-
1
-
-
0028070548
-
The Continuing Unethical Use of Placebo Controls
-
K.J. Rothman and K.B. Michels, "The Continuing Unethical Use of Placebo Controls," N. Engl. J. Med., 331 (1994): 394-98.
-
(1994)
N. Engl. J. Med.
, vol.331
, pp. 394-398
-
-
Rothman, K.J.1
Michels, K.B.2
-
2
-
-
1542733366
-
-
Id.
-
Id.
-
-
-
-
3
-
-
1542523339
-
-
note
-
Declaration of Helsinki (Helsinki: 18th World Medical Assembly, 1964; rev., Tokyo: 29th World Medical Assembly, 1975; rev., Venice, 35th World Medical Assembly, 1983; rev., Hong Kong: 41st World Medical Assembly, 1989; rev., Somerset West, South Africa, 48th General Assembly, 1996): at II.3. The 1996 revision added the following sentence to II.3. "This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists."
-
-
-
-
4
-
-
0028940906
-
The Helsinki Declaration: Timeless Guide or Irrelevant Anachronism?
-
L. Lasagna, "The Helsinki Declaration: Timeless Guide or Irrelevant Anachronism?," Journal of Clinical Psychopharmacology, 2 (1995): 96-98.
-
(1995)
Journal of Clinical Psychopharmacology
, vol.2
, pp. 96-98
-
-
Lasagna, L.1
-
6
-
-
0025514801
-
Placebo Controlled Trials and the Logic of Clinical Purpose
-
B. Freedman, "Placebo Controlled Trials and the Logic of Clinical Purpose," IRB: A Review of Human Subjects Research, 1, no. 6 (1990): 1-6.
-
(1990)
IRB: A Review of Human Subjects Research
, vol.1
, Issue.6
, pp. 1-6
-
-
Freedman, B.1
-
8
-
-
24544448111
-
Ethical Guidelines for Clinical Investigation, 1966
-
New York: Free Press
-
American Medical Association, "Ethical Guidelines for Clinical Investigation, 1966," in W.T. Reich, ed., Encyclopedia of Bioethics (New York: Free Press, vols. 3, 4, 1978): 1773-74.
-
(1978)
Encyclopedia of Bioethics
, vol.3-4
, pp. 1773-1774
-
-
Reich, W.T.1
-
9
-
-
0022600913
-
Use of Placebo in Clinical Trials?
-
K. Rickels, "Use of Placebo in Clinical Trials?," Psychopharmacology Bulletin, 22, no. 1 (1986): 19-24; and G.L. Klerman, "Scientific and Ethical Considerations in the Use of Placebo Controls in Clinical Trials in Psychopharmacology," Psychopharmacology Bulletin, 22, no. 1 (1986): 25-29.
-
(1986)
Psychopharmacology Bulletin
, vol.22
, Issue.1
, pp. 19-24
-
-
Rickels, K.1
-
10
-
-
0022588960
-
Scientific and Ethical Considerations in the Use of Placebo Controls in Clinical Trials in Psychopharmacology
-
K. Rickels, "Use of Placebo in Clinical Trials?," Psychopharmacology Bulletin, 22, no. 1 (1986): 19-24; and G.L. Klerman, "Scientific and Ethical Considerations in the Use of Placebo Controls in Clinical Trials in Psychopharmacology," Psychopharmacology Bulletin, 22, no. 1 (1986): 25-29.
-
(1986)
Psychopharmacology Bulletin
, vol.22
, Issue.1
, pp. 25-29
-
-
Klerman, G.L.1
-
11
-
-
0028870680
-
The Use of Placebo Controls
-
letter; comment; discussion
-
R. Pohl and R. Baron, letter; comment; discussion, "The Use of Placebo Controls," N. Engl. J. Med., 332 (1995): 61-62.
-
(1995)
N. Engl. J. Med.
, vol.332
, pp. 61-62
-
-
Pohl, R.1
Baron, R.2
-
14
-
-
84973728365
-
Government Viewpoint of Clinical Trials
-
Jan./Feb.
