Health Citizenship: A New Social Contract To Improve The Clinical Trial Process

Curated on Posted on by Stefaan Verhulst

Essay by Cynthia Grossman  and Tanisha Carino: “…We call this new social contract health citizenship, which includes a set of implied rights and responsibilities for all parties.

Three fundamental truths underpin our efforts:

  1. The path to better health and the advancement of science begin and end with engaged patients.
  2. The biomedical research enterprise lives all around us — in clinical trials, the data in our wearables, electronic health records, and data used for payment.
  3. The stakeholders that fuel advancement — clinicians, academia, government, the private sector, and investors — must create a system focused on speeding medical research and ensuring that patients have appropriate access to treatments.

To find tomorrow’s cures, treatments, and prevention measures, every aspect of society needs to get involved. Health citizenship recognizes that the future of innovative research and development depends on both patients and the formal healthcare system stepping up to the plate.

Moving Toward A Culture Of Transparency  

Increasing clinical trials registration and posting of research results are steps in the direction of transparency. Access to information about clinical trials — enrollment criteria, endpoints, locations, and results — is critical to empowering patients, their families, and primary care physicians. Also, transparency has a cascading impact on the cost and speed of scientific discovery, through ensuring validation and reproducibility of results…..

Encouraging Data Sharing

Data is the currency of biomedical research, and now patients are poised to contribute more of it than ever. In fact, many patients who participate in clinical research expect that their data will be shared and want to be partners, not just participants, in how data is used to advance the science and clinical practice that impact their disease or condition.

Engaging more patients in data sharing is only one part of what is needed to advance a data-sharing ecosystem. The National Academies of Science, Engineering, and Medicine (formerly the Institute of Medicine) conducted a consensus study that details the challenges to clinical trial data sharing. Out of that study spun a new data-sharing platform, Vivli, which will publicly launch this year. The New England Journal of Medicine took an important step toward demonstrating the value of sharing clinical trial data through its SPRINT Data Challenge, where it opened up a data set and supported projects that sought to derive new insights from the existing data. Examples like these will go a long way toward demonstrating the value of data sharing to advancing science, academic careers, and, most importantly, patient health.

As the technology to share clinical trial data improves, it will become less of an impediment than aligning incentives. The academic environment incentivizes researchers through first author and top-tier journal publications, which contribute to investigators holding on to clinical trial data. A recent publication suggests a way to ensure academic credit, through publication credit, for sharing data sets and allows investigators to tag data sets with unique IDs.

While this effort could assist in incentivizing data sharing, we see the value of tagging data sets as a way to rapidly gather examples of the value of data sharing, including what types of data sets are taken up for analysis and what types of analyses or actions are most valuable. This type of information is currently missing, and, without the value proposition, it is difficult to encourage data sharing behavior.

The value of clinical trial data will need to be collectively reexamined through embracing the sharing of data both across clinical trials and combined with other types of data. Similar to the airline and car manufacturing industries sharing data in support of public safety,7 as more evidence is gathered to support the impact of clinical trial data sharing and as the technology is developed to do this safely and securely, the incentives, resources, and equity issues will need to be addressed collectively…(More)”.

Redefining ‘impact’ so research can help real people right away, even before becoming a journal article

Curated on Posted on by Stefaan Verhulst

Perhaps nowhere is impact of greater importance than in my own fields of ecology and conservation science. Researchers often conduct this work with the explicit goal of contributing to the restoration and long-term survival of the species or ecosystem in question. For instance, research on an endangered plant can help to address the threats facing it.

But scientific impact is a very tricky concept. Science is a process of inquiry; it’s often impossible to know what the outcomes will be at the start. Researchers are asked to imagine potential impacts of their work. And people who live and work in the places where the research is conducted may have different ideas about what impact means.

In collaboration with several Bolivian colleagues, I studied perceptions of research and its impact in a highly biodiverse area in the Bolivian Amazon. We found that researchers – both foreign-based and Bolivian – and people living and working in the area had different hopes and expectations about what ecological research could help them accomplish…

Eighty-three percent of researchers queried told us their work had implications for management at community, regional and national levels rather than at the international level. For example, knowing the approximate populations of local primate species can be important for communities who rely on the animals for food and ecotourism.

