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Volumn 10, Issue 6, 2006, Pages

Bench-to-bedside review: Human subjects research - Are more standards needed?

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONFLICT OF INTEREST; HUMAN; INFORMED CONSENT; MEDICAL LITERATURE; METHODOLOGY; PATENT; PATIENT RIGHT; PRIORITY JOURNAL; QUALITY CONTROL; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; STANDARDIZATION; ETHICS; HISTORY; HUMAN EXPERIMENT; MEDICAL RESEARCH; PROFESSIONAL STANDARD; STANDARDS; TOTAL QUALITY MANAGEMENT;

EID: 34447649924     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/cc5114     Document Type: Review
Times cited : (7)

References (70)
  • 1
    • 34447632387 scopus 로고    scopus 로고
    • NIH funding opportunities and notices
    • National Institute of Health
    • National Institute of Health NIH funding opportunities and notices http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-043.html
  • 2
    • 34447650156 scopus 로고    scopus 로고
    • When drug trials go horribly wrong
    • 9 April
    • Rosenthal E When drug trials go horribly wrong International Herald Tribune http://www.iht.com/articles/2006/04/07/news/drug.php 9 April 2006
    • (2006) International Herald Tribune
    • Rosenthal, E.1
  • 4
    • 0033529020 scopus 로고    scopus 로고
    • Are research ethics bad for our mental health?
    • 10.1056/NEJM199905063401811 10228197
    • Michels R Are research ethics bad for our mental health? N Engl J Med 1999 340 1427-1430 10.1056/NEJM199905063401811 10228197
    • (1999) N Engl J Med , vol.340 , pp. 1427-1430
    • Michels, R.1
  • 5
    • 0346007959 scopus 로고    scopus 로고
    • Conducting ethical research in pediatric emergency medicine
    • 10.1016/S1522-8401(03)00071-5
    • Diekema DS Conducting ethical research in pediatric emergency medicine Clin Pediatr Emerg Med 2003 4 273-284 10.1016/S1522-8401(03)00071-5
    • (2003) Clin Pediatr Emerg Med , vol.4 , pp. 273-284
    • Diekema, D.S.1
  • 6
    • 1542287429 scopus 로고    scopus 로고
    • Pediatric research: What is broken and what needs to be fixed?
    • 10.1016/j.jpeds.2003.12.026 14760250
    • Lantos JD Pediatric research: What is broken and what needs to be fixed? J Pediatr 2004 144 147-149 10.1016/j.jpeds.2003.12.026 14760250
    • (2004) J Pediatr , vol.144 , pp. 147-149
    • Lantos, J.D.1
  • 7
    • 0037394909 scopus 로고    scopus 로고
    • Improving clinical trial design in acute lung injury
    • 10.1097/01.CCM.0000057908.11686.B3 12682457
    • Wood KA Huang D Angus DC Improving clinical trial design in acute lung injury Crit Care Med 2003 Suppl S305-S311 10.1097/ 01.CCM.0000057908.11686.B3 12682457
    • (2003) Crit Care Med , Issue.SUPPL.
    • Wood, K.A.1    Huang, D.2    Angus, D.C.3
  • 8
    • 0031578033 scopus 로고    scopus 로고
    • Declaration of Helsinki: Recommendations guiding physicians in biomedical research involving human subjects
    • World Medical Association 10.1001/jama.277.11.925 9062334
    • World Medical Association Declaration of Helsinki: Recommendations guiding physicians in biomedical research involving human subjects JAMA 1997 277 925-926 10.1001/jama.277.11.925 9062334
    • (1997) JAMA , vol.277 , pp. 925-926
  • 9
    • 0003392972 scopus 로고
    • The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Washington, DC: US Government Printing Office (DHEW publication)
    • The 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 Washington, DC: US Government Printing Office (DHEW publication) 1979
    • (1979) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
  • 10
    • 0037352482 scopus 로고    scopus 로고
    • Educating researchers: Ethics and protection of human research participants
    • 10.1097/01.CCM.0000054900.11370.FC 12626962
    • Rosenbaum JR Educating researchers: Ethics and protection of human research participants Crit Care Med 2003 Suppl S161-S166 10.1097/ 01.CCM.0000054900.11370.FC 12626962
    • (2003) Crit Care Med , Issue.SUPPL.
