-
1
-
-
0001122640
-
21 CFR 50.24. Exception from informed consent requirements for emergency research
-
Food and Drug Administration. 21 CFR 50.24. Exception from informed consent requirements for emergency research. Fed Regist 1996;3:51528–9
-
(1996)
Fed Regist
, vol.3
, pp. 51528-51529
-
-
-
2
-
-
0001122640
-
45 CFR 46.101. Waiver of informed consent requirements in certain emergency research
-
Department of Health and Human Services. 45 CFR 46.101. Waiver of informed consent requirements in certain emergency research. Fed Regist 1996;31:51531–3
-
(1996)
Fed Regist
, vol.31
, pp. 51531-51533
-
-
-
3
-
-
84859883478
-
Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience
-
Silbergleit R, Biros MH, Harney D, Dickert N, Baren J; NETT Investigators. Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience. Acad Emerg Med 2012;19:448–54
-
(2012)
Acad Emerg Med
, vol.19
, pp. 448-454
-
-
Silbergleit, R.1
Biros, M.H.2
Harney, D.3
Dickert, N.4
Baren, J.5
-
4
-
-
84893337052
-
Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings
-
Dickert NW, Mah VA, Biros MH, et al. Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings. Crit Care Med 2014;42:272–80
-
(2014)
Crit Care Med
, vol.42
, pp. 272-280
-
-
Dickert, N.W.1
Mah, V.A.2
Biros, M.H.3
-
5
-
-
84884135352
-
Enrollment in research under exception from informed consent: the Patients’ Experiences in Emergency Research (PEER) study
-
Dickert NW, Mah VA, Baren JM, et al. Enrollment in research under exception from informed consent: the Patients’ Experiences in Emergency Research (PEER) study. Resuscitation 2013;84:1416–21
-
(2013)
Resuscitation
, vol.84
, pp. 1416-1421
-
-
Dickert, N.W.1
Mah, V.A.2
Baren, J.M.3
-
6
-
-
84924288620
-
Patients’ perspectives of enrollment in research without consent: the patients’ experiences in emergency research-progesterone for the treatment of traumatic brain injury study
-
Dickert NW, Scicluna VM, Baren JM, et al. Patients’ perspectives of enrollment in research without consent: the patients’ experiences in emergency research-progesterone for the treatment of traumatic brain injury study. Crit Care Med 2015;43:603–12
-
(2015)
Crit Care Med
, vol.43
, pp. 603-612
-
-
Dickert, N.W.1
Scicluna, V.M.2
Baren, J.M.3
-
7
-
-
0032902987
-
Acting without asking: an ethical analysis of the Food and Drug Administration wavier of informed consent for emergency research
-
Adams JG, Wegener J. Acting without asking: an ethical analysis of the Food and Drug Administration wavier of informed consent for emergency research. Ann Emerg Med 1999;33:218–23
-
(1999)
Ann Emerg Med
, vol.33
, pp. 218-223
-
-
Adams, J.G.1
Wegener, J.2
-
8
-
-
0141532235
-
Research without consent: current status, 2003
-
Biros MH. Research without consent: current status, 2003. Ann Emerg Med 2003;42:550–64
-
(2003)
Ann Emerg Med
, vol.42
, pp. 550-564
-
-
Biros, M.H.1
-
9
-
-
0028963589
-
Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers
-
Biros MH, Lewis RJ, Olson CM, Runge RW, Cummins RO, Foss N. Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. J Am Med Assoc 1995;273:1283–7
-
(1995)
J Am Med Assoc
, vol.273
, pp. 1283-1287
-
-
Biros, M.H.1
Lewis, R.J.2
Olson, C.M.3
Runge, R.W.4
Cummins, R.O.5
Foss, N.6
-
10
-
-
84906935529
-
Looking through the retrospectoscope: reducing bias in emergency medicine chart review studies
-
Kaji AH, Schriger D, Green S. Looking through the retrospectoscope: reducing bias in emergency medicine chart review studies. Ann Emerg Med 2014;64:292–8
-
(2014)
Ann Emerg Med
, vol.64
, pp. 292-298
-
-
Kaji, A.H.1
Schriger, D.2
Green, S.3
-
11
-
-
62049084378
-
Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support
-
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81
-
(2009)
J Biomed Inform
, vol.42
, pp. 377-381
-
-
Harris, P.A.1
Taylor, R.2
Thielke, R.3
Payne, J.4
Gonzalez, N.5
Conde, J.G.6
-
12
-
-
84880416118
-
-
[Internet]., Silver Spring (MD), U.S. Food and Drug Administration, [cited yyyy mmm dd]. Available from, Accessed Dec 29, 2017.
