Sharing ICU Patient Data Responsibly Under the Society of Critical Care Medicine/European Society of Intensive Care Medicine Joint Data Science Collaboration: The Amsterdam University Medical Centers Database (AmsterdamUMCdb) Example.

OBJECTIVES: Critical care medicine is a natural environment for machine learning approaches to improve outcomes for critically ill patients as admissions to ICUs generate vast amounts of data. However, technical, legal, ethical, and privacy concerns have so far limited the critical care medicine community from making these data readily available. The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have identified ICU patient data sharing as one of the priorities under their Joint Data Science Collaboration. To encourage ICUs worldwide to share their patient data responsibly, we now describe the development and release of Amsterdam University Medical Centers Database (AmsterdamUMCdb), the first freely available critical care database in full compliance with privacy laws from both the United States and Europe, as an example of the feasibility of sharing complex critical care data. SETTING: University hospital ICU. SUBJECTS: Data from ICU patients admitted between 2003 and 2016. INTERVENTIONS: We used a risk-based deidentification strategy to maintain data utility while preserving privacy. In addition, we implemented contractual and governance processes, and a communication strategy. Patient organizations, supporting hospitals, and experts on ethics and privacy audited these processes and the database. MEASUREMENTS AND MAIN RESULTS: AmsterdamUMCdb contains approximately 1 billion clinical data points from 23,106 admissions of 20,109 patients. The privacy audit concluded that reidentification is not reasonably likely, and AmsterdamUMCdb can therefore be considered as anonymous information, both in the context of the U.S. Health Insurance Portability and Accountability Act and the European General Data Protection Regulation. The ethics audit concluded that responsible data sharing imposes minimal burden, whereas the potential benefit is tremendous. CONCLUSIONS: Technical, legal, ethical, and privacy challenges related to responsible data sharing can be addressed using a multidisciplinary approach. A risk-based deidentification strategy, that complies with both U.S. and European privacy regulations, should be the preferred approach to releasing ICU patient data. This supports the shared Society of Critical Care Medicine and European Society of Intensive Care Medicine vision to improve critical care outcomes through scientific inquiry of vast and combined ICU datasets.

Demographic and prosocial intrapersonal characteristics of biobank participants and refusers: the findings of a survey in the Netherlands.

Research in genetics relies heavily on voluntary contributions of personal data. We aimed to acquire insights into the differences between participants and refusers of participation in a Dutch population-based biobank. Accordingly, we assessed the demographic and prosocial intrapersonal characteristics of respondents who participated (n = 2615) or refused to participate (n = 404) in the Lifelines biobank and databank. Our results indicated that health-related values critically influence participation decisions. The participation threshold for Lifelines was determined by an absence of health-related values and of trust in government. Therefore, considering these factors in communication and recruitment strategies could enhance participation in biomedical research. No indications were found of a stronger general prosociality of participants or their trust in researchers beyond the context of biobanking. This emphasizes the contextual understanding of the decision of participation in biobanking. Our findings may contribute to improving recruitment strategies by incorporating relevant values and/or highlighting prosocial benefits. Moreover, they foreground the need to address trust issues in collaborations between data repositories and commercial companies. Future research should explore how prosocial intrapersonal characteristics drive participation and withdrawal decisions and relate to contextual attributes.

South Africa's COVID-19 Tracing Database: Risks and rewards of which doctors should be aware.

In response to the COVID-19 pandemic, South Africa (SA) has established a Tracing Database, collecting both aggregated and individualised mobility and locational data on COVID-19 cases and their contacts. There are compelling public health reasons for this development, since the database has the potential to assist with policy formulation and with contact tracing. While potentially demonstrating the rapid facilitation through technology of an important public service, the Tracing Database does, however, infringe immediately upon constitutional rights to privacy and heightens the implications of ethical choices facing medical professionals. The medical community should be aware of this surveillance innovation and the risks and rewards it raises. To deal with some of these risks, including the potential for temporary rights- infringing measures to become permanent, there are significant safeguards designed into the Tracing Database, including a strict duration requirement and reporting to a designated judge. African states including SA should monitor this form of contact tracing closely, and also encourage knowledge-sharing among cross-sectoral interventions such as the Tracing Database in responding to the COVID-19 pandemic.

