Topic: Public Health Ethics

Berman Institute Launches Public Bioethics Program with Creation of the Dracopoulos-Bloomberg iDeas Lab

The COVID-19 pandemic has demonstrated in unprecedented ways the critical need of the public, governments, and the private sector to access clear, accurate and timely information about the ethical issues surrounding decision-making in science, medicine and public health. To help provide such vital information more broadly and effectively than ever before, the Berman Institute of Bioethics today announced its intention to create a new program in public bioethics, fueled by the receipt of $3 million in philanthropic support to establish the The Dracopoulos-Bloomberg Bioethics iDeas Lab.

“Virtually every aspect of our nation’s response to COVID involves an issue of bioethics: balance between personal freedom and public safety in wearing masks, and the closing and reopening of schools and businesses; allocating scarce medical resources; safely developing vaccines; using new contact tracing technology, and much more,” said Jeffrey Kahn, the Andreas C. Dracopoulos Director of the Berman Institute.

“Our public bioethics effort will significantly increase understanding about critically important issues in bioethics and ethics in science more generally. Higher levels of engagement with bioethics issues that impact our communities, locally, nationally, and internationally, will inform public discussion and debate and ultimately impact policy decisions.”

The Dracopoulos-Bloomberg Bioethics iDeas Lab, named in recognition of Andreas C. Dracopoulos, a trustee of Johns Hopkins University and member of the Berman Institute of Bioethics’ national advisory board, and former chair of the University’s board of trustees Michael R. Bloomberg, is an important first step in this effort. The Lab will enable the Berman Institute to pioneer new approaches for creating bioethics content, taking advantage of new media strategies, the latest media technologies, and innovative approaches to visualization of information and research results.

The $3 million contribution will support new physical space to house the iDeas Lab, provide new technology, and support new professional staff and faculty colleagues devoted to the creation and distribution of engaging digital, audio, and video content with a focus on dissemination professionals, policymakers, and critically important, the public. Dracopoulos previously funded creation of a similar and very successful lab at the Center for Strategic & International Studies (CSIS) in Washington, DC, one of the nation’s leading national security think tanks. The CSIS iDeas Lab was an early leader in bringing together their scholars with content producers, developers and designers to create a compelling range of digital products of research.

“The iDeas Lab will make possible for the work of bioethics, and ethics and science more generally what the creation of the Johns Hopkins Coronavirus Resource Center provided for political leaders, journalists and the public looking for authoritative thought leadership,” said Kahn. “We will employ cutting edge techniques and technologies to share the research and analysis of our faculty on the most pressing issues facing our society.”

Additional components of the public bioethics program will unfold in coming years. The Berman Institute will reach policymakers with a series of high-profile bioethics events in Washington, DC. Experts from the iDeas Lab will work with faculty across Johns Hopkins to devise new ways of sharing academic research with the public. And the Berman Institute will seek to add additional faculty with expertise in assessing the societal impact of increased public dissemination of scientific and public health scholarship.

Planning How to Allocate and Distribute a COVID-19 Vaccine

Researchers from the Berman Institute of Bioethics have co-authored a new report providing an ethical framework for making decisions about allocation and distribution of a COVID-19 vaccine during the initial period when such a vaccine has first been authorized for use and is still in limited supply.

Released by the Center for Health Security at Johns Hopkins Bloomberg School of Public Health, the report, Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States, proposes specific tiers of high-priority candidates for receiving a first vaccine based on this framework, including recognizing the contributions of essential workers who have been overlooked in previous allocation schemes:

Tier 1 includes those:

  • Most essential in sustaining the ongoing COVID-19 response.
  • At greatest risk of severe illness and death, and their caregivers.
  • Most essential to maintaining core societal functions.

Tier 2 includes those:

  • Involved in broader health provision.
  • Facing greater barriers to access care if they become seriously ill.
  • Contributing to maintenance of core societal functions.
  • Whose living or working conditions give them elevated risk of infection, even if they have lesser or unknown risk of severe illness and death.