-
Guidance for institutional review boards, clinical investigators, and sponsors: exception from informed consent requirements for emergency research [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2011 [cited yyyy mmm dd]. Available from: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf. Accessed Dec 29, 2017
-
(2011)
Guidance for institutional review boards, clinical investigators, and sponsors: exception from informed consent requirements for emergency research
-
-
-
13
-
-
84898832834
-
Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial
-
Chamberlain JM, Okada P, Holsti M, et al. Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial. JAMA 2014;311:1652–60
-
(2014)
JAMA
, vol.311
, pp. 1652-1660
-
-
Chamberlain, J.M.1
Okada, P.2
Holsti, M.3
-
14
-
-
84861174482
-
Vasopressin rescue for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing: a prospective feasibility pilot trial
-
Carroll TG, Dimas VV, Raymond TT. Vasopressin rescue for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing: a prospective feasibility pilot trial. Pediatr Crit Care Med 2012;13:265–72
-
(2012)
Pediatr Crit Care Med
, vol.13
, pp. 265-272
-
-
Carroll, T.G.1
Dimas, V.V.2
Raymond, T.T.3
-
15
-
-
0033579126
-
Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: a randomized controlled efficacy trial
-
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
-
(1999)
JAMA
, vol.282
, pp. 1857-1864
-
-
Sloan, E.P.1
Koenigsberg, M.2
Gens, D.3
-
16
-
-
84920059259
-
Very early administration of progesterone for acute traumatic brain injury
-
Wright DW, Yeatts SD, Silbergleit R, et al. Very early administration of progesterone for acute traumatic brain injury. N Engl J Med 2014;371:2457–66
-
(2014)
N Engl J Med
, vol.371
, pp. 2457-2466
-
-
Wright, D.W.1
Yeatts, S.D.2
Silbergleit, R.3
-
17
-
-
0035931948
-
Lack of effect of induction of hypothermia after acute brain injury
-
Clifton GL, Miller ER, Choi SC, et al. Lack of effect of induction of hypothermia after acute brain injury. N Engl J Med 2001;344:556–63
-
(2001)
N Engl J Med
, vol.344
, pp. 556-563
-
-
Clifton, G.L.1
Miller, E.R.2
Choi, S.C.3
-
18
-
-
0037183529
-
Randomized clinical trial of magnesium, diazepam, or both after out-of-hospital cardiac arrest
-
Longstreth WT Jr, Fahrenbruch CE, Olsufka M, Walsh TR, Copass MK, Cobb LA. Randomized clinical trial of magnesium, diazepam, or both after out-of-hospital cardiac arrest. Neurology 2002;59:506–14
-
(2002)
Neurology
, vol.59
, pp. 506-514
-
-
Longstreth, W.T.1
Fahrenbruch, C.E.2
Olsufka, M.3
Walsh, T.R.4
Copass, M.K.5
Cobb, L.A.6
-
19
-
-
0036086957
-
Hypotensive resuscitation during active hemorrhage: impact on in-hospital mortality
-
Dutton RP, Mackenzie CF, Scalea TM. Hypotensive resuscitation during active hemorrhage: impact on in-hospital mortality. J Trauma 2002;52:1141–6
-
(2002)
J Trauma
, vol.52
, pp. 1141-1146
-
-
Dutton, R.P.1
Mackenzie, C.F.2
Scalea, T.M.3
-
20
-
-
4043181818
-
Public-access defibrillation and survival after out-of-hospital cardiac arrest
-
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
-
(2004)
N Engl J Med
, vol.351
, pp. 637-646
-
-
Hallstrom, A.P.1
Ornato, J.P.2
Weisfeldt, M.3
-
21
-
-
28044456324
-
Management of acute undifferentiated agitation in the emergency department: a randomized double-blind trial of droperidol, ziprasidone, and midazolam
-
