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Volumn 93, Issue 3, 2015, Pages 186-198

Participants’ understanding of informed consent in clinical trials over three decades: Systematic review and meta-analysis;Compréhension du consentement éclairé par les participants à des essais cliniques sur trois décennies: Revue systématique et méta-analyse;La comprensión del consentimiento informado por parte de los participantes de ensayos clínicos a lo largo de tres décadas: Revisión sistemática y metaanálisis

Author keywords

[No Author keywords available]

Indexed keywords

HEALTH RISK; HETEROGENEITY; LITERATURE REVIEW; META-ANALYSIS; NUMERICAL MODEL; PARTICIPATORY APPROACH;

EID: 84923863238     PISSN: 00429686     EISSN: 15640604     Source Type: Journal    
DOI: 10.2471/BLT.14.141390     Document Type: Article
Times cited : (204)

References (154)
  • 1
    • 0029830427 scopus 로고    scopus 로고
    • Annas GJ. Legacies of Nuremberg. Medical ethics and human rights
    • Nov 27, PMID: 8922458
    • Grodin MA, Annas GJ. Legacies of Nuremberg. Medical ethics and human rights. JAMA. 1996 Nov 27;276 (20):1682-3.doi: http://dx.doi.org/10.1001/jama.1996.03540200068035PMID: 8922458.
    • (1996) JAMA , vol.276 , Issue.20 , pp. 1682-1683
    • Grodin, M.A.1
  • 2
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • May 24-31, PMID: 10819955
    • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283 (20):2701-11.doi: http://dx.doi.org/10.1001/jama.283.20.2701PMID: 10819955.
    • (2000) JAMA , vol.283 , Issue.20 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 3
    • 84864508434 scopus 로고    scopus 로고
    • Doctors, patients, and lawyers-two centuries of health law
    • Aug 2, PMID: 22853015
    • Annas GJ. Doctors, patients, and lawyers-two centuries of health law. N Engl J Med. 2012 Aug 2;367 (5):445-50.doi: http://dx.doi.org/10.1056/NEJMra1108646PMID: 22853015.
    • (2012) N Engl J Med , vol.367 , Issue.5 , pp. 445-450
    • Annas, G.J.1
  • 4
    • 42649086509 scopus 로고    scopus 로고
    • Improvement of informed consent and the quality of consent documents
    • May, PMID: 18452859
    • Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008 May;9 (5):485-93.doi: http://dx.doi.org/10.1016/S1470-2045 (08)70128-1PMID: 18452859.
    • (2008) Lancet Oncol , vol.9 , Issue.5 , pp. 485-493
    • Jefford, M.1    Moore, R.2
  • 5
    • 79958748143 scopus 로고    scopus 로고
    • Brief historical and theoretical perspective on patient autonomy and medical decision making
    • Jun, PMID: 21652559
    • Will JF. A brief historical and theoretical perspective on patient autonomy and medical decision making: Part II: The autonomy model. Chest. 2011 Jun;139 (6):1491-7.doi: http://dx.doi.org/10.1378/chest.11-0516PMID: 21652559.
    • (2011) Part II: The Autonomy Model. Chest. , vol.139 , Issue.6 , pp. 1491-1497
    • Will, J.1
  • 6
    • 79955018233 scopus 로고    scopus 로고
    • How to enroll participants in research ethically
    • Apr 20, PMID: 21505137
    • Wendler D. How to enroll participants in research ethically. JAMA. 2011 Apr 20;305 (15):1587-8.doi: http://dx.doi.org/10.1001/jama.2011.421PMID: 21505137.
    • (2011) JAMA , vol.305 , Issue.15 , pp. 1587-1588
    • Wendler, D.1
  • 7
    • 60849106348 scopus 로고    scopus 로고
    • Ethical and scientific implications of the globalization of clinical research
    • Feb 19, PMID: 19228627
    • Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009 Feb 19;360 (8):816-23.doi: http://dx.doi.org/10.1056/NEJMsb0803929PMID: 19228627.
    • (2009) N Engl J Med , vol.360 , Issue.8 , pp. 816-823
    • Glickman, S.W.1    McHutchison, J.G.2    Peterson, E.D.3    Cairns, C.B.4    Harrington, R.A.5    Califf, R.M.6
  • 8
    • 33846095037 scopus 로고    scopus 로고
    • Informed consent: An international researchers’ perspective
    • Jan, PMID: 17138913
    • Rivera R, Borasky D, Rice R, Carayon F, Wong E. Informed consent: an international researchers’ perspective. Am J Public Health. 2007 Jan;97 (1):25-30.doi: http://dx.doi.org/10.2105/AJPH.2005.081604PMID: 17138913.
    • (2007) Am J Public Health , vol.97 , Issue.1 , pp. 25-30
    • Rivera, R.1    Borasky, D.2    Rice, R.3    Carayon, F.4    Wong, E.5
  • 9
    • 85136408378 scopus 로고    scopus 로고
    • Nov 27, PMID: 24141714
    • World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310 (20):2191-4.doi: http://dx.doi.org/10.1001/jama.2013.281053PMID: 24141714.
    • (2013) JAMA , Issue.20 , pp. 2191-2194
  • 10
    • 80053334179 scopus 로고    scopus 로고
    • Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience
    • Sep, PMID: 21931539
    • Boga M, Davies A, Kamuya D, Kinyanjui SM, Kivaya E, Kombe F, et al. Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience. PLoS Med. 2011 Sep;8 (9):e1001089.doi: http://dx.doi.org/10.1371/journal.pmed.1001089PMID: 21931539.
    • (2011) Plos Med. , vol.8 , Issue.9
    • Boga, M.1    Davies, A.2    Kamuya, D.3    Kinyanjui, S.M.4    Kivaya, E.5    Kombe, F.6
  • 11
    • 26444596581 scopus 로고    scopus 로고
    • Informed consent for medical treatment and research: A review
    • Sep, PMID: 16177288
    • del Carmen MG, Joffe S. Informed consent for medical treatment and research: a review. Oncologist. 2005 Sep;10 (8):636-41.doi: http://dx.doi.org/10.1634/theoncologist.10-8-636PMID: 16177288.
    • (2005) Oncologist , vol.10 , Issue.8 , pp. 636-641
    • Del Carmen, M.G.1    Joffe, S.2
  • 12
    • 0003663231 scopus 로고    scopus 로고
    • Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press; 2001.
  • 13
    • 84870272275 scopus 로고    scopus 로고
    • Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials
    • PMID: 23185138
    • Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, et al.; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9 (11):e1001346.doi: http://dx.doi.org/10.1371/journal.pmed.1001346PMID: 23185138.
    • (2012) Plos Med , vol.9 , Issue.11
    • Weijer, C.1    Grimshaw, J.M.2    Eccles, M.P.3    McRae, A.D.4    White, A.5    Brehaut, J.C.6
  • 14
    • 0346734344 scopus 로고    scopus 로고
    • Does informed consent to research require comprehension?
    • Dec 13PMID: 14683665
    • Sreenivasan G. Does informed consent to research require comprehension? Lancet. 2003 Dec 13;362 (9400):2016-8.doi: http://dx.doi.org/10.1016/S0140-6736 (03)15025-8PMID: 14683665.
    • (2003) Lancet , vol.362 , Issue.9400 , pp. 2016-2018
    • Sreenivasan, G.1
  • 15
    • 84882348036 scopus 로고    scopus 로고
    • Audit of the informed consent process as a part of a clinical research quality assurance program
    • Jun, PMID: 23975172
    • Lad PM, Dahl R. Audit of the informed consent process as a part of a clinical research quality assurance program. Sci Eng Ethics. 2014 Jun;20 (2):469-79.doi: http://dx.doi.org/10.1007/s11948-013-9461-4PMID: 23975172.
    • (2014) Sci Eng Ethics , vol.20 , Issue.2 , pp. 469-479
    • Lad, P.M.1    Dahl, R.2
  • 16
    • 84874459177 scopus 로고    scopus 로고
    • Patient comprehension of informed consent
    • Jan-Feb, PMID: 23413533
    • Richardson V. Patient comprehension of informed consent. J Perioper Pract. 2013 Jan-Feb;23 (1-2):26-30.PMID: 23413533.
    • (2013) J Perioper Pract , vol.23 , Issue.1-2 , pp. 26-30
    • Richardson, V.1
  • 17
    • 7644233007 scopus 로고    scopus 로고
    • Beyond informed consent
    • PMID: 15643799
    • Bhutta ZA. Beyond informed consent. Bull World Health Organ. 2004 Oct;82 (10):771-7.PMID: 15643799.
    • (2004) Bull World Health Organ , vol.82 , Issue.10 , pp. 771-777
    • Bhutta, Z.A.1
  • 18
    • 69249116175 scopus 로고    scopus 로고
    • Informed consent: How much and what do patients understand?
    • Sep, PMID: 19716887
    • Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009 Sep;198 (3):420-35.doi: http://dx.doi.org/10.1016/j.amjsurg.2009.02.010PMID: 19716887.
    • (2009) Am J Surg , vol.198 , Issue.3 , pp. 420-435
    • Falagas, M.E.1    Korbila, I.P.2    Giannopoulou, K.P.3    Kondilis, B.K.4    Peppas, G.5
  • 19
    • 84864015967 scopus 로고    scopus 로고
    • The quality of informed consent: Mapping the landscape. A review of empirical data from developing and developed countries
    • Jun, PMID: 22313664
    • Mandava A, Pace C, Campbell B, Emanuel E, Grady C. The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries. J Med Ethics. 2012 Jun;38 (6):356-65.doi: http://dx.doi.org/10.1136/medethics-2011-100178PMID: 22313664.
    • (2012) J Med Ethics , vol.38 , Issue.6 , pp. 356-365
    • Mandava, A.1    Pace, C.2    Campbell, B.3    Emanuel, E.4    Grady, C.5
  • 20
    • 84899674360 scopus 로고    scopus 로고
    • Constructing a search strategy and searching for evidence. A guide to the literature search for a systematic review
    • May, PMID: 24759479
    • Aromataris E, Riitano D. Constructing a search strategy and searching for evidence. A guide to the literature search for a systematic review. Am J Nurs. 2014 May;114 (5):49-56.doi: http://dx.doi.org/10.1097/01.NAJ.0000446779.99522.f6PMID: 24759479.
    • (2014) Am J Nurs , vol.114 , Issue.5 , pp. 49-56
    • Aromataris, E.1    Riitano, D.2
  • 21
    • 84931682314 scopus 로고    scopus 로고
    • Protection of human subjects. Code Fed Requl Public Welfare. Washington: U.S. Department of Health and Human Services; 1995 Oct 1;Title 4s: sections 46-101 to 46-409.
  • 22
    • 0034685429 scopus 로고    scopus 로고
    • Meta-analysis of observational studies in epidemiology: A proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group
    • Apr 19, PMID: 10789670
    • Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000 Apr 19;283 (15):2008-12.doi: http://dx.doi.org/10.1001/jama.283.15.2008PMID: 10789670.
    • (2000) JAMA , vol.283 , Issue.15 , pp. 2008-2012
    • Stroup, D.F.1    Berlin, J.A.2    Morton, S.C.3    Olkin, I.4    Williamson, G.D.5    Rennie, D.6
  • 23
    • 84879705577 scopus 로고    scopus 로고
    • Sedgwick P. Meta-analyses: heterogeneity and subgroup analysis. BMJ. 2013 June 24;346 jun24 2:f4040.doi: http://dx.doi.org/10.1136/bmj.f4040.