But the scale of relevance didn’t necessarily dictate how researchers actually disseminated the results of their work. Rather, we found that the strongest predictor of how and with whom a researcher shared their work was whether they were based at a foreign or national institution. Foreign-based researchers had extremely low levels of local, regional or even national dissemination. However, they were more likely than national researchers to publish their findings in the international literature….

Rather than impact being addressed at the end of research, societal impacts can be part of the first stages of a study. For example, people living in the region where data is to be collected might have insight into the research questions being investigated; scientists need to build in time and plan ways to ask them. Ecological fieldwork presents many opportunities for knowledge exchange, new ideas and even friendships between different groups. Researchers can take steps to engage more directly with community life, such as by taking a few hours to teach local school kids about their research….(More)”.

How Do You Control 1.4 Billion People?

Curated on Posted on by Stefaan Verhulst

Robert Foyle Hunwick at The New Republic: China’s “social credit system”, which becomes mandatory in 2020, aims to funnel all behavior into a credit score….The quoted text is from a 2014 State Council resolution which promises that every involuntary participant will be rated according to their “commercial sincerity,” “social security,” “trust breaking” and “judicial credibility.”

Some residents welcome it. Decades of political upheaval and endemic corruption has bred widespread mistrust; most still rely on close familial networks (guanxi) to get ahead, rather than public institutions. An endemic lack of trust is corroding society; frequent incidents of “bystander effect”—people refusing to help injured strangers for fear of being held responsible—have become a national embarrassment. Even the most enthusiastic middle-class supporters of the ruling Communist Party (CCP) feel perpetually insecure. “Fraud has become ever more common,” Lian Weiliang, vice chairman of the CCP’s National Development and Reform Commission, recently admitted. “Swindlers must pay a price.”

The solution, apparently, lies in a data-driven system that automatically separates the good, the bad, and the ugly…

once compulsory state “social credit” goes national in 2020, these shadowy algorithms will become even more opaque. Social credit will align with Communist Party policy to become another form of law enforcement. Since Beijing relaxed its One Child Policy to cope with an aging population (400 million seniors by 2035), the government has increasingly indulged in a form of nationalist natalism to encourage more two-child families. Will women be penalized for staying single, and rewarded for swapping their careers for childbirth? In April, one of the country’s largest social-media companies banned homosexual content from its Weibo platform in order to “create a bright and harmonious community environment” (the decision was later rescinded in favor of cracking down on all sexual content). Will people once again be forced to hide non-normative sexual orientations in order to maintain their rights? An investigation by the University of Toronto’s Citizen Lab also warns that social credit policies would be used to discourage protest.

State media has defended social credit against Orwellian charges, arguing that China’s maturing economy requires a “well-functioning” apparatus like the U.S.’s FICO credit score system. But, counters Lubman, “the U.S. systems, maintained by three companies, collect only financially related information.” In the UK, citizens are entitled to an Equifax report itemizing their credit status. In China, only the security services have access to an individual’s dang’an, the personal file containing every scrap of information the state keeps on them, from exam results to their religious and political views….(More)”.

The DNA Data We Have Is Too White. Scientists Want to Fix That

Curated on Posted on by Stefaan Verhulst

Sarah Elizabeth Richards at Smithsonian: “We live in the age of big DNA data. Scientists are eagerly sequencing millions of human genomes in the hopes of gleaning information that will revolutionize health care as we know it, from targeted cancer therapies to personalized drugs that will work according to your own genetic makeup.

There’s a big problem, however: the data we have is too white. The vast majority of participants in worldwide genomics research are of European descent. This disparity could potentially leave out minorities from benefitting from the windfall of precision medicine. “It’s hard to tailor treatments for people’s unique needs, if the people who are suffering from those diseases aren’t included in the studies,” explains Jacquelyn Taylor, associate professor in nursing who researches health equity at New York University.

