Ethical considerations in neuroclinical trials

Bartlett RH, DW Roloff, RG Cornell: Extracorporal Circulation In Neonatal Respiratory Failure: A Prospective Randomized Study. Pediatrics 76 (1985) 479?487

Beauchamp TL: The Ambiguities Of Deferred Consent. IRB: A Review Of Human Subjects Research 2(7) (1980) 6?9

Beauchamp TL, JF Childress: Principles Of Biomedical Ethics, Oxford, New York (1989) 74?116

Brody H: Placebos and the Philosophy of Medicine. University of Chicago Press, Chicago (1980)

Byar DP, RM Simon, WT Friedewald, JJ Schlesselman, DL Demets, JH Ellenberg, MH Gail, JH Ware: Randomized Clinical Trials: Perspectives On Some Recent Ideas. New England Journal Of Medicine 295 (1976) 74?80

Choi SC, PJ Smith, DP Becker: Early decision in clinical trials when the treatment differences are small. Controlled Clinical Trials 6(4) (1985) 280?9

Chuang-Stein C: A new proposal for benefit-less risk analysis in clinical trials. Controlled Clinical Trials 15 (1994) 30?43

Connelly RJ: Deception and The Placebo Effect in Biomedical Research. IRB: A Review Of Human Subjects Research. 9(4) (1987) 5?7

Department Of Health And Human Services, Rules And Regulations. 45CFR46,14.116 (1983)

Duffy TM, P Kabance: Testing Readable Writing Approach To Text Revision. Journal Of Educational Psychology 74 (1982) 733?748

Emanuel EJ, LL Emanuel: Proxy Decision Making For Incompetent Patients. Journal Of The American Medical Association 267(15) (1992) 2067?2071

Freedman B: A Response To A Purported Ethical Difficulty With Randomized Clinical Trials Involving Cancer Patients. The Journal Of Clinical Ethics 3(3) (1992) 231?234

Freedman B: Equipoise and The Ethics Of Clinical Research. New England Journal Of Medicine 317 (1987) 141?145

Food and Drug Administration Rules And Regulations 21 CFR 56, Federal Register 46 (January 27, 1981), 8975; revised 1991 (Federal Commission Policy) Federal Register 56 (June 18, 1991), 28003

Fost N, JA Robertson: Deferring Consent With Incompetent Patients In An Intensive Care Unit. IRB: A Review Of Human Subjects Research 2(7) (1980) 5?6

Gelmers HJ, K Gorter, CJ De Weerdt, HJ Weizer: A Controlled Trial of Nimodipine in Acute Ischemic Stroke. New England Journal of Medicine 318(4) (1988) 203?7

Hayes GJ, SC Hayes, T Dykstra: A Survey of Institutional Review Boards: Characteristics Policies and Procedures IRB: A Review of Human Subjects Research 17(3) (1995) 1?5

Hellman S, DS Hellman: Of Mice But Not Men: Problems Of The Randomized Clinical Trial. New England Journal Of Medicine 324(22) (1994) 1585 bis 1589

Katz J: Ethics And Clinical Research Revisited: A Tribute To Henry K. Beecher. Hastings Center Report 23(5) (1993) 31?39

Katz J: Human Experimentation and Human Rights. St. Louis University Law Journal 38(1) (1993) 7?54

Kopelman L: Consent and Randomized Clinical Trials: Are There Moral Or Design Problems? Journal Of Medicine And Philosophy 11 (1986) 317?345

Lawson SL, HM Adavison: Informed Consent Readability: Subject Understanding of 15 Common Sonsent Form Phases IRB: A Review of Human Subject Research 17(6) (1995) 16?19

Levine RJ: Clarifying The Concepts Of Research Ethics. Hastings Center Report 6 (1979) 21?26

Levine RJ: Deferred Consent. Controlled Clinical Trials 12 (1991) 546?550

Menasche A: FDA Revises Informed Consent Regulations for Emergency Research IRB: A Review of Human Subjects Research 17(6) (1995) 19?21

Meslin E: Protecting Human Subjects From Harm Through Improved Risk Judgments. IRB: A Review Of Human Subjects Research 12(1) (1990) 7?10

Meslin EM, JV Lavery, AJ Sutherland, JE Till: Judging the Ethical Merit of Clinical Trials: What Criteria Do Research Ethics Board Members Use? IRB: A Review of Human Subjects 16(4) (1994) 6?10

Oczkowski WJ, VC Hachinsky, JBogousslavsky, HJ Aarnett, SG Caruthers: A double-blind, randomized trial of PY108-068 in acute ischemic cerebral infarction. Stroke. 20 (5) (1989) 604?8

Ohman J, O Heiskanen: Effects of Nimoclopine on The Outcome of patients After Aneurysmal Subarachnoid Hemorrhage. Journal of Neurosurgery 69 (1988) 683?686

Parmar MK: Pitfalls and biases in the reporting and interpretation of the results of clinical trials. Lung Cancer 10 Suppl 1 (1994) S143?50

Petruk KC, M West, G Mohr, BG Benoit, F Gentilli, LB Disney, M Khan, M Grace, RD Holness: Nimodipine treatment in poor-grade aneurysm pa tients. Results of a multicenter double-blind placebocontrolled trial. Journal of Neurosurgery 68(4) (1988) 505?17

Protecting human research subjects. Institutional review board guidebook US Department of Health and Human Services (1993)

Rabeneck L, CM Viscoli, RI Horowitz: Problems In The Conduct And Analysis Of Randomized Clinical Trials. Arch Int Med 152 (1992) 507?512

Rosner R: The Ethics Of Randomized Clinical Trials. The American Journal Of Medicine 82 (1987) 283?290

Rothman DJ: Ethics In Human Experimentation: Henry Beecher Revisited. New England Journal Of Medicine 317(19) (1987) 1195?1199

Rothman KJ, KB Michels: The Continuing Unethical Use of Placebo Controls. The New England Journal of Medicine 331(6) (1994) 394?398

Schafer A: The Randomized Clinical Trial: For Whose Benefit. IRB: Review Of Human Subject Research 7(2) (1985) 4?6

Simel DL, JR Feussner: Clinical Trials Of Informed Consent. Controlled Clinical Trials 13 (1992) 321?324

Straus JL, SVA Cavanaugh: Placebo Effects: Issues for Clinical Practice in Psychiatry and Medicine 37(4) (1996)315?325

Taub HA: Comprehension Of Informed Consent For Research: Issues And Directions For Future Study. IRB: A Review Of Human Subjects Research 8 (1986) 7?10

Weinstein MC: Allocation Of Subjects In Medical Experiments. New England Journal Of Medicine 291(24) (1974) 1278?1285

Williams CJ, M Szitter: Informed Consent in European Multicentre Randomized Clinical Trials ? Are Patients Really Informed? European Journal of Cancer 30A (7) (1994) 907?910