  • 24
    • 32144440794 scopus 로고    scopus 로고
    • Comparison of two methods to detect publication bias in meta-analysis
    • 6 Feb 8, PMID: 16467236
    • Peters JL, Sutton AJ, Jones DR, Abrams KR, Rushton L. Comparison of two methods to detect publication bias in meta-analysis. JAMA. 2006 Feb 8;295 (6):676-80.doi: http://dx.doi.org/10.1001/jama.295.6.676PMID: 16467236.
    • (2006) JAMA , vol.295 , Issue.6 , pp. 676-680
    • Peters, J.L.1    Sutton, A.J.2    Jones, D.R.3    Abrams, K.R.4    Rushton, L.5
  • 25
    • 0033934949 scopus 로고    scopus 로고
    • Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis
    • Jun, PMID: 10877304
    • Duval S, Tweedie R. Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics. 2000 Jun;56 (2):455-63.doi: http://dx.doi.org/10.1111/j.0006-341X.2000.00455.xPMID: 10877304.
    • (2000) Biometrics , vol.56 , Issue.2 , pp. 455-463
    • Duval, S.1    Tweedie, R.2
  • 26
    • 58549118484 scopus 로고    scopus 로고
    • Use of PCR for diagnosis of invasive aspergillosis: Systematic review and meta-analysis
    • Feb, PMID: 19179225
    • Mengoli C, Cruciani M, Barnes RA, Loeffler J, Donnelly JP. Use of PCR for diagnosis of invasive aspergillosis: systematic review and meta-analysis. Lancet Infect Dis. 2009 Feb;9 (2):89-96.doi: http://dx.doi.org/10.1016/S1473-3099 (09)70019-2PMID: 19179225.
    • (2009) Lancet Infect Dis , vol.9 , Issue.2 , pp. 89-96
    • Mengoli, C.1    Cruciani, M.2    Barnes, R.A.3    Loeffler, J.4    Donnelly, J.P.5
  • 27
    • 84931682316 scopus 로고    scopus 로고
    • Kaufert JM, O’Neil J. Culture, power and informed consent: the impact of Aboriginal health interpreters on decision-making. In: Coburn D, D’Arcy C, Torrance G, editors. Health and Canadian society: sociological perspectives. Toronto: University of Toronto Press; 1998.
  • 28
    • 79958030360 scopus 로고    scopus 로고
    • Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali
    • Oct, PMID: 20889881
    • Ellis RD, Sagara I, Durbin A, Dicko A, Shaffer D, Miller L, et al. Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali. Am J Trop Med Hyg. 2010 Oct;83 (4):868-72.doi: http://dx.doi.org/10.4269/ajtmh.2010.10-0062PMID: 20889881.
    • (2010) Am J Trop Med Hyg , vol.83 , Issue.4 , pp. 868-872
    • Ellis, R.D.1    Sagara, I.2    Durbin, A.3    Dicko, A.4    Shaffer, D.5    Miller, L.6
  • 29
    • 77953305400 scopus 로고    scopus 로고
    • Microbicides Development Programme (MDP). How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania
    • PMID: 20540803
    • Vallely A, Lees S, Shagi C, Kasindi S, Soteli S, Kavit N, et al.; Microbicides Development Programme (MDP). How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Med Ethics. 2010;11 (1):10.doi: http://dx.doi.org/10.1186/1472-6939-11-10PMID: 20540803.
    • (2010) BMC Med Ethics , vol.11 , Issue.1 , pp. 10
    • Vallely, A.1    Lees, S.2    Shagi, C.3    Kasindi, S.4    Soteli, S.5    Kavit, N.6
  • 30
    • 38049078918 scopus 로고    scopus 로고
    • Informed consent in Ghana: What do participants really understand?
    • Jan, PMID: 18156522
    • Hill Z, Tawiah-Agyemang C, Odei-Danso S, Kirkwood B. Informed consent in Ghana: what do participants really understand? J Med Ethics. 2008 Jan;34 (1):48-53.doi: http://dx.doi.org/10.1136/jme.2006.019059PMID: 18156522.
    • (2008) J Med Ethics , vol.34 , Issue.1 , pp. 48-53
    • Hill, Z.1    Tawiah-Agyemang, C.2    Odei-Danso, S.3    Kirkwood, B.4
  • 31
    • 55149125393 scopus 로고    scopus 로고
    • Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting
    • PMID: 18826637
    • Minnies D, Hawkridge T, Hanekom W, Ehrlich R, London L, Hussey G. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Med Ethics. 2008;9 (1):15.doi: http://dx.doi.org/10.1186/1472-6939-9-15PMID: 18826637.
    • (2008) BMC Med Ethics , vol.9 , Issue.1 , pp. 15
    • Minnies, D.1    Hawkridge, T.2    Hanekom, W.3    Ehrlich, R.4    London, L.5    Hussey, G.6
  • 33
    • 33746253178 scopus 로고    scopus 로고
    • Ranney ML. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa
    • PMID: 16895047
    • Krosin MT, Klitzman R, Levin B, Cheng J, Ranney ML. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clin Trials. 2006;3 (3):306-13.doi: http://dx.doi.org/10.1191/1740774506cn150oaPMID: 16895047.
    • (2006) Clin Trials , vol.3 , Issue.3 , pp. 306-313
    • Krosin, M.T.1    Klitzman, R.2    Levin, B.3    Cheng, J.4
  • 34
    • 29544448363 scopus 로고    scopus 로고
    • Informed consent and participant perceptions of influenza vaccine trials in South Africa
    • Dec, PMID: 16319239
    • Moodley K, Pather M, Myer L. Informed consent and participant perceptions of influenza vaccine trials in South Africa. J Med Ethics. 2005 Dec;31 (12):727-32.doi: http://dx.doi.org/10.1136/jme.2004.009910PMID: 16319239.
    • (2005) J Med Ethics , vol.31 , Issue.12 , pp. 727-732
    • Moodley, K.1    Pather, M.2    Myer, L.3
  • 36
    • 11444260689 scopus 로고    scopus 로고
    • Quality of parental consent in a Ugandan malaria study
    • PMID: 15933235
    • Pace C, Talisuna A, Wendler D, Maiso F, Wabwire-Mangen F, Bakyaita N, et al. Quality of parental consent in a Ugandan malaria study. Am J Public Health. 2005 Jul;95 (7):1184-9.doi: http://dx.doi.org/10.2105/AJPH.2004.053082PMID: 15933235.
    • (2005) Am J Public Health , vol.95 , Issue.7 , pp. 1184-1189
    • Pace, C.1    Talisuna, A.2    Wendler, D.3    Maiso, F.4    Wabwire-Mangen, F.5    Bakyaita, N.6
  • 37
    • 3142657129 scopus 로고    scopus 로고
    • Obtaining informed consent from HIV-infected pregnant women, Abidjan, Côte d’Ivoire. AIDS. 2004 Jul 2, PMID: 15199334
    • ANRS1201/1202 Ditrame Plus Study Group. Obtaining informed consent from HIV-infected pregnant women, Abidjan, Côte d’Ivoire. AIDS. 2004 Jul 2;18 (10):1486-8.doi: http://dx.doi.org/10.1097/01.aids.0000131349.22032.63PMID: 15199334.
    • , vol.18 , Issue.10 , pp. 1486-1488
  • 38
    • 0037799072 scopus 로고    scopus 로고
    • Consent for participation in the Bloemfontein vitamin A trial: How informed and voluntary?
    • Apr, PMID: 12660201
    • Joubert G, Steinberg H, van der Ryst E, Chikobvu P. Consent for participation in the Bloemfontein vitamin A trial: how informed and voluntary? Am J Public Health. 2003 Apr;93 (4):582-4.doi: http://dx.doi.org/10.2105/AJPH.93.4.582PMID: 12660201.
    • (2003) Am J Public Health , vol.93 , Issue.4 , pp. 582-584
    • Joubert, G.1    Steinberg, H.2    Van Der Ryst, E.3    Chikobvu, P.4
  • 39
    • 0035825727 scopus 로고    scopus 로고
    • Obtaining informed consent in Bangladesh
    • Feb 8, PMID: 11221611
    • Lynöe N, Hyder Z, Chowdhury M, Ekström L. Obtaining informed consent in Bangladesh. N Engl J Med. 2001 Feb 8;344 (6):460-1.doi: http://dx.doi.org/10.1056/NEJM200102083440617PMID: 11221611.
    • (2001) N Engl J Med , vol.344 , Issue.6 , pp. 460-461
    • Lynöe, N.1    Hyder, Z.2    Chowdhury, M.3    Ekström, L.4
  • 40
    • 10844262655 scopus 로고    scopus 로고
    • Study of the quality of information given to patients participating in a clinical trial regarding chronic hemodialysis
    • PMID: 15841789
    • Lynöe N, Näsström B, Sandlund M. Study of the quality of information given to patients participating in a clinical trial regarding chronic hemodialysis. Scand J Urol Nephrol. 2004;38 (6):517-20.doi: http://dx.doi.org/10.1080/00365590410033362PMID: 15841789.
    • (2004) Scand J Urol Nephrol , vol.38 , Issue.6 , pp. 517-520
    • Lynöe, N.1    Näsström, B.2    Sandlund, M.3
  • 41
    • 0025772201 scopus 로고
    • Informed consent: Study of quality of information given to participants in a clinical trial
    • Sep 14, PMID: 1932901
    • Lynöe N, Sandlund M, Dahlqvist G, Jacobsson L. Informed consent: study of quality of information given to participants in a clinical trial. BMJ. 1991 Sep 14;303 (6803):610-3.doi: http://dx.doi.org/10.1136/bmj.303.6803.610PMID: 1932901.
    • (1991) BMJ , vol.303 , Issue.6803 , pp. 610-613
    • Lynöe, N.1    Sandlund, M.2    Dahlqvist, G.3    Jacobsson, L.4
  • 42
    • 11244324227 scopus 로고    scopus 로고
    • Informed consent and participants’ inclination to delegate decision-making to the doctor
    • PMID: 15764224
    • Lynöe N, Boman K, Andersson H, Sandlund M. Informed consent and participants’ inclination to delegate decision-making to the doctor. Acta Oncol. 2004;43 (8):769.doi: http://dx.doi.org/10.1080/02841860410002734PMID: 15764224.
    • (2004) Acta Oncol , vol.43 , Issue.8 , pp. 769
    • Lynöe, N.1    Boman, K.2    Ersson, H.3    Sandlund, M.4
  • 43
    • 0035684684 scopus 로고    scopus 로고
    • Informed consent in two Swedish prisons: A study of quality of information and reasons for participating in a clinical trial
    • PMID: 11817382
    • Lynöe N, Sandlund M, Jacobsson L. Informed consent in two Swedish prisons: a study of quality of information and reasons for participating in a clinical trial. Med Law. 2001;20 (4):515-23.PMID: 11817382.
    • (2001) Med Law , vol.20 , Issue.4 , pp. 515-523
    • Lynöe, N.1    Sandlund, M.2    Jacobsson, L.3
  • 44
    • 0032946207 scopus 로고    scopus 로고
    • An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in the Gambia, West Africa
    • Jan, PMID: 10048773
    • Leach A, Hilton S, Greenwood BM, Manneh E, Dibba B, Wilkins A, et al. An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in the Gambia, West Africa. Soc Sci Med. 1999 Jan;48 (2):139-48.doi: http://dx.doi.org/10.1016/S0277-9536 (98)00317-7PMID: 10048773.
