Research involving the vulnerable sick

References

• Abramson , N.S. 1991 . Informed consent for clinical resuscitation research . Annals of Emergency Medicine , 20 : 1252 – 1254 .
   Google Scholar
• Abramson , N.S. , Meisel , A. and Safar , P. 1986 . Deferred consent: A new approach for resuscitation research on comatose patients . JAMA , 255 : 2466 – 2471 .
   Google Scholar
• Advisory Committee on Human Radiation Experiments . 1996 . The Human Radiation Experiments , New York : Oxford University Press .
   Google Scholar
• American Society of Clinical Oncology . 1997 . Critical role of phase I clinical trials in cancer treatment . Journal of Clinical Oncology , 15 : 853 – 859 .
   PubMed Web of Science ®Google Scholar
• Appelbaum , P.S. , Litz , C.W. and Meisel , A. 1987 . Informed Consent: Legal Theory and Clinical Practice , New York : Oxford University Press .
   Google Scholar
• Arbuck , S.G. 1996 . Workshop on phase I study design . Annals of Oncology , 7 : 567 – 573 .
   Google Scholar
• Cassell , E.J. 1977 . The function of medicine . Hastings Center Report 7 , 6 : 16 – 19 .
   Google Scholar
• Clery , D. 1995 . Use of placebo controls in clinical trials disputed . Science , 267 : 25 – 6 .
   Google Scholar
• Collins , J.M. , Grieshaber , C.K. and Chabner , B.A. 1990 . Pharmacologically guided phase I clinical trials based upon preclinical drug development . Journal of the National Cancer Institute , 82 : 1321 – 1326 .
   PubMed Web of Science ®Google Scholar
• Decoster , G. , Stein , G. and Holdener , E.E. 1990 . Responses and toxic deaths in phase I clinical trials . Annals of Oncology , 1 : 175 – 181 .
   PubMed Web of Science ®Google Scholar
• Dent , S.F. and Eisenhauer , E.A. 1996 . Phase I design: Are new methodologies being put into practice? . Annals of Oncology , 7 : 561 – 566 .
   PubMed Web of Science ®Google Scholar
• Estey , E. , Hoth , D. , Simon , R. , Marsoni , S. , Leyland‐Jones , B. and Wittes , R. 1986 . Therapeutic response in phase I trials of antineoplastic agents . Cancer Treatment Reports , 70 : 1105 – 1115 .
   PubMedGoogle Scholar
• Freedman , B. 1987 . Equipoise and the ethics of clinical research . New England Journal of Medicine , 317 : 141 – 145 .
   PubMed Web of Science ®Google Scholar
• Freedman , B. 1990 . Placebo‐controlled trials and the logic of clinical purpose . IRB: A Review of Human Subjects Research , 12 ( 6 ) : 1 – 6 .
   Google Scholar
• Freedman , B. , Fuks , A. and Weijer , C. 1992 . Demarcating research and treatment: A systematic approach for the analysis of the ethics of clinical research . Clinical Research , 40 : 653 – 660 .
   PubMedGoogle Scholar
• Freedman , B. , Fuks , A. and Weijer , C. 1993 . In loco parentis: Minimal risk as an ethical threshold for research upon children . Hastings Center Report , 23 ( 2 ) : 13 – 19 .
   PubMed Web of Science ®Google Scholar
• Freedman , B. , Glass , K.C. and Weijer , C. 1996 . Placebo orthodoxy in clinical research II: Ethical, legal and regulatory myths . Journal of Law, Medicine and Ethics , 24 : 252 – 259 .
   PubMed Web of Science ®Google Scholar
• Freedman , B. , Weijer , C. and Glass , K.C. 1996 . Placebo orthodoxy in clinical research I: empirical and methodological myths . Journal of Law, Medicine and Ethics , 24 : 243 – 251 .
   PubMed Web of Science ®Google Scholar
• Geller , N.L. 1984 . Design of phase I and phase II clinical trials in cancer: A statistician's view . Cancer Investigation , 2 : 483 – 491 .
   PubMed Web of Science ®Google Scholar
• Gordon , N.H. and Willson , J.K.V. 1992 . Using toxicity grades in the design and analysis of cancer phase I clinical trials . Statistics in Medicine , 11 : 2063 – 2075 .
   PubMed Web of Science ®Google Scholar
• Gram , L. 1994 . Fluoxetine . New England Journal of Medicine , 331 : 1354 – 1361 .
   PubMed Web of Science ®Google Scholar
• Jones , J.H. 1993 . Bad Blood: The Tuskegee Syphilis Experiment , New York : Free Press .
   Google Scholar
• Kane , J.M. 1996 . Schizophrenia . New England Journal of Medicine , 334 : 34 – 41 .
