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Volumn 41, Issue 2, 2003, Pages 93-99

Of consents and CONSORTS: Reporting ethics, law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the "consort" guidelines

Author keywords

CONSORT; Ethics; Overdose; RCTs; Volunteers

Indexed keywords

ACTIVATED CARBON;

EID: 0037278668     PISSN: 07313810     EISSN: None     Source Type: Journal    
DOI: 10.1081/CLT-120019120     Document Type: Article
Times cited : (14)

References (39)
  • 2
    • 0028771491 scopus 로고
    • Phase one trials can exploit terminally ill patients
    • McBride G. Phase one trials can exploit terminally ill patients. Br Med J 1994, 308 (6930): 679-680.
    • (1994) Br Med J , vol.308 , Issue.6930 , pp. 679-680
    • McBride, G.1
  • 3
    • 0037007685 scopus 로고    scopus 로고
    • Improving protection for research subjects
    • Steinbrook R. Improving protection for research subjects. N Engl J Med 2002, 346 (18): 1425-1430.
    • (2002) N Engl J Med , vol.346 , Issue.18 , pp. 1425-1430
    • Steinbrook, R.1
  • 4
    • 0032482243 scopus 로고    scopus 로고
    • The death of a healthy volunteer in a human research project: Implications for Australian clinical research
    • Day RO, Chalmers DR, Williams KM, Campbell TJ. The death of a healthy volunteer in a human research project: implications for Australian clinical research. Med J Aust 1998, 168 (9): 449-451.
    • (1998) Med J Aust , vol.168 , Issue.9 , pp. 449-451
    • Day, R.O.1    Chalmers, D.R.2    Williams, K.M.3    Campbell, T.J.4
  • 5
    • 0034648728 scopus 로고    scopus 로고
    • Protecting research subjects-what must be done
    • Shalala D. Protecting research subjects-what must be done. N Engl J Med 2000, 343 (11): 808-810.
    • (2000) N Engl J Med , vol.343 , Issue.11 , pp. 808-810
    • Shalala, D.1
  • 7
    • 85007752782 scopus 로고    scopus 로고
    • A view from the man in the seat opposite
    • Boyd R. A view from the man in the seat opposite. Br Med J 1998, 317 (7155): 410.
    • (1998) Br Med J , vol.317 , Issue.7155 , pp. 410
    • Boyd, R.1
  • 8
    • 0026654957 scopus 로고
    • An international appraisal of the minimum duration of chronic animal toxicity studies
    • Lumley CE, Parkinson C, Walker SR. An international appraisal of the minimum duration of chronic animal toxicity studies. Hum Exp Toxicol 1992, 11 (3): 155-162.
    • (1992) Hum Exp Toxicol , vol.11 , Issue.3 , pp. 155-162
    • Lumley, C.E.1    Parkinson, C.2    Walker, S.R.3
  • 9
    • 0029687160 scopus 로고    scopus 로고
    • Unanticipated human toxicology of recombinant proteins
    • Ryffel B. Unanticipated human toxicology of recombinant proteins. Arch. Toxicol. Suppl 1996, 18, 333-341.
    • (1996) Arch Toxicol Suppl , vol.18 , pp. 333-341
    • Ryffel, B.1
  • 10
    • 0029056212 scopus 로고
    • How to do it. Get patients' consent to enter clinical trials
    • Wager E, Tooley PJ, Emanuel MB, Wood SF. How to do it. Get patients' consent to enter clinical trials. Br Med J 1995, 311 (7007): 734-737.
    • (1995) Br Med J , vol.311 , Issue.7007 , pp. 734-737
    • Wager, E.1    Tooley, P.J.2    Emanuel, M.B.3    Wood, S.F.4
  • 11
    • 0037006120 scopus 로고    scopus 로고
    • Legal issues in scientific research
