The ethics of sharing preliminary research findings during public health emergencies: a case study from the 2009 influenza pandemic

Abstract

During the 2009 A(H1N1) influenza pandemic, a suite of studies conducted in Canada showed an unexpected finding, that patients with medically attended laboratory-confirmed pandemic influenza were more likely to have received seasonal influenza vaccination than test-negative control patients. Different bodies, including scientific journals and government scientific advisory committees, reviewed the evidence simultaneously to determine its scientific validity and implications. Decision-making was complicated when the findings made their way into the media. The normal trajectory of non-urgent research includes peer-review publication after which decision-makers can process the information taking into account other evidence and logistic considerations. In the situation that arose, however, the congruence of an unexpected finding and the simultaneous review of the evidence both within and outside the traditional peer-review sphere raised several interesting issues about how to deal with emerging evidence during a public health emergency. These events are used in this article to aid discussion of the complex interrelationship between researchers, public health decision-makers and scientific journals, the trade-offs between sharing information early and maintaining the peer-review quality assurance process, and to emphasise the need for critical reflection on the practical and ethical norms that govern the way in which research is evaluated, published and communicated in public health emergencies. Context of research, public health and scientific journals -three solitudes?Improving population health relies on the generation of knowledge by researchers as well as the communication and translation of knowledge to action by public health decision-makers. During public health emergencies, undertaking rapid high-quality scientific research and communicating research findings is a practical, professional and ethical imperative. In such contexts, the need for evidence is most pressing, but short timelines, limited data and the pressure of competing priorities make acquiring this evidence challenging. The speed at which information is needed by policymakers may be faster than usually possible through traditional mechanisms of research dissemination. As an example, only 7% of studies on severe acute respiratory syndrome (SARS) were published during the 2003 outbreak [1].

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

“…Integrating all stakeholders into each step of the developing research programme [3,48,69], engaging communities as partners [1,3] and gaining an understanding of power dynamics [34] were facilitators cited to address this. It was also emphasised that interventions need to be culturally sensitive [27,29,44,50,51,58] and respond to national as well as global need [36]. Examples of community engagement included regular information sessions [3,5,16,29,34,42,[69][70][71], joint communication plans [20,29], outreach health promotion teams [69] and formation of community advisory boards [69].…”

Is ‘conflict of interest’ a Misnomer? Managing interests in immunization research and evaluation

“…For example, reports of increased risk of 2009 pandemic influenza A (H1N1) requiring medical attention among individuals who had received the 2008–09 seasonal influenza vaccine were challenging for many researchers, public health decision-makers, and academic journals to accept. 6 Findings of increased risk of childhood narcolepsy following H1N1 vaccination were similarly difficult for many to accept, resulting in delayed publication and dissemination of findings. 7 Initially, both of these observations were actively dismissed by many as they were counter to the existing knowledge paradigm.…”

Ebola and Learning Lessons from Moral Failures: Who Cares about Ethics?: Table 1.

“…The emphasis on the common and collective good that is at risk in pandemics is in fact at the very center of the relational public health ethics perspective (Kenny et al, 2010). The importance of solidarity has even been translated into guidance for how to actually realize ethical requirements in outbreak preparedness and response, such as for data and tissue sharing during a global infectious disease outbreak (Langat et al, 2011;Crowcroft et al, 2014). Yet, regressions on these ethical lessons appear to have occurred with little controversy during the EVD outbreak; travel bans and restrictions, trade restrictions, limited data and resource sharing and other practices geared toward protecting national selfinterest were again adopted rather than accepting shared responsibility (World Health Organization, 2015a).…”