Drc Chalmers

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.

<p>The scientific community, research funders, and governments have repeatedly recognized the importance of open access to genomic data for scientific research and medical progress. Open access is becoming a well-established practice for large-scale, publicly funded, data-intensive community science projects, particularly in the field of genomics. Given this consensus, restrictions to open access should be regarded as exceptional and treated with caution. Yet, several developments have led scientists and policymakers to investigate and implement open access restrictions. Notably, there are privacy concerns within the genomics community and critiques from some researchers that open access, if left completely unregulated, could raise significant scientific, ethical, and legal issues (e.g., quality of the data, appropriate credit to data generators, relevance of the system for small and medium projects, etc.). A recent paper by Greenbaum and colleagues in this journal identified protecting the privacy of study participants as the main challenge to open genomic data sharing.</p>One possible way to reconcile open data sharing with privacy concerns is to use a tiered access system to separate access into open and controlled. Open access remains the norm for data that cannot be linked with other data to generate a dataset that would uniquely identify an individual. A controlled access mechanism, on the other hand, regulates access to certain, more sensitive data (e.g., detailed phenotype and outcome data, genome sequences files, raw genotype calls) by requiring third parties to apply to a body (e.g., custodian, original data collectors, independent body, or data access committee) and complete an access application that contains privacy safeguards. This mechanism, while primarily designed to protect study participants, can also be used to protect investigators, database hosting institutions, and funders from perceptions or acts of favoritism or impropriety. The experience of controlled access bodies to date has been only minimally documented in the literature. To address this lacuna, we present the experience of the Data Access Compliance Office (DACO) of the International Cancer Genome Consortium (ICGC). The goal is to provide information on this increasingly important type of database governance body.

BACKGROUND: Governments, funding bodies, institutions, and publishers have developed a number of strategies to encourage researchers to facilitate access to datasets. The rationale behind this approach is that this will bring a number of benefits and enable advances in healthcare and medicine by allowing the maximum returns from the investment in research, as well as reducing waste and promoting transparency. As this approach gains momentum, these data-sharing practices have implications for many kinds of research as they become standard practice across the world. MAIN TEXT: The governance frameworks that have been developed to support biomedical research are not well equipped to deal with the complexities of international data sharing. This system is nationally based and is dependent upon expert committees for oversight and compliance, which has often led to piece-meal decision-making. This system tends to perpetuate inequalities by obscuring the contributions and the important role of different data providers along the data stream, whether they be low- or middle-income country researchers, patients, research participants, groups, or communities. As research and data-sharing activities are largely publicly funded, there is a strong moral argument for including the people who provide the data in decision-making and to develop governance systems for their continued participation. CONCLUSIONS: We recommend that governance of science becomes more transparent, representative, and responsive to the voices of many constituencies by conducting public consultations about data-sharing addressing issues of access and use; including all data providers in decision-making about the use and sharing of data along the whole of the data stream; and using digital technologies to encourage accessibility, transparency, and accountability. We anticipate that this approach could enhance the legitimacy of the research process, generate insights that may otherwise be overlooked or ignored, and help to bring valuable perspectives into the decision-making around international data sharing.

A healthy 19-year-old United States college student volunteer in a clinical research program underwent a bronchoscopy and died as a result of acute lignocaine toxicity. The major contributing factor in the tragedy was that the research protocol failed to specify an upper dose limit for lignocaine spray, although previous versions of the protocol had done so. We look at the implications of this case for Australian institutional ethics committees.