    • (1999) Soc Sci Med , vol.48 , Issue.2 , pp. 139-148
    • Leach, A.1    Hilton, S.2    Greenwood, B.M.3    Manneh, E.4    Dibba, B.5    Wilkins, A.6
  • 45
    • 0030642209 scopus 로고    scopus 로고
    • Risk behaviours and comprehension among intravenous drug users volunteered for HIV vaccine trial
    • Jan, PMID: 9078816
    • Pitisuttithum P, Migasena S, Laothai A, Suntharasamai P, Kumpong C, Vanichseni S. Risk behaviours and comprehension among intravenous drug users volunteered for HIV vaccine trial. J Med Assoc Thai. 1997 Jan;80 (1):47-50.PMID: 9078816.
    • (1997) J Med Assoc Thai , vol.80 , Issue.1 , pp. 47-50
    • Pitisuttithum, P.1    Migasena, S.2    Laothai, A.3    Suntharasamai, P.4    Kumpong, C.5    Vanichseni, S.6
  • 46
    • 55249114341 scopus 로고    scopus 로고
    • Knowledge and understanding among cancer patients consenting to participate in clinical trials
    • Nov, PMID: 18818068
    • Bergenmar M, Molin C, Wilking N, Brandberg Y. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer. 2008 Nov;44 (17):2627-33.doi: http://dx.doi.org/10.1016/j.ejca.2008.08.013PMID: 18818068.
    • (2008) Eur J Cancer , vol.44 , Issue.17 , pp. 2627-2633
    • Bergenmar, M.1    Molin, C.2    Wilking, N.3    Brandberg, Y.4
  • 47
    • 60849128807 scopus 로고    scopus 로고
    • Patients’ perception of the informed consent process for neurooncology clinical trials
    • Jun, PMID: 18388256
    • Knifed E, Lipsman N, Mason W, Bernstein M. Patients’ perception of the informed consent process for neurooncology clinical trials. Neuro-oncol. 2008 Jun;10 (3):348-54.doi: http://dx.doi.org/10.1215/15228517-2008-007PMID: 18388256.
    • (2008) Neuro-Oncol , vol.10 , Issue.3 , pp. 348-354
    • Knifed, E.1    Lipsman, N.2    Mason, W.3    Bernstein, M.4
  • 48
    • 33749056147 scopus 로고    scopus 로고
    • Patients’ decision-making process regarding participation in phase I oncology research
    • Sep 20, PMID: 16983117
    • Agrawal M, Grady C, Fairclough DL, Meropol NJ, Maynard K, Emanuel EJ. Patients’ decision-making process regarding participation in phase I oncology research. J Clin Oncol. 2006 Sep 20;24 (27):4479-84.doi: http://dx.doi.org/10.1200/JCO.2006.06.0269PMID: 16983117.
    • (2006) J Clin Oncol , vol.24 , Issue.27 , pp. 4479-4484
    • Agrawal, M.1    Grady, C.2    Fairclough, D.L.3    Meropol, N.J.4    Maynard, K.5    Emanuel, E.J.6
  • 49
    • 34247149692 scopus 로고    scopus 로고
    • The quality of parental consent for research with children: A prospective repeated measure self-report survey
    • May, PMID: 16712850
    • Franck LS, Winter I, Oulton K. The quality of parental consent for research with children: a prospective repeated measure self-report survey. Int J Nurs Stud. 2007 May;44 (4):525-33.doi: http://dx.doi.org/10.1016/j.ijnurstu.2006.03.014PMID: 16712850.
    • (2007) Int J Nurs Stud , vol.44 , Issue.4 , pp. 525-533
    • Franck, L.S.1    Winter, I.2    Oulton, K.3
  • 50
    • 4644268736 scopus 로고    scopus 로고
    • DANAMI-2 Investigators. Patients’ perceptions of informed consent in acute myocardial infarction research: A questionnaire based survey of the consent process in the DANAMI-2 trial
    • Oct, PMID: 15367504
    • Gammelgaard A, Mortensen OS, Rossel P; DANAMI-2 Investigators. Patients’ perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial. Heart. 2004 Oct;90 (10):1124-8.doi: http://dx.doi.org/10.1136/hrt.2003.021931PMID: 15367504.
    • (2004) Heart , vol.90 , Issue.10 , pp. 1124-1128
    • Gammelgaard, A.1    Mortensen, O.S.2    Rossel, P.3
  • 51
    • 9144271021 scopus 로고    scopus 로고
    • Communication of randomization in childhood leukemia trials
    • Jan 28, PMID: 14747504
    • Kodish E, Eder M, Noll RB, Ruccione K, Lange B, Angiolillo A, et al. Communication of randomization in childhood leukemia trials. JAMA. 2004 Jan 28;291 (4):470-5.doi: http://dx.doi.org/10.1001/jama.291.4.470PMID: 14747504.
    • (2004) JAMA , vol.291 , Issue.4 , pp. 470-475
    • Kodish, E.1    Eder, M.2    Noll, R.B.3    Ruccione, K.4    Lange, B.5    Angiolillo, A.6
  • 52
    • 0038386055 scopus 로고    scopus 로고
    • Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis
    • Jun 15;, PMID: 12794792
    • Criscione LG, Sugarman J, Sanders L, Pisetsky DS, St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum. 2003 Jun 15;49 (3):361-7.doi: http://dx.doi.org/10.1002/art.11057PMID: 12794792.
    • (2003) Arthritis Rheum , vol.49 , Issue.3 , pp. 361-367
    • Criscione, L.G.1    Sugarman, J.2    Sanders, L.3    Pisetsky, D.S.4    St Clair, E.W.5
  • 53
    • 0141992777 scopus 로고    scopus 로고
    • Clinical trials in pediatric cancer: Parental perspectives on informed consent
    • Oct, PMID: 14528101
    • Kupst MJ, Patenaude AF, Walco GA, Sterling C. Clinical trials in pediatric cancer: parental perspectives on informed consent. J Pediatr Hematol Oncol. 2003 Oct;25 (10):787-90.doi: http://dx.doi.org/10.1097/00043426-200310000-00009PMID: 14528101.
    • (2003) J Pediatr Hematol Oncol , vol.25 , Issue.10 , pp. 787-790
    • Kupst, M.J.1    Patenaude, A.F.2    Walco, G.A.3    Sterling, C.4
  • 54
    • 12444301894 scopus 로고    scopus 로고
    • Are subjects satisfied with the informed consent process? A survey of research participants
    • Apr, PMID: 12672205
    • Pope JE, Tingey DP, Arnold JM, Hong P, Ouimet JM, Krizova A. Are subjects satisfied with the informed consent process? A survey of research participants. J Rheumatol. 2003 Apr;30 (4):815-24.PMID: 12672205.
    • (2003) J Rheumatol , vol.30 , Issue.4 , pp. 815-824
    • Pope, J.E.1    Tingey, D.P.2    Arnold, J.M.3    Hong, P.4    Ouimet, J.M.5    Krizova, A.6
  • 55
    • 0038480211 scopus 로고    scopus 로고
    • Informed consent in trials for neurological emergencies: The example of subarachnoid haemorrhage
    • Jul, PMID: 12810803
    • Schats R, Brilstra EH, Rinkel GJ, Algra A, Van Gijn J. Informed consent in trials for neurological emergencies: the example of subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2003 Jul;74 (7):988-91.doi: http://dx.doi.org/10.1136/jnnp.74.7.988PMID: 12810803.
    • (2003) J Neurol Neurosurg Psychiatry , vol.74 , Issue.7 , pp. 988-991
    • Schats, R.1    Brilstra, E.H.2    Rinkel, G.J.3    Algra, A.4    Van Gijn, J.5
  • 56
    • 0037530503 scopus 로고    scopus 로고
    • Groups potentially at risk for making poorly informed decisions about entry into clinical trials for childhood cancer
    • Jun 1, PMID: 12775743
    • Simon C, Zyzanski SJ, Eder M, Raiz P, Kodish ED, Siminoff LA. Groups potentially at risk for making poorly informed decisions about entry into clinical trials for childhood cancer. J Clin Oncol. 2003 Jun 1;21 (11):2173-8.doi: http://dx.doi.org/10.1200/JCO.2003.03.003PMID: 12775743.
    • (2003) J Clin Oncol , vol.21 , Issue.11 , pp. 2173-2178
    • Simon, C.1    Zyzanski, S.J.2    Eder, M.3    Raiz, P.4    Kodish, E.D.5    Siminoff, L.A.6
  • 57
    • 0035944839 scopus 로고    scopus 로고
    • Quality of informed consent in cancer clinical trials: A cross-sectional survey
    • Nov 24, PMID: 11734235
    • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001 Nov 24;358 (9295):1772-7.doi: http://dx.doi.org/10.1016/S0140-6736 (01)06805-2PMID: 11734235.
    • (2001) Lancet , vol.358 , Issue.9295 , pp. 1772-1777
    • Joffe, S.1    Cook, E.F.2    Cleary, P.D.3    Clark, J.W.4    Weeks, J.C.5
  • 58
    • 0029002997 scopus 로고
    • Perceptions of cancer patients and their physicians involved in phase I trials
    • May, PMID: 7738612
    • Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995 May;13 (5):1062-72.PMID: 7738612.
    • (1995) J Clin Oncol , vol.13 , Issue.5 , pp. 1062-1072
    • Daugherty, C.1    Ratain, M.J.2    Grochowski, E.3    Stocking, C.4    Kodish, E.5    Mick, R.6
  • 60
    • 0033816160 scopus 로고    scopus 로고
    • Information and communication in the context of a clinical trial
    • Oct, PMID: 11044647
    • Hietanen P, Aro AR, Holli K, Absetz P. Information and communication in the context of a clinical trial. Eur J Cancer. 2000 Oct;36 (16):2096-104.doi: http://dx.doi.org/10.1016/S0959-8049 (00)00191-XPMID: 11044647.
    • (2000) Eur J Cancer , vol.36 , Issue.16 , pp. 2096-2104
    • Hietanen, P.1    Aro, A.R.2    Holli, K.3    Absetz, P.4
  • 61
    • 0031932009 scopus 로고    scopus 로고
    • Consent to clinical trials in anaesthesia
    • PMID: 9613266
    • Montgomery JE, Sneyd JR. Consent to clinical trials in anaesthesia. Anaesthesia. 1998 Mar;53 (3):227-30.doi: http://dx.doi.org/10.1046/j.1365-2044.1998.00309.xPMID: 9613266.
    • (1998) Anaesthesia , vol.53 , Issue.3 , pp. 227-230
    • Montgomery, J.E.1    Sneyd, J.R.2
  • 62
    • 0031950501 scopus 로고    scopus 로고
    • Informed consent, parental awareness, and reasons for participating in a randomised controlled study
    • Aug, PMID: 9797591
    • van Stuijvenberg M, Suur MH, de Vos S, Tjiang GC, Steyerberg EW, Derksen-Lubsen G, et al. Informed consent, parental awareness, and reasons for participating in a randomised controlled study. Arch Dis Child. 1998 Aug;79 (2):120-5.doi: http://dx.doi.org/10.1136/adc.79.2.120PMID: 9797591.
