622) agreeing that he should be allowed to donate his organs under anaesthesia, but 60% (610) also agreed that he should first be declared dead. CONCLUSIONS: We found high levels of support for treatment withdrawal in severe brain injury and when requested by a quadriplegic patient. While there was variable agreement with the timing of death determination and with OD under anaesthesia, support for OD was high in both scenarios. For many people death determination prior to OD may not be of paramount importance.

Death, dying and donation: community perceptions of brain death and their relationship to decisions regarding withdrawal of vital organ support and organ donation.

Despite brain death (BD) being established as a definition of death for over 50 years, the concept remains controversial. Little is known about public perception of death determination in decision-making about withdrawal of organ support and organ donation (OD), and the importance of the 'Dead Donor Rule' (DDR). We examined perceptions about death in a BD patient and their relationship to decisions about withdrawal of vital organ support, OD and the DDR, using an online survey of 1017 Australian adults. A BD patient scenario was presented, followed by a series of questions. Statistically significant differences in responses were determined using repeated measures analyses of variance and t tests. Seven hundred and fourteen respondents (70.2%) agreed that a hypothetical BD patient was dead. Those disagreeing most commonly cited the presence of heartbeat and breathing. Seven hundred and seventy (75.7%) favoured removal of 'life support', including 136 (13.3%) who had not agreed the patient was dead. Support for OD was high, but most favoured organ removal only after heartbeat and breathing had ceased. Where OD was in keeping with the patient's known wishes, 464 (45.6%) agreed that organs could be removed even if this caused death. Forty-one (20%) of those who had indicated they considered the patient was not dead agreed to organ removal even if it caused death. Australian public views on BD, withdrawal of 'life support' and OD are complex. Emphasis on prognosis and the impact of significant brain injury may be more appropriate in these situations, rather than focussing on death determination and upholding the DDR.

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.

Australian Perspectives on the Ethical and Regulatory Considerations for Responsible Data Sharing in Response to the COVID-19 Pandemic.

As the rush to understand and find solutions to the coronavirus disease 2019 pandemic continues, it is timely to re-examine the legal, social and ethical drivers for sharing health-related data from individuals around the globe. International collaboration and data sharing will be essential to the research effort. This raises the question of whether the urgent imperative to find therapies and vaccines may justify some temporary rebalancing of existing ethical and regulatory standards. The Global Alliance for Genomic Health is playing a leading role in collecting information about national approaches to these challenging questions. In this section, we examine some of the initiatives being taken in Australia against this global backdrop.

Trust in genomic data sharing among members of the general public in the UK, USA, Canada and Australia.

Trust may be important in shaping public attitudes to genetics and intentions to participate in genomics research and big data initiatives. As such, we examined trust in data sharing among the general public. A cross-sectional online survey collected responses from representative publics in the USA, Canada, UK and Australia (n = 8967). Participants were most likely to trust their medical doctor and less likely to trust other entities named. Company researchers were least likely to be trusted. Low, Variable and High Trust classes were defined using latent class analysis. Members of the High Trust class were more likely to be under 50 years, male, with children, hold religious beliefs, have personal experience of genetics and be from the USA. They were most likely to be willing to donate their genomic and health data for clinical and research uses. The Low Trust class were less reassured than other respondents by laws preventing exploitation of donated information. Variation in trust, its relation to areas of concern about the use of genomic data and potential of legislation are considered. These findings have relevance for efforts to expand genomic medicine and data sharing beyond those with personal experience of genetics or research participants.

Australia: regulating genomic data sharing to promote public trust.

The regulation of genomic data sharing in Australia is a confusing mix of common law, legislation, ethical guidelines, and codes of practice. Beyond privacy laws, which only apply to genomic data that meets the definition of personal information, the key regulatory lever is the National Health and Medical Research Council (NHMRC) National Statement for Ethical Conduct in Human Research ("National Statement") (2007). Compliance with the National Statement is a requirement for institutions to apply to the NHMRC for funding, and includes-among other things-requirements for review of most genomic research by Human Research Ethics Committees. The sections of the National Statement specifying requirements for research with human genomic data are currently under review, including proposed new requirements addressing the return of genetic research findings and oversight of transfer agreements. Ensuring the willingness of Australians to donate their genomic information and participate in medical research will require clarification and harmonisation of the applicable regulatory framework, along with reforms to ensure that these regulations reflect the conditions necessary to promote ongoing public trust in researchers and institutions.

Correction to: Australia: regulating genomic data sharing to promote public trust.

This article was inadvertently published under a draft title.

Impact of choice of coping strategies and family functioning on psychosocial function of young people with epilepsy.