    • Kalb PE, Koehler KG. Legal issues in scientific research. J Am Med Assoc 2002, 287 (1): 85-91.
    • (2002) J Am Med Assoc , vol.287 , Issue.1 , pp. 85-91
    • Kalb, P.E.1    Koehler, K.G.2
  • 12
    • 0033535526 scopus 로고    scopus 로고
    • Informed consent and approval by institutional review boards in published reports on clinical trials
    • Ruiz-Canela M, Martinez-Gonzalez MA, Gomez-Gracia E, Fernandez-Crehuet J. Informed consent and approval by institutional review boards in published reports on clinical trials. N Engl J Med 1999, 340 (14): 1114-1115.
    • (1999) N Engl J Med , vol.340 , Issue.14 , pp. 1114-1115
    • Ruiz-Canela, M.1    Martinez-Gonzalez, M.A.2    Gomez-Gracia, E.3    Fernandez-Crehuet, J.4
  • 13
    • 85008279652 scopus 로고    scopus 로고
    • CONSORT statement on the reporting standards of clinical trials. Reporting of refusal of consent to take part in clinical trials is still poor
    • Bromhead HJ, Goodman NW. CONSORT statement on the reporting standards of clinical trials. Reporting of refusal of consent to take part in clinical trials is still poor. Br Med J 1997, 314 (7087): 1126-1127.
    • (1997) Br Med J , vol.314 , Issue.7087 , pp. 1126-1127
    • Bromhead, H.J.1    Goodman, N.W.2
  • 15
    • 0028597041 scopus 로고
    • Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature
    • Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med 1994, 121 (11): 894-895.
    • (1994) Ann Intern Med , vol.121 , Issue.11 , pp. 894-895
  • 16
    • 0028603428 scopus 로고
    • A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group
    • A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. J Am Med Assoc 1994, 272 (24): 1926-1931.
    • (1994) J Am Med Assoc , vol.272 , Issue.24 , pp. 1926-1931
  • 18
    • 0034254505 scopus 로고    scopus 로고
    • News from the International Committee of Medical Journal Editors
    • Davidoff F. News from the International Committee of Medical Journal Editors. Ann Intem. Med 2000, 133 (3): 229-231.
    • (2000) Ann Intem Med , vol.133 , Issue.3 , pp. 229-231
    • Davidoff, F.1
  • 19
    • 0035906286 scopus 로고    scopus 로고
    • Use of the CONSORT statement and quality of reports of randomized trials: A comparative before-and-after evaluation
    • Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: A comparative before-and-after evaluation. J Am Med Assoc 2001, 285 (15): 1992-1995.
    • (2001) J Am Med Assoc , vol.285 , Issue.15 , pp. 1992-1995
    • Moher, D.1    Jones, A.2    Lepage, L.3
  • 20
    • 0242597256 scopus 로고    scopus 로고
    • Guidelines for Good Clinical Practice
    • Foster C, ed. London: Kings College
    • International Conference on Harmonisation Good Clinical Practice (ICHGCP). Guidelines for Good Clinical Practice. In: Foster C, ed. Manual for Research Ethics Committees. 5th ed. London: Kings College; 1997, p. 1-30.
    • (1997) Manual for Research Ethics Committees. 5th Ed. , pp. 1-30
  • 21
    • 0024450659 scopus 로고
    • Efficacy of charcoal cathartic versus ipecac in reducing serum acetaminophen in a simulated overdose
    • McNamara RM, Aaron CK, Gemborys M, Davidheiser S. Efficacy of charcoal cathartic versus ipecac in reducing serum acetaminophen in a simulated overdose. Ann Emerg Med 1989, 18 (9): 934-938.