    • (1998) Arch Dis Child , vol.79 , Issue.2 , pp. 120-125
    • Van Stuijvenberg, M.1    Suur, M.H.2    De Vos, S.3    Tjiang, G.C.4    Steyerberg, E.W.5    Derksen-Lubsen, G.6
  • 63
    • 0028788544 scopus 로고
    • Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial
    • Nov 1, PMID: 7552502
    • Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Nov 1;10 (3):386-90.doi: http://dx.doi.org/10.1097/00042560-199511000-00012PMID: 7552502.
    • (1995) J Acquir Immune Defic Syndr Hum Retrovirol , vol.10 , Issue.3 , pp. 386-390
    • Harrison, K.1    Vlahov, D.2    Jones, K.3    Charron, K.4    Clements, M.L.5
  • 64
    • 0029058996 scopus 로고
    • Parental perceptions and attitudes about informed consent in clinical research involving children
    • Jun, PMID: 7667661
    • Harth SC, Thong YH. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med. 1995 Jun;40 (11):1573-7.doi: http://dx.doi.org/10.1016/0277-9536 (94)00412-MPMID: 7667661.
    • (1995) Soc Sci Med , vol.40 , Issue.11 , pp. 1573-1577
    • Harth, S.C.1    Thong, Y.H.2
  • 65
    • 0004938843 scopus 로고
    • Are research subjects able to retain the information they are given during the consent process
    • Estey A, Wilkin G, Dossetor J. Are research subjects able to retain the information they are given during the consent process. Health Law Rev. 1994;3:37-41.
    • (1994) Health Law Rev , vol.3 , pp. 37-41
    • Estey, A.1    Wilkin, G.2    Dossetor, J.3
  • 66
    • 0019838828 scopus 로고
    • How informed is informed consent? The BHAT experience
    • Dec;, PMID: 6120794
    • Howard JM, DeMets D. How informed is informed consent? The BHAT experience. Control Clin Trials. 1981 Dec;2 (4):287-303.doi: http://dx.doi.org/10.1016/0197-2456 (81)90019-2PMID: 6120794.
    • (1981) Control Clin Trials , vol.2 , Issue.4 , pp. 287-303
    • Howard, J.M.1    Demets, D.2
  • 67
    • 33746920544 scopus 로고    scopus 로고
    • Long term clinical trials: How much information do participants retain from the informed consent process?
    • Oct, PMID: 16798101
    • Griffin JM, Struve JK, Collins D, Liu A, Nelson DB, Bloomfield HE. Long term clinical trials: how much information do participants retain from the informed consent process? Contemp Clin Trials. 2006 Oct;27 (5):441-8.doi: http://dx.doi.org/10.1016/j.cct.2006.04.006PMID: 16798101.
    • (2006) Contemp Clin Trials , vol.27 , Issue.5 , pp. 441-448
    • Griffin, J.M.1    Struve, J.K.2    Collins, D.3    Liu, A.4    Nelson, D.B.5    Bloomfield, H.E.6
  • 68
    • 33646517939 scopus 로고    scopus 로고
    • A brief measure of perceived understanding of informed consent in a clinical trial was validated
    • Jun, PMID: 16713523
    • Guarino P, Lamping DL, Elbourne D, Carpenter J, Peduzzi P. A brief measure of perceived understanding of informed consent in a clinical trial was validated. J Clin Epidemiol. 2006 Jun;59 (6):608-14.doi: http://dx.doi.org/10.1016/j.jclinepi.2005.11.009PMID: 16713523.
    • (2006) J Clin Epidemiol , vol.59 , Issue.6 , pp. 608-614
    • Guarino, P.1    Lamping, D.L.2    Elbourne, D.3    Carpenter, J.4    Peduzzi, P.5
  • 69
    • 33645860526 scopus 로고    scopus 로고
    • Quality of informed consent: Measuring understanding among participants in oncology clinical trials
    • Jul, PMID: 15990904
    • Barrett R. Quality of informed consent: measuring understanding among participants in oncology clinical trials. Oncol Nurs Forum. 2005 Jul;32 (4):751-5.doi: http://dx.doi.org/10.1188/05.ONF.751-755PMID: 15990904.
    • (2005) Oncol Nurs Forum , vol.32 , Issue.4 , pp. 751-755
    • Barrett, R.1
  • 70
    • 14744283614 scopus 로고    scopus 로고
    • Evaluating the quality of informed consent
    • PMID: 16279577
    • Sugarman J, Lavori PW, Boeger M, Cain C, Edsond R, Morrison V, et al. Evaluating the quality of informed consent. Clin Trials. 2005;2 (1):34-41.doi: http://dx.doi.org/10.1191/1740774505cn066oaPMID: 16279577.
    • (2005) Clin Trials , vol.2 , Issue.1 , pp. 34-41
    • Sugarman, J.1    Lavori, P.W.2    Boeger, M.3    Cain, C.4    Edsond, R.5    Morrison, V.6
  • 71
    • 4344596053 scopus 로고    scopus 로고
    • Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology
    • Jul 1, PMID: 15226338
    • Simon CM, Siminoff LA, Kodish ED, Burant C. Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol. 2004 Jul 1;22 (13):2708-17.doi: http://dx.doi.org/10.1200/JCO.2004.10.034PMID: 15226338.
    • (2004) J Clin Oncol , vol.22 , Issue.13 , pp. 2708-2717
    • Simon, C.M.1    Siminoff, L.A.2    Kodish, E.D.3    Burant, C.4
  • 72
    • 0037106270 scopus 로고    scopus 로고
    • Study of the media’s potential influence on prospective research participants’ understanding of and motivations for participation in a high-profile phase I trial
    • Sep 15, PMID: 12228198
    • Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Daniel Ayers G, Herbst RS, et al. Study of the media’s potential influence on prospective research participants’ understanding of and motivations for participation in a high-profile phase I trial. J Clin Oncol. 2002 Sep 15;20 (18):3785-91.doi: http://dx.doi.org/10.1200/JCO.2002.04.084PMID: 12228198.
    • (2002) J Clin Oncol , vol.20 , Issue.18 , pp. 3785-3791
    • Pentz, R.D.1    Flamm, A.L.2    Sugarman, J.3    Cohen, M.Z.4    Daniel Ayers, G.5    Herbst, R.S.6
  • 73
    • 0035873327 scopus 로고    scopus 로고
    • The association between treatment-specific optimism and depressive symptomatology in patients enrolled in a phase I cancer clinical trial
    • May 15, PMID: 11346878
    • Cohen L, de Moor C, Amato RJ. The association between treatment-specific optimism and depressive symptomatology in patients enrolled in a phase I cancer clinical trial. Cancer. 2001 May 15;91 (10):1949-55.doi: http://dx.doi.org/10.1002/1097-0142 (20010515)91:10<1949::AID-CNCR1218>3.0.CO;2-APMID: 11346878.
    • (2001) Cancer , vol.91 , Issue.10 , pp. 1949-1955
    • Cohen, L.1    De Moor, C.2    Amato, R.J.3
  • 74
    • 0033501190 scopus 로고    scopus 로고
    • Assessing recall and understanding of informed consent in a contraceptive clinical trial
    • Dec, PMID: 10674329
    • Fortney JA. Assessing recall and understanding of informed consent in a contraceptive clinical trial. Stud Fam Plann. 1999 Dec;30 (4):339-46.doi: http://dx.doi.org/10.1111/j.1728-4465.1999.t01-5-.xPMID: 10674329.
    • (1999) Stud Fam Plann , vol.30 , Issue.4 , pp. 339-346
    • Fortney, J.A.1
  • 75
    • 0032009828 scopus 로고    scopus 로고
    • Phase I trials in cancer patients: Participants’ perceptions
    • Mar, PMID: 9582747
    • Hutchison C. Phase I trials in cancer patients: participants’ perceptions. Eur J Cancer Care (Engl). 1998 Mar;7 (1):15-22.doi: http://dx.doi.org/10.1046/j.1365-2354.1998.00062.xPMID: 9582747.
    • (1998) Eur J Cancer Care (Engl) , vol.7 , Issue.1 , pp. 15-22
    • Hutchison, C.1
  • 76
    • 0028827226 scopus 로고
    • Evaluation of the informed consent procedure in cancer patients candidate to immunotherapy
    • Sep, PMID: 7488418
    • Négrier S, Lanier-Demma F, Lacroix-Kante V, Chauvin F, Saltel P, Mercatello A, et al. Evaluation of the informed consent procedure in cancer patients candidate to immunotherapy. Eur J Cancer. 1995 Sep;31A (10):1650-2.doi: http://dx.doi.org/10.1016/0959-8049 (95)00329-HPMID: 7488418.
    • (1995) Eur J Cancer , vol.31 , Issue.10 , pp. 1650-1652
    • Négrier, S.1    Lanier-Demma, F.2    Lacroix-Kante, V.3    Chauvin, F.4    Saltel, P.5    Mercatello, A.6
  • 77
    • 0026645639 scopus 로고
    • Patients’ perceived understanding of informed consent in investigational drug studies
    • Mar, PMID: 1598945
    • Tankanow RM, Sweet BV, Weiskopf JA. Patients’ perceived understanding of informed consent in investigational drug studies. Am J Hosp Pharm. 1992 Mar;49 (3):633-5.PMID: 1598945.
    • (1992) Am J Hosp Pharm , vol.49 , Issue.3 , pp. 633-635
    • Tankanow, R.M.1    Sweet, B.V.2    Weiskopf, J.A.3
  • 78
    • 0021340621 scopus 로고
    • Patient motivation and informed consent in a phase I study of an anticancer agent
    • Apr, PMID: 6539201
    • Rodenhuis S, van den Heuvel WJ, Annyas AA, Koops HS, Sleijfer DT, Mulder NH. Patient motivation and informed consent in a phase I study of an anticancer agent. Eur J Cancer Clin Oncol. 1984 Apr;20 (4):457-62.doi: http://dx.doi.org/10.1016/0277-5379 (84)90229-3PMID: 6539201.
    • (1984) Eur J Cancer Clin Oncol , vol.20 , Issue.4 , pp. 457-462
    • Rodenhuis, S.1    Van Den Heuvel, W.J.2    Annyas, A.A.3    Koops, H.S.4    Sleijfer, D.T.5    Mulder, N.H.6
  • 79
    • 0021128898 scopus 로고
    • Informed consent for investigational chemotherapy: Patients’ and physicians’ perceptions
    • Jul, PMID: 6737023
    • Penman DT, Holland JC, Bahna GF, Morrow G, Schmale AH, Derogatis LR, et al. Informed consent for investigational chemotherapy: patients’ and physicians’ perceptions. J Clin Oncol. 1984 Jul;2 (7):849-55.PMID: 6737023.
    • (1984) J Clin Oncol , vol.2 , Issue.7 , pp. 849-855
    • Penman, D.T.1    Holland, J.C.2    Bahna, G.F.3    Morrow, G.4    Schmale, A.H.5    Derogatis, L.R.6
  • 80
    • 0021612021 scopus 로고
    • The validity of informed consent in a clinical study
    • Sep, PMID: 6545095
    • Goodman NW, Cooper GM, Malins AF, Prys-Roberts C. The validity of informed consent in a clinical study. Anaesthesia. 1984 Sep;39 (9):911-6.doi: http://dx.doi.org/10.1111/j.1365-2044.1984.tb06582.xPMID: 6545095.
    • (1984) Anaesthesia , vol.39 , Issue.9 , pp. 911-916
    • Goodman, N.W.1    Cooper, G.M.2    Malins, A.F.3    Prys-Roberts, C.4
  • 81
    • 0019968931 scopus 로고
    • Informed consent to biomedical research in Veterans Administration Hospitals
    • Jul 16, PMID: 7045434
    • Riecken HW, Ravich R. Informed consent to biomedical research in Veterans Administration Hospitals. JAMA. 1982 Jul 16;248 (3):344-8.doi: http://dx.doi.org/10.1001/jama.1982.03330030050025PMID: 7045434.