-
R. Temple, "Government Viewpoint of Clinical Trials," Drug Information Journal, Jan./Feb. (1982): 10-17.
-
(1982)
Drug Information Journal
, pp. 10-17
-
-
Temple, R.1
-
15
-
-
0022022537
-
The Use of Placebos in Randomized Clinical Trials
-
R.J. Levine, "The Use of Placebos in Randomized Clinical Trials," IRB: A Review of Human Subjects Research, 7, no. 2 (1985): 1-4.
-
(1985)
IRB: A Review of Human Subjects Research
, vol.7
, Issue.2
, pp. 1-4
-
-
Levine, R.J.1
-
16
-
-
0028913007
-
Use of Placebo Controls in Clinical Trials Disputed
-
D. Clery, "Use of Placebo Controls in Clinical Trials Disputed," Science, 267 (1995): 2-26.
-
(1995)
Science
, vol.267
, pp. 2-26
-
-
Clery, D.1
-
17
-
-
0026053048
-
Ethics and Placebo-Controlled Thrombolytic Trials: The Future
-
B. Freedman, "Ethics and Placebo-Controlled Thrombolytic Trials: The Future," Coronary Artery Disease, 2 (1991): 849-52; E. Geraci, "Enrolment in Trials of Thrombolysis," Lancet, 336 (1990): 1069-70; and B.A. Brody, Ethical Issues in Drug Testing, Approval, and Pricing (New York: Oxford University Press, 1995): ch. 2.
-
(1991)
Coronary Artery Disease
, vol.2
, pp. 849-852
-
-
Freedman, B.1
-
18
-
-
0025149461
-
Enrolment in Trials of Thrombolysis
-
B. Freedman, "Ethics and Placebo-Controlled Thrombolytic Trials: The Future," Coronary Artery Disease, 2 (1991): 849-52; E. Geraci, "Enrolment in Trials of Thrombolysis," Lancet, 336 (1990): 1069-70; and B.A. Brody, Ethical Issues in Drug Testing, Approval, and Pricing (New York: Oxford University Press, 1995): ch. 2.
-
(1990)
Lancet
, vol.336
, pp. 1069-1070
-
-
Geraci, E.1
-
19
-
-
0026053048
-
-
New York: Oxford University Press: ch. 2
-
B. Freedman, "Ethics and Placebo-Controlled Thrombolytic Trials: The Future," Coronary Artery Disease, 2 (1991): 849-52; E. Geraci, "Enrolment in Trials of Thrombolysis," Lancet, 336 (1990): 1069-70; and B.A. Brody, Ethical Issues in Drug Testing, Approval, and Pricing (New York: Oxford University Press, 1995): ch. 2.
-
(1995)
Ethical Issues in Drug Testing, Approval, and Pricing
-
-
Brody, B.A.1
-
20
-
-
0022543129
-
Does Short Term Placebo Treatment of Chronic Schizophrenia Produce Long Term Harm?
-
D.A. Curson et al., "Does Short Term Placebo Treatment of Chronic Schizophrenia Produce Long Term Harm?," British Medical Journal (Clinical Research Edition), 293 (1986): 726-28.
-
(1986)
British Medical Journal (Clinical Research Edition)
, vol.293
, pp. 726-728
-
-
Curson, D.A.1
-
21
-
-
1542733363
-
-
Id.
-
Id.
-
-
-
-
22
-
-
1542733364
-
-
Id.
-
Id.
-
-
-
-
23
-
-
0003392968
-
-
Washington, D.C.; U.S. Government Printing Office
-
National Institutes of Health, Office for Protection from Research Risks, Protecting Human Subjects: Institutional Review Board Handbook (Washington, D.C.; U.S. Government Printing Office, 1993): at 4-23.
-
(1993)
Protecting Human Subjects: Institutional Review Board Handbook
, pp. 4-23
-
-
-
25
-
-
0004306822
-
-
St. Paul: West, 5th ed.
-
E. Picard, Legal Liability of Doctors and Hospitals in Canada (Toronto: Carswell, 2nd ed., 1994); and W. Prosser and W. Keaton, The Law of Torts (St. Paul: West, 5th ed., 1984).