The framework is guided by the following ethical principles, which the report authors believe should guide COVID-19 vaccine allocation and help identify more specific policy goals and objectives around vaccine policies:

  • Promotion of the common good, by promoting public health while enabling social and economic activity.
  • The importance of treating individuals fairly and promoting social equity, for example by addressing racial and ethnic disparities in COVID-19 mortality, and by recognizing the contributions of essential workers who have been overlooked in previous allocation schemes. 
  • The promotion of legitimacy, trust and a sense of community ownership over vaccine policy, while respecting the diversity of values and beliefs in our pluralist society.

The Berman Institute’s Anne Barnhill, Carleigh Krubiner and Alan Regenberg are among the co-authors, as is former Hecht-Levi Fellow Justin Bernstein, and Ruth Faden contributed.

You can access the new report here.

Maternal Health Pandemic Act Proposes Concrete Actions

By Carleigh Krubiner, Ruth Faden and Ruth Karron
Originally published by the Center for Global Development

Prior to COVID-19,  the US already had some of the worst maternal mortality rates among high-income countries. Now, the country faces growing concerns about how the pandemic can negatively impact maternal health and exacerbate racial inequities in care and outcomes surrounding childbirth. But even as the pandemic poses new challenges to supporting healthy pregnancies and deliveries, there are also opportunities to address longstanding data gaps, break down structural barriers to quality care, and reform outmoded paradigms that leave pregnant individuals behind as medicine advances.

And there’s a move afoot in the US Congress to do just that. Senator Elizabeth Warren and Representative Lauren Underwood have introduced new legislation that aims to address shortcomings in maternal and postpartum care across the ongoing pandemic response. The Maternal Health Pandemic Response Act includes provisions authorizing much-needed funding to (1) strengthen disease surveillance and data collection related to pregnancy, (2) appropriately include pregnant people in the development of new COVID-19 therapeutics and vaccines, (3) enhance health communication efforts, and (4) monitor and address sources of structural racism that put people of color at especially high risk of preventable maternal death during the ongoing crisis and beyond.

We previously issued guidance to equitably address the health interests of pregnant women in emerging epidemics, and a call to action for COVID-19 vaccines, and are encouraged the legislation seeks to advance a number of key recommendations we put forward. Below are a few highlights from the measure.

Data Collection, Surveillance, and Research on Maternal Health Outcomes:

The bill would authorize $190 million to enhance existing surveillance programs and data collection efforts related to pregnancy and COVID-19. Routine health information systems and infectious disease surveillance systems are essential to an appropriate and rapid response to emerging threats like COVID-19. Without high-quality and timely data, there is no way to know whether or how a new infectious agent puts pregnant women and their developing babies at risk. Importantly, this bill not only calls for just this kind of data; it also calls for data to be disaggregated by race, ethnicity, State, and Tribal location. Disaggregating data in this way is critical to assessing and addressing how the COVID-19 pandemic is differentially impacting various communities and population subgroups.

Fair Inclusion of Pregnant and Lactating People in Vaccine and Therapeutic Development for COVID-19:

Section 6 of the bill incorporates several key recommendations to ensure pregnant and lactating people will not be unjustifiably excluded from participating in COVID-19 research trials. Including them in trials is the best way to generate much-needed evidence on the safe and appropriate use of new treatments and vaccines in pregnancy; they should be offered the opportunity to join trials whenever the prospect of the benefits to participating outweigh the risks. The bill’s provisions also address the importance of shaping the portfolio of investments in vaccine development to help ensure that at least one product will be suitable to their needs. For example, the legislation includes reporting requirements for all drug and vaccine developers receiving federal funds to submit their plans for evaluating safety, efficacy, and dosing of products as it relates to pregnancy and lactation. There are also provisions related to using other important sources of data, such as systematic data collection from inadvertent exposures in pregnancy, and animal studies that may shed light on potential safety signals.