    • Rosenbaum, J.R.1
  • 11
    • 0003713736 scopus 로고    scopus 로고
    • Required Education in the Protection of Human Research Subjects
    • National Institute of Health
    • National Institute of Health Required Education in the Protection of Human Research Subjects http://grants1.nih.gov/grants/guide/notice-files/ NOT-OD-00-039.html
  • 12
    • 0035279416 scopus 로고    scopus 로고
    • Required education on the protection of human subjects: An NIH initiative
    • 10.1353/ken.2001.0007 12166447
    • Seto B Required education on the protection of human subjects: An NIH initiative Kennedy Inst Ethics J 2001 11 87-90 10.1353/ken.2001.0007 12166447
    • (2001) Kennedy Inst Ethics J , vol.11 , pp. 87-90
    • Seto, B.1
  • 13
    • 0033613487 scopus 로고    scopus 로고
    • The biotech death of Jesse Gelsinger
    • Stolberg SG The biotech death of Jesse Gelsinger NY Times Magazine 1999 28 136-150
    • (1999) NY Times Magazine , vol.28 , pp. 136-150
    • Stolberg, S.G.1
  • 14
    • 0033618926 scopus 로고    scopus 로고
    • Death leads to concerns for future of gene therapy
    • September
    • Wade N Death leads to concerns for future of gene therapy NY Times 1999 30 September A22
    • (1999) NY Times , vol.30
    • Wade, N.1
  • 15
    • 0034682384 scopus 로고    scopus 로고
    • Is academic medicine for sale?
    • 10.1056/NEJM200005183422009 10816191
    • Angell M Is academic medicine for sale? N Engl J Med 2000 342 1516-1518 10.1056/NEJM200005183422009 10816191
    • (2000) N Engl J Med , vol.342 , pp. 1516-1518
    • Angell, M.1
  • 16
    • 0034648728 scopus 로고    scopus 로고
    • Protecting research subjects: What must be done?
    • 10.1056/NEJM200009143431112 10984573
    • Shalala D Protecting research subjects: What must be done? N Engl J Med 2000 343 808-810 10.1056/NEJM200009143431112 10984573
    • (2000) N Engl J Med , vol.343 , pp. 808-810
    • Shalala, D.1
  • 17
    • 0037329077 scopus 로고    scopus 로고
    • Informed consent for pediatric research: Is it really possible?
    • 10.1067/mpd.2003.64 12584521
    • Kodish E Informed consent for pediatric research: Is it really possible? J Pediatr 2003 142 89-90 10.1067/mpd.2003.64 12584521
    • (2003) J Pediatr , vol.142 , pp. 89-90
    • Kodish, E.1
  • 18
    • 32844470604 scopus 로고    scopus 로고
    • Informed consent
    • 10.1016/j.amjmed.2005.10.040 16490461
    • Naarden AL Informed consent Am J Med 2006 119 194-197 10.1016/ j.amjmed.2005.10.040 16490461
    • (2006) Am J Med , vol.119 , pp. 194-197
    • Naarden, A.L.1
  • 19
    • 0037417244 scopus 로고    scopus 로고
    • Research involving cognitive impaired adults
    • 10.1056/NEJMsb030172 12672869
    • Karlawish JHT Research involving cognitive impaired adults N Engl J Med 2003 348 1389-1392 10.1056/NEJMsb030172 12672869
    • (2003) N Engl J Med , vol.348 , pp. 1389-1392
    • Karlawish, J.H.T.1
  • 21
    • 0030684073 scopus 로고    scopus 로고
    • Informed consent: Protection or obstacle?
    • 10.1016/S0197-2456(96)00130-4 9408725
    • Ellensberg SS Informed consent: Protection or obstacle? Control Clin Trials 1997 18 628-636 10.1016/S0197-2456(96)00130-4 9408725
    • (1997) Control Clin Trials , vol.18 , pp. 628-636
    • Ellensberg, S.S.1
  • 22
    • 27644529733 scopus 로고    scopus 로고
    • What do people at risk for Alzheimer disease think about surrogate consent for research?