-
(1984)
The Law of Torts
-
-
Prosser, W.1
Keaton, W.2
-
26
-
-
1542733350
-
-
Halushka v. University of Saskatchewan, (1965) 93 D.L.R. 2d 436; and Kus v. Sherman Hospital, 644 N.E.2d 1214 (Ill. App. 1995)
-
Halushka v. University of Saskatchewan, (1965) 93 D.L.R. 2d 436; and Kus v. Sherman Hospital, 644 N.E.2d 1214 (Ill. App. 1995).
-
-
-
-
27
-
-
0004201635
-
-
London: Butterworth, 2nd ed.
-
J.K. Mason and R.A. McCall-Smith, Law & Medical Ethics (London: Butterworth, 2nd ed., 1987); D. Giesen, International Medical Malpractice Law (Dordrecht: Nijhoff, 1988): at § 48, para. 1200; and J.-L. Baudouin, "L'Experimentation sur les Humains: Un Conflit de Valeurs," McGill Law Journal, 26 (1986): 809-46.
-
(1987)
Law & Medical Ethics
-
-
Mason, J.K.1
McCall-Smith, R.A.2
-
28
-
-
0003732078
-
-
Dordrecht: Nijhoff, para. 1200
-
J.K. Mason and R.A. McCall-Smith, Law & Medical Ethics (London: Butterworth, 2nd ed., 1987); D. Giesen, International Medical Malpractice Law (Dordrecht: Nijhoff, 1988): at § 48, para. 1200; and J.-L. Baudouin, "L'Experimentation sur les Humains: Un Conflit de Valeurs," McGill Law Journal, 26 (1986): 809-46.
-
(1988)
International Medical Malpractice Law
, pp. 48
-
-
Giesen, D.1
-
29
-
-
0005858371
-
L'Experimentation sur les Humains: Un Conflit de Valeurs
-
J.K. Mason and R.A. McCall-Smith, Law & Medical Ethics (London: Butterworth, 2nd ed., 1987); D. Giesen, International Medical Malpractice Law (Dordrecht: Nijhoff, 1988): at § 48, para. 1200; and J.-L. Baudouin, "L'Experimentation sur les Humains: Un Conflit de Valeurs," McGill Law Journal, 26 (1986): 809-46.
-
(1986)
McGill Law Journal
, vol.26
, pp. 809-846
-
-
Baudouin, J.-L.1
-
30
-
-
0018214622
-
Problems in Deceptive Medical Procedures: An Ethical and Legal Analysis of the Administration of Placebos
-
L. Simmons, "Problems in Deceptive Medical Procedures: An Ethical and Legal Analysis of the Administration of Placebos," Journal of Medical Ethics, 4 (1978): 172-81; M.B. Kapp, "Placebo Therapy & the Law: Prescribe with Care," American Journal of Law & Medicine, 8 (1983): 371-405; Mason and McCall-Smith, supra note 23; Giesen, supra note 23; and Baudouin, supra note 23.
-
(1978)
Journal of Medical Ethics
, vol.4
, pp. 172-181
-
-
Simmons, L.1
-
31
-
-
0020576825
-
Placebo Therapy & the Law: Prescribe with Care
-
L. Simmons, "Problems in Deceptive Medical Procedures: An Ethical and Legal Analysis of the Administration of Placebos," Journal of Medical Ethics, 4 (1978): 172-81; M.B. Kapp, "Placebo Therapy & the Law: Prescribe with Care," American Journal of Law & Medicine, 8 (1983): 371-405; Mason and McCall-Smith, supra note 23; Giesen, supra note 23; and Baudouin, supra note 23.
-
(1983)
American Journal of Law & Medicine
, vol.8
, pp. 371-405
-
-
Kapp, M.B.1
-
32
-
-
0018214622
-
-
L. Simmons, "Problems in Deceptive Medical Procedures: An Ethical and Legal Analysis of the Administration of Placebos," Journal of Medical Ethics, 4 (1978): 172-81; M.B. Kapp, "Placebo Therapy & the Law: Prescribe with Care," American Journal of Law & Medicine, 8 (1983): 371-405; Mason and McCall-Smith, supra note 23; Giesen, supra note 23; and Baudouin, supra note 23.