Research on COVID-19 in South Africa: Guiding principles for informed consent.

Research is imperative in addressing the COVID-19 epidemic, both in the short and long term. Informed consent is a key pillar of research and should be central to the conduct of COVID-19 research. Yet a range of factors, including physical distancing requirements, risk of exposure and infection to research staff, and multiple pressures on the healthcare environment, have added layers of challenges to the consent process in COVID-19 patients. Internationally, the recognition that consent for COVID-19 research may be imperfect has led to a range of suggestions to ensure that research remains ethical. Drawing on these guidelines, we propose a consent process for COVID-19 research in the South African context that combines individual consent with delayed and proxy consent for individuals who may be temporarily incapacitated, combined with key principles that should be considered in the design of a consent process for COVID-19 research.

Review of policies of companies and databases regarding access to customers' genealogy data for law enforcement purposes.

The rapidly evolving popularity of direct-to-consumer genetic genealogy companies has made it possible to retrieve genomic information for unintended reasons by third parties, including the emerging use for law enforcement purposes. The question remains whether users of direct-to-consumer genetic genealogy companies and genealogical databases are aware that their genetic and/or genealogical data could be used as means to solving forensic cases. Our review of 22 companies' and databases' policies showed that only four companies have provided additional information on how law enforcement agencies should request permission to use their services for law enforcement purposes. Moreover, two databases have adopted a different approach by providing a special service for law enforcement. Although all companies and databases included in the study provide at least some provisions about police access, there is an ongoing debate over the ethics of these practices, and how to balance users' privacy with law enforcement requests.

Engineering Bias in AI.

After working at Apple designing circuits and signal processing algorithms for products including the first iPad, Timnit Gebru (Figure 1) received her Ph.D. from the Stanford Artificial Intelligence Laboratory in the area of computer vision. She recently completed a postdoc with Microsoft Research in the FATE (Fairness, Transparency, Accountability, and Ethics in Artificial Intelligence (AI)) group, was a cofounder of Black in AI, and is currently working as a research scientist in the Ethical AI team at Google. Her research in algorithmic bias and the ethical implications of data mining have appeared in multiple publications, including The New York Times and The Economist. IEEE Pulse recently spoke with Gebru about the role societal bias plays in engineering AI, the deficits and dangers in the field caused by limited diversity, and the challenges inherent in addressing these complex issues.

The use of clinical databases in disease outcomes research: Is the ethics of IRB review keeping up?

There is a perceived tension in research ethics between protecting the interests of participants and promoting good research as a societal good. The challenge of balancing the potential benefits of large clinical databases for disease outcomes research while protecting patients' privacy and confidentiality is an example of this dynamic. What is new about this tension in the context of "data warehousing" is the conflation of many differing interpretations of relevant ethics terminology, the proliferation of different kinds of databases, as well as the growth of research on a global level without the requisite harmonization of regulatory frameworks. The evolution of electronic medical records, the blurring of lines between clinical care and research in some rare orphan diseases, the growing trend to advocate for patient-centered research, and the advent of "open science" to facilitate global research initiatives have also contributed to challenging the existing norms for degrees of consent to this kind of research.

[Big data and their perspectives in radiation therapy]. / Métadonnées et leurs applications possibles en radiothérapie.

The concept of big data indicates a change of scale in the use of data and data aggregation into large databases through improved computer technology. One of the current challenges in the creation of big data in the context of radiation therapy is the transformation of routine care items into dark data, i.e. data not yet collected, and the fusion of databases collecting different types of information (dose-volume histograms and toxicity data for example). Processes and infrastructures devoted to big data collection should not impact negatively on the doctor-patient relationship, the general process of care or the quality of the data collected. The use of big data requires a collective effort of physicians, physicists, software manufacturers and health authorities to create, organize and exploit big data in radiotherapy and, beyond, oncology. Big data involve a new culture to build an appropriate infrastructure legally and ethically. Processes and issues are discussed in this article.

The Adoption of Cloud Computing in the Field of Genomics Research: The Influence of Ethical and Legal Issues.