    • (1982) JAMA , vol.248 , Issue.3 , pp. 344-348
    • Riecken, H.W.1    Ravich, R.2
  • 82
    • 0018869385 scopus 로고
    • Informed consent: How much does the patient understand?
    • Apr, PMID: 6987027
    • Bergler JH, Pennington AC, Metcalfe M, Freis ED. Informed consent: how much does the patient understand? Clin Pharmacol Ther. 1980 Apr;27 (4):435-40.doi: http://dx.doi.org/10.1038/clpt.1980.60PMID: 6987027.
    • (1980) Clin Pharmacol Ther , vol.27 , Issue.4 , pp. 435-440
    • Bergler, J.H.1    Pennington, A.C.2    Metcalfe, M.3    Freis, E.D.4
  • 83
    • 79952204829 scopus 로고    scopus 로고
    • Survey of participants to clinical trial in Fukuoka university hospital: Relationship between the participant’s understanding of informed consent and their feeling of unease for clinical trials
    • Japanese
    • Ritsuko A, Noda K, Etsuko S, Etsuko M, Tomoko S, Midori N, et al. [Survey of participants to clinical trial in Fukuoka university hospital: relationship between the participant’s understanding of informed consent and their feeling of unease for clinical trials]. Fukuoka Daigaku Igaku Kiyō. 2006;33 (1):25-9. Japanese.
    • (2006) Fukuoka Daigaku Igaku Kiyō , vol.33 , Issue.1 , pp. 25-29
    • Ritsuko, A.1    Noda, K.2    Etsuko, S.3    Etsuko, M.4    Tomoko, S.5    Midori, N.6
  • 84
    • 33746534832 scopus 로고    scopus 로고
    • Parents’ attitudes to their HIV-infected children being enrolled into a placebo-controlled trial: The PENTA 1 trial
    • Oct, PMID: 11737326
    • Paediatric European Network for Treatment of AIDS. Parents’ attitudes to their HIV-infected children being enrolled into a placebo-controlled trial: the PENTA 1 trial. HIV Med. 1999 Oct;1 (1):25-31.doi: http://dx.doi.org/10.1046/j.1468-1293.1999.00005.xPMID: 11737326.
    • (1999) HIV Med , vol.1 , Issue.1 , pp. 25-31
  • 85
    • 4043068015 scopus 로고    scopus 로고
    • Neonatal research and the validity of informed consent obtained in the perinatal period
    • Jul, PMID: 15152271
    • Ballard HO, Shook LA, Desai NS, Anand KJ. Neonatal research and the validity of informed consent obtained in the perinatal period. J Perinatol. 2004 Jul;24 (7):409-15.doi: http://dx.doi.org/10.1038/sj.jp.7211142PMID: 15152271.
    • (2004) J Perinatol , vol.24 , Issue.7 , pp. 409-415
    • Ballard, H.O.1    Shook, L.A.2    Desai, N.S.3    Anand, K.J.4
  • 86
    • 34848917114 scopus 로고    scopus 로고
    • Lack of correlation between satisfaction and knowledge in clinical trials participants: A pilot study
    • PMID: 17581796
    • Bertoli AM, Strusberg I, Fierro GA, Ramos M, Strusberg AM. Lack of correlation between satisfaction and knowledge in clinical trials participants: a pilot study. Contemp Clin Trials. 2007 Nov;28 (6):730-6.doi: http://dx.doi.org/10.1016/j.cct.2007.04.005PMID: 17581796.
    • (2007) Contemp Clin Trials , vol.28 , Issue.6 , pp. 730-736
    • Bertoli, A.M.1    Strusberg, I.2    Fierro, G.A.3    Ramos, M.4    Strusberg, A.M.5
  • 87
    • 0037713715 scopus 로고    scopus 로고
    • Consent for clinical research in the neonatal intensive care unit: A retrospective survey and a prospective study
    • Jul, discussion F285-6, PMID: 12819158
    • Burgess E, Singhal N, Amin H, McMillan DD, Devrome H. Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study. Arch Dis Child Fetal Neonatal Ed. 2003 Jul;88 (4):F280-5, discussion F285-6.doi: http://dx.doi.org/10.1136/fn.88.4.F280PMID: 12819158.
    • (2003) Arch Dis Child Fetal Neonatal Ed , vol.88 , Issue.4 , pp. 280-285
    • Burgess, E.1    Singhal, N.2    Amin, H.3    McMillan, D.D.4    Devrome, H.5
  • 88
    • 80055044959 scopus 로고    scopus 로고
    • Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana
    • PMID: 22046230
    • Chaisson LH, Kass NE, Chengeta B, Mathebula U, Samandari T. Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. PLoS ONE. 2011;6 (10):e22696.doi: http://dx.doi.org/10.1371/journal.pone.0022696PMID: 22046230.
    • (2011) Plos ONE , vol.6 , Issue.10 , pp. e22696
    • Chaisson, L.H.1    Kass, N.E.2    Chengeta, B.3    Mathebula, U.4    Samandari, T.5
  • 89
    • 77957350881 scopus 로고    scopus 로고
    • Parental comprehension and satisfaction in informed consent in paediatric clinical trials: A prospective study on childhood leukaemia
    • Oct, PMID: 20551191
    • Chappuy H, Baruchel A, Leverger G, Oudot C, Brethon B, Haouy S, et al. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia. Arch Dis Child. 2010 Oct;95 (10):800-4.doi: http://dx.doi.org/10.1136/adc.2009.180695PMID: 20551191.
    • (2010) Arch Dis Child , vol.95 , Issue.10 , pp. 800-804
    • Chappuy, H.1    Baruchel, A.2    Leverger, G.3    Oudot, C.4    Brethon, B.5    Haouy, S.6
  • 90
    • 84878434181 scopus 로고    scopus 로고
    • Arental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: A two-stage cross-sectional interview study
    • PMID: 23793670
    • Chappuy H, Bouazza N, Minard-Colin V, Patte C, Brugières L, Landman-Parker J, et al. Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study. BMJ Open. 2013;3 (5):e002733.doi: http://dx.doi.org/10.1136/bmjopen-2013-002733PMID: 23793670.
    • (2013) BMJ Open , vol.3 , Issue.5
    • Chappuy, H.1    Bouazza, N.2    Minard-Colin, V.3    Patte, C.4    Brugières, L.5    Landman-Parker, J.6
  • 91
    • 33644819965 scopus 로고    scopus 로고
    • Parental consent in paediatric clinical research
    • Feb, PMID: 16246853
    • Chappuy H, Doz F, Blanche S, Gentet JC, Pons G, Tréluyer JM. Parental consent in paediatric clinical research. Arch Dis Child. 2006 Feb;91 (2):112-6.doi: http://dx.doi.org/10.1136/adc.2005.076141PMID: 16246853.
    • (2006) Arch Dis Child , vol.91 , Issue.2 , pp. 112-116
    • Chappuy, H.1    Doz, F.2    Blanche, S.3    Gentet, J.C.4    Pons, G.5    Tréluyer, J.M.6
  • 92
    • 41849099696 scopus 로고    scopus 로고
    • Children’s views on their involvement in clinical research
    • May, PMID: 17960770
    • Chappuy H, Doz F, Blanche S, Gentet JC, Tréluyer JM. Children’s views on their involvement in clinical research. Pediatr Blood Cancer. 2008 May;50 (5):1043-6.doi: http://dx.doi.org/10.1002/pbc.21359PMID: 17960770.
    • (2008) Pediatr Blood Cancer , vol.50 , Issue.5 , pp. 1043-1046
    • Chappuy, H.1    Doz, F.2    Blanche, S.3    Gentet, J.C.4    Tréluyer, J.M.5
  • 93
    • 33847321580 scopus 로고    scopus 로고
    • Informed consent for research obtained during the intensive care unit stay
    • PMID: 17156444
    • Chenaud C, Merlani P, Luyasu S, Ricou B. Informed consent for research obtained during the intensive care unit stay. Crit Care. 2006;10 (6):R170.doi: http://dx.doi.org/10.1186/cc5120PMID: 17156444.
    • (2006) Crit Care , vol.10 , Issue.6 , pp. R170
    • Chenaud, C.1    Merlani, P.2    Luyasu, S.3    Ricou, B.4
  • 94
    • 84861531182 scopus 로고    scopus 로고
    • The views of patients and healthy volunteers on participation in clinical trials: An exploratory survey study
    • Jul, PMID: 22405971
    • Chu SH, Jeong SH, Kim EJ, Park MS, Park K, Nam M, et al. The views of patients and healthy volunteers on participation in clinical trials: an exploratory survey study. Contemp Clin Trials. 2012 Jul;33 (4):611-9.doi: http://dx.doi.org/10.1016/j.cct.2012.02.018PMID: 22405971.
    • (2012) Contemp Clin Trials , vol.33 , Issue.4 , pp. 611-619
    • Chu, S.H.1    Jeong, S.H.2    Kim, E.J.3    Park, M.S.4    Park, K.5    Nam, M.6
  • 95
    • 84862274448 scopus 로고    scopus 로고
    • Determinants of informed consent in a cataract surgery clinical trial: Why patients participate
    • Apr, PMID: 22560415
    • Constantinou M, Jhanji V, Chiang PP, Lamoureux EL, Rees G, Vajpayee RB. Determinants of informed consent in a cataract surgery clinical trial: why patients participate. Can J Ophthalmol. 2012 Apr;47 (2):118-23.doi: http://dx.doi.org/10.1016/j.jcjo.2012.01.006PMID: 22560415.
    • (2012) Can J Ophthalmol , vol.47 , Issue.2 , pp. 118-123
    • Constantinou, M.1    Jhanji, V.2    Chiang, P.P.3    Lamoureux, E.L.4    Rees, G.5    Vajpayee, R.B.6
  • 96
    • 84870731935 scopus 로고    scopus 로고
    • Communicating and understanding the purpose of pediatric phase I cancer trials
    • Dec 10, PMID: 23071225
    • Cousino MK, Zyzanski SJ, Yamokoski AD, Hazen RA, Baker JN, Noll RB, et al. Communicating and understanding the purpose of pediatric phase I cancer trials. J Clin Oncol. 2012 Dec 10;30 (35):4367-72.doi: http://dx.doi.org/10.1200/JCO.2012.42.3004PMID: 23071225.
    • (2012) J Clin Oncol , vol.30 , Issue.35 , pp. 4367-4372
    • Cousino, M.K.1    Zyzanski, S.J.2    Yamokoski, A.D.3    Hazen, R.A.4    Baker, J.N.5    Noll, R.B.6
  • 97
    • 56749161654 scopus 로고    scopus 로고
    • Informed consent in clinical research in France: Assessment and factors associated with therapeutic misconception
    • Sep, PMID: 18757616
    • Durand-Zaleski IS, Alberti C, Durieux P, Duval X, Gottot S, Ravaud P, et al. Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception. J Med Ethics. 2008 Sep;34 (9):e16.doi: http://dx.doi.org/10.1136/jme.2007.023473PMID: 18757616.
