Index
Abstract
Dedication
Preface
Definition of EMS for this Document
Federal Agencies Can Help Advance EMS Research
Executive Summary
Introduction
History of EMS Research
The Present State of EMS Research
Overcoming the Barriers to EMS Research

• Primary Barriers: Developing Researchers
• Primary Barriers: Funding
• Secondary Barriers: Recognizing the Need for EMS Research
  • The Culture of EMS
  • EMS Systems
  • EMS Education
  • The Public and Policy Makers
  • EMS Professionals
• Secondary Barriers: Information Systems
  • Data Definitions
  • Hardware and Software Infrastructure
  • Data Set Linkages
  • Statistical Implications of Large Databases
• Secondary Barriers: Ethical Concerns
  • Principles
  • Informed Consent
  • IRBs and EMS Research
  • Valuing Individual Autonomy

Summary
Appendix A: The National EMS Research Agenda Writing Team
Appendix B: Organizations Invited to Participate in the National Review Team
Appendix C: Ethical Standards and IRB Requirements
Appendix D Inclusion Of Women And Minorities In Research Study Populations Involving Human Subjects
Inclusion Of Children As Participants In Research Involving Human Subjects
Appendix E: Bibliographic List of Internet Links
Appendix F: Published EMS Randomized Clinical Trials
References

IRBs and EMS Research

Some institutional review boards are unfamiliar with the scope of prehospital emergency medical care and thus may have difficulty understanding the issues associated with conducting research in that environment. The prospective EMS investigator needs to become familiar with the local IRB guidelines and process. Through positive interactions with the IRB, a researcher can help educate the members about EMS issues; and, together, the researcher and the IRB can develop study or consent methodologies that meet the needs of the investigator while fulfilling current legal requirements.

One possible concern that might be raised by an IRB is that study enrollment will delay patient transport. It is incumbent upon the investigator to determine the risks associated with such a delay. For most prehospital patients, those risks are minimal. The researcher may have to overcome preconceptions among IRB members that all patients who call EMS need rapid response and transport.

An IRB might also express concern about altering the existing standard of care for a prehospital study. Yet, little that is considered “standard care” has ever been rigorously evaluated in the prehospital setting. It is considered ethical to alter or remove a non-evidence-based pattern of care in order to evaluate prehospital practices, so long as such studies are designed to minimize the risks to subjects. Two notable examples of this practice are the study of pneumatic anti-shock garments in which the garments, long part of standard care for trauma patients, were removed from ambulances as part of a study evaluating their efficacy⁵⁰ and the pediatric intubation study in which children were allocated to receive either bag-valve-mask ventilation or endotracheal intubation.¹⁸

Concerns about altering standard of care can be addressed, at least in part, through the use of data and safety monitoring boards.¹⁰⁴ Such entities are set up as part of the study design and review the data at predetermined interim periods to assess for any untoward affects of the study. This can be accomplished without breaking the blinding scheme and without giving the researchers any indication of the study results. If it appears that a study is resulting in unacceptable risks to patients, the data and safety monitoring board can stop it. The concept of such boards is not new; their use by EMS researchers is simply one technique that might be successful for addressing IRB concerns.