Research involving humans : ethics, law and regulation

6 Pages·2002·0.23 MB·English

by  Lemmens, Trudo

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RESEARCH INVOLVING HUMANS:
ETHICS, LAW AND REGULATION
VOLUME III
PROFESSOR TRUDO LEMMENS
With the assistance of Paul Miller
Faculty of Law
University of Toronto
FALL 2002
(FOR INTERNAL USE BY STUDENTS)
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2002
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OCT I 3 2002
FACULTY OF LH
RESEARCH INVOLVING HUMANS:
ETHICS, LAW AND REGULATION
VOLUME III
PROFESSOR TRUDO LEMMENS
With the assistance of Paul Miller
Faculty of Law
University of Toronto
FALL 2002
(FOR INTERNAL USE BY STUDENTS)
m
VOLUME
I. Genetics and Research
T. Lemmens & L. Austin, “The Challenges of Regulating the Use of Genetic 1
Information” (2001) 2:3 ISUMA: Can. J. Pol’y Research 26-37.
K.C. Glass, et al., “Structuring the Review of Human Genetics Protocols Part I: 13
Gene Localization and Identification Studies” (1996) 18:4 IRB: A Review of Human
Subjects Research 1-9.
K.C. Glass, et al., “Structuring the Review of Human Genetics Protocols Part II: 22
Diagnostic and Screening Studies” (1997) 19:3-4 IRB: A Review of Human Subjects
Research 1-13.
K. C. Glass, et al., “Structuring the Review of Human Genetics Protocols Part III. 34
Gene Therapy Studies” (1999) 21 IRB: A Review of Human Subjects Research 1-9.
J. F. Merz, “Is Genetics Research Minimal Risk?” (1996) 18:6 IRB: A Review of 43
Human Subjects Research 7-8.
American Society of Human Genetics, “ASHG Report: Statement of Informed Consent 45
for Genetic Research” (1995) 59 Am. J. Hum. Genet. 471-474.
M. Deschenes, et al., “Human Genetic Research, DNA Banking and Consent: 49
A Question of‘Form’?” (2001) 59 Clin. Genet. 221-239.
L. M. Beskow, et al., “Informed Consent for Population-Based Research Involving 68
Genetics” (2001) 286:18 J. Am. Med. Assoc. 2315-2321.
J.F. Merz, et al., “Protecting subjects' interests in genetics research” (2002) 70:4 75
Am. J. Hum Genet. 965-71.
II. Justice and International Research
G. Annas & M. Grodin, “Research Forum: Ethics and Studies of HIV; Human Rights 82
and Maternal-Fetal HIV Transmission Prevention Trials in Africa” (1998) 88:4 Am. J.
Pub. Health 560-563.
N. Christakis & M. J. Panner, “Existing International Ethical Guidelines for Human 86
Subjects Research: Some Open Questions” (1991) 19 L. Med. & Healthcare 214-221.
R.A. Crouch & J.D. Arras, “AZT Trials and Tribulations” (1998) Nov-Dec Hastings 94
Center Report 26-34.
C. Levine, “Placebos and HIV: Lessons Learned” (1998) Nov-Dec Hastings Center 102
Report 43-48.
III. Legal Liability
H. Sava, et al., “Legal Liability of Physicians in Medical Research” (1994) 17 Clin. 108
Invest. Med. 148-184.
M.A. Rodwin, “Strains in the Fiduciary Metaphor. Divided Physician Loyalties and 145
Obligations in a Changing Health Care System” (1995) 21 Am. J. L. & Med. 241-257.
P.E. Kalb & K.G. Koehler, “Legal Issues in Scientific Research” (2002) 287:1 J. Am. 154
Med. Assoc. 85-91.
B. Freedman & K.C. Glass, “Weiss v. Solomon. A Case Study in Institutional 161
Responsibility for Clinical Research” (1990) 18 L. Med. & Healthcare 395-403.
I. Harvey & R. Chadwick, “Compensation for Harm: the Implications for Medical 170
Research” (1992) 34 Social Sci. Med. 1399-1404.
W.K. Mariner, “Compensation for Research Injuries,” in A C. Mastroianni, et al., eds., 176
Women and Health Research: Ethical and Legal Issues of Including Women in Clinical
Studies (Vol. 2) (Washington, DC: National Academy Press, 1994) 113-126.
Addendum
Burton v. Brooklyn Doctors Hosp. 452 N.Y.S. 2d 875 (App. Div. 1982) 184
Halikasv. University of Minnesota 856 F.Supp. 1331 (D.Minn 1994) 189
Halushka v. University of Saskatchewan et al. (1965) 52 W.W.R. 608 193
Kus v. Sherman Hosp. 664 N.E. 2d (Ill.App.2Dist. 1995) 199
Moore v. Regents of the University of California 793 P.2d 479 (Cal. 1990) 204
Zimmer v. Ringrose (1981) 4 W.W.R. 75 227
Bailey v. Lally 481 F.Supp. 203 (1979) 234
Stewart v. Cleveland Clinic Foundation 1999 WL 1068225 (Ohio App.8 Dist.) 248
Norberg v. Wynrib (1992), 92 D.L.R. (4th) 449 (SCC) 257