That’s about to change with the “All of Us” initiative, an ambitious health research endeavor by the National Institutes of Health that launches in May. Originally created in 2015 under President Obama as the Precision Medicine Initiative, the project aims to collect data from at least 1 million people of all ages, races, sexual identities, income and education levels. Volunteers will be asked to donate their DNA, complete health surveys and wear fitness and blood pressure trackers to offer clues about the interplay of their stats, their genetics and their environment….(More)”.

Government to establish a ‘National Data Commissioner’

Curated on Posted on by Stefaan Verhulst

Rohan Pearce at Computerworld – Australia: “A new position of the ‘National Data Commissioner’ will be established as part of a $65 million, four-year open data push by the federal government.

The creation of the new position is part of the government’s response to the Productivity Commission inquiry into the availability and use of public and private data by individuals and organisations.

The government in November revealed that it would legislate a new Consumer Data Right as part of its response to the PC’s recommendations. The government said that this will allow individuals to access data relating to their banking, energy, phone and Internet usage, potentially making it easier to compare and switch between service providers.

The Office of the Australian Information Commissioner and the Australian Competition and Consumer Commission will have oversight of the Consumer Data Right.

The government said today it would introduce a new data sharing and release framework to streamline the way government data is made available for use by researchers and public and private sector organisations.

The framework’s aim will be to promote the greater use of data and drive related economic and innovation benefits as well as to “Build trust with the Australian community about the government’s use of data”.

The government said it would push a risk-based approach to releasing publicly funded data sets.

The National Data Commissioner will be supported by a National Data Advisory Council. The council “will advise the National Data Commissioner on ethical data use, technical best practice, and industry and international developments.”…(More).

Examining Civil Society Legitimacy

Curated on Posted on by Stefaan Verhulst

Saskia Brechenmacher and Thomas Carothers at Carnegie Endowment for International Peace: “Civil society is under stress globally as dozens of governments across multiple regions are reducing space for independent civil society organizations, restricting or prohibiting international support for civic groups, and propagating government-controlled nongovernmental organizations. Although civic activists in most places are no strangers to repression, this wave of anti–civil society actions and attitudes is the widest and deepest in decades. It is an integral part of two broader global shifts that raise concerns about the overall health of the international liberal order: the stagnation of democracy worldwide and the rekindling of nationalistic sovereignty, often with authoritarian features.

Attacks on civil society take myriad forms, from legal and regulatory measures to physical harassment, and usually include efforts to delegitimize civil society. Governments engaged in closing civil society spaces not only target specific civic groups but also spread doubt about the legitimacy of the very idea of an autonomous civic sphere that can activate and channel citizens’ interests and demands. These legitimacy attacks typically revolve around four arguments or accusations:

  • That civil society organizations are self-appointed rather than elected, and thus do not represent the popular will. For example, the Hungarian government justified new restrictions on foreign-funded civil society organizations by arguing that “society is represented by the elected governments and elected politicians, and no one voted for a single civil organization.”
  • That civil society organizations receiving foreign funding are accountable to external rather than domestic constituencies, and advance foreign rather than local agendas. In India, for example, the Modi government has denounced foreign-funded environmental NGOs as “anti-national,” echoing similar accusations in Egypt, Macedonia, Romania, Turkey, and elsewhere.
  • That civil society groups are partisan political actors disguised as nonpartisan civic actors: political wolves in citizen sheep’s clothing. Governments denounce both the goals and methods of civic groups as being illegitimately political, and hold up any contacts between civic groups and opposition parties as proof of the accusation.
  • That civil society groups are elite actors who are not representative of the people they claim to represent. Critics point to the foreign education backgrounds, high salaries, and frequent foreign travel of civic activists to portray them as out of touch with the concerns of ordinary citizens and only working to perpetuate their own privileged lifestyle.

