by Nuriel Moghavem
A New York Times article published this week describes a clinical trial in Pittsburgh where incapacitated and rapidly exsanguinating gunshot victims have their blood replaced by cold saline for up to an hour in an effort to preserve neurological function and life. This trial has raised many ethical concerns, one of which is whether the community consultation conducted before and during the trial (which is required by federal guidelines) was adequate enough to inform the community about the opt-out trial and to collect extensive feedback from it. In my opinion, the trial’s failure to integrate new technologies, especially social media, represents a missed opportunity to fully meet the ethical goal of legitimacy in community consultation (Dickert and Sugarman, 2005).
The issue of community consultation was last extensively evaluated in 2006, following the clinical trial of a synthetic blood product, PolyHeme. Most of an entire issue of AJOB focused on the issue of community consultation in obtaining an emergency waiver of consent from an IRB; the debate at that time focused on questions of race, defining community, methods used to consult the community, and contemporary research paradigms. Since that debate nearly a decade ago, social media has introduced what should be a new paradigm shift in this discussion. Unfortunately, IRB approval of the EPR-CAT trial in Pittsburgh shows that the same methods for community communication are still being used after the lessons learned in 2006, and that social media’s redefinition of community and communication has failed to make an impact on IRB protocols.
Central to the question of whether the goals of community consultation were met in the EPR-CAT trial – and the key to why social media should be an important part of the process – is a discussion of the makeup of likely trial participants. A 2010 Alleghany County report indicates that 97% of homicide victims there are Black, meaning that it is statistically unlikely that a single member of the 20-person trial will be White. Furthermore, that same 2010 report indicates that 63% of gunshot victims were between 15 and 34; a similar report from the State of Pennsylvania claims a figure of 68% for Alleghany County between 2007-2011.
In sum, Black race and youth are inextricable qualities of the “community” that this trial sought to consult, yet, according to the New York Times, the community consultation focused on town hall meetings (at the university campus, not in Black neighborhoods), bus ads, and newspaper ads. The data below show that these are not the best methods to reach young or Black Americans. Further, the approach taken is better characterized as a process of notification, given limited options for feedback from the targeted population.
First, researchers would have been far better served to take out an advertisement on Facebook than in a newspaper. According to the Pew Research Journalism Project, very few young Americans read newspapers: 20% of those between 18-24, and 21% of those between 25-34 report reading any newspaper frequently. Of African-Americans of all ages, 32% report frequent newspaper readership. In contrast, Pew shows that Blacks use social media more than any other racial group (76% of all Blacks online use Facebook vs 71% of all Whites), and that young Americans use it frequently: 84% of online Americans between 18-29 use Facebook daily. In other words, advertisements on social media platforms would substantially increase the visibility of a trial such as EPR-CAT by allowing for targeted ads that would amplify themselves once shared by community members. Furthermore, social media advertisements allow for the engagement and feedback that would help such a trial engage in a consultation rather than a notification, and ultimately reach a threshold of legitimacy in a given community.
Second, while bus advertisements may reach eyes, a more successful approach in the 21st century may be a dedicated webpage using lay terms and keywords that would make the site easy to find through a search engine. A Google search today for the trial brings up two jargon-heavy press releases and one YouTube video with less than 50,000 views (nearly all occurring since publication of the New York Times story) and only 63 shares on social media (again, almost all in the last week). The Internet is noisy, and publicly accessible information online needs to be amplified and delivered to the public to qualify as de facto public information. That amplification can be achieved by buying advertisements online, particularly on social media platforms shown by data to be most used by the community in question (today, that platform is Facebook, but that may change in the future). To ensure that the amplification of online content is occurring, IRBs should establish timetables and endpoints for number of views on webpages, videos and social media advertisements when massive opt-out trials seek to inform the public using the Internet. There is an obvious pitfall in this – mandating the number of ads would be more clear than mandating the result of those ads – but if the goal is to get true community buy-in for a study of this sort, the result should be considered.
Ultimately, IRBs and researchers should make better use of social media and seek to better understand the nature of communication between young people. Due diligence must be given to the shifting of society’s sources of information, and given the ubiquity of social media today – across all races and age groups – it should be considered an absolute ethical must in obtaining legitimate community consultation. In fact, platforms that allow viral distribution of local news and can track the exact number of views attained, with a built-in functionality for commenting and discussion, are perfect for trials like EPR-CAT. If online feedback showed overwhelmingly negative responses to a trial, it may give the researchers pause and may call into question issues of autonomy and consent. My hope is that researchers and IRBs treat these new technologies as a blessing rather than a burden, and an opportunity in the future to get real community consultation in the pursuit of better medicine.