    • 10.1212/01.wnl.0000183144.61428.73 16275826
    • Kim SYH Kim HM McCallum C Tariot PN What do people at risk for Alzheimer disease think about surrogate consent for research? Neurology 2005 65 1395-1401 10.1212/01.wnl.0000183144.61428.73 16275826
    • (2005) Neurology , vol.65 , pp. 1395-1401
    • Kim, S.Y.H.1    Kim, H.M.2    McCallum, C.3    Tariot, P.N.4
  • 23
    • 0035116532 scopus 로고    scopus 로고
    • Do surrogate decision makers provide accurate consent for intensive care research?
    • 10.1378/chest.119.2.603 11171743
    • Coppolino M Ackerson L Do surrogate decision makers provide accurate consent for intensive care research? Chest 2001 119 603-612 10.1378/ chest.119.2.603 11171743
    • (2001) Chest , vol.119 , pp. 603-612
    • Coppolino, M.1    Ackerson, L.2
  • 24
    • 0037350241 scopus 로고    scopus 로고
    • Is the concept of informed consent applicable to clinical research involving critically ill patients?
    • 10.1097/01.CCM.0000054901.80339.01 12626961
    • Luce JM Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 2003 Suppl 3 S153-S160 10.1097/01.CCM.0000054901.80339.01 12626961
    • (2003) Crit Care Med , Issue.SUPPL. 3
    • Luce, J.M.1
  • 25
    • 0141532235 scopus 로고    scopus 로고
    • Research without consent: Current status, 2003
    • 10.1067/S0196-0644(03)00490-6 14520326
    • Biros MH Research without consent: Current status, 2003 Ann Emerg Med 2003 42 550-564 10.1067/S0196-0644(03)00490-6 14520326
    • (2003) Ann Emerg Med , vol.42 , pp. 550-564
    • Biros, M.H.1
  • 26
    • 0001122640 scopus 로고    scopus 로고
    • Protection of human subjects: Informed consent and waiver of consent requirements in certain emergency research: Final rules
    • Department of Health and Human Services October
    • Department of Health and Human Services Protection of human subjects: informed consent and waiver of consent requirements in certain emergency research: Final rules Federal Register 1996 October 51500-51533
    • (1996) Federal Register , pp. 51500-51533
  • 27
    • 0001632381 scopus 로고    scopus 로고
    • Emergency medicine and the development of the FDA's final rule on informed consent and waiver of informed consent in emergency research circumstances
    • 9562204
    • Brios MH Runge JW Lewis RJ Emergency medicine and the development of the FDA's final rule on informed consent and waiver of informed consent in emergency research circumstances Acad Emerg Med 1998 5 359-368 9562204
    • (1998) Acad Emerg Med , vol.5 , pp. 359-368
    • Brios, M.H.1    Runge, J.W.2    Lewis, R.J.3
  • 28
    • 0029069577 scopus 로고
    • Regulated to death: The matter of informed consent for human experimentation in emergency research
    • 10.1111/j.1540-8159.1995.tb02607.x 7567598
    • Lurie K Benditt D Regulated to death: The matter of informed consent for human experimentation in emergency research Pacing Clin Electrophysiol 1995 18 1443-1447 10.1111/j.1540-8159.1995.tb02607.x 7567598
    • (1995) Pacing Clin Electrophysiol , vol.18 , pp. 1443-1447
    • Lurie, K.1    Benditt, D.2
  • 29
    • 85047692459 scopus 로고
    • Deferred consent: A new approach for resuscitation research on comatose patients
    • 10.1001/jama.255.18.2466 3701965
    • Abramson NS Meisel A Safar P Deferred consent: A new approach for resuscitation research on comatose patients JAMA 1986 255 2466-2471 10.1001/jama.255.18.2466 3701965
    • (1986) JAMA , vol.255 , pp. 2466-2471
    • Abramson, N.S.1    Meisel, A.2    Safar, P.3
  • 31
    • 0042527710 scopus 로고    scopus 로고
    • Characteristics of faculty serving on IRBs: Research of a national survey of medical school faculty
    • 10.1097/00001888-200308000-00019 12915379
    • Campbell EG Weissman JS Clarridge B Yucel R Causino N Blumenthal D Characteristics of faculty serving on IRBs: Research of a national survey of medical school faculty Acad Med 2003 78 831-837 10.1097/ 00001888-200308000-00019 12915379