This study aims to understand the influence of the ethical and legal issues on cloud computing adoption in the field of genomics research. To do so, we adapted Diffusion of Innovation (DoI) theory to enable understanding of how key stakeholders manage the various ethical and legal issues they encounter when adopting cloud computing. Twenty semi-structured interviews were conducted with genomics researchers, patient advocates and cloud service providers. Thematic analysis generated five major themes: 1) Getting comfortable with cloud computing; 2) Weighing the advantages and the risks of cloud computing; 3) Reconciling cloud computing with data privacy; 4) Maintaining trust and 5) Anticipating the cloud by creating the conditions for cloud adoption. Our analysis highlights the tendency among genomics researchers to gradually adopt cloud technology. Efforts made by cloud service providers to promote cloud computing adoption are confronted by researchers' perpetual cost and security concerns, along with a lack of familiarity with the technology. Further underlying those fears are researchers' legal responsibility with respect to the data that is stored on the cloud. Alternative consent mechanisms aimed at increasing patients' control over the use of their data also provide a means to circumvent various institutional and jurisdictional hurdles that restrict access by creating siloed databases. However, the risk of creating new, cloud-based silos may run counter to the goal in genomics research to increase data sharing on a global scale.

If you build it, they will come: unintended future uses of organised health data collections.

BACKGROUND: Health research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include: 1) Population biobanks, cohort studies, and genome databases 2) Clinical and public health data 3) Direct-to-consumer genetic testing 4) Social media 5) Fitness trackers, health apps, and biometric data sensors Ethical, legal, and social challenges of such collections are well recognized, but there has been limited attention to the broader societal implications of the existence of these collections. DISCUSSION: Although health research conducted using these collections is broadly recognized as beneficent, secondary uses of these data and samples may be controversial. We examine both documented and hypothetical scenarios of secondary uses of health data and samples. In particular, we focus on the use of health data for purposes of: Forensic investigations Civil lawsuits Identification of victims of mass casualty events Denial of entry for border security and immigration Making health resource rationing decisions Facilitating human rights abuses in autocratic regimes CONCLUSIONS: Current safeguards relating to the use of health data and samples include research ethics oversight and privacy laws. These safeguards have a strong focus on informed consent and anonymization, which are aimed at the protection of the individual research subject. They are not intended to address broader societal implications of health data and sample collections. As such, existing arrangements are insufficient to protect against subversion of health databases for non-sanctioned secondary uses, or to provide guidance for reasonable but controversial secondary uses. We are concerned that existing debate in the scholarly literature and beyond has not sufficiently recognized the secondary data uses we outline in this paper. Our main purpose, therefore, is to raise awareness of the potential for unforeseen and unintended consequences, in particular negative consequences, of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data.

Sharing with More Caring: Coordinating and Improving the Ethical Governance of Data and Biomaterials Obtained from Children.

INTRODUCTION: Research on complex health conditions such as neurodevelopmental disorders increasingly relies on large-scale research and clinical studies that would benefit from data sharing initiatives. Organizations that share data stand to maximize the efficiency of invested research dollars, expedite research findings, minimize the burden on the patient community, and increase citation rates of publications associated with the data. OBJECTIVE: This study examined ethics and governance information on websites of databases involving neurodevelopmental disorders to determine the availability of information on key factors crucial for comprehension of, and trust and participation in such initiatives. METHODS: We identified relevant databases identified using online keyword searches. Two researchers reviewed each of the websites and identified thematic content using principles from grounded theory. The content for each organization was interrogated using the gap analysis method. RESULTS: Sixteen websites from data sharing organizations met our inclusion criteria. Information about types of data and tissues stored, data access requirements and procedures, and protections for confidentiality were significantly addressed by data sharing organizations. However, special considerations for minors (absent from 63%), controls to check if data and tissues are being submitted (absent from 81%), disaster recovery plans (absent from 81%), and discussions of incidental findings (absent from 88%) emerged as major gaps in thematic website content. When present, content pertaining to special considerations for youth, along with other ethics guidelines and requirements, were scattered throughout the websites or available only from associated documents accessed through live links. CONCLUSION: The complexities of sharing data acquired from children and adolescents will only increase with advances in genomic and neuro science. Our findings suggest that there is a need to improve the consistency, depth and accessibility of governance and policies on which these collaborations can lean specifically for vulnerable young populations.

