SGEM Peds Xtra: Making Research Better, Faster, Stronger

Date: October 24, 2022 Guest Skeptic: Dr. Damian Roland is a Consultant at the University of Leicester NHS Trust and Honorary Professor for the University of Leicester’s SAPPHIRE group. He specializes in Pediatric Emergency Medicine and is a passionate believer and advocate of FOAMed. Damian is also part of the Don’t Forget the Bubbles team. Dr. Damian Roland I sent Damian a message on Twitter after he posted about his pre-print paper, “Concomitant infection of COVID19 & Serious Bacterial infection in Infants <90 Days Old during Omicron Surge.”  It was a rapid evaluation under the remit of the Public Health/Disease Control so did not require review by a Research Ethics Committee (REC). Unfortunately, journals, do not typically accept this and want to see ethics derogation. This led to a conversation about research ethics and governance. It is important to acknowledge that historically, the medical community has not always conducted research ethically. We took advantage of vulnerable and minority populations as evidenced by Nazi medical experimentation in the concentration camps, the Tuskegee Syphilis Study, or the HeLa cells of Henrietta Lacks. We recognize the importance of research oversight and ethical research, but our world is changing… How have emerging pandemics, technology, and social media impacted the way we conduct and disseminate research? We covered five topics: Ethics of Research in Pandemics Maintaining Research Quality Deferred Consent Big Data Sharing Research on Social Media Ethics of Research in Pandemics Many processes that govern research were scaled back to enable rapid translation of ideas. Some of this was good (ex. steroids in Covid, vaccines) but some had some potentially detrimental consequences (think pre-prints) [1]. It was much easier (in the UK) to access national data sets, and this enabled real-time research to take place. During pandemics, we need to be nimble but governed when conducting research. For example, when a new disease process (ex. PIMS TS or MIS-C) is of such a public health importance that we need to understand it as fast as possible, it is difficult to do so under stringent ethics and governance practices. For the next pandemic, we need to have systems in place for research studies to be pre-approved and ready to go as soon as a pandemic hits. Maintaining Research Quality At one point there were over 100 articles being published per day about COVID-19 [2]. Not all of them were useful or high quality. Keep in mind the words of Professor Altman, “we need less research, better research, and research done for the right reasons.”[3] It is possible to have well-governed research that is poor quality but finds itself through poor review, disseminated widely in a high-quality journal. Conversely, there can be well-governed research that is high-quality, but journals disagree, and that research has less impact because it is not perceived by journals to be good. The issue of ethical review should be separate from quality and governance. Does ethical review encompass the standard or quality of research or the mechanism of ensuring that the research is ethically performed? A randomized control trial is always going to have ethical review whereas an observational study may not. Should research that is well thought out and robust but lacking ethical approval be excluded from journals because editors perceive it does not meet the standard for high-quality research? We separated 1) the governance of conducting research 2) the process of research, and 3) the publication of research and 4) the application of research findings. There are many factors that come into in play when making clinical decisions while facing the pressures of a novel pandemic. Dr. Simon Carley on SGEM Xtra: EBM and the Changingman discussed his publication, Evidence-based medicine and COVID-19: what to believe and when to change.