    • (2003) Acad Med , vol.78 , pp. 831-837
    • Campbell, E.G.1    Weissman, J.S.2    Clarridge, B.3    Yucel, R.4    Causino, N.5    Blumenthal, D.6
  • 32
    • 0037460196 scopus 로고    scopus 로고
    • Scope and impact of financial conflicts of interest in biomedical research: A systemic review
    • 10.1001/jama.289.4.454 12533125
    • Bekelman JE Li Y Gross CP Scope and impact of financial conflicts of interest in biomedical research: A systemic review JAMA 2003 289 454-465 10.1001/jama.289.4.454 12533125
    • (2003) JAMA , vol.289 , pp. 454-465
    • Bekelman, J.E.1    Li, Y.2    Gross, C.P.3
  • 33
    • 2142658873 scopus 로고    scopus 로고
    • The future of institutional review boards
    • 10.1016/S1470-2045(04)01473-1 15120672
    • Ghersi D The future of institutional review boards Lancet Oncol 2004 4 325-329 10.1016/S1470-2045(04)01473-1 15120672
    • (2004) Lancet Oncol , vol.4 , pp. 325-329
    • Ghersi, D.1
  • 34
    • 13444301017 scopus 로고    scopus 로고
    • Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injury
    • 10.1016/j.amjmed.2004.03.045 15694904
    • Paasche-Orlow MK Brancati FL Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injury Am J Med 2005 118 175-180 10.1016/ j.amjmed.2004.03.045 15694904
    • (2005) Am J Med , vol.118 , pp. 175-180
    • Paasche-Orlow, M.K.1    Brancati, F.L.2
  • 35
    • 34447626538 scopus 로고    scopus 로고
    • NIH announces final ethics rules. Ban on outside consulting with industry remains in force
    • NIH News August 25
    • NIH NIH announces final ethics rules Ban on outside consulting with industry remains in force NIH News 2005 August 25 http://www.nih.gov/ news/pr/aug2005/od-25.htm
    • (2005)
  • 36
    • 33645751580 scopus 로고    scopus 로고
    • Are any of the criticisms of the CNEP trial true?
    • 10.1016/S0140-6736(06)68445-6 16581384
    • Hey E Chalmers L Are any of the criticisms of the CNEP trial true? Lancet 2006 367 1032-1033 10.1016/S0140-6736(06)68445-6 16581384
    • (2006) Lancet , vol.367 , pp. 1032-1033
    • Hey, E.1    Chalmers, L.2
  • 37
    • 33645750309 scopus 로고    scopus 로고
    • CNEP needs to return
    • 10.1016/S0140-6736(06)68446-8 16581385
    • Southall DP Samuel MP CNEP needs to return Lancet 2006 367 1033-1035 10.1016/S0140-6736(06)68446-8 16581385
    • (2006) Lancet , vol.367 , pp. 1033-1035
    • Southall, D.P.1    Samuel, M.P.2
  • 38
    • 33645728677 scopus 로고    scopus 로고
    • Southall and colleagues vindicated once more
    • 10.1016/S0140-6736(06)68447-X 16581386
    • Craft AW McIntosh N Southall and colleagues vindicated once more Lancet 2006 367 1035-1037 10.1016/S0140-6736(06)68447-X 16581386
    • (2006) Lancet , vol.367 , pp. 1035-1037
    • Craft, A.W.1    McIntosh, N.2
  • 39
    • 77954204796 scopus 로고    scopus 로고
    • Hospitals see possible conflict on medical devices for doctors
    • September
    • Abelson R Hospitals see possible conflict on medical devices for doctors New York Times 2005 22 September 1
    • (2005) New York Times , vol.22 , pp. 1
    • Abelson, R.1
  • 40
    • 0033574825 scopus 로고    scopus 로고
    • Drug trials hide conflicts for doctors
    • May
    • Eichenwald K Kolata G Drug trials hide conflicts for doctors New York Times 1999 16 May 1
    • (1999) New York Times , vol.16 , pp. 1
    • Eichenwald, K.1    Kolata, G.2
  • 41
    • 0035116519 scopus 로고    scopus 로고
    • Variability among institutional review boards' decisions within the context of a muti-center trial
    • 10.1097/00003246-200102000-00002 11246299
    • Silverman H Hull SC Sugarman J Variability among institutional review boards' decisions within the context of a muti-center trial Crit Care Med 2001 29 235-241 10.1097/00003246-200102000-00002 11246299
    • (2001) Crit Care Med , vol.29 , pp. 235-241
    • Silverman, H.1    Hull, S.C.2    Sugarman, J.3
  • 42
    • 1642458616 scopus 로고    scopus 로고
    • How do IRBs apply the federal risk and benefit standards for pediatrics research?
