DAY ONE
8:30 - 9:15 Introduction to the Emergency Research Symposium
Silas Bussmann MPH, MBA, CCRP, Sr. Lecturer III, UNM Department of Emergency Medicine
Mr. Bussmann will provide an introduction and overview to the Emergency Research Conference. During this time there will be discussion to assist the faculty in getting to know our attendees and their learning objectives and highlight current trends in emergency care and emergency care research.
9:15 – 10:00 Structure and Function of Multi-center Studies and Study Networks in Emergency Medicine
Valerie L. Stevenson, BAS, LRT, CCRP, Administrative Director, University of Michigan Health System
NIH funded clinical study networks provide a vital resource in addressing the most prescient challenges in Emergency Medicine. Site managers and personnel benefit from understanding the structure and function of the networks focused on acute care research to get the most of out of study participation and collaboration.
10:00 – 10:15 Break
10:15 – 11:00 Exception from Informed Consent (EFIC) Primer
Deneil M. Harney, MPH, MSW, Associate Administrative Director, SIREN Clinical Coordinating Center, University of Michigan
This session will cover the regulation in 21 CFR 50.24 Exemption From Informed Consent and the Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) experience.
11:00 – 12:00 Practical Knowledge and Experience for the Implementation of EFIC Studies
Kammy Jacobsen, BS, CCRC, Program Director, Utah Data Coordinating Center, University of Utah
This presentation will provide best practices and practical experiences from the implementation of Exception from Informed Consent (EFIC) Research including a review of operational challenges and experiences. In this session we will examine the Belmont principles and discuss adaptations for EFIC. The speaker will examine previous EFIC research studies and discuss challenges encountered while conducting community consultation and public disclosure activities for multi-site studies as well as the various challenges of enrolling participants in the hospital, EMS, and community setting.
12:00 – 1:00 Lunch (provided)
1:00 - 2:00 Staffing, Onboarding, Training, and Professional Development in Emergency Clinical Research
Jennifer Frey, PhD, Director, Research Operations, The Ohio State University
Acute care clinical research teams are comprised of a variety of team members. This session will discuss how to identify the positions needed and strategies for onboarding and training. We will also discuss professional development opportunities for acute care clinical research staff.
2:00 - 2:45 Successes and Pitfalls Centralizing and Using an e-Consent in an NIH funded Multi-site Clinical Trials Network
Natalie Fisher, RN, BSN, Project Manager University of Michigan
This session will explore the successes and challenges of implementing a centralized electronic consent platform for emergency care research within an NIH-funded multi-site clinical trials network. Attendees will gain insights into the regulatory, technological, and operational considerations involved, learning how these factors impact consent processes and network efficiency
2:45 - 3:00 Break
3:15 - 4:15 Managing Clinical Research Trials that Enroll Pediatric Participants in Emergency Settings
Kammy Jacobsen, BS, CCRC, Program Director, Utah Data Coordinating Center, University of Utah
This session will cover particular nuances for enrolling children in clinical trials within the emergency setting. The speaker will draw on 20 years of experience of the Pediatric Emergency Care Applied Research network (PECARN) to illustrate key considerations for planning emergency research in the pediatric setting. We will review challenges encountered in planning for and carrying out pediatric emergency research and discuss ways to overcome barriers.
DAY TWO
8:30 – 8:45 Welcome
8:45 - 9:30 Inclusion and Cultural Competency in Emergency Medicine Research
Jennifer Frey, PhD, Director, Research Operations, The Ohio State University
Clinical research has traditionally disproportionately impacted individuals from racial and ethnic minority groups. This session will discuss strategies and approaches to move toward greater inclusivity and diversity in the acute care clinical research workforce and in study recruitment and retention.
9:30 - 10:45 Research Associate Programs in Emergency Medicine
Whitney Covington Taylor, MPH, MLS, Manager - Clinical Research Coordinator, The University of Alabama at Birmingham
Opportunities for students, even in clinical education tracks, to gain exposure to hospital-based research are very limited. This session will cover the structure and function of a Research Associate Programs in Emergency Medicine, discuss needs and strategies for program start-up and why the emergency department is an ideal setting for learners new to clinical research.
10:45 – 11:00 Break
11:00 – 12:00 Point-of-Care and diagnostic research technologies in acute care research
Silas Bussmann MPH, MBA, CCRP, Sr. Lecturer III, UNM Department of Emergency Medicine
Emergency care is particularly dependent on fast and reliable diagnostic technologies to advance care. This session will discuss medical product development trends and regulations and the particular needs of diagnostic device companies developing technologies for the acute care setting.
12:00 - 1:00 Lunch (provided)
1:00 – 1:30 ROUNDTABLE: The Impact of COVID-19 on Emergency Medicine Research
Course Faculty
COVID-19 presents incredible opportunities and challenges for researchers. Many of the changes required to adapt to the pandemic, such as working virtually, adapting to e-consent and increased emphasis on safe practices may be here to stay. This will provide an opportunity for participants to reflect and exchange on the impact of COVID-19 on their profession and ways in which we are, or are not, prepared for future similar public health emergencies.
1:30 - 2:15 Site Level Program Management in Emergency Medicine
Silas Bussmann MPH, MBA, CCRP, Sr. Lecturer III, UNM Department of Emergency Medicine
This session will cover site-level structures and strategies used for managing and administering a sustainable research enterprise. This session will include both lecture and exercises for skill development. While this may be most relevant to those working at or in collaboration with academic medical centers, the basic management tenants are transferable or adaptable to a variety of team-based research settings.
2:15 – 2:30 Break
2:30 -3:15 The Impact of Technological Advancements and Broader Social and Demographic Trends on Emergency Care and Emergency Care Research
Silas Bussmann MPH, MBA, CCRP, Sr. Lecturer III, UNM Department of Emergency Medicine
Technological aptitude and continual learning are important for clinical research professionals to maintain an edge in the job market. This session will summarize the broad topics and trends driving changes in emergency care and emergency care research to give our participants an enhanced understanding of the future of their profession.
3:15 - 4:00 Wrap-up - Group Discussion - Q & A
ADVANCING INNOVATION AND INTEGRITY:
A TIME FOR TRANSFORMATION IN CLINICAL RESEARCH
8 tracks I 20+ Topic Areas I 100+ Sessions I 70+CE