-
1
-
-
0029778835
-
Macciocchi SNEthical considerations in clinical neuroscience. Current concepts in neuroclinical trials
-
Alves WA Macciocchi SNEthical considerations in clinical neuroscience. Current concepts in neuroclinical trials. Stroke 1996, 27:1903-1909.
-
(1996)
Stroke
, vol.27
, pp. 1903-1909
-
-
Alves, W.A.1
-
2
-
-
0030802944
-
Ethical considerations in neuroclinical trials
-
Macciocchi SN, Alves WA Ethical considerations in neuroclinical trials. Neurosurg Rev 1997, 20:161-170.
-
(1997)
Neurosurg Rev
, vol.20
, pp. 161-170
-
-
Macciocchi, S.N.1
Alves, W.A.2
-
3
-
-
0003491133
-
-
Ferney-Voltaire, World Medical AssociationWorld Medical Association, (Last Amended October, 2000; Last Clarification, 2004)., The World Medical Association, France, (Last Amended October, 2000; Last Clarification, 2004).
-
Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 1964, Ferney-Voltaire, World Medical AssociationWorld Medical Association, (Last Amended October, 2000; Last Clarification, 2004)., The World Medical Association, France, (Last Amended October, 2000; Last Clarification, 2004).
-
(1964)
Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
-
-
-
4
-
-
4544323552
-
Executive summary of the National Institute of Neurological Disorders and Stroke conference on Emergency Neurologic Clinical Trials Network
-
Barsan WG, Pancioli AM, Conwit RA Executive summary of the National Institute of Neurological Disorders and Stroke conference on Emergency Neurologic Clinical Trials Network. Ann Emerg Med 2004, 44:407-412.
-
(2004)
Ann Emerg Med
, vol.44
, pp. 407-412
-
-
Barsan, W.G.1
Pancioli, A.M.2
Conwit, R.A.3
-
5
-
-
0003713743
-
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
-
Department of Health Education and Welfare, Washington, D.C.
-
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 of Research 1979, Department of Health Education and Welfare, Washington, D.C.
-
(1979)
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
-
-
-
6
-
-
11844271965
-
Neuroethics: the practical and the philosophical
-
Farah MJ Neuroethics: the practical and the philosophical. Trends Cogn Sci 2005, 9:34-40.
-
(2005)
Trends Cogn Sci
, vol.9
, pp. 34-40
-
-
Farah, M.J.1
-
7
-
-
0036937001
-
Neuroethics: an emerging new discipline in the study of brain and cognition
-
Illes J, Raffin TA Neuroethics: an emerging new discipline in the study of brain and cognition. Brain Cogn 2002, 50:341-344.
-
(2002)
Brain Cogn
, vol.50
, pp. 341-344
-
-
Illes, J.1
Raffin, T.A.2
-
8
-
-
0036937048
-
Legal and ethical issues in neuro-imaging research: human subjects protection, medical privacy, and the public communication of research results
-
Kulynych J Legal and ethical issues in neuro-imaging research: human subjects protection, medical privacy, and the public communication of research results. Brain Cogn 2002, 50:345-357.
-
(2002)
Brain Cogn
, vol.50
, pp. 345-357
-
-
Kulynych, J.1
-
10
-
-
2942521775
-
Neuroethical considerations: cognitive liberty and converging technologies for improving human cognition
-
Sententia W Neuroethical considerations: cognitive liberty and converging technologies for improving human cognition. Ann N Y Acad Sci 2004, 1013:221-228.
-
(2004)
Ann N Y Acad Sci
, vol.1013
, pp. 221-228
-
-
Sententia, W.1
-
11
-
-
0033641943
-
The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place
-
Cooper J The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place. Med Law 2000, 19:189-195.
-
(2000)
Med Law
, vol.19
, pp. 189-195
-
-
Cooper, J.1
-
12
-
-
0035689477
-
The problem of informed consent in emergency medicine research
-
Foex BA The problem of informed consent in emergency medicine research. Emerg Med J 2001, 18:198-204.
-
(2001)
Emerg Med J
, vol.18
, pp. 198-204
-
-
Foex, B.A.1
-
13
-
-
15844414335
-
Potato, potato, proxy consent, permission-just don't call the whole thing off
-
Epub 2005 Jan 7.
-
Shaul RZ Potato, potato, proxy consent, permission-just don't call the whole thing off. Crit Care 2005, 9:123-124. Epub 2005 Jan 7.
-
(2005)
Crit Care
, vol.9
, pp. 123-124
-
-
Shaul, R.Z.1
-
14
-
-
1842430968
-
Investigators in the Registry of the Canadian Stroke Network. Impracticability of informed consent in the Registry of the Canadian Stroke Network
-
Tu JV, Willison DJ, Silver FL, Fang J, Richards JA, Laupacis A, Kapral MK Investigators in the Registry of the Canadian Stroke Network. Impracticability of informed consent in the Registry of the Canadian Stroke Network. N Engl J Med 2004, 350:414-421.