Attacks on civil society legitimacy are particularly appealing for populist leaders who draw on their nationalist, majoritarian, and anti-elite positioning to deride civil society groups as foreign, unrepresentative, and elitist. Other leaders borrow from the populist toolbox to boost their negative campaigns against civil society support. The overall aim is clear: to close civil society space, governments seek to exploit and widen existing cleavages between civil society and potential supporters in the population. Rather than engaging with the substantive issues and critiques raised by civil society groups, they draw public attention to the real and alleged shortcomings of civil society actors as channels for citizen grievances and demands.

The widening attacks on the legitimacy of civil society oblige civil society organizations and their supporters to revisit various fundamental questions: What are the sources of legitimacy of civil society? How can civil society organizations strengthen their legitimacy to help them weather government attacks and build strong coalitions to advance their causes? And how can international actors ensure that their support reinforces rather than undermines the legitimacy of local civic activism?

To help us find answers to these questions, we asked civil society activists working in ten countries around the world—from Guatemala to Tunisia and from Kenya to Thailand—to write about their experiences with and responses to legitimacy challenges. Their essays follow here. We conclude with a final section in which we extract and discuss the key themes that emerge from their contributions as well as our own research…

  1. Saskia Brechenmacher and Thomas Carothers, The Legitimacy Landscape
  2. César Rodríguez-Garavito, Objectivity Without Neutrality: Reflections From Colombia
  3. Walter Flores, Legitimacy From Below: Supporting Indigenous Rights in Guatemala
  4. Arthur Larok, Pushing Back: Lessons From Civic Activism in Uganda
  5. Kimani Njogu, Confronting Partisanship and Divisions in Kenya
  6. Youssef Cherif, Delegitimizing Civil Society in Tunisia
  7. Janjira Sombatpoonsiri, The Legitimacy Deficit of Thailand’s Civil Society
  8. Özge Zihnioğlu, Navigating Politics and Polarization in Turkey
  9. Stefánia Kapronczay, Beyond Apathy and Mistrust: Defending Civic Activism in Hungary
  10. Zohra Moosa, On Our Own Behalf: The Legitimacy of Feminist Movements
  11. Nilda Bullain and Douglas Rutzen, All for One, One for All: Protecting Sectoral Legitimacy
  12. Saskia Brechenmacher and Thomas Carothers, The Legitimacy Menu….(More)”.

The global identification challenge: Who are the 1 billion people without proof of identity?

Curated on Posted on by Stefaan Verhulst

Vyjayanti Desai at The Worldbank: “…Using a combination of the self-reported figures from country authorities, birth registration and other proxy data, the 2018 ID4D Global Dataset suggests that as many as 1 billion people struggle to prove who they are. The data also revealed that of the 1 billion people without an official proof of identity:

  • 81% live in Sub-Saharan Africa and South Asia, indicating the need to scale up efforts in these regions
  • 47% are below the national ID age of their country, highlighting the importance of strengthening birth registration efforts and creating a unique, lifetime identity;
  • 63% live in lower-middle income economies, while 28% live in low-income economies, reinforcing that lack of identification is a critical concern for the global poor….

In addition, to further strengthen understanding of who the undocumented are and the barriers they face, ID4D partnered with the 2017 Global Findex to gather for the first time this year, nationally-representative survey data from 99 countries on foundational ID coverage, use, and barriers to access. Early findings suggest that residents of low income countries, particularly women and the poorest 40%, are the most affected by a lack of ID. The survey data (albeit limited in its coverage to people aged 15 and older) confirm that the coverage gap is largest in low income countries (LICs), where 38% of the surveyed population does not have a foundational ID. Regionally, sub-Saharan Africa shows the largest coverage gap, where close to one in three people in surveyed countries lack a foundational ID.

Although global gender gaps in foundational ID coverage are relatively small, there is a large gender gap for the unregistered population in low income countries – where over 45% of women lack a foundational ID, compared to 30% of men.  The countries with the greatest #gender gaps in foundational ID coverage also tend to be those with #legal barriers for women’s access to #identity documents….(More)”.