Stakeholders' perspectives on biobank-based genomic research: systematic review of the literature.

The success of biobank-based genomic research is widely dependent on people's willingness to donate their tissue. Thus, stakeholders' opinions should be considered in the development of best practice guidelines for research and recruiting participants. We systematically analyzed the empirical literature describing different stakeholders' views towards ethical questions with regard to type of consent, data sharing and return of incidental findings. Patients are more open to one-time general consent than the public. Only a small proportion desires recontact if the research aim changed. A broad consent model would prevent only a small proportion of patients from participating in research. Although professionals are concerned about a risk of reidentification, patients and the public support data sharing and find that the benefit of research outweighs the potential risk of reidentification. However, they desire detailed information about the privacy protection measures. Regarding the return of incidental findings, the public and professionals focus on clinically actionable results, whereas patients are interested in receiving as much information as possible. For professionals, concrete guidelines that help managing the return of incidental findings should be warranted. For this it would be helpful addressing the different categories - actionable, untreatable and inheritable diseases - upfront with patients and public.

DataSHIELD: an ethically robust solution to multiple-site individual-level data analysis.

BACKGROUND: DataSHIELD (Data Aggregation Through Anonymous Summary-statistics from Harmonised Individual levEL Databases) has been proposed to facilitate the co-analysis of individual-level data from multiple studies without physically sharing the data. In a previous paper, we investigated whether DataSHIELD could protect participant confidentiality in accordance with UK law. In this follow-up paper, we investigate whether DataSHIELD addresses a broader range of ethics-related data-sharing concerns. METHODS: Ethics-related data-sharing concerns of Institutional Review Boards, ethics experts, international research consortia and research participants were identified through a literature search and systematically examined at a multidisciplinary workshop to determine whether DataSHIELD proposes mechanisms which can address these concerns. RESULTS: DataSHIELD addresses several ethics-related data-sharing concerns related to privacy, confidentiality, and the protection of the research participant's rights while sharing data and after the data have been shared. The data remain entirely under the direct management of the study that collected them. Data processing commands are strictly supervised, and the data are queried in a protected environment. Issues related to the return of individual research results when data are shared are eliminated; the responsibility for return remains at the study of origin. CONCLUSION: DataSHIELD can provide an innovative and robust solution for addressing commonly encountered ethics-related data-sharing concerns.

Comparative effects of antihypertensive drugs on stroke outcome in China.

BACKGROUND: Antihypertensive drugs are useful in the prevention of stroke; however, much debate surrounds which class of agent provides the most benefit post-stroke. AIMS: The aim of this study was to examine the impact of different classes of antihypertensive agent on stroke outcome using data from the ChinaQUEST study, a prospective, hospital-based stroke registry undertaken across 62 hospitals in China. METHODS: Logistic regression analysis was used to determine the comparative associations of different antihypertensive medications when initiated in-hospital post-stroke on the following poor outcomes in stroke survivors at three- and 12 months post-stroke: (1) death and dependency, based on modified Rankin Scale scores 3-5; (2) death; and (3) dependency. RESULTS: Of the 6416 patients with baseline data, 3986 (62%) were on at least one antihypertensive agent. After adjustment for baseline characteristics and concomitant therapies, there were no differences in outcomes between therapies at three- and 12 months, but at 12 months, calcium channel blocker use was associated with reduced risks of death/dependency (odds ratio 0·78, P = 0·001) and death (odds ratio 0·66, P < 0·001). In addition, angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist use was associated with reduced risk of death (odds ratio 0·76, P = 0·009), whereas both beta-blockers and diuretics were shown to increase the risk of death/dependency and death but had no effect on the risk of dependency. CONCLUSION: This study suggests that early initiation of calcium channel blockers is associated with improved outcome after stroke. Further randomized studies are warranted to confirm these findings and to delineate differential beneficial effects of antihypertensive therapy in stroke prevention.