Martel M, Sterzinger A, Miner J, Clinton J, Biros M. Management of acute undifferentiated agitation in the emergency department: a randomized double-blind trial of droperidol, ziprasidone, and midazolam. Acad Emerg Med 2005;12:1167–72
-
(2005)
Acad Emerg Med
, vol.12
, pp. 1167-1172
-
-
Martel, M.1
Sterzinger, A.2
Miner, J.3
Clinton, J.4
Biros, M.5
-
22
-
-
33745101183
-
Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial
-
Hallstrom A, Rea TD, Sayre MR, et al. Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial. JAMA 2006;295:2620–8
-
(2006)
JAMA
, vol.295
, pp. 2620-2628
-
-
Hallstrom, A.1
Rea, T.D.2
Sayre, M.R.3
-
23
-
-
57749197384
-
Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial
-
Moore EE, Moore FA, Fabian TC, et al. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. J Am Coll Surg 2009;208:1–13
-
(2009)
J Am Coll Surg
, vol.208
, pp. 1-13
-
-
Moore, E.E.1
Moore, F.A.2
Fabian, T.C.3
-
24
-
-
77957661947
-
Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial
-
Bulger EM, May S, Brasel KJ, et al. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA 2010;304:1455–64
-
(2010)
JAMA
, vol.304
, pp. 1455-1464
-
-
Bulger, E.M.1
May, S.2
Brasel, K.J.3
-
25
-
-
78651367791
-
Impact of low-dose vasopressin on trauma outcome: prospective randomized study
-
Cohn SM, McCarthy J, Stewart RM, Jonas RB, Dent DL, Michalek JE. Impact of low-dose vasopressin on trauma outcome: prospective randomized study. World J Surg 2011;35:430–9
-
(2011)
World J Surg
, vol.35
, pp. 430-439
-
-
Cohn, S.M.1
McCarthy, J.2
Stewart, R.M.3
Jonas, R.B.4
Dent, D.L.5
Michalek, J.E.6
-
26
-
-
80052484033
-
Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest
-
Stiell IG, Nichol G, Leroux BG, et al. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med 2011;365:787–97
-
(2011)
N Engl J Med
, vol.365
, pp. 787-797
-
-
Stiell, I.G.1
Nichol, G.2
Leroux, B.G.3
-
27
-
-
78751569803
-
Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial
-
Clifton GL, Valadka A, Zygun D, et al. Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial. Lancet Neurol 2011;10:131–9
-
(2011)
Lancet Neurol
, vol.10
, pp. 131-139
-
-
Clifton, G.L.1
Valadka, A.2
Zygun, D.3
-
28
-
-
80052441593
-
A trial of an impedance threshold device in out-of-hospital cardiac arrest
-
Aufderheide TP, Nichol G, Rea TD, et al. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011;365:798–806
-
(2011)
N Engl J Med.
, vol.365
, pp. 798-806
-
-
Aufderheide, T.P.1
Nichol, G.2
Rea, T.D.3
-
29
-
-
78751642476
-
Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial
-
Aufderheide TP, Frascone RJ, Wayne MA, et al. Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial. Lancet 2011;377:301–11
-
(2011)
Lancet
, vol.377
, pp. 301-311
-
-
Aufderheide, T.P.1
Frascone, R.J.2
Wayne, M.A.3
-
30
-
-
84857132739
-
Intramuscular versus intravenous therapy for prehospital status epilepticus
-
Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med 2012;366:591–600
-
(2012)
N Engl J Med
, vol.366
, pp. 591-600
-
-
Silbergleit, R.1
Durkalski, V.2
Lowenstein, D.3
-
31
-
-
84860771658
-
Out-of-hospital administration of intravenous glucose-insulin-potassium in patients with suspected acute coronary syndromes: the IMMEDIATE randomized controlled trial
-
Selker HP, Beshansky JR, Sheehan PR, et al. Out-of-hospital administration of intravenous glucose-insulin-potassium in patients with suspected acute coronary syndromes: the IMMEDIATE randomized controlled trial. JAMA 2012;307:1925–33
