COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise.

A key aspect of the National Institutes of Health (NIH) funded Rapid Acceleration of Diagnostics (RADx) Tech program was an active Clinical Studies Core including Committees with unique expertise to facilitate the development and implementation of studies to test novel diagnostic devices for Covid-19. The Ethics and Human Subjects Oversight Team (EHSO) was tasked to provide ethics and regulatory expertise to stakeholders in the RADx Tech effort. The EHSO developed a set of Ethical Principles to guide the overall effort and provided consultation on a wide range of ethical and regulatory concerns. Having access to a pool of experts with ethical and regulatory knowledge who met weekly to tackle issues of importance to the investigators was critical to the overall success of the project.

The ethics of global COVID-19 vaccine allocation

IntroductionPolicies to increase global vaccine access involve HICs making ethically fraught tradeoffs between saving lives at home or abroad. Such policies should be justifiable to the affected populations. Yet there is little robust data on whether HIC residents endorse their countries’ policy choices. Most existing data asks highly simplified questions, without providing background on the ethical tradeoffs involved. These data do not capture the public’s informed views, giving policymakers limited guidance on how to craft international vaccine policy. This paper provides the first nuanced data on the informed views of a representative sample of the U.S. public about providing COVID vaccine to poorer countries.MethodsThis study involved two interventions: a description of ethical arguments for/against providing vaccine to poorer countries and visuals depiction of ethically relevant tradeoffs about providing vaccine to poorer countries at different time points in the US vaccination campaign. A representative sample of 4000 U.S. adults were surveyed, divided evenly into four arms: 1) arguments only;2) tradeoffs only;3) both interventions;4) no interventions.ResultsAcross all four arms, people are more willing to donate vaccines than previously reported, with generosity increasing over time. 43% of respondents were willing to share at an early timepoint when supply was extremely limited, increasing to 54% and 71% at intermediate and current timepoints, respectively. Some specific variables (e.g., political affiliation, age, acceptability of masks) were predictive of willingness to donate and endorsement of specific arguments.DiscussionThese data can guide policy about providing or keeping U.S. vaccine doses as the world navigates the effects of new variants and the potential need for booster shots in the coming months. Given high levels of willingness to donate, U.S. policy could have initiated global vaccine donations earlier and could be more generous currently.

A snapshot of U.S. IRB review of COVID-19 research in the early pandemic.

BACKGROUND/OBJECTIVE: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered. METHODS: Structured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP). RESULTS: Fourteen of the 32 HRPP director members responded to a questionnaire about their approach to review and oversight during COVID-19. Eleven of the 14 provided summary data on COVID-19-specific protocols and six of the 11 provided protocol-related documents for our review. All respondents adopted at least one additional COVID-19-specific step to their usual review process. The average turnaround time for convened and expedited IRB reviews was 15 calendar days. In our review of the documents from 194 COVID-19-specific protocols (n = 302 documents), we identified only a single review that raised ethical concerns unique to COVID-19. CONCLUSIONS: Our data provide a snapshot of how HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA. While not generalizable to all HRPPs, these data indicate that HRPPs can adapt and respond quickly response to a pandemic and likely need little novel expertise in the review and oversight of COVID-19-specific protocols.

The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic.

In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision-making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast-moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.

So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development.

BACKGROUND: A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms. METHODS: Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks. RESULTS: Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust. CONCLUSION: Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.