    • 10.1001/jama.291.4.476 14747505
    • Shah S Whittle A Wilfond B Gensler G Wendler D How do IRBs apply the federal risk and benefit standards for pediatrics research? JAMA 2004 291 476-482 10.1001/jama.291.4.476 14747505
    • (2004) JAMA , vol.291 , pp. 476-482
    • Shah, S.1    Whittle, A.2    Wilfond, B.3    Gensler, G.4    Wendler, D.5
  • 44
    • 26844473083 scopus 로고    scopus 로고
    • Variation in Institutional Review processes for a multisite observational study
    • 10.1016/j.amjsurg.2005.07.024 16226962
    • Vick CC Finan KR Kiefe C Neumayer L Hawn MT Variation in Institutional Review processes for a multisite observational study Am J Surg 2005 190 805-809 10.1016/j.amjsurg.2005.07.024 16226962
    • (2005) Am J Surg , vol.190 , pp. 805-809
    • Vick, C.C.1    Finan, K.R.2    Kiefe, C.3    Neumayer, L.4    Hawn, M.T.5
  • 45
    • 27744441296 scopus 로고    scopus 로고
    • What is a 'minor' increase over minimal risk?
    • 10.1016/j.jpeds.2005.07.013 16291344
    • Wendler D Emanuel EJ What is a 'minor' increase over minimal risk? J Pediatr 2005 147 575-578 10.1016/j.jpeds.2005.07.013 16291344
    • (2005) J Pediatr , vol.147 , pp. 575-578
    • Wendler, D.1    Emanuel, E.J.2
  • 46
    • 4043134573 scopus 로고    scopus 로고
    • Ethics review procedures for research in developing countries: A basic presumption of guilt
    • 490076 15289424
    • Gilman RH Garcia HH Ethics review procedures for research in developing countries: A basic presumption of guilt CMAJ 2004 171 248-249 490076 15289424
    • (2004) CMAJ , vol.171 , pp. 248-249
    • Gilman, R.H.1    Garcia, H.H.2
  • 47
    • 0035895292 scopus 로고    scopus 로고
    • Breaking the camel's back: Multicenter clinical trials and local institutional review boards
    • 11177319
    • Burman WJ Reves RR Cohn DL Schooley RT Breaking the camel's back: multicenter clinical trials and local institutional review boards Am Intern Med 2001 134 152-157 11177319
    • (2001) Am Intern Med , vol.134 , pp. 152-157
    • Burman, W.J.1    Reves, R.R.2    Cohn, D.L.3    Schooley, R.T.4
  • 48
    • 20444389188 scopus 로고    scopus 로고
    • Human subjects issues and IRB review in practice-based research
    • 10.1370/afm.302 15928216 1466958
    • Wolf LE Walden JF Lo B Human subjects issues and IRB review in practice-based research Ann Fam Med 2005 Suppl S30-S37 10.1370/afm.302 15928216 1466958
    • (2005) Ann Fam Med , Issue.SUPPL.
    • Wolf, L.E.1    Walden, J.F.2    Lo, B.3
  • 49
    • 0037350187 scopus 로고    scopus 로고
    • Research ethics and law of healthcare system quality improvement: The conflict of cost containment and quality
    • 10.1097/01.CCM.0000054902.85329.50 12626960
    • Kofke WA Rie MA Research ethics and law of healthcare system quality improvement: The conflict of cost containment and quality Crit Care Med 2003 Suppl S143-S152 10.1097/01.CCM.0000054902.85329.50 12626960
    • (2003) Crit Care Med , Issue.SUPPL.
    • Kofke, W.A.1    Rie, M.A.2
  • 50
    • 0037984823 scopus 로고    scopus 로고
    • Who oversees innovative practice? Is there a structire that meets the monitoring needs of new techniques?