    • (2008) J Med Ethics , vol.34 , Issue.9 , pp. e16
    • Durand-Zaleski, I.S.1    Alberti, C.2    Durieux, P.3    Duval, X.4    Gottot, S.5    Ravaud, P.6
  • 98
    • 23844492536 scopus 로고    scopus 로고
    • Mothers’ attitudes to the randomized controlled trial (RCT): The case of acute lymphoblastic leukaemia (ALL) in children
    • Sep, PMID: 16101646
    • Eiser C, Davies H, Jenney M, Glaser A. Mothers’ attitudes to the randomized controlled trial (RCT): the case of acute lymphoblastic leukaemia (ALL) in children. Child Care Health Dev. 2005 Sep;31 (5):517-23.doi: http://dx.doi.org/10.1111/j.1365-2214.2005.00538.xPMID: 16101646.
    • (2005) Child Care Health Dev , vol.31 , Issue.5 , pp. 517-523
    • Eiser, C.1    Davies, H.2    Jenney, M.3    Glaser, A.4
  • 99
    • 0032585195 scopus 로고    scopus 로고
    • Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial
    • Oct 31, PMID: 9794849
    • Featherstone K, Donovan JL. Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial. BMJ. 1998 Oct 31;317 (7167):1177-80.doi: http://dx.doi.org/10.1136/bmj.317.7167.1177PMID: 9794849.
    • (1998) BMJ , vol.317 , Issue.7167 , pp. 1177-1180
    • Featherstone, K.1    Donovan, J.L.2
  • 100
    • 34248554146 scopus 로고    scopus 로고
    • The role of the consent document in informed consent for pediatric leukemia trials
    • Jul, PMID: 17196888
    • Hazen RA, Drotar D, Kodish E. The role of the consent document in informed consent for pediatric leukemia trials. Contemp Clin Trials. 2007 Jul;28 (4):401-8.doi: http://dx.doi.org/10.1016/j.cct.2006.10.011PMID: 17196888.
    • (2007) Contemp Clin Trials , vol.28 , Issue.4 , pp. 401-408
    • Hazen, R.A.1    Drotar, D.2    Kodish, E.3
  • 101
    • 77957749490 scopus 로고    scopus 로고
    • Consent in clinical trials: What do patients know?
    • Sep, PMID: 20462521
    • Hereu P, Pérez E, Fuentes I, Vidal X, Suñé P, Arnau JM. Consent in clinical trials: what do patients know? Contemp Clin Trials. 2010 Sep;31 (5):443-6.doi: http://dx.doi.org/10.1016/j.cct.2010.05.004PMID: 20462521.
    • (2010) Contemp Clin Trials , vol.31 , Issue.5 , pp. 443-446
    • Hereu, P.1    Pérez, E.2    Fuentes, I.3    Vidal, X.4    Suñé, P.5    Arnau, J.M.6
  • 102
    • 34848832366 scopus 로고    scopus 로고
    • PAIS investigators. Appreciation of the informed consent procedure in a randomised trial of decompressive surgery for space occupying hemispheric infarction
    • Oct, PMID: 17400593
    • Hofmeijer J, Amelink GJ, den Hertog HM, Algra A, Kappelle LJ, van der Worp HB, et al.; PAIS investigators. Appreciation of the informed consent procedure in a randomised trial of decompressive surgery for space occupying hemispheric infarction. J Neurol Neurosurg Psychiatry. 2007 Oct;78 (10):1124-8.doi: http://dx.doi.org/10.1136/jnnp.2006.110726PMID: 17400593.
    • (2007) J Neurol Neurosurg Psychiatry , vol.78 , Issue.10 , pp. 1124-1128
    • Hofmeijer, J.1    Amelink, G.J.2    Den Hertog, H.M.3    Algra, A.4    Kappelle, L.J.5    Van Der Worp, H.B.6
  • 103
    • 0030950354 scopus 로고    scopus 로고
    • Patients in phase I trials of anti-cancer agents in Japan: Motivation, comprehension and expectations
    • PMID: 9218741
    • Itoh K, Sasaki Y, Fujii H, Ohtsu T, Wakita H, Igarashi T, et al. Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations. Br J Cancer. 1997;76 (1):107-13.doi: http://dx.doi.org/10.1038/bjc.1997.344PMID: 9218741.
    • (1997) Br J Cancer , vol.76 , Issue.1 , pp. 107-113
    • Itoh, K.1    Sasaki, Y.2    Fujii, H.3    Ohtsu, T.4    Wakita, H.5    Igarashi, T.6
  • 104
    • 0034025634 scopus 로고    scopus 로고
    • Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy
    • Jun, PMID: 10839291
    • Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000 Jun;82 (11):1783-8.doi: http://dx.doi.org/10.1054/bjoc.2000.1142PMID: 10839291.
    • (2000) Br J Cancer , vol.82 , Issue.11 , pp. 1783-1788
    • Jenkins, V.1    Fallowfield, L.2
  • 105
    • 28844443502 scopus 로고    scopus 로고
    • Motivations, understanding, and voluntariness in international randomized trials
    • Nov-Dec, PMID: 16425478
    • Kass NE, Maman S, Atkinson J. Motivations, understanding, and voluntariness in international randomized trials. IRB. 2005 Nov-Dec;27 (6):1-8.doi: http://dx.doi.org/10.2307/3563534PMID: 16425478.
    • (2005) IRB , vol.27 , Issue.6 , pp. 1-8
    • Kass, N.E.1    Maman, S.2    Atkinson, J.3
  • 106
    • 33645952360 scopus 로고    scopus 로고
    • Participating in a trial in a critical situation: A qualitative study in pregnancy
    • PMID: 16585108
    • Kenyon S, Dixon-Woods M, Jackson CJ, Windridge K, Pitchforth E. Participating in a trial in a critical situation: a qualitative study in pregnancy. Qual Saf Health Care. 2006 Apr;15 (2):98-101.doi: http://dx.doi.org/10.1136/qshc.2005.015636PMID: 16585108.
    • (2006) Qual Saf Health Care , vol.15 , Issue.2 , pp. 98-101
    • Kenyon, S.1    Dixon-Woods, M.2    Jackson, C.J.3    Windridge, K.4    Pitchforth, E.5
  • 107
    • 84865084004 scopus 로고    scopus 로고
    • Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study
    • PMID: 22906301
    • Kiguba R, Kutyabami P, Kiwuwa S, Katabira E, Sewankambo NK. Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study. BMC Med Ethics. 2012;13 (1):21.doi: http://dx.doi.org/10.1186/1472-6939-13-21PMID: 22906301.
    • (2012) BMC Med Ethics , vol.13 , Issue.1 , pp. 21
    • Kiguba, R.1    Kutyabami, P.2    Kiwuwa, S.3    Katabira, E.4    Sewankambo, N.K.5
  • 108
    • 1442311081 scopus 로고    scopus 로고
    • Therapeutic misconception and the appreciation of risks in clinical trials
    • PMID: 14990370
    • Lidz CW, Appelbaum PS, Grisso T, Renaud M. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med. 2004 May;58 (9):1689-97.doi: http://dx.doi.org/10.1016/S0277-9536 (03)00338-1PMID: 14990370.
    • (2004) Soc Sci Med , vol.58 , Issue.9 , pp. 1689-1697
    • Lidz, C.W.1    Appelbaum, P.S.2    Grisso, T.3    Renaud, M.4
  • 109
    • 79959770363 scopus 로고    scopus 로고
    • Factual understanding of randomized clinical trials: A multicenter case-control study in cancer patients
    • Aug, PMID: 19760365
    • Leroy T, Christophe V, Penel N, Antoine P, Clisant S. Factual understanding of randomized clinical trials: a multicenter case-control study in cancer patients. Invest New Drugs. 2011 Aug;29 (4):700-5.doi: http://dx.doi.org/10.1007/s10637-009-9315-8PMID: 19760365.
    • (2011) Invest New Drugs , vol.29 , Issue.4 , pp. 700-705
    • Leroy, T.1    Christophe, V.2    Penel, N.3    Antoine, P.4    Clisant, S.5
  • 110
    • 0034457588 scopus 로고    scopus 로고
    • Diagnosis, disclosure, and informed consent: Learning from parents of children with cancer
    • Jan-Feb, PMID: 10695815
    • Levi RB, Marsick R, Drotar D, Kodish ED. Diagnosis, disclosure, and informed consent: learning from parents of children with cancer. J Pediatr Hematol Oncol. 2000 Jan-Feb;22 (1):3-12.doi: http://dx.doi.org/10.1097/00043426-200001000-00002PMID: 10695815.
    • (2000) J Pediatr Hematol Oncol , vol.22 , Issue.1 , pp. 3-12
    • Levi, R.B.1    Marsick, R.2    Drotar, D.3    Kodish, E.D.4
  • 111
    • 49249091844 scopus 로고    scopus 로고
    • Ijsselmuiden C. Informed consent in an antiretroviral trial in Nigeria
    • Jan-Mar, PMID: 18630217
    • Manafa O, Lindegger G, Ijsselmuiden C. Informed consent in an antiretroviral trial in Nigeria. Indian J Med Ethics. 2007 Jan-Mar;4 (1):26-30.PMID: 18630217.
    • (2007) Indian J Med Ethics , vol.4 , Issue.1 , pp. 26-30
    • Manafa, O.1    Lindegger, G.2
  • 112
    • 0035352241 scopus 로고    scopus 로고
    • Parents’ understanding of a randomised double-blind controlled trial
    • May, PMID: 12025022
    • McNally T, Grigg J. Parents’ understanding of a randomised double-blind controlled trial. Paediatr Nurs. 2001 May;13 (4):11-4.doi: http://dx.doi.org/10.7748/paed2001.05.13.4.11.c736PMID: 12025022.
    • (2001) Paediatr Nurs , vol.13 , Issue.4 , pp. 11-14
    • McNally, T.1    Grigg, J.2
  • 113
    • 56749157971 scopus 로고    scopus 로고
    • I don’t like that, it’s tricking people too much…: Acute informed consent to participation in a trial of thrombolysis for stroke
    • Oct, PMID: 18827109
    • Mangset M, Førde R, Nessa J, Berge E, Wyller TB. I don’t like that, it’s tricking people too much…: acute informed consent to participation in a trial of thrombolysis for stroke. J Med Ethics. 2008 Oct;34 (10):751-6.doi: http://dx.doi.org/10.1136/jme.2007.023168PMID: 18827109.
    • (2008) J Med Ethics , vol.34 , Issue.10 , pp. 751-756
    • Mangset, M.1    Førde, R.2    Nessa, J.3    Berge, E.4    Wyller, T.B.5
  • 114
    • 77951523665 scopus 로고    scopus 로고
    • Informed consent as viewed by patients participating in cardiology drug trial
    • Jan, Portuguese, PMID: 20414520
    • Meneguin S, Zoboli EL, Domingues RZ, Nobre MR, César LA. [Informed consent as viewed by patients participating in cardiology drug trial]. Arq Bras Cardiol. 2010 Jan;94 (1):4-9. Portuguese.doi: http://dx.doi.org/10.1590/S0066-782X2010000100003PMID: 20414520.
    • (2010) Arq Bras Cardiol , vol.94 , Issue.1 , pp. 4-9
    • Meneguin, S.1    Zoboli, E.L.2    Domingues, R.Z.3    Nobre, M.R.4    César, L.A.5
  • 116
    • 0037693198 scopus 로고    scopus 로고
    • Perceptions of equipoise are crucial to trial participation: A qualitative study of men in the ProtecT study
    • Jun, PMID: 12757993
    • Mills N, Donovan JL, Smith M, Jacoby A, Neal DE, Hamdy FC. Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Control Clin Trials. 2003 Jun;24 (3):272-82.doi: http://dx.doi.org/10.1016/S0197-2456 (03)00020-5PMID: 12757993.
