International variation in policies and practices related to informed consent in acute cardiovascular research: Results from a 44 country survey

Resuscitation

Volumn 91, Issue , 2015, Pages 76-83

  Van Belle, Gerald ^a   Mentzelopoulos, Spyros D ^b   Aufderheide, Tom ^c   May, Susanne ^a   Nichol, Graham ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^c MEDICAL COLLEGE OF WISCONSIN   (United States)

Author keywords

Cardiac arrest; Consent; Emergency medicine; Research; Survey

Indexed keywords

ARTICLE; CONSENSUS; EMERGENCY HEALTH SERVICE; EMERGENCY MEDICINE; EMERGENCY PHYSICIAN; HEALTH CARE POLICY; HEALTH CARE SURVEY; HUMAN; INFORMED CONSENT; MEDICAL PRACTICE; MEDICAL RESEARCH; PRIORITY JOURNAL; PUBLIC HEALTH; RESEARCH ETHICS; CLINICAL TRIAL; ETHICS; FEMALE; HEART ARREST; MALE; MULTICENTER STUDY; POLICY; QUESTIONNAIRE; RESUSCITATION;

BIOMEDICAL RESEARCH; EMERGENCY MEDICINE; ETHICS, RESEARCH; FEMALE; HEART ARREST; HUMANS; INFORMED CONSENT; MALE; POLICY; RESUSCITATION; SURVEYS AND QUESTIONNAIRES;

EID: 84929275009     PISSN: 03009572     EISSN: 18731570     Source Type: Journal    
DOI: 10.1016/j.resuscitation.2014.11.029     Document Type: Article

References (34)

1. Go A.S., Mozaffarian D., Roger V.L., et al. Heart disease and stroke statistics - 2014 update: a report from the American Heart Association. Circulation 2014, 129:e28-e292.
2. Merchant R.M., Yang L., Becker L.B., et al. Incidence of treated cardiac arrest in hospitalized patients in the United States. Crit Care Med 2011, 39:2401-2406.
3. Berdowski J., Berg R.A., Tijssen J.G., Koster R.W. Global incidences of out-of-hospital cardiac arrest and survival rates: systematic review of 67 prospective studies. Resuscitation 2010, 81:1479-1487.
4. Nichols M., Townsend N., Scarborough P., Rayner M. Cardiovascular disease in Europe 2014: epidemiological update. Eur Heart J 2014.
5. Watkins S., Thiemann D., Coresh J., Powe N., Folsom A.R., Rosamond W. Fourteen-year (1987 to 2000) trends in the attack rates of therapy for, and mortality from non-st-elevation acute coronary syndromes in Four United States communities. Am J Cardiol 2005, 96:1349-1355.
6. Stepanova M., Venkatesan C., Altaweel L., Mishra A., Younossi Z.M. Recent trends in inpatient mortality and resource utilization for patients with stroke in the United States: 2005-2009. J Stroke Cerebrovasc Dis 2013, 22:491-499.
7. Sasson C., Rogers M.A., Dahl J., Kellermann A.L. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes 2010, 3:63-81.
8. Nichol G., Thomas E., Callaway C.W., et al. Regional variation in out-of-hospital cardiac arrest incidence and outcome. JAMA 2008, 300:1423-1431.
9. U.S.Food and Drug Administration Protection of human subjects; informed consent - FDA. Final rule. Fed Regist 1996, 61:51498-51533.
10. Department of Health and Human Services Protection of human research subjects. Final rule. Fed Regist 2001, 66:56775-56780.
11. Williams B.F., French J.K., White H.D. Informed consent during the clinical emergency of acute myocardial infarction (Hero-2 Consent Substudy): a prospective observational study. Lancet 2003, 361:918-922. HERO-2 Consent Substudy Investigators.
12. Hsieh M., Dailey M.W., Callaway C.W. Surrogate consent by family members for out-of-hospital cardiac arrest research. Acad Emerg Med 2001, 8:851-853.
13. Nichol G., Huszti E., Rokosh J., Dumbrell A., McGowan J., Becker L. Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research?. Resuscitation 2004, 62:3-23.
14. McMahon A.D., Conway D.I., Macdonald T.M., McInnes G.T. The unintended consequences of clinical trials regulations. PLoS Med 2009, 3:e1000131.
15. Druml C., Singer E. Consent in emergency care research. Lancet 2011, 378:26-27. [author reply 7].
16. Dresser R. Research ethics aligning regulations and ethics in human research. Science 2012, 337:527-528.
17. Roberts I., Prieto-Merino D., Shakur H., Chalmers I., Nicholl J. Effect of consent rituals on mortality in emergency care research. Lancet 2011, 377:1071-1072.
18. Nichol G., Powell J., van Ottingham L., et al. Consent in resuscitation trials: benefit or harm for patients and society?. Resuscitation 2006, 70:360-368.
19. 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 1993, 329:600-606.
20. Iwashyna T.J., Christakis N.A., Becker L.B. Neighborhoods matter: a population-based study of provision of cardiopulmonary resuscitation. Ann Emerg Med 1999, 34:459-468.
21. Sampson R.J., Raudenbush S.W., Earls F. Neighborhoods and violent crime: a multilevel study of collective efficacy. Science 1997, 277:918-924.
22. Dunn L., Henry J., Beard D. Social deprivation and adult head injury: a national study. J Neurol Neurosurg Psychiatry 2003, 74:1060-1064.
23. Cubbin C., LeClere F.B., Smith G.S. Socioeconomic Status and injury mortality: individual and neighbourhood determinants. J Epidemiol Community Health 2000, 54:517-524.
24. Lim S.S., Vos T., Flaxman A.D., et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the global burden of disease study 2010. Lancet 2012, 380:2224-2260.
25. Sugarman J., Sitlani C., Andrusiek D., et al. Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?. Resuscitation 2009, 80:644-649.
26. Article 35 of regulation (Eu) No 536/2014 of the European parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing directive 2001/20/EC. Off J Eur Union 2014, L158:1-158.
27. Protection of human subjects; Belmont report: notice of report for public comment. Fed Regist 1979, 44:23191-23197.
28. Clifton G.L., Knudson P., McDonald M. Waiver of consent in studies of acute brain injury. J Neurotrauma 2002, 19:1121-1126.
29. Nelson M.J., Deiorio N.M., Schmidt T.A., Zive D.M., Griffiths D., Newgard C.D. Why persons choose to opt out of an exception from informed consent cardiac arrest trial. Resuscitation 2013, 84:825-830.
30. Jansen T.C., Bakker J., Kompanje E.J. Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results. Intensive Care Med 2010, 36:1962-1965.
31. Jansen T.C., Kompanje E.J., Druml C., Menon D.K., Wiedermann C.J., Bakker J. Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not?. Intensive Care Med 2007, 33:894-900.
32. Liddell K., Chamberlain D., Menon D.K., et al. The European clinical trials directive revisited: the visear recommendations. Resuscitation 2006, 69:9-14.
33. Tisherman S.A., Powell J.L., Schmidt T.A., et al. Regulatory challenges for the resuscitation outcomes consortium. Circulation 2008, 118:1585-1592.
34. Lewis R.J., Duber H.C., Biros M.H., Cone D.C. International regulatory status of emergency exception to informed consent study G. International resuscitation research, exception from informed consent, and the European Union directive 2001/20/Ec. Eur J Emerg Med 2009, 16:234-241.