New Repository of Government Data Visualizations and Maps

Curated on Posted on by Stefaan Verhulst

Press Release: “Data-Smart City Solutions, a program of Harvard Kennedy School’s Ash Center for Democratic Governance and Innovation, today launched a searchable public database comprising cutting-edge examples of public sector data use. The “Solutions Search” indexes interactive maps and visualizations, spanning civic issue areas such as transportation, public health, and housing, that are helping data innovators more accurately understand and illustrate challenges, leading to optimized solutions.

The new user-friendly public database includes 200 data-driven models for civic technologists, community organizations, and government employees. “By showcasing successful data-driven initiatives from across the country, we have the opportunity to help city leaders learn from each other and avoid reinventing the wheel,” noted Stephen Goldsmith, Daniel Paul Professor of the Practice of Government and faculty director of the Innovations in Government Program at the Ash Center, who also leads the Civic Analytics Network, a national network of municipal chief data officers.

This new Harvard database spans city, county, state, and federal levels, and features a wide variety of interventions and initiatives, including maps, data visualizations, and dashboards. Examples include the California Report Card and GradeDC.gov, dashboards that measurecommunity health – and run on citizen input, allowing residents to rank various city services and agencies. Users can also find Redlining Louisville: The History of Race, Class, and Real Estate, a visualization that explores the impact of disinvestment in Louisville neighborhoods….(More)”.

China asserts firm grip on research data

Curated on Posted on by Stefaan Verhulst

ScienceMag: “In a move few scientists anticipated, the Chinese government has decreed that all scientific data generated in China must be submitted to government-sanctioned data centers before appearing in publications. At the same time, the regulations, posted last week, call for open access and data sharing.

The possibly conflicting directives puzzle researchers, who note that the yet-to-be-established data centers will have latitude in interpreting the rules. Scientists in China can still share results with overseas collaborators, says Xie Xuemei, who specializes in innovation economics at Shanghai University. Xie also believes that the new requirements to register data with authorities before submitting papers to journals will not affect most research areas. Gaining approval could mean publishing delays, Xie says, but “it will not have a serious impact on scientific research.”

The new rules, issued by the powerful State Council, apply to all groups and individuals generating research data in China. The creation of a national data center will apparently fall to the science ministry, though other ministries and local governments are expected to create their own centers as well. Exempted from the call for open access and sharing are data involving state and business secrets, national security, “public interest,” and individual privacy… (More)”

Accountability in modern government: what are the issues?

Curated on Posted on by Stefaan Verhulst

Discussion Paper by Benoit Guerin, Julian McCrae and Marcus Shepheard: “…Accountability lies at the heart of democratic government. It enables people to know how the Government is doing and how to gain redress when things go wrong. It ensures ministers and civil servants are acting in the interests of the people they serve.

Accountability is a part of good governance and it can increase the trustworthiness and legitimacy of the state in the eyes of the public. Every day, 5.4 million public sector workers deliver services ranging from health care to schools to national defence.1 A host of bodies hold them to account – whether the National Audit Office undertaking around 60 value for money inquiries a year,2 Ofsted inspecting more than 5,000 schools per year, or the main Government ombudsman services dealing with nearly 80,000 complaints from the public in 2016/17 alone. More than 21,000 elected officials, ranging from MPs to local councillors, scrutinise these services on behalf of citizens.

When that accountability works properly, it helps the UK’s government to be among the best in the world. For example, public spending is authorised by Parliament and routinely stays within the limits set. The accountability that surrounds this – provided through oversight by the Treasury, audit by the National Audit Office and scrutiny by the Public Accounts Committee – is strong and dates back to the 19th century. However, in areas where that accountability is weak, the risk of failure – whether financial mismanagement, the collapse of services or chronic underperformance – increases. …

There are three factors underpinning the weak accountability that is perpetuating failure. They are: fundamental gaps in accountability in Whitehall; a failure of accountability beyond Whitehall to keep pace with an increasingly complex public sector landscape; and a pervading culture of blame….

This paper suggests potential options for strengthening accountability, based on our analysis. These involve changes to structures, increased transparency and moves to improve the culture. These options are meant to elicit discussion rather than to set the Institute for Government’s position at this stage….(More)”