    • (1989) Ann Emerg Med , vol.18 , Issue.9 , pp. 934-938
    • McNamara, R.M.1    Aaron, C.K.2    Gemborys, M.3    Davidheiser, S.4
  • 23
    • 0025300689 scopus 로고
    • Contribution of sorbitol combined with activated charcoal in prevention of salicylate absorption
    • Keller RE, Schwab RA, Krenzelok EP. Contribution of sorbitol combined with activated charcoal in prevention of salicylate absorption. Ann Emerg Med 1990, 19 (6): 654-656.
    • (1990) Ann Emerg Med , vol.19 , Issue.6 , pp. 654-656
    • Keller, R.E.1    Schwab, R.A.2    Krenzelok, E.P.3
  • 24
    • 0024590139 scopus 로고
    • Large surface area activated charcoal and the inhibition of aspirin absorption
    • Dillon EC, Jr. Wilton JH, Barlow JC, Watson WA. Large surface area activated charcoal and the inhibition of aspirin absorption. Ann Emerg Med 1989, 18 (5): 547-552.
    • (1989) Ann Emerg Med , vol.18 , Issue.5 , pp. 547-552
    • Dillon, E.C.1    Wilton J.H., Jr.2    Barlow, J.C.3    Watson, W.A.4
  • 25
    • 0025252424 scopus 로고
    • Comparative antidotal efficacy of activated charcoal tablets, capsules and suspension in healthy volunteers
    • Remmert HP, Olling M, Slob W, van der Giesen WF, van Dijk A, et al. Comparative antidotal efficacy of activated charcoal tablets, capsules and suspension in healthy volunteers. Eur J Clin Pharmacol 1990, 39 (5): 501-505.
    • (1990) Eur J Clin Pharmacol , vol.39 , Issue.5 , pp. 501-505
    • Remmert, H.P.1    Olling, M.2    Slob, W.3    Van der Giesen, W.F.4    Van Dijk, A.5
  • 26
    • 0025996178 scopus 로고
    • Simulated acetaminophen overdose: Pharmacokinetics and effectiveness of activated charcoal
    • Rose SR, Gorman RL, Oderda GM, Klein-Schwartz W, Watson WA. Simulated acetaminophen overdose: pharmacokinetics and effectiveness of activated charcoal. Ann Emerg Med 1991, 20 (10): 1064-1068.
    • (1991) Ann Emerg Med , vol.20 , Issue.10 , pp. 1064-1068
    • Rose, S.R.1    Gorman, R.L.2    Oderda, G.M.3    Klein-Schwartz, W.4    Watson, W.A.5
  • 27
    • 0024330169 scopus 로고
    • Whole-bowel irrigation versus activated charcoal in sorbitol for the ingestion of modified-release pharmaceuticals
    • Kirshenbaum LA, Mathews SC, Sitar DS, Tenenbein M. Whole-bowel irrigation versus activated charcoal in sorbitol for the ingestion of modified-release pharmaceuticals. Clin Pharmacol Ther 1989, 46 (3): 264-271.
    • (1989) Clin Pharmacol Ther , vol.46 , Issue.3 , pp. 264-271
    • Kirshenbaum, L.A.1    Mathews, S.C.2    Sitar, D.S.3    Tenenbein, M.4
  • 28
    • 0033957575 scopus 로고    scopus 로고
    • Effectiveness of delayed activated charcoal administration in simulated paracetamol (acetaminophen) overdose
    • Yeates PJ, Thomas SH. Effectiveness of delayed activated charcoal administration in simulated paracetamol (acetaminophen) overdose. Br J Clin Pharmacol 2000, 49 (1): 11-14.
    • (2000) Br J Clin Pharmacol , vol.49 , Issue.1 , pp. 11-14
    • Yeates, P.J.1    Thomas, S.H.2
  • 29
    • 0032796645 scopus 로고    scopus 로고
    • Effect of activated charcoal alone or given after gastric lavage in reducing the absorption of diazepam, ibuprofen and citalopram
