Chapter 116
Informed consent in EMS research
Lynn J. White,
Lynn J. White
Search for more papers by this authorLynn J. White,
Lynn J. White
Search for more papers by this authorBook Editor(s):David C. Cone MD,
Jane H. Brice MD, MPH,
Theodore R. Delbridge MD, MPH,
J. Brent Myers MD, MPH,
David C. Cone MD
Professor of Emergency Medicine
Yale University School of Medicine, New Haven, Connecticut
Search for more papers by this authorJane H. Brice MD, MPH
Professor of Emergency Medicine
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
Search for more papers by this authorTheodore R. Delbridge MD, MPH
Executive Director
Maryland Institute for Emergency Medical Services Systems, Baltimore, Maryland
Search for more papers by this authorJ. Brent Myers MD, MPH
Chief Medical Officer ESO Associate Medical Director
Wake County EMS, Raleigh, North Carolina
Search for more papers by this authorFirst published: 18 August 2021
Summary
The goal of clinical research is to develop generalizable knowledge to improve health or develop effective prevention and treatment strategies for injury or disease. Research subjects make it possible to secure that knowledge. Participating in clinical research can put some people at risk of harm for the good of others. In this chapter we review the basic ethical principles developed to protect human research subjects, as well as the development of uniform federal regulations, called the Common Rule, which is designed to help ensure the ethical conduct of research and includes provisions for conduct of research during emergency situations.
References
- World Medical Association . Declaration of Helsinki: Ethical principles for medical research involving human subjects . JAMA . 2013 ; 310 : 2191 – 94 .
- An act to establish a program of National Research Service Awards and to provide for the protection of human subjects involved in biomedical and behavioral research . Approved 12 Jul 1974. United States Statutes at Large . 1974 ; 88 342 – 54 .
- Curran WJ . The Tuskegee syphilis study . N Engl J Med . 1973 ; 289 : 730 – 1 .
- National Commission for the Protection of Human Subjects of of Biomedical and Behavioral Research . The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . 1979. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html . Accessed July 24, 2020.
- Department of Health and Human Services , 45 CFR 46:Subpart A. Protection of human research subjects . Fed Regist . 2017 ; 82 FR 7259-73:51 531 – 3 . Available at: https://ecfr.io/Title-45/Part-46/Subpart-A . Accessed July 24, 2020.
- Menikoff J , Kaneshiro J , Pritchard I . The Common Rule, updated . N Engl J Med . 2017 ; 376 : 613 – 15 .
- Food and Drug Administration , 21 CFR 50.24. Exception from informed consent requirements for emergency research . Fed Regist 1996 ; 3 : 51 528 – 9 .
- Office of Emergency Medical Services, National Highway Transportation Safety Administration . Progress on Evidence-Based Guidelines for Prehospital Emergency Care . Washington, D.C .: U.S. Department of Transportation , 2013 .
- National Association of EMS Physicians . A National Strategy to Promote Prehospital Evidence Based Guideline Development , Implementation, and Evaluation. 2015. Available at: https://naemsp.org/resources/prehospital-guidelines-consortium . Accessed July 24, 2020.
- Segal MB. Editorial: In emergencies, is consent essential? J Legal Med . 1975 ; 3 : 4 – 5 .
- Whalan DJ. The ethics and morality of clinical trials in man . Med J Aust . 1975 ; 1 : 491 – 4 .
- Sayre MR , White LJ , Brown LH , McHenry SD. National EMS Research Agenda . Prehosp Emerg Care . 2002 ; 6 : S1 – 43 .
- Abramson NS , Meisel A , Safar P . Deferred consent. A new approach for resuscitation research on comatose patients . JAMA . 1986 ; 255 : 2466 – 71 .
- Prentice ED , Antonson DL , Leibrock LG , Kelso TK , Sears TD . IRB review of a phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury . IRB . 1993 ; 15 : 1 – 7 .
- Lurie KG , Shultz JJ , Callaham ML , et al. Evaluation of active compression-decompression CPR in victims of out-of-hospital cardiac arrest . JAMA . 1994 ; 271 : 1405 – 11 .
- Abramson NS , Safar P , Detre KM , et al. Neurologic recovery after cardiac arrest: effect of duration of ischemia. Brain Resuscitation Clinical Trial I Study Group . Crit Care Med . 1985 ; 13 : 930 – 1 .
- Biros MH. Research without consent: current status, 2003 . Ann Emerg Med . 2003 ; 42 : 550 – 64 .
- Lurie KG , Benditt D . Regulated to death: the matter of informed consent for human experimentation in emergency resuscitation research . PACE . 1995 ; 18 : 1443 – 7 .
- Biros MH , Runge JW , Lewis RJ , Doherty C . Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances . Acad Emerg Med . 1998 ; 5 : 359 – 68 .
- Newgard CD , Hui SH , Stamps-White P , Lewis RJ . Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research . Health Services Res . 2005 ; 40 : 1247 – 58 .
- Mann NC , Schmidt TA , Richardson LD. Confronting the ethical conduct of resuscitation research: a consensus opinion . Acad Emerg Med . 2005 ; 12 : 1078 – 81 .
- Sayre MR , White LJ , Brown LH , McHenry SD . The National EMS Research Agenda executive summary . Ann Emerg Med . 2002 ; 40 : 636 – 43 .
- Sloan EP , Koenigsberg M , Gens D , et al. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: a randomized controlled efficacy trial . JAMA . 1999 ; 282 : 1857 – 64 .
- Sloan EP , Koenigsberg M , Houghton J , et al. The informed consent process and the use of the exception to informed consent in the clinical trial of diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock . Acad Emerg Med . 1999 ; 6 : 1203 – 9 .
- Hallstrom AP , Ornato JP , Weisfeldt M , et al. Public-access defibrillation and survival after out-of-hospital cardiac arrest . N Engl J Med . 2004 ; 351 : 637 – 46 .
- Mosesso VN Jr. , Brown LH , Greene HL , et al. Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience . Resuscitation . 2004 ; 61 : 29 – 36 .
- Klein l , Moore J Biros M . A 20-year review: the use of exception from informed consent and waiver of informed consent in emergency research . Acad Emerg Med . 2018 ; 25 : 1169 – 77 .
-
Lynch CA
,
Houry DE
,
Dai D
et al.
Evidence-based community consultation for traumatic brain injury
.
Acad Emerg Med
.
2011
;
19
:
972
–
76
.
10.1111/j.1553-2712.2011.01153.x Google Scholar
-
Moghavem N
.
Using technology to facilitate better community consultation with marginalized communities
.
Am J Bioethics
.
2017
;
5
:
29
–
31
.
10.1080/15265161.2017.1299248 Google Scholar
- Fordyce CB , Roe MT , Dickert NW . Maximizing value and minimizing barriers: patient-centered community consultation for research in emergency settings . Clin Trials . 2017 ; 14 : 88 – 93 .
- Nichol G , Huszti E . Design and implementation of resuscitation research: special challenges and potential solutions . Resuscitation . 2007 ; 73 : 337 – 46 .