-
(2004)
N Engl J Med
, vol.350
, pp. 414-421
-
-
Tu, J.V.1
Willison, D.J.2
Silver, F.L.3
Fang, J.4
Richards, J.A.5
Laupacis, A.6
Kapral, M.K.7
-
15
-
-
0742289910
-
Clinical trials in an emergency setting: implications from the fifth version of the Declaration of Helsinki
-
Vanpee D, Gillet JB, Dupuis M Clinical trials in an emergency setting: implications from the fifth version of the Declaration of Helsinki. J Emerg Med 2004, 26:127-131.
-
(2004)
J Emerg Med
, vol.26
, pp. 127-131
-
-
Vanpee, D.1
Gillet, J.B.2
Dupuis, M.3
-
17
-
-
1842433689
-
Research on minimally conscious patients: innovation or exploitation?
-
Winslade WJ Research on minimally conscious patients: innovation or exploitation?. J Head Trauma Rehabil 2004, 19:178-179.
-
(2004)
J Head Trauma Rehabil
, vol.19
, pp. 178-179
-
-
Winslade, W.J.1
-
19
-
-
0344308227
-
The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles
-
Ijichi S, Ijichi N The scientific establishment of a new therapeutic intervention for developmental conditions: practical and ethical principles. Childs Nerv Syst 2003, 19:711-715.
-
(2003)
Childs Nerv Syst
, vol.19
, pp. 711-715
-
-
Ijichi, S.1
Ijichi, N.2
-
20
-
-
17844376277
-
Research with children: a critical review of the guidelines
-
Neill SJ Research with children: a critical review of the guidelines. J Child Health Care 2005, 9:46-58.
-
(2005)
J Child Health Care
, vol.9
, pp. 46-58
-
-
Neill, S.J.1
-
21
-
-
0037167309
-
Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial
-
Koops L, Lindley RI Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. Br Med J 2002, 325:415.
-
(2002)
Br Med J
, vol.325
, pp. 415
-
-
Koops, L.1
Lindley, R.I.2
-
22
-
-
14644408707
-
Patients may be less risk averse than committees
-
Nurock S Patients may be less risk averse than committees. Br Med J 2005, 330:471-472.
-
(2005)
Br Med J
, vol.330
, pp. 471-472
-
-
Nurock, S.1
-
24
-
-
84882496875
-
-
Code of Federal Regulations 21 CFR 50, 50.24, 50.25(a)(1)-(5), 56, 56.108(e), 56.111(a)(2), 312.7 (dl)-(d2), 312.23(a)(1)(iv), 312.34-35, 312.60, 314.126.
-
-
-
-
25
-
-
84882561068
-
-
Code of Federal Regulations 45 CFR 46 (Sub-part A), 46.103(a), 46.107, 46.109, 46.111, 46.116, 46.402(d), 46.404-409.
-
-
-
-
26
-
-
84882480093
-
The European Union Directive 2001/20/EC, 4 April 2001
-
1 May, L121 European Medicines Agency
-
European Medicines Agency The European Union Directive 2001/20/EC, 4 April 2001. Published in Official Journal of the European Communities 2001, 34-44. 1 May, L121.
-
(2001)
Published in Official Journal of the European Communities
, pp. 34-44
-
-
-
27
-
-
14644397278
-
Academic clinical research in the new regulatory environment
-
Gennery B Academic clinical research in the new regulatory environment. Clin Med 2005, 5:39-41.
-
(2005)
Clin Med
, vol.5
, pp. 39-41
-
-
Gennery, B.1
-
28
-
-
0042825896
-
Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation
-
Kompanje EJ, Maas AI, Dippel DW Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation. Tijdschr Geneeskd 2003, 147:1585-1589.
-
(2003)
Tijdschr Geneeskd
, vol.147
, pp. 1585-1589
-
-
Kompanje, E.J.1
Maas, A.I.2
Dippel, D.W.3
-
29
-
-
12144288981
-
New European directive on clinical trials: implications for traumatic head injury research
-
Epub 2004 Jan 16
-
Stocchetti N, Dearden M, Karimi A, Lapierre F, Maas A, Murray GD, Ohman J, Persson L, Servadei F, Trojanowski T, Unterberg A New European directive on clinical trials: implications for traumatic head injury research. Intensive Care Med 2004, 30:517-518. Epub 2004 Jan 16.