    • Lapatto-Reiniluoto O, Kivisto KT, Neuvonen PJ. Effect of activated charcoal alone or given after gastric lavage in reducing the absorption of diazepam, ibuprofen and citalopram. Br J Clin Pharmacol 1999, 48 (2): 148-153.
    • (1999) Br J Clin Pharmacol , vol.48 , Issue.2 , pp. 148-153
    • Lapatto-Reiniluoto, O.1    Kivisto, K.T.2    Neuvonen, P.J.3
  • 30
    • 0035213309 scopus 로고    scopus 로고
    • How long after drug ingestion is activated charcoal still effective?
    • Green R, Grierson R, Sitar DS, Tenenbein M. How long after drug ingestion is activated charcoal still effective? J Toxicol Clin Toxicol 2001, 39 (6): 601-605.
    • (2001) J Toxicol Clin Toxicol , vol.39 , Issue.6 , pp. 601-605
    • Green, R.1    Grierson, R.2    Sitar, D.S.3    Tenenbein, M.4
  • 31
    • 0035152340 scopus 로고    scopus 로고
    • Treatment of acetaminophen ingestion with a super-activated charcoal-cola mixture
    • Rangan C, Nordt SP, Hamilton R, Ingels M, Clark RF. Treatment of acetaminophen ingestion with a super-activated charcoal-cola mixture. Ann Emerg Med 2001, 37 (1): 55-58.
    • (2001) Ann Emerg Med , vol.37 , Issue.1 , pp. 55-58
    • Rangan, C.1    Nordt, S.P.2    Hamilton, R.3    Ingels, M.4    Clark, R.F.5
  • 32
    • 0035190218 scopus 로고    scopus 로고
    • Charcoal treatment and risk of escape ovulation in oral contraceptive users
    • Elomaa K, Ranta S, Tuominen J, Lahteenmaki P. Charcoal treatment and risk of escape ovulation in oral contraceptive users. Hum Reprod 2001, 16 (1): 76-81.
    • (2001) Hum Reprod , vol.16 , Issue.1 , pp. 76-81
    • Elomaa, K.1    Ranta, S.2    Tuominen, J.3    Lahteenmaki, P.4
  • 34
    • 0032554483 scopus 로고    scopus 로고
    • Commentary: Safety of participants in non-therapeutic research must be ensured
    • Savulescu J. Commentary: safety of participants in non-therapeutic research must be ensured. Br Med J 1998, 316 (7135): 891-892.
    • (1998) Br Med J , vol.316 , Issue.7135 , pp. 891-892
    • Savulescu, J.1
  • 35
    • 0037021846 scopus 로고    scopus 로고
    • Informed consent: Lessons from Australia
    • Skene L, Smallwood R. Informed consent: lessons from Australia. Br Med J 2002, 324 (7328): 39-41.
    • (2002) Br Med J , vol.324 , Issue.7328 , pp. 39-41
    • Skene, L.1    Smallwood, R.2
  • 36
    • 0037024312 scopus 로고    scopus 로고
    • Reporting of informed consent and ethics committee approval in clinical trials
    • Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. J Am Med Assoc 2002, 287 (21): 2835-2838.
    • (2002) J Am Med Assoc , vol.287 , Issue.21 , pp. 2835-2838
    • Yank, V.1    Rennie, D.2
  • 37
    • 0037186921 scopus 로고    scopus 로고
    • Protecting research subjects - The crisis at Johns Hopkins
    • Steinbrook R. Protecting research subjects - the crisis at Johns Hopkins. N Engl J Med 2002, 346 (9): 716-720.
    • (2002) N Engl J Med , vol.346 , Issue.9 , pp. 716-720
    • Steinbrook, R.1
  • 39
    • 0037180244 scopus 로고    scopus 로고
    • Reporting of ethical issues in publications of medical research
    • Miller FG, Rosenstein DL. Reporting of ethical issues in publications of medical research. Lancet 2002, 360, 1326-1328.
    • (2002) Lancet , vol.360 , pp. 1326-1328
    • Miller, F.G.1    Rosenstein, D.L.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.