Developing a Working Group to Standardize the Ethical Conduct of Global Emergency Medicine Research (GEMA and Research Committee Sponsored)

Research ethics is truly a human concern, but few researchers have ever considered how ethical standards for the conduct of human subjects’ research may differ across national borders. Seeking to explore and understand research ethics governance is similar and may vary across different world regions. To address this issue we held a didactic in May of 2023, focusing on ethics in emergency medicine(EM) research and had key EM researchers from different world regions discus how research ethics is governed in their respective country and the existing challenges in research ethics in low and middle income countries (LMICs), in addition to an overview of the current ethics landscape. We found that there are many challenges and areas of improvement in global emergency medicine research ethics, including quality of consent, fair participant selection, blurring the role of clinician and research, and determining the risk/benefit assessment–areas which all of the audience members agreed upon. Additionally, the audience poll results showed that over half, 67%, thought it would be useful to create a working group to standardize global EM research and address the issues with governance of research in LMIC/MIC and LICs. Moving forward, it is thus imperative to work towards standardizing the field of global EM research ethics, especially in the global south.

Didactic Plan: In the first part of the presentation, we will have the panelists engage in a discussion about challenges we face in global EM ethics, including quality of consent, fair participant selection, blurring the role of clinician and research, and determining the risk/benefit assessment. We will discuss the ways in which a working group could make EM research ethics less stringent but still compliant with the Belmont Report. Additionally, we will also engage in a discussion on how to refine and develop minimum ethical requirements for conducting research in LMICs. In the second part, we will engage the audience into interactive breakout sessions, in which they will brainstorm ways in which a working group could combat existing challenges in global EM research ethics and how we can build an adaptive ethics model that would consider local ethical guidelines along with international guidelines.

Presenters:

  • Vijaya A. Kumar, MD, MPH
  • James H. Paxton, MD MBA
  • Tej Prakash Sinha, MD
  • Giles N. Cattermole, FRCEM
  • Nina Entcheva, Undergraduate Student
Authors

  • Vijaya Kumar, MD, MPH

    Wayne State University/Detroit Medical Center

    After completing his graduation in medicine and post-graduation in public health from India, Dr. Kumar went on to complete his residency and fellowship in Clinical Research in Emergency Medicine(EM) at Wayne State University (WSU), followed by an MPH from University of Michigan. He has been research faculty in the department of EM at WSU since 2012 and his EM Research focus is cardiovascular diseases and quality and safety in the ED while his Global Health (GH) research focus is women's health in the rural health setting and research capacity development.

    As PI or co-Investigator on several university and federally funded grants, Dr. Kumar has successfully administered the projects (e.g., staffing, research protections, budget), collaborated with other researchers, and produced several peer-reviewed publications. He has continued his passion for cardiovascular medicine through his research career, he has secured a grant to study the outpatient follow up of low risk chest pain patients form the ED, his focus now is the association between COVID 19 and Thromboembolic disease and long COVID Syndrome. During the COVID 19 Pandemic he has been working on several global collaborative efforts to create a cohesive global effort, this includes a survey to assess the global response to the pandemic, comparison of ED triage and resilience of the health force during the pandemic.

    Dr. Kumar was part of a working group which wrote an international perspective to emergency department overcrowding, travelled to Jamaica and multiple cities in India conducting research workshops for emergency medicine faculty, residents and fellows. He is the founder and co-director of the GH research collaborative (GHRC) at WSU which coducts an online GH research training and mentoring workshop aling with assisting with reseach capacity devepopment in LMIC's.

    He is presently the Associate Director of the Global Health Section and International Emergency Medicine Fellowship in the department of EM at WSU; his goal is to improve clinical research and standardization of emergency medicine care globally. He is a manuscript reviewer for Annals of Emergency Medicine and Journal of ACEP while being on the research committees at ACEP and SAEM and the global emergency medicine committee at SAEM.
     
    Dr. Kumar is a full time EM physician for Michigan Center Emergency Services (DMC/WSU), he is the associate director of Global and Urban EM fellowship at WSU, EM Research Director at Harper University Hospital and the vice chair of the MP2 IRB Board at WSU.

  • James H. Paxton, MD, MBA

    Associate Professor and Director of Clinical Research

    Detroit Receiving Hospital / Wayne State University Department of Emergency Medicine

    James H. Paxton, MD, MBA, is an associate professor and the Director of Clinical Research for Detroit Receiving Hospital / Wayne State University (WSU) Department of Emergency Medicine, and previously served as Chairman of the WSU MP2 Institutional Review Board (2015-2020). He is a senior member of multiple national emergency medicine research committees, and recently served as Chairman of the SAEM research committee (2021-2024). Dr. Paxton received both his MD and MBA from the University of Cincinnati and completed EM residency training at Henry Ford Hospital. He has been core academic faculty for the EM residencies at both Sinai-Grace Hospital and Detroit Receiving Hospital since 2011, and has mentored hundreds of medical students and residents at WSU during that time. He is an active clinical researcher and has served as PI for dozens of industry- and publicly-funded trials.

  • Tej Prakash Sinha, MD

    All India Institute of Medical Sciences, New Delhi

    Tej Prakash Sinha, M.S. is an Associate Professor of Emergency Medicine at JPN Apex Trauma Center, All India Institute of Medical Sciences, New Delhi (India). He is the chief coordinator of the WHO collaborative center for emergency and trauma care in the South East Asian region.

  • Giles N. Cattermole, FRCEM

    Kings College Hospital NHS Trust

    Giles Cattermole FRCEM DTM&H is a Consultant Emergency Physician at King's College Hospital NHS Trust, London, UK. He holds honorary associate professorships at the Chinese University of Hong Kong and the University of Rwanda. His interests include global emergency care, research ethics in the global south, and has been part of emergency medicine education in several countries in Africa and SE Asia.

  • Nina Entcheva, Undergraduate Student

    University of Michigan

    Nina Entcheva is an undergraduate student at the University of Michigan in Ann Arbor and has been a part of the working group to standardize the ethical conduct of global emergency medicine research.

Related Media