-
(2004)
Intensive Care Med
, vol.30
, pp. 517-518
-
-
Stocchetti, N.1
Dearden, M.2
Karimi, A.3
Lapierre, F.4
Maas, A.5
Murray, G.D.6
Ohman, J.7
Persson, L.8
Servadei, F.9
Trojanowski, T.10
Unterberg, A.11
-
30
-
-
14644404979
-
Over-regulation of clinical research: a threat to public health
-
Warlow C Over-regulation of clinical research: a threat to public health. Clin Med 2005, 5:33-58.
-
(2005)
Clin Med
, vol.5
, pp. 33-58
-
-
Warlow, C.1
-
31
-
-
14644413526
-
The challenge of assuring continued post-trial access to beneficial treatment
-
Grady C The challenge of assuring continued post-trial access to beneficial treatment. Yale J Health Policy Law Ethics 2005, 5:425-435.
-
(2005)
Yale J Health Policy Law Ethics
, vol.5
, pp. 425-435
-
-
Grady, C.1
-
32
-
-
0035007148
-
The ethical use of placebo controls in clinical research: the Declaration of Helsinki
-
discussion 61-65
-
La Vaque TJ, Rossiter T The ethical use of placebo controls in clinical research: the Declaration of Helsinki. Appl Psychophysiol Biofeedback 2001, 26:23-37. discussion 61-65.
-
(2001)
Appl Psychophysiol Biofeedback
, vol.26
, pp. 23-37
-
-
La Vaque, T.J.1
Rossiter, T.2
-
33
-
-
0028070548
-
The continuing unethical use of placebo controls
-
Rothman KJ, Michels KB The continuing unethical use of placebo controls. N Engl J Med 1994, 331:394-398.
-
(1994)
N Engl J Med
, vol.331
, pp. 394-398
-
-
Rothman, K.J.1
Michels, K.B.2
-
34
-
-
0036025359
-
Ethics in publication
-
(suppl)
-
Guc MO Ethics in publication. Acta Neurochir 2002, 83:101-104. (suppl).
-
(2002)
Acta Neurochir
, vol.83
, pp. 101-104
-
-
Guc, M.O.1
-
35
-
-
0038168166
-
A case of fraud in a neurological pharmaceutical clinical trial
-
[in Dutch]
-
Hoeksema HL, Troost J, Grobbee DE, Wiersinga WM, van Wijmen FC, Klasen EC A case of fraud in a neurological pharmaceutical clinical trial. Ned Tijdschr Geneeskd 2003, 147:1372-1377. [in Dutch].
-
(2003)
Ned Tijdschr Geneeskd
, vol.147
, pp. 1372-1377
-
-
Hoeksema, H.L.1
Troost, J.2
Grobbee, D.E.3
Wiersinga, W.M.4
van Wijmen, F.C.5
Klasen, E.C.6
-
36
-
-
18844383680
-
Methodological quality and reporting of ethical requirements in phase III cancer trials
-
Tuech JJ, Pessaux P, Moutel G, Thoma V, Schraub S, Herve C Methodological quality and reporting of ethical requirements in phase III cancer trials. J Med Ethics 2005, 31:251-255.
-
(2005)
J Med Ethics
, vol.31
, pp. 251-255
-
-
Tuech, J.J.1
Pessaux, P.2
Moutel, G.3
Thoma, V.4
Schraub, S.5
Herve, C.6
-
37
-
-
0036025349
-
Research ethics and scientific misconduct in biomedical research
-
(suppl)
-
Kansu E, Ruacan S Research ethics and scientific misconduct in biomedical research. Acta Neurochir 2002, 83:11-15. (suppl).
-
(2002)
Acta Neurochir
, vol.83
, pp. 11-15
-
-
Kansu, E.1
Ruacan, S.2
-
38
-
-
18744402782
-
Improving the governance of health research
-
Walsh MK, McNeil JJ, Breen KJ Improving the governance of health research. Med J Aust 2005, 182:468-471.
-
(2005)
Med J Aust
, vol.182
, pp. 468-471
-
-
Walsh, M.K.1
McNeil, J.J.2
Breen, K.J.3
-
39
-
-
11844300444
-
Ethics and sample size
-
Bacchetti P, Wolf LE, Segal MR, McCulloch CE Ethics and sample size. Am J Epidemiol 2005, 161:105-110.
-
(2005)
Am J Epidemiol
, vol.161
, pp. 105-110
-
-
Bacchetti, P.1
Wolf, L.E.2
Segal, M.R.3
McCulloch, C.E.4
-
40
-
-
0023185342
-
Equipoise and the ethics of clinical research
-
Freedman B Equipoise and the ethics of clinical research. N Engl J Med 1987, 317:141-145.
-
(1987)
N Engl J Med
, vol.317
, pp. 141-145
-
-
Freedman, B.1
-
41
-
-
14044276267
-
The practice of obtaining approval from medical research ethics committees: a comparison within 12 European countries for a descriptive study on acetylcholinesterase inhibitors in Alzheimer's dementia
-
Rikkert MG, Lauque S, Frolich L, Vellas B, Dekkers W The practice of obtaining approval from medical research ethics committees: a comparison within 12 European countries for a descriptive study on acetylcholinesterase inhibitors in Alzheimer's dementia. Eur J Neurol 2005, 12:212-217.