Both medical and psychological factors have an important impact upon the psychosocial functioning of young people with epilepsy. The purpose of this study was to identify factors that distinguish young people with epilepsy and high psychosocial functioning from those with lower levels. The participants were 114 young people (40 males, 74 females) with active epilepsy and a mean age of 17.92years (SD=3.90) who completed either a paper (60.5%) or a web-based survey (39.5%) comprising demographic, medical, and psychosocial measures. Psychosocial measures included family functioning, adolescent coping, anxiety, depression, and quality of life. A latent class analysis produced two psychosocial functioning groups based on participants' scores for anxiety, depression, and quality of life. Young people were more likely to be members of the group with poor psychosocial functioning if they had a seizure in the last month (Wald=5.63, p<.05), came from families with lower levels of communication and problem solving (Wald=5.28, p<.05), and made greater use of non-productive (emotion-focused) coping strategies such as wishful thinking, withdrawal, and worry (Wald=12.00, p<.01). The findings suggest that, in addition to standard medical treatment, clinicians may promote better outcomes by strengthening family functioning and encouraging less use of nonproductive coping strategies.

Disclosure of Individual Research Results and Incidental Findings in Biobank Research: Why We Need an Evidence-based Approach.

Globally, genomic research is generating unprecedented advances in the understanding of the biology, pathogenetic mechanisms and prognostic markers of many cancers and is creating the possibility of precision (personalised) therapies. As more data are generated, it becomes increasingly necessary to determine the clinical significance of this data and to know when this data should be acted upon. The return of individual research results (IRRs) and incidental findings (IFs) from genomic research, in a well-informed and applicable manner, is becoming increasingly important and is already presenting practical challenges in Australian genetics clinics and familial clinics. This article argues for the need to develop an evidence-based approach to help frame ethical-legal responses to address these tensions ­ one that may offer flexible and defensible parameters to inform the management of disclosure of IRRs and IFs, safeguarding the health and wellbeing of tissue donors and allowing translational biobank genomic research to flourish.

Attitudes to genetically modified food over time: How trust in organizations and the media cycle predict support.

This research examined public opinion toward genetically modified plants and animals for food, and how trust in organizations and media coverage explained attitudes toward these organisms. Nationally representative samples (N=8821) over 10 years showed Australians were less positive toward genetically modified animals compared to genetically modified plants for food, especially in years where media coverage was high. Structural equation modeling found that positive attitudes toward different genetically modified organisms for food were significantly associated with higher trust in scientists and regulators (e.g. governments), and with lower trust in watchdogs (e.g. environmental movement). Public trust in scientists and watchdogs was a stronger predictor of attitudes toward the use of genetically modified plants for food than animals, but only when media coverage was low. Results are discussed regarding the moral acceptability of genetically modified organisms for food, the media's role in shaping public opinion, and the role public trust in organizations has on attitudes toward genetically modified organisms.

Public reaction to direct-to-consumer online genetic tests: Comparing attitudes, trust and intentions across commercial and conventional providers.

The success of personalised medicine depends upon the public's embracing genetic tests. Tests that claim to predict an individual's future health can now be accessed via online companies outside of conventional health regulations. This research assessed the extent to which the public embrace direct-to-consumer (DTC) genetic tests relative to those obtained by a conventional medical practitioner (MP). It also examined the reasons for differences across providers using a randomised experimental telephone survey of 1000 Australians. Results suggest that people were significantly less likely to approve of, and order a DTC genetic test administered by a company compared to a MP because they were less trusting of companies' being able to protect their privacy and provide them with access to genetic expertise and counselling. Markets for DTC genetic tests provided by companies would therefore significantly increase if trust in privacy protection and access to expertise are enhanced through regulation.

Personalised medicine in the genome era.

The "Genome Era", a term that has been used to describe the period following the sequencing of the human genome, has heralded significant changes in biomedical research and clinical practice. Personalised medicine aims to use this increased genetic knowledge base to identify predisposition to disease and to tailor treatment to the individual based on an analysis of their genome. In 2003, the Australian Law Reform Commission and the Australian Health Ethics Committee released a report recommending regulatory reform to ensure adequate protection of genetic information. There have been significant developments in this area since that report was released, and the authors argue that it is time to reconsider the regulatory framework of personalised medicine in Australia. The authors identify a number of ethical concerns that need to be addressed if the promise of personalised medicine is to be fully realised.

Context matters in genomic data sharing: a qualitative investigation into responses from the Australian public.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Predicting intention to biobank: a national survey.