-
Supra Note
, vol.23
-
-
Mason1
McCall-Smith2
-
33
-
-
0018214622
-
-
L. Simmons, "Problems in Deceptive Medical Procedures: An Ethical and Legal Analysis of the Administration of Placebos," Journal of Medical Ethics, 4 (1978): 172-81; M.B. Kapp, "Placebo Therapy & the Law: Prescribe with Care," American Journal of Law & Medicine, 8 (1983): 371-405; Mason and McCall-Smith, supra note 23; Giesen, supra note 23; and Baudouin, supra note 23.
-
Supra Note
, vol.23
-
-
Giesen1
-
34
-
-
0018214622
-
-
L. Simmons, "Problems in Deceptive Medical Procedures: An Ethical and Legal Analysis of the Administration of Placebos," Journal of Medical Ethics, 4 (1978): 172-81; M.B. Kapp, "Placebo Therapy & the Law: Prescribe with Care," American Journal of Law & Medicine, 8 (1983): 371-405; Mason and McCall-Smith, supra note 23; Giesen, supra note 23; and Baudouin, supra note 23.
-
Supra Note
, vol.23
-
-
Baudouin1
-
36
-
-
1542628083
-
-
Mason and McCall Smith, supra note 23; and Giesen, supra note 23,
-
Supra Note
, vol.23
-
-
Giesen1
-
37
-
-
1542523324
-
-
Halushka, 93 D.L.R. 2d at 436; and Sherman Hospital, 644 N.E.2d at 1214
-
Halushka, 93 D.L.R. 2d at 436; and Sherman Hospital, 644 N.E.2d at 1214.
-
-
-
-
39
-
-
0003415998
-
-
London: Butterworth
-
I. Kennedy and I. Grubb, Medical Law: Text and Materials (London: Butterworth, 1989): at 452; and C.B. Perry, "Conflicts of Interest and the Physician's Duty to Inform," American Journal of Medicine, 96 (1994): 375-80.
-
(1989)
Medical Law: Text and Materials
, pp. 452
-
-
Kennedy, I.1
Grubb, I.2
-
40
-
-
0028198133
-
Conflicts of Interest and the Physician's Duty to Inform
-
I. Kennedy and I. Grubb, Medical Law: Text and Materials (London: Butterworth, 1989): at 452; and C.B. Perry, "Conflicts of Interest and the Physician's Duty to Inform," American Journal of Medicine, 96 (1994): 375-80.
-
(1994)
American Journal of Medicine
, vol.96
, pp. 375-380
-
-
Perry, C.B.1
-
41
-
-
1542628080
-
-
para. 1200
-
Giesen, supra note 23, § 46, para. 1200.
-
Supra Note
, vol.23
, pp. 46
-
-
Giesen1
-
42
-
-
1542418658
-
-
Prosser and Keaton, supra note 21, at §§ 106-07; and Perry, supra note 28.
-
Supra Note
, vol.21
, pp. 106-107
-
-
Prosser1
Keaton2
-
43
-
-
1542523336
-
-
Prosser and Keaton, supra note 21, at §§ 106-07; and Perry, supra note 28.
-
Supra Note
, vol.28
-
-
Perry1
-
47
-
-
1542733358
-
-
45 C.F.R. § 46.111(a)(2) (1991)
-
45 C.F.R. § 46.111(a)(2) (1991).
-
-
-
-
51
-
-
0012619633
-
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
-
Apr. 18
-
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," OPRR Reports, Apr. 18 (1979): 1-8; and R. Ratzan, "Being Old Makes You Different: The Ethics of Research with Elderly Subjects," Hastings Center Report, 10, no. 5 (1980): 32-46.
-
(1979)
OPRR Reports
, pp. 1-8
-
-
-
52
-
-
84977359215
-
Being Old Makes You Different: The Ethics of Research with Elderly Subjects
-
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," OPRR Reports, Apr. 18 (1979): 1-8; and R. Ratzan, "Being Old Makes You Different: The Ethics of Research with Elderly Subjects," Hastings Center Report, 10, no. 5 (1980): 32-46.
