D Nicol

A review of the key issues associated with the commercialization of biobanks

A review of the key issues associated with the commercialization of biobanks Timothy Caulfield∗, Sarah Burningham, Yann Joly, ZubinMaster, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, AmyMcGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, HelenWallace andMa’n H. Zawati†

Commercialisation of biotechnology: public trust and research

The success of the biotechnology revolution depends on an array of interwoven factors, not the least of which is the protection, preservation and promotion of public trust in the science, the scientists and the regulators. This paper considers some of the areas in which the commercialisation of biotechnology research may affect public trust. The increasing involvement of the private sector in basic research and the need for the public sector to commercialise its research has resulted in a blurring of the divide between the two sectors. The expanding public and private partnerships are creating an elision between the two sectors. In biotechnology, knowledge itself has become commodified and subject to confidentiality agreements and patent protections. These trends are challenging the traditional science norms of universalism, collegiality, disinterestedness and organised scepticism. These trends may equally have a detrimental flow on effect in relation to public trust in science. This paper considers and emphasises the appropriate roles of regulation, public consultation and corporate social responsibility and benefit sharing in protecting and restoring the key factor of public trust.

Patent landscaping for life sciences innovation: toward consistent and transparent practices

As industry, governments and academia increasingly rely on patent landscapes to map scientific and technological trends, an interdisciplinary workshop provides recommendations for developing consistent and transparent landscaping practices.

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.

Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era

Biobanks have been heralded as essential tools for translating biomedical research into practice, driving precision medicine to improve pathways for global healthcare treatment and services. Many nations have established specific governance systems to facilitate research and to address the complex ethical, legal and social challenges that they present, but this has not lead to uniformity across the world. Despite significant progress in responding to the ethical, legal and social implications of biobanking, operational, sustainability and funding challenges continue to emerge. No coherent strategy has yet been identified for addressing them. This has brought into question the overall viability and usefulness of biobanks in light of the significant resources required to keep them running. This review sets out the challenges that the biobanking community has had to overcome since their inception in the early 2000s. The first section provides a brief outline of the diversity in biobank and regulatory architecture in seven countries: Australia, Germany, Japan, Singapore, Taiwan, the UK, and the USA. The article then discusses four waves of responses to biobanking challenges. This article had its genesis in a discussion on biobanks during the Centre for Health, Law and Emerging Technologies (HeLEX) conference in Oxford UK, co-sponsored by the Centre for Law and Genetics (University of Tasmania). This article aims to provide a review of the issues associated with biobank practices and governance, with a view to informing the future course of both large-scale and smaller scale biobanks.

The Impact of Commercialisation and Genetic Data Sharing Arrangements on Public Trust and the Intention to Participate in Biobank Research

Objectives: The necessity for biobanks to share their resources with third parties poses potential risks to public trust and the intention to participate in genetic research. We explore the effects of data sharing and the type of third-party access (public vs. private) on public trust and, in turn, the intention to participate in biobank research. Methods: An experimental design was used to assess a national sample of 1,701 Australians via a computer-assisted telephone interview. Results: The results revealed that trust and the intention to participate significantly decreased in relation to private compared to public biobanks, and when access to third-party researchers was allowed compared to when it was not. Somewhat surprisingly, no differences were found in relation to the third party being international compared to Australian, but trust and the intention to participate were significantly eroded when private third parties were allowed access. Those with a university education were particularly distrustful of private biobanks and biobanks that allowed access, while those who were more aware of genetic databases appeared more confident with biobanks sharing with private-sector third parties. Conclusion: The pattern of results suggests that public awareness of the need for biobanks to share their resources widely needs to be increased to maintain public trust and support.

Community Engagement for Big Epidemiology: Deliberative Democracy as a Tool

Public trust is critical in any project requiring significant public support, both in monetary terms and to encourage participation. The research community has widely recognized the centrality of public trust, garnered through community consultation, to the success of large-scale epidemiology. This paper examines the potential utility of the deliberative democracy methodology within the public health research setting. A deliberative democracy event was undertaken in Tasmania, Australia, as part of a wider program of community consultation regarding the potential development of a Tasmanian Biobank. Twenty-five Tasmanians of diverse backgrounds participated in two weekends of deliberation; involving elements of information gathering; discussion; identification of issues and formation of group resolutions. Participants demonstrated strong support for a Tasmanian Biobank and their deliberations resulted in specific proposals in relation to consent; privacy; return of results; governance; funding; and, commercialization and benefit sharing. They exhibited a high degree of satisfaction with the event, and confidence in the outcomes. Deliberative democracy methodology is a useful tool for community engagement that addresses some of the limitations of traditional consultation methods.

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.

Capital, trust & consultation: Databanks and regulation in Australia

The new genetics ‘industry’ has emerged at a time of public ambivalence towards science, an ambivalence that could move to outright distrust when the commercial imperatives of increasingly market-oriented science gradually replace the more traditional imperative of ‘public good’. Genetics research and development is at the vanguard of the movement of science into the market economy and, as such, has come under intense public scrutiny. The political and social environment now demands public participation in the development of regulatory structures. Commercialization aims for rapid advances in research, leading to new genetic therapies and other public health benefits. However, this rapid progress has resulted in human tissue banks and genetic databases un(der)regulated in many countries, and challenges to accepted notions of privacy, ownership and consent. This paper presents an outline of the way Australia has embraced public participation in the development of a regulatory framework governing human genetic databanks. It argues that after a two-year, two-stage national inquiry into the protection of genetic information, the country now stands at a crossroads: it either addresses the recommendations of the inquiry—providing a model for the development of public trust in the human genetics industry, and in the state to regulate it, or continues to ignore the recommendations, fostering cynicism regarding the consultation process and an even greater level of distrust in the ability/willingness of the state to regulate the industry.

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.