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Volumn 6, Issue 4, 2011, Pages

Readability of the Written Study Information in Pediatric Research in France

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; CHILD; CLINICAL EVALUATION; CLINICAL PROTOCOL; CONTROLLED STUDY; FRANCE; HUMAN; INFORMATION PROCESSING; MEDICAL RESEARCH; PATIENT SELECTION; PEDIATRICS; PRESCHOOL CHILD; READING; RESEARCH ETHICS; RESEARCH SUBJECT; SCHOOL CHILD; SCORING SYSTEM; COMPREHENSION; INFORMED CONSENT; WRITING;

EID: 79953754171     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0018484     Document Type: Article
Times cited : (21)

References (24)
  • 1
    • 79953760905 scopus 로고    scopus 로고
    • Declaration of Helsinki: ethical principles for research involving human subjects
    • World Medical Association, Accessed September 30, 2010
    • World Medical Association (2008) Declaration of Helsinki: ethical principles for research involving human subjects. http://www.wma.net/en/20activities/10ethics/10helsinki/index.html Accessed September 30, 2010.
    • (2008)
  • 2
    • 79953756276 scopus 로고    scopus 로고
    • International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, 1996. Accessed September 30, 2010
    • (1996) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Guideline for Good Clinical Practice. 1996. http://www.ich.org/cache/compo/276-254-1.html Accessed September 30, 2010.
    • (1996) Guideline for Good Clinical Practice
  • 3
    • 79953741964 scopus 로고
    • The WHO/CIOMS guidelines, proposed international guidelines for biomedical research involving human subjects
    • World Health Organization and CIOMS, Accessed September 30, 2010
    • World Health Organization and CIOMS (1981) The WHO/CIOMS guidelines, proposed international guidelines for biomedical research involving human subjects. http://www.tbethics.org/documents.htm Accessed September 30, 2010.
    • (1981)
  • 4
    • 79953751406 scopus 로고    scopus 로고
    • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Accessed September 30, 2010
    • (2010) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/index_en.htm Accessed September 30, 2010.
    • (2010)
  • 5
    • 33646827983 scopus 로고    scopus 로고
    • Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board approved informed permission and assent forms for 3 multicenter pediatric clinical trials
    • Kimberly MB, Hoehn KS, Feudtner C, Nelson RM, Schreiner M, (2006) Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board approved informed permission and assent forms for 3 multicenter pediatric clinical trials. Pediatrics 117: 1706-11.
    • (2006) Pediatrics , vol.117 , pp. 1706-1711
    • Kimberly, M.B.1    Hoehn, K.S.2    Feudtner, C.3    Nelson, R.M.4    Schreiner, M.5
  • 6
    • 2542643189 scopus 로고    scopus 로고
    • Institutional review board practices regarding assent in pediatric research
    • Whittle A, Shah S, Wilfond B, Gensler G, Wendler D, (2004) Institutional review board practices regarding assent in pediatric research. Pediatrics 113: 1747-52.
    • (2004) Pediatrics , vol.113 , pp. 1747-1752
    • Whittle, A.1    Shah, S.2    Wilfond, B.3    Gensler, G.4    Wendler, D.5
  • 7
    • 0018843826 scopus 로고
    • On the readability of surgical consent forms
    • Grundner TM, (1980) On the readability of surgical consent forms. N Engl J Med 302: 900-2.
    • (1980) N Engl J Med , vol.302 , pp. 900-902
    • Grundner, T.M.1
  • 8
    • 0018849820 scopus 로고
    • How readable are subject consent forms?
    • Morrow GR, (1980) How readable are subject consent forms? JAMA 244: 56-58.
    • (1980) JAMA , vol.244 , pp. 56-58
    • Morrow, G.R.1
  • 9
    • 0025157233 scopus 로고
    • Readability of pediatric biomedical research informed consent forms
    • Tarnowski KJ, Allen DM, Mayhall C, Kelly PA, (1990) Readability of pediatric biomedical research informed consent forms. Pediatrics 85: 58-62.
    • (1990) Pediatrics , vol.85 , pp. 58-62
    • Tarnowski, K.J.1    Allen, D.M.2    Mayhall, C.3    Kelly, P.A.4
  • 10
    • 0028893528 scopus 로고
    • Informed consent forms for clinical and research imaging procedures: how much do patients understand?
    • Hopper KD, TenHave TR, Hartzel J, (1995) Informed consent forms for clinical and research imaging procedures: how much do patients understand? AJR Am J Roentgenol 164: 493-96.
    • (1995) AJR Am J Roentgenol , vol.164 , pp. 493-496
    • Hopper, K.D.1    TenHave, T.R.2    Hartzel, J.3
  • 11
    • 0027943564 scopus 로고
    • Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?