-
(1980)
Hastings Center Report
, vol.10
, Issue.5
, pp. 32-46
-
-
Ratzan, R.1
-
54
-
-
1542523335
-
-
London: Sweet & Maxwell, 2nd ed.
-
C.D. Baker, Tort (London: Sweet & Maxwell, 2nd ed., 1976): at 52; and Kennedy and Grubb, supra note 28, at 279.
-
(1976)
Tort
, pp. 52
-
-
Baker, C.D.1
-
55
-
-
1542418656
-
-
C.D. Baker, Tort (London: Sweet & Maxwell, 2nd ed., 1976): at 52; and Kennedy and Grubb, supra note 28, at 279.
-
Supra Note
, vol.28
, pp. 279
-
-
Kennedy1
Grubb2
-
58
-
-
1542628093
-
-
Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040, 21 U.S.C. §§ 301 et seq. at § 505(d) (as amended 1962)
-
Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040, 21 U.S.C. §§ 301 et seq. at § 505(d) (as amended 1962).
-
-
-
-
59
-
-
1542523332
-
-
21 C.F.R. § 314.26(b)(2) (1991)
-
21 C.F.R. § 314.26(b)(2) (1991).
-
-
-
-
61
-
-
0016259698
-
Guidelines for the Conduct of Clinical Trials: FDA Guidelines for Psychotropic Drugs
-
"Guidelines for the Conduct of Clinical Trials: FDA Guidelines for Psychotropic Drugs," Psychopharmacology Bulletin, 1, no. 4 (1974): 70-91; and "FDA Guidelines for the Clinical Evaluation of Psychotropic Drugs-Antidepressant and Antianxiety Drugs," Psychopharmacology Bulletin, 14, no. 2 (1978): 45-63.
-
(1974)
Psychopharmacology Bulletin
, vol.1
, Issue.4
, pp. 70-91
-
-
-
62
-
-
0017861848
-
FDA Guidelines for the Clinical Evaluation of Psychotropic Drugs-Antidepressant and Antianxiety Drugs
-
"Guidelines for the Conduct of Clinical Trials: FDA Guidelines for Psychotropic Drugs," Psychopharmacology Bulletin, 1, no. 4 (1974): 70-91; and "FDA Guidelines for the Clinical Evaluation of Psychotropic Drugs-Antidepressant and Antianxiety Drugs," Psychopharmacology Bulletin, 14, no. 2 (1978): 45-63.
-
(1978)
Psychopharmacology Bulletin
, vol.14
, Issue.2
, pp. 45-63
-
-
-
63
-
-
1542523330
-
FDA Guidelines
-
"FDA Guidelines," supra note 46.
-
Supra Note
, vol.46
-
-
-
64
-
-
1542628097
-
Guidelines for the Conduct of Clinical Trials
-
"Guidelines for the Conduct of Clinical Trials," supra note 46.
-
Supra Note
, vol.46
-
-
-
65
-
-
1542523333
-
Investigation of Drugs in Humans
-
"Investigation of Drugs in Humans," supra note 45.
-
Supra Note
, vol.45
-
-
-
66
-
-
1542628097
-
Guidelines for the Conduct of Clinical Trials
-
"Guidelines for the Conduct of Clinical Trials," supra note 46.
-
Supra Note
, vol.46
-
-
-
67
-
-
1542628090
-
-
21 C.F.R. § 314.26(b)(2)(iv) (1991)
-
21 C.F.R. § 314.26(b)(2)(iv) (1991).
-
-
-
-
68
-
-
0018803632
-
Who Makes the Therapeutic Decisions?
-
J.C. Ballin, "Who Makes the Therapeutic Decisions?," JAMA, 242 (1979): 2875.
-
(1979)
JAMA
, vol.242
, pp. 2875
-
-
Ballin, J.C.1
-
70
-
-
1542628091
-
-
44 Fed. Reg. 51,512 (Aug. 31, 1979)
-
44 Fed. Reg. 51,512 (Aug. 31, 1979).
-
-
-
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