-
(2005)
Eur J Neurol
, vol.12
, pp. 212-217
-
-
Rikkert, M.G.1
Lauque, S.2
Frolich, L.3
Vellas, B.4
Dekkers, W.5
-
42
-
-
0026511742
-
Proxy decision making for incompetent patients
-
Emanuel EJ, Emanuel LL Proxy decision making for incompetent patients. JAMA 1992, 267:2067-2071.
-
(1992)
JAMA
, vol.267
, pp. 2067-2071
-
-
Emanuel, E.J.1
Emanuel, L.L.2
-
43
-
-
0025338743
-
Deferred consent: use in clinical resuscitation research. Brain Resuscitation Clinical Trial II Study Group
-
Abramson NS, Safar P Deferred consent: use in clinical resuscitation research. Brain Resuscitation Clinical Trial II Study Group. Ann Emerg Med 1990, 19:781-784.
-
(1990)
Ann Emerg Med
, vol.19
, pp. 781-784
-
-
Abramson, N.S.1
Safar, P.2
-
45
-
-
0019044714
-
Deferring consent with incompetent patients in an intensive care unit
-
Fost N, Robertson JA Deferring consent with incompetent patients in an intensive care unit. IRB Rev Hum Subj Res 1980, 2:5-6.
-
(1980)
IRB Rev Hum Subj Res
, vol.2
, pp. 5-6
-
-
Fost, N.1
Robertson, J.A.2
-
46
-
-
0028927463
-
Research in emergency situations. The role of deferred consent
-
Levine RJ Research in emergency situations. The role of deferred consent. JAMA 1995, 273:1300-1302.
-
(1995)
JAMA
, vol.273
, pp. 1300-1302
-
-
Levine, R.J.1
-
48
-
-
0027390557
-
The ethics of cardiac arrest research
-
Miller BL The ethics of cardiac arrest research. Ann Emerg Med 1993, 22:118-124.
-
(1993)
Ann Emerg Med
, vol.22
, pp. 118-124
-
-
Miller, B.L.1
-
49
-
-
0023724485
-
Miller BLPhilosophical, ethical, and legal aspects of resuscitation medicine. I. Deferred consent and justification of resuscitation research
-
Miller BLPhilosophical, ethical, and legal aspects of resuscitation medicine. I. Deferred consent and justification of resuscitation research. Crit Care Med 1988, 16:1059-1062.
-
(1988)
Crit Care Med
, vol.16
, pp. 1059-1062
-
-
-
51
-
-
84970679768
-
FDA's conduct, review, and evaluation of inspections of clinical investigators
-
Turner G, Lisook AB, Delman DP FDA's conduct, review, and evaluation of inspections of clinical investigators. Drug Inf J 1987, 21:117-125.
-
(1987)
Drug Inf J
, vol.21
, pp. 117-125
-
-
Turner, G.1
Lisook, A.B.2
Delman, D.P.3
-
52
-
-
12344321755
-
Research agendas in global emergency medicine
-
Arnold LK, Razzak J Research agendas in global emergency medicine. Emerg Med Clin North Am 2005, 23:231-257.
-
(2005)
Emerg Med Clin North Am
, vol.23
, pp. 231-257
-
-
Arnold, L.K.1
Razzak, J.2
-
53
-
-
18844380471
-
Defining standard of care in the developing world: the intersection of international research ethics and health systems analysis
-
Hyder AA, Dawson L Defining standard of care in the developing world: the intersection of international research ethics and health systems analysis. Dev World Bioeth 2005, 5:142-152.
-
(2005)
Dev World Bioeth
, vol.5
, pp. 142-152
-
-
Hyder, A.A.1
Dawson, L.2
-
54
-
-
18744383322
-
Many worlds, one ethic: design and development of a global research ethics training curriculum
-
Rivera R, Borasky D, Rice R, Carayon F Many worlds, one ethic: design and development of a global research ethics training curriculum. Developing World Bioeth 2005, 5:169-175.
-
(2005)
Developing World Bioeth
, vol.5
, pp. 169-175
-
-
Rivera, R.1
Borasky, D.2
Rice, R.3
Carayon, F.4
-
55
-
-
0034981884
-
Ethical and methodological issues in pedigree stroke research
-
Worrall BB, Chen DT, Meschia JF Ethical and methodological issues in pedigree stroke research. Stroke 2001, 32:1242-1249.
-
(2001)
Stroke
, vol.32
, pp. 1242-1249
-
-
Worrall, B.B.1
Chen, D.T.2
Meschia, J.F.3
|