“Over 1000 randomized clinical trials (RCTs) for the treatment and prevention of COVID-19 have been initiated. With access to the data from RCTs, researchers can integrate and summarize findings, evaluate new hypotheses, design future trials, and prioritize the next research questions to be addressed. This ensures that the value from the investment in the RCTs goes beyond the original intent of the trial protocols. None of this is possible without first having easy and responsible systems to allow access to data: the primary tenets of the open science FAIR principles dictate a proactive intent to share results and patient data from clinical trials [Wilkinson]. While much has been written and progress has been made, there is more to be done in this journey to true openness [Rockhold]. Reasons for this include (1) the well-known complexities of data access (patient privacy, content of the trial’s informed consent and the primary data holder’s decision rights as to sharing), (2) concerns about mis-interpretation of data in the context of secondary research (beyond the original intent of the trial), and (3) the use of platform trials where multiple intervention arms are studied relative to a single control arm.
The International COVID-19 Data Alliance (ICODA) is one of the groups initiating concerted data sharing as a powerful mechanism to address COVID-19. We focus our attention to RCTs recognizing that the Alliance will encompass many other data types….”
“When people think of getting information from public bodies, they often think of Freedom of Information (FOI). But when it comes to accessing records which contain your personal information, there are now more avenues than FOI.
Of course, it’s still a useful route – while many think of the FOI request as the preserve of journalists for stories about politicians’ expenses or the behind the scenes of some dubious government decision, in fact of the nearly 40,000 FOI requests last year, nearly 60% were for personal information….”
“Are you sick of health care systems not communicating with each other? Do you wish you could access more of your medical information — or your patients’ information — online? Do you ever wonder whether a health pattern you see is part of a larger trend? Two key developments have advanced the vision of seamless, secure exchange of electronic health records (EHRs) among health care institutions and patients.
That vision includes being able to learn from our data at a population scale. Through federal regulations issued this year, it will finally become reality in 2022. And the vision began at Boston Children’s Hospital more than a decade ago….”
“OpenNotes is the international movement promoting and studying transparent communication in healthcare. We help patients and clinicians share meaningful notes in medical records. We call these open notes….
OpenNotes is not software or a product. It’s a call to action.”
“Taking effect in April, 2021, rules implementing the bipartisan federal Cures Act specify that clinical notes are among electronic information that must not be blocked and must be made available free of charge to patients. To meet the interests of some patients, the rules allow specified exceptions….”
“Two thousand servers containing 45 million images of X-rays and other medical scans were left online during the course of the past twelve months, freely accessible by anyone, with no security protections at all.
Or so says research by CybelAngel, which sells a Digital Risk Protection Platform. Not only was the sensitive personal information unsecured, but malicious folk had also accessed those servers and poisoned them with apparent malware, the company added….”
Open source – All software required to run the infrastructure should be available under an open source license. This does not include other software that may be involved with running the organisation.
Open data (within constraints of privacy laws) – For an infrastructure to be forked it will be necessary to replicate all relevant data. The CC0 waiver is best practice in making data legally available. Privacy and data protection laws will limit the extent to which this is possible
Available data (within constraints of privacy laws) – It is not enough that the data be made “open” if there is not a practical way to actually obtain it. Underlying data should be made easily available via periodic data dumps.
Patent non-assertion – The organisation should commit to a patent non-assertion covenant. The organisation may obtain patents to protect its own operations, but not use them to prevent the community from replicating the infrastructure….”
Abstract: The importance of data sharing and biobanking are increasingly being recognised in global health research. Such practices are perceived to have the potential to promote science by maximising the utility of data and samples. However, they also raise ethical challenges which can be exacerbated by existing disparities in power, infrastructure and capacity. The Global Forum on Bioethics in Research (GFBR) convened in Stellenbosch, South Africa in November 2018, to explore the ethics of data sharing and biobanking in health research. Ninety-five participants from 35 countries drew on case studies and their experiences with sharing in their discussion of issues relating to respecting research participants and communities, promoting equitable sharing, and international and national approaches to governing data sharing and biobanking. In this editorial we will briefly review insights relating to each of these three themes.
“There are more than 25 million Open Access versions of otherwise “paywalled” scientific articles, however they are often not easy to find.
Open Access Helper for iOS & macOS is designed to help you get easy access to these documents, with a lot of help from some amazing APIs….
Open Access Helper is designed to make finding the best Open Access location easy. Whenever my app comes across a DOI, it will query the APIs of unpaywall.org & core.ac.uk to see if an Open Access copy is available elsewhere.
The App is free and Open Source and I have no intention to change that….”
Abstract: Privacy and confidentiality are core considerations in education, while at the same time, using and sharing data—and, more broadly, open science—is increasingly valued by editors, funding agencies, and the public. This manuscript responds to an empirical investigation of students’ perceptions of the use of their data in learning analytics systems by Ifentahler and Schumacher (Educational Technology Research and Development, 64: 923-938, 2016). We summarize their work in the context of the COVID-19 pandemic and the resulting shift to digital modes of teaching and learning by many teachers, using the tension between privacy and open science to frame our response. We offer informed recommendations for educational technology researchers in light of Ifentahler and Schumacher’s findings as well as strategies for navigating the tension between these important values. We conclude with a call for educational technology scholars to meet the challenge of studying learning (and disruptions to learning) in light of COVID-19 while protecting the privacy of students in ways that go beyond what Institutional Review Boards consider to be within their purview.