   PubMed Web of Science ®Google Scholar
• Lasagna , L. 1995 . The Helsinki Declaration: Timeless guide or irrelevant anachronism? . Journal of Clinical Psychopharmacology , 15 : 96 – 98 .
   Google Scholar
• Levine , R.J. 1988 . Ethics and Regulation of Clinical Research , (2nd ed) , New Haven : Yale University Press .
   Google Scholar
• Janish , L. , Mick , R. , Schilsky , R.L. , Vogelzang , N.J. , O'Brien , S. , Kut , M. and Ratain , M.J. 1994 . Prognostic factors for survival in patients treated in phase I clinical trials . Cancer , 74 : 1965 – 1973 .
   Google Scholar
• Jonas , H. 1974 . “ Philosophical reflections on experimenting with human subjects ” . In Philosophical Essays: From Ancient Creed To Technological Man , 105 – 131 . Englewood Cliffs, New Jersey : Prentice‐Hall, Inc. .
   Google Scholar
• Mastroianni , A.C. , Faden , R. and Federman , D. , eds. 1994 . Women and Health Research , Washington : National Academy Press .
   Google Scholar
• Melink , T.J. , Clark , G.M. and Von Hoff , D.D. 1992 . The impact of phase I clinical trials on the quality of life of patients with cancer . Anti‐Cancer Drugs , 3 : 571 – 576 .
   PubMed Web of Science ®Google Scholar
• Michels , R. and Marzuk , P.M. 1993 . Progress in psychiatry II . New England Journal of Medicine , 329 : 628 – 638 .
   PubMed Web of Science ®Google Scholar
• Mick , R. and Ratain , M.J. 1993 . Model‐guided determination of maximum tolerated dose in phase I clinical trials: Evidence for increased precision . Journal of the National Cancer Institute , 85 : 217 – 223 .
   PubMed Web of Science ®Google Scholar
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . 1979 . The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . OPRR Reports , April 18 : 1 – 8 .
   Google Scholar
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . 1978 . Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations , DHEW Publication No. (OS) 78–0006, Appendix, DHEW Publication No. (OS) 78–0007 Washington
   Google Scholar
• Office for Protection of Research Risks . 1993 . Protecting Human Research Subjects: Institutional Review Board Guidebook , Washington, D.C. : U.S. Government Printing Office .
   Google Scholar
• O'Quigley , J. and Chevret , S. 1991 . Methods for dose finding studies in cancer clinical trials: A review and results of a Monte Carlo study . Statistics in Medicine , 10 : 1647 – 1664 .
   PubMed Web of Science ®Google Scholar
• O'Quigley , J. , Pepe , M. and Fisher , L. 1990 . Continual reassessment method: A practical design for phase I clinical trials in cancer . Biometrics , 46 : 33 – 48 .
   PubMed Web of Science ®Google Scholar
• Rothman , K.J. and Michels , K.B. 1994 . The continuing unethical use of placebo controls . New England Journal of Medicine , 331 : 394 – 398 .
   PubMed Web of Science ®Google Scholar
• Skrutkowski , M. , Weijer , C. , Shapiro , S. , Fuks , A. , Langleben , A. and Freedman , B. 1998 . Monitoring informed consent in an oncology study posing serious risk to subjects . IRB: A Review of Human Subjects Research , 20 ( 6 ) : 1 – 6 .
   Google Scholar
• Von Hoff , D.D. and Turner , J. 1991 . Response rates, duration of response, and dose response effects in phase I studies of antineoplastics . Investigational New Drugs , 9 : 115 – 122 .
   PubMed Web of Science ®Google Scholar
• Weijer , C. 1996 . Evolving ethical issues in selection of subjects for clinical research . Cambridge Quarterly of Healthcare Ethics , 5 : 334 – 345 .
   Google Scholar
• Weijer , C. and Fuks , A. 1994 . The duty to exclude: Excluding people at undue risk from research . Clinical and Investigative Medicine , 17 : 115 – 122 .
   Google Scholar
• Weijer , C. , Shapiro , S. , Fuks , A. , Glass , K.C. and Skrutkowska , M. 1995 . Monitoring clinical research: An obligation unfulfilled . Canadian Medical Association Journal , 152 : 1973 – 1980 .
   PubMed Web of Science ®Google Scholar
• World Medical Association . 1997 . Declaration of Helsinki [1964, revised 1975, 1983, 1989, 1996] . JAMA , 277 : 925 – 926 .
   PubMed Web of Science ®Google Scholar
• Prof. Weijer's research is supported by a Scholar Award and Operating Grant from the Medical Research Council of Canada, as well as a Clinical Scholar Award from Dalhousie University. 5849 University Ave., Room 105, Halifax, Nova Scotia, Canada, B3H 4H7. Tel.: 902–494–3801. Fax: 902–494–3865. E‐mail: [email protected].
   Google Scholar