Additionally, the bill addresses plans for the fair inclusion of pregnant and lactating people in clinical trials, taking the position that exclusion would require justified rationale. This reflects an important shift away from the historical trend of automatic exclusion without justification toward a default position of inclusion. Decisions to exclude pregnant or lactating women should be based on sound scientific and ethical reasoning.

This bill is incredibly timely. As of August 4, there were nearly 16,000 pregnant women in the US confirmed positive for COVID-19 and 37 maternal deaths recorded. With jurisdictions across the country exploring options to sustain essential services, re-open schools, and meet the ongoing health needs of patients affected by COVID-19, there will be many pregnant individuals among those working the front lines as essential workers–particularly true in fields like education that tend to skew highly female. Compounding concern is emerging evidence published by the CDC that COVID-19 can be more severe in pregnancy as compared to in non-pregnant populations in similar age bands, with higher rates of hospitalization and ICU admission among pregnant COVID-19 patients. Pregnant and lactating people must not be overlooked as we work to combat COVID-19. To ensure that, strengthening efforts to collect much-needed evidence on how maternal health is being affected by the pandemic–particularly among those disproportionately burdened by this disease–and shaping the pipeline for new therapies and preventives that can be safely offered to people across their reproductive journeys are both critically important to achieve that goal. And while this bill is focused on the domestic context, US efforts to enhance our understanding of COVID-19 disease in pregnancy and bring about products suitable for pregnancy could also have implications for ongoing global response efforts that address maternal health needs.

The Public’s Role in COVID-19 Vaccination

Authors:
Schoch-Spana M, Brunson E, Long R, Ravi S, Ruth A, Trotochaud M on behalf of the Working Group on Readying Populations for COVID-19 Vaccine
Date posted:
July 09, 2020
Publication type:
Report
Publisher:
The Johns Hopkins Center for Health Security
See also: View PDF

Introduction

This report considers human factors in relation to future vaccines against the novel coronavirus (SARS-CoV-2), drawing on insights from design thinking and the social, behavioral, and communication sciences. It provides recommendations—directed to both US policymakers and practitioners, as well as nontraditional partners new to public health’s mission of vaccination—on how to advance public understanding of, access to, and acceptance of vaccines that protect against COVID-19.

Problem

The protracted COVID-19 pandemic has placed multiple stresses on the US public: the threat of illness and death, the isolating effects of physical distancing measures, and the uncertainties and hardships associated with disrupted economic activities. People’s resilience is being sorely tested. Operation Warp Speed (OWS) is taking extraordinary steps to develop SARS-CoV-2 vaccines as swiftly as possible and, along the way, to inspire hope that relief is coming. Despite vaccination’s promise of release, some Americans—including those most at risk of COVID-19 impacts—may miss out on, or opt out of, this life-preserving public health measure. Some may worry about whether SARS-CoV-2 vaccines are safe or if they work at all. Some may be mistrustful of vaccine manufacturers, the agencies that regulate the industry, and/or the public health authorities recommending the products. For others, the issue may be access: Will a COVID-19 vaccine be affordable, easy to get to without losing wages or taking public transportation and risking infection, and/or provided in a place that feels safe? Under these circumstances, what can be done to ensure that target populations benefit from SARS-CoV-2 vaccines? With the current lag time in vaccine availability, US vaccination planners and implementers can exercise foresight and take proactive steps now to overcome potential hurdles to vaccine uptake.

Cross-Cutting Recommendation: Put People at the Center of a Revolutionary SARS-CoV-2 Vaccine Enterprise

US research requires reconfiguring to value the contributions of both bioscience and social and behavioral science to inform SARS-CoV-2 vaccine development. If embedded within the COVID-19 response, rapid social, behavioral, and communication science can deliver timely data and empirically based advice to support vaccine delivery strategies and uptake. In the SARS-CoV-2 vaccine enterprise, communities can be active research partners, rather than passive study subjects. Finally, human-centered design principles (aka “design thinking”) can help improve the planning and implementation of the COVID-19 vaccination program.