    • (2003) Control Clin Trials , vol.24 , Issue.3 , pp. 272-282
    • Mills, N.1    Donovan, J.L.2    Smith, M.3    Jacoby, A.4    Neal, D.E.5    Hamdy, F.C.6
  • 117
    • 17444423346 scopus 로고    scopus 로고
    • Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy
    • Mar 28, PMID: 15770219
    • Nurgat ZA, Craig W, Campbell NC, Bissett JD, Cassidy J, Nicolson MC. Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer. 2005 Mar 28;92 (6):1001-5.doi: http://dx.doi.org/10.1038/sj.bjc.6602423PMID: 15770219.
    • (2005) Br J Cancer , vol.92 , Issue.6 , pp. 1001-1005
    • Nurgat, Z.A.1    Craig, W.2    Campbell, N.C.3    Bissett, J.D.4    Cassidy, J.5    Nicolson, M.C.6
  • 118
    • 0026113397 scopus 로고
    • The consent process in the Thrombolysis in Myocardial Infarction (TIMI-phase I) trial
    • Feb, PMID: 1999082
    • Ockene IS, Miner J, Shannon TA, Gore JM, Weiner BH, Ball SP. The consent process in the Thrombolysis in Myocardial Infarction (TIMI-phase I) trial. Clin Res. 1991 Feb;39 (1):13-7.PMID: 1999082.
    • (1991) Clin Res , vol.39 , Issue.1 , pp. 13-17
    • Ockene, I.S.1    Miner, J.2    Shannon, T.A.3    Gore, J.M.4    Weiner, B.H.5    Ball, S.P.6
  • 119
    • 84872473664 scopus 로고    scopus 로고
    • Parental informed consent in pediatric cancer trials: A population-based survey in Germany
    • PMID: 23015470
    • Petersen I, Spix C, Kaatsch P, Graf N, Janka G, Kollek R. Parental informed consent in pediatric cancer trials: a population-based survey in Germany. Pediatr Blood Cancer. 2013 Mar;60 (3):446-50.doi: http://dx.doi.org/10.1002/pbc.24330PMID: 23015470.
    • (2013) Pediatr Blood Cancer , vol.60 , Issue.3 , pp. 446-450
    • Petersen, I.1    Spix, C.2    Kaatsch, P.3    Graf, N.4    Janka, G.5    Kollek, R.6
  • 120
    • 0342545448 scopus 로고    scopus 로고
    • Comprehension of the informed consent form and general knowledge of vaccines among potential participants for an HIV vaccine trial in Brazil
    • Queiroz da Fonseca O, Lie RK. Comprehension of the informed consent form and general knowledge of vaccines among potential participants for an HIV vaccine trial in Brazil. Int J Pharm Med. 1999;13 (5):253-60.
    • (1999) Int J Pharm Med , vol.13 , Issue.5 , pp. 253-260
    • Da Queiroz Fonseca, O.1    Lie, R.K.2
  • 121
    • 23644441523 scopus 로고    scopus 로고
    • A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials
    • Aug, PMID: 16076978
    • Russell FM, Carapetis JR, Liddle H, Edwards T, Ruff TA, Devitt J. A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials. J Med Ethics. 2005 Aug;31 (8):490-4.doi: http://dx.doi.org/10.1136/jme.2002.002279PMID: 16076978.
    • (2005) J Med Ethics , vol.31 , Issue.8 , pp. 490-494
    • Russell, F.M.1    Carapetis, J.R.2    Liddle, H.3    Edwards, T.4    Ruff, T.A.5    Devitt, J.6
  • 122
    • 0029927575 scopus 로고    scopus 로고
    • The impact of disease severity on the informed consent process in clinical research
    • Mar, PMID: 8629670
    • Schaeffer MH, Krantz DS, Wichman A, Masur H, Reed E, Vinicky JK. The impact of disease severity on the informed consent process in clinical research. Am J Med. 1996 Mar;100 (3):261-8.doi: http://dx.doi.org/10.1016/S0002-9343 (97)89483-1PMID: 8629670.
    • (1996) Am J Med , vol.100 , Issue.3 , pp. 261-268
    • Schaeffer, M.H.1    Krantz, D.S.2    Wichman, A.3    Masur, H.4    Reed, E.5    Vinicky, J.K.6
  • 123
    • 0344406878 scopus 로고    scopus 로고
    • The Ditrame (ANRS 049) clinical trial aimed at reducing the mother-child transmission of HIV in Abidjan. Participants’ understanding of the trial principles
    • Mar 1, French.PMID: 12712680
    • Coulibaly-Traoré D, Msellati P, Vidal L, Ekra CW, Dabis F. [The Ditrame (ANRS 049) clinical trial aimed at reducing the mother-child transmission of HIV in Abidjan. Participants’ understanding of the trial principles]. Presse Med. 2003 Mar 1;32 (8):343-50. French.PMID: 12712680.
    • (2003) Presse Med. , vol.32 , Issue.8 , pp. 343-350
    • Coulibaly-Traoré, D.1    Msellati, P.2    Vidal, L.3    Ekra, C.W.4    Dabis, F.5
  • 124
    • 0034622166 scopus 로고    scopus 로고
    • Ethical approach to informed consent for participation in clinical studies in acute cerebral infarct
    • Jul 8-15, French.PMID: 10938684
    • Ducrocq X, Taillandier L, Anxionnat R, Lacour JC, Debouverie M, Lanotte L, et al. [Ethical approach to informed consent for participation in clinical studies in acute cerebral infarct]. Presse Med. 2000 Jul 8-15;29 (24):1335-40. French.PMID: 10938684.
    • (2000) Presse Med. , vol.29 , Issue.24 , pp. 1335-1340
    • Ducrocq, X.1    Taillandier, L.2    Anxionnat, R.3    Lacour, J.C.4    Debouverie, M.5    Lanotte, L.6
  • 125
    • 0034305268 scopus 로고    scopus 로고
    • Factors that influence a patient’s decision to participate in a phase I cancer clinical trial
    • Oct, PMID: 11058975
    • Schutta KM, Burnett CB. Factors that influence a patient’s decision to participate in a phase I cancer clinical trial. Oncol Nurs Forum. 2000 Oct;27 (9):1435-8.PMID: 11058975.
    • (2000) Oncol Nurs Forum , vol.27 , Issue.9 , pp. 1435-1438
    • Schutta, K.M.1    Burnett, C.B.2
  • 126
    • 0030839611 scopus 로고    scopus 로고
    • Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial
    • PMID: 9351153
    • Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med. 1997 Nov;45 (9):1337-55.doi: http://dx.doi.org/10.1016/S0277-9536 (97)00063-4PMID: 9351153.
    • (1997) Soc Sci Med , vol.45 , Issue.9 , pp. 1337-1355
    • Snowdon, C.1    Garcia, J.2    Elbourne, D.3
  • 127
    • 3042828629 scopus 로고    scopus 로고
    • Neonatal research: The parental perspective
    • Jul, PMID: 15210665
    • Stenson BJ, Becher JC, McIntosh N. Neonatal research: the parental perspective. Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89 (4):F321-4.doi: http://dx.doi.org/10.1136/adc.2002.021931PMID: 15210665.
    • (2004) Arch Dis Child Fetal Neonatal Ed , vol.89 , Issue.4 , pp. 321-324
    • Stenson, B.J.1    Becher, J.C.2    McIntosh, N.3
  • 128
    • 77950573933 scopus 로고    scopus 로고
    • The experiences of children enrolled in pediatric oncology research: Implications for assent
    • Apr;, PMID: 20351001
    • Unguru Y, Sill AM, Kamani N. The experiences of children enrolled in pediatric oncology research: implications for assent. Pediatrics. 2010 Apr;125 (4):e876-83.doi: http://dx.doi.org/10.1542/peds.2008-3429PMID: 20351001.
    • (2010) Pediatrics , vol.125 , Issue.4 , pp. 876-883
    • Unguru, Y.1    Sill, A.M.2    Kamani, N.3
  • 129
    • 80051577655 scopus 로고    scopus 로고
    • Patients’ understanding of clinical trials needs to be assessed in the context of understanding of overall goals of care
    • Aug, PMID: 21637973
    • Yoong J, Jefford M, Mileshkin L. Patients’ understanding of clinical trials needs to be assessed in the context of understanding of overall goals of care. Support Care Cancer. 2011 Aug;19 (8):1067-8.doi: http://dx.doi.org/10.1007/s00520-011-1201-1PMID: 21637973.
    • (2011) Support Care Cancer , vol.19 , Issue.8 , pp. 1067-1068
    • Yoong, J.1    Jefford, M.2    Mileshkin, L.3
  • 130
    • 0030298589 scopus 로고    scopus 로고
    • Patients’ perceptions on informed consent and the quality of information disclosure in clinical trials
    • Nov, PMID: 9006231
    • Verheggen FW, Jonkers R, Kok G. Patients’ perceptions on informed consent and the quality of information disclosure in clinical trials. Patient Educ Couns. 1996 Nov;29 (2):137-53.doi: http://dx.doi.org/10.1016/0738-3991 (96)00859-2PMID: 9006231.
    • (1996) Patient Educ Couns , vol.29 , Issue.2 , pp. 137-153
    • Verheggen, F.W.1    Jonkers, R.2    Kok, G.3
  • 131
    • 84931682317 scopus 로고    scopus 로고
    • Country and lending groups [Internet]. Washington: World Bank; 2014. Available from: http://data.worldbank.org/about/country-and-lending-groups [cited 2014 Dec 12].
  • 132
    • 0028349564 scopus 로고
    • WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: Responsibilities of the investigator
    • Apr, PMID: 8024733
    • Idänpäänheikkilä JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med. 1994 Apr;26 (2):89-94.doi: http://dx.doi.org/10.3109/07853899409147334PMID: 8024733.
    • (1994) Ann Med , vol.26 , Issue.2 , pp. 89-94
    • Idänpäänheikkilä, J.E.1
  • 133
    • 0032501363 scopus 로고    scopus 로고
    • Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group
    • Dec, PMID: 9851484
    • Moreno J, Caplan AL, Wolpe PR. Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group. JAMA. 1998 Dec 9;280 (22):1951-8.doi: http://dx.doi.org/10.1001/jama.280.22.1951PMID: 9851484.
    • (1998) JAMA , vol.280 , Issue.22 , pp. 1951-1958
    • Moreno, J.1    Caplan, A.L.2    Wolpe, P.R.3
  • 134
    • 40649123598 scopus 로고    scopus 로고
    • Beyond informed consent: The therapeutic misconception and trust
    • Mar, PMID: 18316464
    • de Melo-Martín I, Ho A. Beyond informed consent: the therapeutic misconception and trust. J Med Ethics. 2008 Mar;34 (3):202-5.doi: http://dx.doi.org/10.1136/jme.2006.019406PMID: 18316464.
    • (2008) J Med Ethics , vol.34 , Issue.3 , pp. 202-205
    • De Melo-Martín, I.1    Ho, A.2
  • 135
    • 55249114341 scopus 로고    scopus 로고
    • Knowledge and understanding among cancer patients consenting to participate in clinical trials
    • Nov, PMID: 18818068
    • Bergenmar M, Molin C, Wilking N, Brandberg Y. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer. 2008 Nov;44 (17):2627-33.doi: http://dx.doi.org/10.1016/j.ejca.2008.08.013PMID: 18818068.