BACKGROUND: The success of human population biobanks are dependent on the publics' willingness to participate. This research aimed to determine those factors important in determining the public's intention to donate a biological sample to a publicly funded biobank, and allow that sample to be linked with medical records. METHODS: A national sample of 1000 Australians was surveyed via telephonic interviews. Questions included the reported likelihood that respondents would participate in biobank research, ratings of trust in biobanks, beliefs that biobank research will lead to improved health care and general ratings of comfort with blood taking and DNA analysis. RESULTS: The sample reported a high level of trust in university biobanks, a strong belief that biobank research will lead to improved health care and a strong willingness to participate in biobank research. Using structural equation modelling, trust in the biobank was found to be the most important determinant of intention to participate in biobank research, followed by general comfort with blood taking and DNA analysis, belief in health-care benefits and higher education. Gender, age, parental status and experience of genetic conditions were not significantly associated with intention to participate. CONCLUSIONS: Australians are generally willing to participate in biobank research, and this is strongly determined by trust. While benefit beliefs and comfort with research are also relevant, higher trust was associated with intention regardless of these factors, suggesting reasons other than concern for improved health care are important in determining the publics' willingness to participate in biobank research.

Benefit sharing and biobanking in Australia.

Biobanks are essential tools for facilitating biomedical research, because they provide collections of human tissue linked with personal information. There is still little understanding of the underlying reasons why people participate in biobanking in the increasingly commercialised and internationalised biomedical research environment. This paper reports the results of an Australia-wide telephone survey. The paper analyses the types of obligations that members of the public may wish to see incorporated in biobank benefit sharing arrangements and the extent to which their views might be influenced by underlying norms of sharing behaviour. Latent class analysis of the dataset reveals three distinct classes of respondents. We link one of these with the norm of reciprocity, one with the norm of social responsibility. The third is not clearly linked with any one norm of sharing behaviour. The implications of these findings on biobank benefit sharing arrangements are discussed.

Understanding the impact of commercialization on public support for scientific research: is it about the funding source or the organization conducting the research.

This research examines the influence of commercialization on support for scientific research. It compares the effects of the funding source with the type of organization on public support for stem cell research. Using a national Australian telephone survey (n = 1000), the results reveal that support drops significantly when scientific research is funded by private rather than public interests, and even more so when it is conducted in a private company rather than a public university. Respondents' preference for university research was enhanced if they trusted universities, distrusted major companies and believed that the research would be beneficial. A preference for public funding was also associated with lower trust in companies and a belief that the research would benefit people. Implications of these results are discussed in relation to the challenge of maintaining public support in an increasingly commercialized research environment.

Determining the willingness of Australians to export their corneas on death.

BACKGROUND: 12.7 million people await a corneal transplant, but 53% are without access to corneal tissue. Sharing corneal tissue across nations can provide some access, however the willingness of export populations, like Australians, to export their donation on death, has never been evaluated. Our research samples the Australian population, determining their willingness to export. MATERIALS AND METHOD: We conducted e-surveys. N = 1044 Australians participated. The sample represented the Australian population, based on population demographics. Chi-Square and bivariate correlation coefficients examined associations between categorical variables, with a sample size of N = 1044, power of 0.80, and alpha of p = 0.05. Outcome measures were based on population sampling, by exploring willingness export, through the e-survey method. RESULTS: 38% (n = 397) of respondents said yes to exportation, 23.8% (n = 248) said no, and 38.2% (n = 399) were undecided. We found no relationship between willingness to export and general demographics, though those registered on the Donatelife Register (p = < .001), and those already willing to donate their eyes (p = < .001) were significantly more willing to export. DISCUSSION: More Australians are willing to export their corneas than not, though a significant portion remain undecided. The Donatelife Register, and donation awareness, are key components of respondent decision making. Therefore, the provision of information about exportation prior to, and at the point-of-donation, is essential for assisting Australian's to decide to export or not. Further examination and development of consent-for-export systems are necessary before routine exportation is undertaken.

Identifying the nature and extent of public and donor concern about the commercialisation of biobanks for genomic research.

Various forms of private investment are considered necessary for the sustainability of biobanks, yet pose significant challenges to public trust. To manage this tension, it is vital to identify the concerns of relevant stakeholders to ensure effective and acceptable policy and practice. This research examines the aspects of commercialisation that are of most concern to the Australian public (n = 800) and patients who had donated their tissue to two large disease specific (cancer) public biobanks (n = 564). Overall, we found a commercialisation effect (higher support for public relative to private) in relation to funding, research location and access to stored biospecimens. The effect was strongest for research locations and access compared to funding. A latent class analysis revealed the pattern of concern differed, with the majority (34.1%) opposing all aspects of commercialisation, a minority supporting all (15.7%), one quarter (26.8%) opposing some (sharing and selling tissue) but not others (research locations and funding), and a group who were unsure about most aspects but opposed selling tissue (23.5%). Patient donors were found to be more accepting of and unsure about most aspects of commercialisation. Members of the (general) public who were motivated to participate in biobanking were more likely to oppose some aspects while supporting others, while those who indicated they would not donate to a biobank were more likely to oppose all aspects of commercialisation. The results suggest that approaches to policy, engagement and awareness raising need to be tailored for different publics and patient groups to increase participation.