    • 10.1016/S1072-7515(03)00112-1 12788432
    • Strasberg SM Ludbrook PA Who oversees innovative practice? Is there a structire that meets the monitoring needs of new techniques? J Am Coll Surg 2003 196 938-948 10.1016/S1072-7515(03)00112-1 12788432
    • (2003) J Am Coll Surg , vol.196 , pp. 938-948
    • Strasberg, S.M.1    Ludbrook, P.A.2
  • 51
    • 13844299607 scopus 로고    scopus 로고
    • Ethics of innovative surgery: US Surgeons' definition, knowledge, and attitudes
    • 10.1016/j.jamcollsurg.2004.09.032 15631926
    • Reitsma AM Moreno JD Ethics of innovative surgery: US Surgeons' definition, knowledge, and attitudes J Am Coll Surg 2005 200 103-110 10.1016/j.jamcollsurg.2004.09.032 15631926
    • (2005) J Am Coll Surg , vol.200 , pp. 103-110
    • Reitsma, A.M.1    Moreno, J.D.2
  • 52
    • 0028512834 scopus 로고
    • Research in palliative care populations: Ethical issues
    • 7531225
    • Kristjanson LJ Hanson EJ Balneaves L Research in palliative care populations: Ethical issues J Palliat Care 1994 10 10-15 7531225
    • (1994) J Palliat Care , vol.10 , pp. 10-15
    • Kristjanson, L.J.1    Hanson, E.J.2    Balneaves, L.3
  • 53
    • 0037345679 scopus 로고    scopus 로고
    • Ethical considerations and barriers to research in surgical palliative care
    • 10.1016/S1072-7515(02)01890-2 12648701
    • Krouse RS Easson AM Angelos P Ethical considerations and barriers to research in surgical palliative care J Am Coll Surg 2003 196 469-474 10.1016/S1072-7515(02)01890-2 12648701
    • (2003) J Am Coll Surg , vol.196 , pp. 469-474
    • Krouse, R.S.1    Easson, A.M.2    Angelos, P.3
  • 54
    • 0034799578 scopus 로고    scopus 로고
    • Palliative care research
    • 10.1016/S0959-8049(01)00260-X 11602381
    • Kasa S De Conno F Palliative care research Eur J Cancer 2001 37 S153-S159 10.1016/S0959-8049(01)00260-X 11602381
    • (2001) Eur J Cancer , vol.37
    • Kasa, S.1    De Conno, F.2
  • 55
    • 24644513424 scopus 로고    scopus 로고
    • A comprehensive ethical framework for responsibly designing and conducting pharmacologic research that involves pregnant women
    • 10.1016/j.ajog.2005.06.020 16157085
    • McCullough LB Coverdale JH Chervenak FA A comprehensive ethical framework for responsibly designing and conducting pharmacologic research that involves pregnant women Am J Obstet Gynecol 2005 193 901-907 10.1016/j.ajog.2005.06.020 16157085
    • (2005) Am J Obstet Gynecol , vol.193 , pp. 901-907
    • McCullough, L.B.1    Coverdale, J.H.2    Chervenak, F.A.3
  • 56
    • 0037346672 scopus 로고    scopus 로고
    • Meternal-fetal research and human research protections policy
    • 10.1016/S0095-5108(02)00079-9 12696792
    • Reitsma AM Moreno JD Meternal-fetal research and human research protections policy Clin Perinatol 2003 30 141-153 10.1016/ S0095-5108(02)00079-9 12696792
    • (2003) Clin Perinatol , vol.30 , pp. 141-153
    • Reitsma, A.M.1    Moreno, J.D.2
  • 57
    • 2442756544 scopus 로고
    • The Regents of the University of California
    • 271 Cal Rptr 1436 793 2nd 479 (Cal)
    • Moore V The Regents of the University of California 271 Cal Rptr 1436 793 2nd 479 (Cal 1990)
    • (1990)
    • Moore, V.1
  • 58
    • 84860902117 scopus 로고    scopus 로고
    • Taking the least of you
    • Skloot R Taking the least of you New York Times 2006 http://www.nytimes.com/2006/04/16/magazine/16tissue.html?ex= 1166072400&en=2dbbceb4d90c4731&ei=5070
    • (2006) New York Times
    • Skloot, R.1
  • 59
    • 84926127725 scopus 로고    scopus 로고
    • Court decides tissue samples belong to university, not patients
    • Kaiser J Court decides tissue samples belong to university, not patients Science Magazine 2006 312 5772
    • (2006) Science Magazine , vol.312 , pp. 5772
    • Kaiser, J.1
  • 60
    • 1542347730 scopus 로고    scopus 로고
    • Why we need legal standards for pediatric research
    • 10.1016/j.jpeds.2003.10.033 14760251
    • Wendler D Foster H Why we need legal standards for pediatric research J Pediatr 2004 144 150-153 10.1016/j.jpeds.2003.10.033 14760251
    • (2004) J Pediatr , vol.144 , pp. 150-153
    • Wendler, D.1    Foster, H.2
  • 61
    • 0033545528 scopus 로고    scopus 로고
    • Is informed consent always necessary for randomized controlled trials?