-
(2012)
JAMA
, vol.307
, pp. 1925-1933
-
-
Selker, H.P.1
Beshansky, J.R.2
Sheehan, P.R.3
-
32
-
-
84891943003
-
Effect of prehospital induction of mild hypothermia on survival and neurological status among adults with cardiac arrest: a randomized clinical trial
-
Kim F, Nichol G, Maynard C, et al. Effect of prehospital induction of mild hypothermia on survival and neurological status among adults with cardiac arrest: a randomized clinical trial. JAMA 2014;311:45–52
-
(2014)
JAMA
, vol.311
, pp. 45-52
-
-
Kim, F.1
Nichol, G.2
Maynard, C.3
-
33
-
-
84903642484
-
Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial
-
Robertson CS, Hannay HJ, Yamal JM, et al. Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial. JAMA 2014;312:36–47
-
(2014)
JAMA
, vol.312
, pp. 36-47
-
-
Robertson, C.S.1
Hannay, H.J.2
Yamal, J.M.3
-
34
-
-
84922309595
-
Prehospital use of magnesium sulfate as neuroprotection in acute stroke
-
Saver JL, Starkman S, Eckstein M, et al. Prehospital use of magnesium sulfate as neuroprotection in acute stroke. N Engl J Med 2015;372:528–36
-
(2015)
N Engl J Med
, vol.372
, pp. 528-536
-
-
Saver, J.L.1
Starkman, S.2
Eckstein, M.3
-
35
-
-
84922431269
-
Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial
-
Holcomb JB, Tilley BC, Baraniuk S, et al. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA 2015;313:471–82
-
(2015)
JAMA
, vol.313
, pp. 471-482
-
-
Holcomb, J.B.1
Tilley, B.C.2
Baraniuk, S.3
-
36
-
-
84926388475
-
A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial
-
discussion 695–7.
-
Schreiber MA, Meier EN, Tisherman SA, et al. A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial. J Trauma Acute Care Surg 2015;78:687–95; discussion 695–7
-
(2015)
J Trauma Acute Care Surg
, vol.78
, pp. 687-695
-
-
Schreiber, M.A.1
Meier, E.N.2
Tisherman, S.A.3
-
37
-
-
84948799467
-
Trial of continuous or interrupted chest compressions during CPR
-
Nichol G, Leroux B, Wang H, et al. Trial of continuous or interrupted chest compressions during CPR. N Engl J Med 2015;373:2203–14
-
(2015)
N Engl J Med
, vol.373
, pp. 2203-2214
-
-
Nichol, G.1
Leroux, B.2
Wang, H.3
-
38
-
-
84964558109
-
A prospective study of ketamine versus haloperidol for severe prehospital agitation
-
Cole JB, Moore JC, Nystrom PC, et al. A prospective study of ketamine versus haloperidol for severe prehospital agitation. Clin Toxicol 2016;54:556–62
-
(2016)
Clin Toxicol
, vol.54
, pp. 556-562
-
-
Cole, J.B.1
Moore, J.C.2
Nystrom, P.C.3
-
39
-
-
84983552154
-
Amiodarone, lidocaine, or placebo in out-of-hospital cardiac arrest
-
Kudenchuk PJ, Daya M, Dorian P; Resuscitation Outcomes Consortium Investigators. Amiodarone, lidocaine, or placebo in out-of-hospital cardiac arrest. N Engl J Med 2016;375:802–3
-
(2016)
N Engl J Med
, vol.375
, pp. 802-803
-
-
Kudenchuk, P.J.1
Daya, M.2
Dorian, P.3
-
40
-
-
84961836208
-
Direct versus video laryngoscopy using the C-MAC for tracheal intubation in the emergency department, a randomized controlled trial
-
Driver BE, Prekker ME, Moore JC, Schick AL, Reardon RF, Miner JR. Direct versus video laryngoscopy using the C-MAC for tracheal intubation in the emergency department, a randomized controlled trial. Acad Emerg Med 2016;23:433–9
-
(2016)
Acad Emerg Med
, vol.23
, pp. 433-439
-
-
Driver, B.E.1
Prekker, M.E.2
Moore, J.C.3
Schick, A.L.4
Reardon, R.F.5
Miner, J.R.6
|