    • (2008) Eur J Cancer , vol.44 , Issue.17 , pp. 2627-2633
    • Bergenmar, M.1    Molin, C.2    Wilking, N.3    Brandberg, Y.4
  • 136
    • 56749161654 scopus 로고    scopus 로고
    • Informed consent in clinical research in France: Assessment and factors associated with therapeutic misconception
    • Sep, PMID: 18757616
    • Durand-Zaleski IS, Alberti C, Durieux P, Duval X, Gottot S, Ravaud P, et al. Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception. J Med Ethics. 2008 Sep;34 (9):e16.doi: http://dx.doi.org/10.1136/jme.2007.023473PMID: 18757616.
    • (2008) J Med Ethics , vol.34 , Issue.9 , pp. e16
    • Durand-Zaleski, I.S.1    Alberti, C.2    Durieux, P.3    Duval, X.4    Gottot, S.5    Ravaud, P.6
  • 137
    • 4043068015 scopus 로고    scopus 로고
    • Neonatal research and the validity of informed consent obtained in the perinatal period
    • Jul, PMID: 15152271
    • Ballard HO, Shook LA, Desai NS, Anand KJ. Neonatal research and the validity of informed consent obtained in the perinatal period. J Perinatol. 2004 Jul;24 (7):409-15.doi: http://dx.doi.org/10.1038/sj.jp.7211142PMID: 15152271.
    • (2004) J Perinatol , vol.24 , Issue.7 , pp. 409-415
    • Ballard, H.O.1    Shook, L.A.2    Desai, N.S.3    Anand, K.J.4
  • 138
    • 84890158082 scopus 로고    scopus 로고
    • Phase 1 oncology trials and informed consent
    • Dec, PMID: 23161617
    • Miller FG, Joffe S. Phase 1 oncology trials and informed consent. J Med Ethics. 2013 Dec;39 (12):761-4.doi: http://dx.doi.org/10.1136/medethics-2012-100832PMID: 23161617.
    • (2013) J Med Ethics , vol.39 , Issue.12 , pp. 761-764
    • Miller, F.G.1    Joffe, S.2
  • 139
    • 84872495057 scopus 로고    scopus 로고
    • Improving the informed consent process for research subjects with low literacy: A systematic review
    • Jan, PMID: 22782275
    • Tamariz L, Palacio A, Robert M, Marcus EN. Improving the informed consent process for research subjects with low literacy: a systematic review. J Gen Intern Med. 2013 Jan;28 (1):121-6.doi: http://dx.doi.org/10.1007/s11606-012-2133-2PMID: 22782275.
    • (2013) J Gen Intern Med , vol.28 , Issue.1 , pp. 121-126
    • Tamariz, L.1    Palacio, A.2    Robert, M.3    Marcus, E.N.4
  • 140
    • 4644281540 scopus 로고    scopus 로고
    • Interventions to improve research participants’ understanding in informed consent for research: A systematic review
    • Oct 6, PMID: 15467062
    • Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292 (13):1593-601.doi: http://dx.doi.org/10.1001/jama.292.13.1593PMID: 15467062.
    • (2004) JAMA , vol.292 , Issue.13 , pp. 1593-1601
    • Flory, J.1    Emanuel, E.2
  • 141
    • 84893941601 scopus 로고    scopus 로고
    • Ethical review of health systems research in low- and middle-income countries: A conceptual exploration
    • PMID: 24521334
    • Hyder AA, Rattani A, Krubiner C, Bachani AM, Tran NT. Ethical review of health systems research in low- and middle-income countries: a conceptual exploration. Am J Bioeth. 2014;14 (2):28-37.doi: http://dx.doi.org/10.1080/15265161.2013.868950PMID: 24521334.
    • (2014) Am J Bioeth , vol.14 , Issue.2 , pp. 28-37
    • Hyder, A.A.1    Rattani, A.2    Krubiner, C.3    Bachani, A.M.4    Tran, N.T.5
  • 142
    • 84931682318 scopus 로고    scopus 로고
    • Cargan L. Doing social research. Lanham: Rowman and Littlefield Publishers; 2007.
  • 143
    • 21244451952 scopus 로고    scopus 로고
    • Open-ended questions: Are they really beneficial for gathering medical information from patients?
    • Jun, PMID: 15888971
    • Takemura Y, Sakurai Y, Yokoya S, Otaki J, Matsuoka T, Ban N, et al. Open-ended questions: are they really beneficial for gathering medical information from patients? Tohoku J Exp Med. 2005 Jun;206 (2):151-4.doi: http://dx.doi.org/10.1620/tjem.206.151PMID: 15888971.
    • (2005) Tohoku J Exp Med , vol.206 , Issue.2 , pp. 151-154
    • Takemura, Y.1    Sakurai, Y.2    Yokoya, S.3    Otaki, J.4    Matsuoka, T.5    Ban, N.6
  • 144
    • 84931682319 scopus 로고    scopus 로고
    • Faralli C. Informed consent in medicine: ethical and juridical aspects. Milan: Salute e Società; 2013.
  • 145
    • 84923933911 scopus 로고    scopus 로고
    • Understood consent versus informed consent: A new paradigm for obtaining consent for pediatric research studies
    • PMID: 24400284
    • Isles AF. Understood consent versus informed consent: a new paradigm for obtaining consent for pediatric research studies. Front Pediatr. 2013;1:38.doi: http://dx.doi.org/10.3389/fped.2013.00038PMID: 24400284.
    • (2013) Front Pediatr , vol.1 , pp. 38
    • Isles, A.F.1
  • 146
    • 84880334513 scopus 로고    scopus 로고
    • Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials
    • PMID: 23879694
    • Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14 (1):28.doi: http://dx.doi.org/10.1186/1472-6939-14-28PMID: 23879694.
    • (2013) BMC Med Ethics , vol.14 , Issue.1 , pp. 28
    • Nishimura, A.1    Carey, J.2    Erwin, P.J.3    Tilburt, J.C.4    Murad, M.H.5    McCormick, J.B.6
  • 147
    • 84887995604 scopus 로고    scopus 로고
    • Suggestions from adolescents, young adults, and parents for improving informed consent in phase 1 pediatric oncology trials
    • Dec 1, PMID: 24006119
    • Baker JN, Leek AC, Salas HS, Drotar D, Noll R, Rheingold SR, et al. Suggestions from adolescents, young adults, and parents for improving informed consent in phase 1 pediatric oncology trials. Cancer. 2013 Dec 1;119 (23):4154-61.doi: http://dx.doi.org/10.1002/cncr.28335PMID: 24006119.
    • (2013) Cancer , vol.119 , Issue.23 , pp. 4154-4161
    • Baker, J.N.1    Leek, A.C.2    Salas, H.S.3    Drotar, D.4    Noll, R.5    Rheingold, S.R.6
  • 148
    • 84862196166 scopus 로고    scopus 로고
    • Low quality and lack of clarity of current informed consent forms in cardiology: How to improve them
    • Jun, PMID: 22698536
    • Terranova G, Ferro M, Carpeggiani C, Recchia V, Braga L, Semelka RC, et al. Low quality and lack of clarity of current informed consent forms in cardiology: how to improve them. JACC Cardiovasc Imaging. 2012 Jun;5 (6):649-55.doi: http://dx.doi.org/10.1016/j.jcmg.2012.03.007PMID: 22698536.
    • (2012) JACC Cardiovasc Imaging , vol.5 , Issue.6 , pp. 649-655
    • Terranova, G.1    Ferro, M.2    Carpeggiani, C.3    Recchia, V.4    Braga, L.5    Semelka, R.C.6
  • 149
    • 56349120248 scopus 로고    scopus 로고
    • A review of children’s decision-making competence in health care
    • PMID: 18005126
    • Mårtenson EK, Fägerskiöld AM. A review of children’s decision-making competence in health care. J Clin Nurs. 2008 Dec;17 (23):3131-41.doi: http://dx.doi.org/10.1111/j.1365-2702.2006.01920.xPMID: 18005126.
    • (2008) J Clin Nurs , vol.17 , Issue.23 , pp. 3131-3141
    • Mårtenson, E.K.1    Fägerskiöld, A.M.2
  • 150
    • 0028989425 scopus 로고
    • Informed consent by children: The new reality
    • May 1, PMID: 7728701
    • Kluge EH. Informed consent by children: the new reality. CMAJ. 1995 May 1;152 (9):1495-7.PMID: 7728701.
    • (1995) CMAJ , vol.152 , Issue.9 , pp. 1495-1497
    • Kluge, E.H.1
  • 151
    • 20444364441 scopus 로고    scopus 로고
    • Combination of data
    • In: Kotz S, Johnson NL, Read CB, Balakrishnan N, Vidakovic B, editors, 2nd ed. Hoboken: John Wiley & Sons
    • Cox DR. Combination of data. In: Kotz S, Johnson NL, Read CB, Balakrishnan N, Vidakovic B, editors. Encyclopedia of statistical sciences. 2nd ed. Hoboken: John Wiley & Sons; 2006.pp. 1074-81.
    • (2006) Encyclopedia of Statistical Sciences , pp. 1074-1081
    • Cox, D.R.1
  • 152
    • 70349235819 scopus 로고    scopus 로고
    • Understanding heterogeneity in meta-analysis: The role of meta-regression
    • Health Outcomes, Policy, and Economics (HOPE) Collaborative Group, Oct, PMID: 19769699
    • Baker WL, White CM, Cappelleri JC, Kluger J, Coleman CI; Health Outcomes, Policy, and Economics (HOPE) Collaborative Group. Understanding heterogeneity in meta-analysis: the role of meta-regression. Int J Clin Pract. 2009 Oct;63 (10):1426-34.doi: http://dx.doi.org/10.1111/j.1742-1241.2009.02168.xPMID: 19769699.
    • (2009) Int J Clin Pract , vol.63 , Issue.10 , pp. 1426-1434
    • Baker, W.L.1    White, C.M.2    Cappelleri, J.C.3    Kluger, J.4    Coleman, C.I.5
  • 153
    • 84884696789 scopus 로고    scopus 로고
    • Factors associated with dengue shock syndrome: A systematic review and meta-analysis
    • PMID: 24086778
    • Huy NT, Van Giang T, Thuy DH, Kikuchi M, Hien TT, Zamora J, et al. Factors associated with dengue shock syndrome: a systematic review and meta-analysis. PLoS Negl Trop Dis. 2013;7 (9):e2412.doi: http://dx.doi.org/10.1371/journal.pntd.0002412PMID: 24086778.
    • (2013) Plos Negl Trop Dis , vol.7 , Issue.9 , pp. e2412
    • Huy, N.T.1    Van Giang, T.2    Thuy, D.H.3    Kikuchi, M.4    Hien, T.T.5    Zamora, J.6
  • 154
    • 46749099101 scopus 로고    scopus 로고
    • Reasons or excuses for avoiding meta-analysis in forest plots
    • Jun 21, PMID: 18566080
    • Ioannidis JP, Patsopoulos NA, Rothstein HR. Reasons or excuses for avoiding meta-analysis in forest plots. BMJ. 2008 Jun 21;336 (7658):1413-5.doi: http://dx.doi.org/10.1136/bmj.a117PMID: 18566080.
    • (2008) BMJ , vol.336 , Issue.7658 , pp. 1413-1415
    • Ioannidis, J.P.1    Patsopoulos, N.A.2    Rothstein, H.R.3


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