    • 10.1056/NEJM199903113401013 10072420
    • Truog RD Robinson W Randolph A Morris A Is informed consent always necessary for randomized controlled trials? N Engl J Med 1999 340 804-807 10.1056/NEJM199903113401013 10072420
    • (1999) N Engl J Med , vol.340 , pp. 804-807
    • Truog, R.D.1    Robinson, W.2    Randolph, A.3    Morris, A.4
  • 62
    • 23044476283 scopus 로고    scopus 로고
    • Will ethical requirements bring critical care research to a halt?
    • 10.1007/s00134-004-2480-5 15526188
    • Truog RD will ethical requirements bring critical care research to a halt? Intensive Care Med 2005 31 338-344 10.1007/s00134-004-2480-5 15526188
    • (2005) Intensive Care Med , vol.31 , pp. 338-344
    • Truog, R.D.1
  • 63
    • 2942711455 scopus 로고    scopus 로고
    • When are research risks reasonable in relation to anticipated benefits?
    • 10.1038/nm0604-570 15170195
    • Weijer C Miller PB When are research risks reasonable in relation to anticipated benefits? Nat Med 2004 10 570-573 10.1038/nm0604-570 15170195
    • (2004) Nat Med , vol.10 , pp. 570-573
    • Weijer, C.1    Miller, P.B.2
  • 64
    • 85047684325 scopus 로고    scopus 로고
    • Institutional review board reform
    • 10.1056/NEJM200210173471620 12393832
    • Emanuel EJ Institutional review board reform N Engl J Med 2002 347 1285-1286 10.1056/NEJM200210173471620 12393832
    • (2002) N Engl J Med , vol.347 , pp. 1285-1286
    • Emanuel, E.J.1
  • 66
    • 34447623647 scopus 로고    scopus 로고
    • National Cancer Institute
    • National Cancer Institute The Central Institutional Review Board http://www.ncicirb.org
  • 67
    • 34447631933 scopus 로고    scopus 로고
    • Website
    • Multicenter Academic Clinical Research Organization (MACRO) Website http://www.mc.vanderbilt.edu/ctc/macro.html
  • 68
    • 34447627778 scopus 로고    scopus 로고
    • Additional safeguards for children in clinical investigations of FDA-regulated products
    • US Food and Drug Administration
    • US Food and Drug Administration Additional safeguards for children in clinical investigations of FDA-regulated products http://www.fda.gov/ ohrms/dockets/98fr/042401a.htm
  • 69
    • 14744294156 scopus 로고    scopus 로고
    • Grimes v. Kennedy Krieger Institute, Inc
    • (Md Ct of App, reconsideration denied, Oct. 11, 2001)
    • Grimes v. Kennedy Krieger Institute, Inc 782 A.2d 807 (Md Ct of App 2001, reconsideration denied, Oct. 11, 2001)
    • (2001) A.2d , vol.782 , pp. 807
  • 70
    • 0014019552 scopus 로고
    • Ethics and clinical research
    • 5327352
    • Beecher HK Ethics and clinical research N Engl J Med 1966 274 1354-1360 5327352
    • (1966) N Engl J Med , vol.274 , pp. 1354-1360
    • Beecher, H.K.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.