Consent in resuscitation trials: Benefit or harm for patients and society?

Resuscitation

Volumn 70, Issue 3, 2006, Pages 360-368

  Nichol, Graham ^a,b   Powell, Judy ^a   van Ottingham, Lois ^a   Maier, Ron ^c   Rea, Tom ^a   Christenson, Jim ^d   Hallstrom, Al ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b Emergency Medical Services Division   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

Clinical trials; Emergency treatment; Ethics; Resuscitation

Indexed keywords

CONSULTATION; EMERGENCY HEALTH SERVICE; HARM REDUCTION; HEALTH INSURANCE; HOSPITAL INFORMATION SYSTEM; HOSPITALIZATION; INFORMED CONSENT; OUTCOME ASSESSMENT; PATIENT PARTICIPATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRIVACY; PROFESSIONAL SECRECY; RESEARCH ETHICS; RESUSCITATION; REVIEW; RISK BENEFIT ANALYSIS; TREATMENT PLANNING;

CLINICAL PROTOCOLS; CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; HUMANS; INFORMED CONSENT; RESUSCITATION; THERAPEUTIC HUMAN EXPERIMENTATION;

EID: 33747884773     PISSN: 03009572     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.resuscitation.2006.01.020     Document Type: Review

References (23)

1. US Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46116;1997. p. 115.
2. Food and Drug Administration of the United States. Protection of Human Subjects. 21 CFR 5023 (1979);1998. p. 246-7.
3. Kahn J.P., Mastroianni A.C., and Sugarman J. Changing claims about justice in research: an introduction and overview. In: Kahn J.P., Mastroianni A.C., and Sugarman J. (Eds). Beyond consent seeking justice in research (1998), Oxford University Press, New York 4
4. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects. Washington, DC;1979.
5. Becker L.B., Han B.H., Meyer P.M., et al. Racial differences in the incidence of cardiac arrest and subsequent survival. The CPR Chicago Project. N Engl J Med 329 9 (1993) 600-606
6. Iwashyna T.J., Christakis N.A., and Becker L.B. Neighborhoods matter: a population-based study of provision of cardiopulmonary resuscitation. Ann Emerg Med 34 4 Pt 1 (1999) 459-468
7. Sampson R.J., Raudenbush S.W., and Earls F. Neighborhoods and violent crime: a multilevel study of collective efficacy. Science 277 5328 (1997) 918-924
8. Sampson R.J., Morenoff J.D., and Raudenbush S. Social anatomy of racial and ethnic disparities in violence. Am J Public Health 95 2 (2005) 224-232
9. Dunn L., Henry J., and Beard D. Social deprivation and head injury: a national study. J Neurol Neurosurg Psychiatry 74 8 (2003) 1060-1064
10. Cubbin C., LeClere F.B., and Smith G.S. Socioeconomic status and the occurrence of fatal and nonfatal injury in the United States. Am J Public Health 90 1 (2000) 70-77
11. Cubbin C., LeClere F.B., and Smith G.S. Socioeconomic status and injury mortality: individual and neighbourhood determinants. J Epidemiol Community Health 54 7 (2000) 517-524
12. McRae A.D., and Weijer C. Lessons from everyday lives: a moral justification for acute care research. Crit Care Med 30 5 (2002) 1146-1151
13. Anonymous. Chapter 4: assessing risks and potential benefits and evaluating vulnerability. Ethical and policy issues in research involving human participants (2001), National Bioethics Advisory Commission, Betheseda, MD p. 69-96
14. Kudenchuk P.J., Cobb L.A., Copass M.K., et al. Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation. N Engl J Med 341 12 (1999) 871-878
15. Dorian P., Cass D., Schwartz B., Cooper R., Gelaznikas R., and Barr A. Amiodarone as compared with lidocaine for shock-resistant ventricular fibrillation. N Engl J Med 346 12 (2002) 884-890
16. Clifton G.L., Miller E.R., Choi S.C., et al. Lack of effect of induction of hypothermia after acute brain injury. N Engl J Med 344 8 (2001) 556-563
17. Clifton G.L., Knudson P., and McDonald M. Waiver of consent in studies of acute brain injury. J Neurotrauma 19 10 (2002) 1121-1126
18. Anonymous. Public-access defibrillation and survival after out-of-hospital cardiac arrest. N Engl J Med 351 7 (2004) 637-646
19. Wilkoff B.L., Cook J.R., Epstein A.E., et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) trial. JAMA 288 24 (2002) 3115-3123
20. Rector T.S., and Cohn J.N. Assessment of patient outcome with the Minnesota living with heart failure questionnaire: reliability and validity during a randomized double-blind, placebo controlled trial of pimobendan. Am Heart J 124 (1992) 1017-1025
21. Lachin J.M. Introduction to sample size determination and power analysis for clinical trials. Controlled Clin Trials 2 (1981) 93-114
22. Anonymous. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl J Med 321 6 (1989) 406-412
23. Pfeffer M.A., Keech A., Sacks F.M., et al. Safety and tolerability of pravastatin in long-term clinical trials: prospective Pravastatin Pooling (PPP) Project. Circulation 105 20 (2002) 2341-2346