    • Grossman SA, Piantadosi S, Covahey C, (1994) Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 12: 2211-15.
    • (1994) J Clin Oncol , vol.12 , pp. 2211-2215
    • Grossman, S.A.1    Piantadosi, S.2    Covahey, C.3
  • 12
    • 0029384956 scopus 로고
    • Informed consent for research: a study to evaluate readability and processability to effect change
    • Philipson SJ, Doyle MA, Gabram SG, Nightingale C, Philipson EH, (1995) Informed consent for research: a study to evaluate readability and processability to effect change. J Investig Med 43: 459-67.
    • (1995) J Investig Med , vol.43 , pp. 459-467
    • Philipson, S.J.1    Doyle, M.A.2    Gabram, S.G.3    Nightingale, C.4    Philipson, E.H.5
  • 13
    • 0029786155 scopus 로고    scopus 로고
    • Informed consent for medical research: common discrepancies and readability
    • White LJ, Jones JS, Felton CW, Pool LC, (1996) Informed consent for medical research: common discrepancies and readability. Acad Emerg Med 3: 745-50.
    • (1996) Acad Emerg Med , vol.3 , pp. 745-750
    • White, L.J.1    Jones, J.S.2    Felton, C.W.3    Pool, L.C.4
  • 14
    • 0030980456 scopus 로고    scopus 로고
    • Emergency medicine research consent form readability assessment
    • Mader TJ, Playe SJ, (1997) Emergency medicine research consent form readability assessment. Ann Emerg Med 29: 534-39.
    • (1997) Ann Emerg Med , vol.29 , pp. 534-539
    • Mader, T.J.1    Playe, S.J.2
  • 15
    • 10044248733 scopus 로고    scopus 로고
    • Consent documents for oncology trials: does anybody read these things?
    • Sharp SM, (2004) Consent documents for oncology trials: does anybody read these things? Am J Clin Oncol 27: 570-75.
    • (2004) Am J Clin Oncol , vol.27 , pp. 570-575
    • Sharp, S.M.1
  • 16
    • 12544253459 scopus 로고    scopus 로고
    • [Readability of informed consent forms for subjects participating in biomedical research: updating is required]
    • Paris A, Cracowski JL, Ravanel N, Cornu C, Gueyffier F, et al. (2005) [Readability of informed consent forms for subjects participating in biomedical research: updating is required]. Presse Med 34: 13-18.
    • (2005) Presse Med , vol.34 , pp. 13-18
    • Paris, A.1    Cracowski, J.L.2    Ravanel, N.3    Cornu, C.4    Gueyffier, F.5
  • 17
    • 33847381902 scopus 로고    scopus 로고
    • Consent form readability and educational levels of potential participants in mental health research
    • Christopher PP, Foti ME, Roy-Bujnowski K, Appelbaum PS, (2007) Consent form readability and educational levels of potential participants in mental health research. Psychiatr Serv 58: 227-32.
    • (2007) Psychiatr Serv , vol.58 , pp. 227-232
    • Christopher, P.P.1    Foti, M.E.2    Roy-Bujnowski, K.3    Appelbaum, P.S.4
  • 18
    • 0037456358 scopus 로고    scopus 로고
    • Readability standards for informed-consent forms as compared with actual readability
    • Paasche-Orlow MK, Taylor HA, Brancati FL, (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348: 721-26.
    • (2003) N Engl J Med , vol.348 , pp. 721-726
    • Paasche-Orlow, M.K.1    Taylor, H.A.2    Brancati, F.L.3
  • 20
    • 34547559188 scopus 로고    scopus 로고
    • Presenting research information to children: a tale of two methods
    • Tait AR, Voepel-Lewis T, Malviya S, (2007) Presenting research information to children: a tale of two methods. Anesth Analg 105: 358-64.
    • (2007) Anesth Analg , vol.105 , pp. 358-364
    • Tait, A.R.1    Voepel-Lewis, T.2    Malviya, S.3
  • 21
    • 77956416719 scopus 로고    scopus 로고
    • The readability of information and consent forms in clinical research in France
    • 5(5)
    • Ménoni V, Lucas N, Leforestier JF, Dimet J, Doz F, et al. (2010) The readability of information and consent forms in clinical research in France. PLoS One 11: 5(5).
    • (2010) PLoS One , vol.11
    • Ménoni, V.1    Lucas, N.2    Leforestier, J.F.3    Dimet, J.4    Doz, F.5
  • 22
    • 0344229953 scopus 로고
    • A new readability yardstick
    • Flesch R, (1948) A new readability yardstick. J Appl Psychol 32: 221-33.
    • (1948) J Appl Psychol , vol.32 , pp. 221-233
    • Flesch, R.1
  • 24
    • 77956644767 scopus 로고    scopus 로고
    • The contents and readability of informed consent Forms for oncology clinical trials
    • Cheung WY, Pond GR, Heslegrave RJ, Enright K, Potanina L, et al. (2010) The contents and readability of informed consent Forms for oncology clinical trials. Am J Clin Oncol 33: 387-92.
    • (2010) Am J Clin Oncol , vol.33 , pp. 387-392
    • Cheung, W.Y.1    Pond, G.R.2    Heslegrave, R.J.3    Enright, K.4    Potanina, L.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.