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

Secondary Barriers: Ethical Concerns

Principles

Adhering to ethical research principles results in higher quality research, ensures that all individuals are respected, and protects vulnerable people. The ethics of conducting research in the EMS environment are sometimes complicated by time urgency and decreased patient competency.⁹⁸ Despite these challenges, EMS related research has to follow the same basic ethical guidelines as any other human subjects research.

The Federal government has assumed the lead role in protecting the rights of human research subjects. The Office of the Inspector General of the Department of Health and Human Services (HHS) recently published a report on the status of protecting the rights of research subject. The Office of Human Research Protections (OHRP) is charged with assuring compliance with ethical guidelines. Grant reviewers, funding agency staff, clinicians, journal editors, and other researchers all share in the responsibility to protect human subjects.

EMS researchers must fulfill all of the requirements for human research delineated at the federal, state, local, and institutional level. Federal regulations have been developed with hospital and outpatient based clinical research in mind. As a result, researchers may often view these requirements as impediments to conducting prehospital research. While burdensome to the researcher, the process of ethical review often will result in an improved research plan because of the structure provided by the process and by suggestions from the reviewers.