  • Joined by private foundations, OWS should commit a portion of its budget and work through the National Institutes of Health (NIH), the National Science Foundation (NSF), and the Centers for Disease Control and Prevention (CDC) to support rapid response research into the social, behavioral, and communication issues related to COVID-19 vaccination.
  • NIH should adapt the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) model to include social/behavioral research on COVID-19 vaccination. Minority serving institutions are well-placed for partnering with communities in which hyper-localized understanding of vaccine access and acceptance issues is very much needed.
  • State and local health officials, along with university researchers from the social, behavioral, and communication sciences, should partner with grassroots groups in projects to understand how their communities are thinking about, and wanting to learn more about, SARS-CoV-2 vaccines.

Johns Hopkins Launches K-12 School Reopening Policy Tracker

A multidisciplinary team of Johns Hopkins University researchers today launched a new website that provides a range of tools dedicated to assessing and guiding K-12 school reopening plans across the United States, including a School Reopening Policy Tracker that provides real-time analysis of the latest guidance documents from every state.

According to researchers from the JHU eSchool+ Initiative, 46 State Boards of Education and 13 national policy organizations have thus far issued policy guidance about reopening K-12 schools. Equity issues are at the crux of a safe return for low-income children and children of color, and yet, one-third of reopening plans do not mention equity considerations for disadvantaged students at all, and most others mention them with little detail.

“As the United States continues to think about reopening, schools are at the forefront of every conversation. For parents to resume full-time work, schools will need to reopen, but only in a way that makes every effort to protect the safety and health of students, teachers and staff,” said Annette Campbell Anderson, deputy director of the JHU Center for Safe and Healthy Schools and an assistant professor at the School of Education. “Schools will also need to find new ways to make up for losses in learning, health, and support systems that occurred as a result of the closure. These discussions are happening right now, and our tracker analyzes how states’ proposed recovery plans support students, teachers, and parents.”

The Tracker and additional resources created by JHU’s eSchool+ Initiative are available here, and include:

“What children lose by not being in school is enormous; school attendance is a life-defining experience that is critical for educational, social and emotional development. School-age children, who very rarely die or become seriously ill from COVID-19, are being denied the benefits of attending school to protect the rest of us, particularly those at greatest risk of contracting the virus,” said Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics.

“The biggest ethical challenge for decision makers is determining how to balance the interests of children and the interests of the rest of society. Factored into this moral calculus is the additional argument that school reopening is integral to economic reopening; parents need the full-day child care schools provide in order to return to their stores, offices and factories. This big-picture trade-off decision does not, however, exhaust what is ethically at stake. Many difficult ethical decisions about exactly how schools should reopen need to be resolved.”

A collaboration between JHU’s Consortium for School-Based Health Solutions, the Berman Institute, the Rales Center for the Integration of Health and Education, and schools of Education, Medicine, and Public Health, the eSchool+ Initiative is a cross-disciplinary effort to provide actionable real-world information and guidance that has characterized the University’s response to the COVID-19 pandemic.

“Schools are a nexus of health and well-being for children, particularly in less resourced communities where the burdens of the pandemic are being borne disproportionately,” said Dr. Megan Collins, an assistant professor of ophthalmology at the Wilmer Eye Institute and Berman Institute, and co-director of the Hopkins Consortium for School-Based Health Solutions. “While schools will be monitoring the COVID-19 ‘learning slide,’ what is missing is an eye on equity for disadvantaged groups. Even as education and public health leaders advocate for making classroom-based education a priority for those children most at risk for missing school, there is no clear guidance from school districts about how structural justice problems should be addressed. By creating the eSchool+ Initiative, we hope to contribute to ongoing discussions about narrowing health and academic equity gaps for disadvantaged students.”