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Volumn 33, Issue 2, 2007, Pages 113-118

Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; ETHICS; GERMANY; HUMAN; MULTICENTER STUDY; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS; REVIEW; SUTURE;

EID: 33847004778     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2005.014605     Document Type: Review
Times cited : (8)

References (10)
  • 1
    • 16844362484 scopus 로고    scopus 로고
    • The Study Centre of the German Surgical Society - Rationale and current status
    • Knoebel HP, Diener MK, Wente MN, et al. The Study Centre of the German Surgical Society - rationale and current status. Langenbecks Arch surg 2005;390:171-7.
    • (2005) Langenbecks Arch Surg , vol.390 , pp. 171-177
    • Knoebel, H.P.1    Diener, M.K.2    Wente, M.N.3
  • 2
    • 18044389501 scopus 로고    scopus 로고
    • Interrupted or continuous slowly absorbable sutures - Design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial
    • [ISRCTN24023541]
    • Knaebel HP, Koch M, Souerland S, et al. Interrupted or continuous slowly absorbable sutures - design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial [ISRCTN24023541]. BMC Surg 2005;5:3.
    • (2005) BMC Surg , vol.5 , pp. 3
    • Knaebel, H.P.1    Koch, M.2    Souerland, S.3
  • 3
    • 0036835815 scopus 로고    scopus 로고
    • Meta-analysis of techniques for closure of midline abdominal incisions
    • van't Riet M, Steyerberg EW, Nellensteyn J, et al. Meta-analysis of techniques for closure of midline abdominal incisions. Br J Surg 2002;89:1350-6.
    • (2002) Br J Surg , vol.89 , pp. 1350-1356
    • van't Riet, M.1    Steyerberg, E.W.2    Nellensteyn, J.3
  • 4
    • 23844449061 scopus 로고    scopus 로고
    • Die 12. Novelle des Arzneimittelgesetzes in Deutschland Chancen und Hindernisse für Investigator-initiierte Studien
    • Dreier G, Marx C, Schmoor C, et al. Die 12. Novelle des Arzneimittelgesetzes in Deutschland Chancen und Hindernisse für Investigator-initiierte Studien. Bundesgesundheits Gesundheitsforsch Gesundheitsschutz 2005;48:445-52.
    • (2005) Bundesgesundheits Gesundheitsforsch Gesundheitsschutz , vol.48 , pp. 445-452
    • Dreier, G.1    Marx, C.2    Schmoor, C.3
  • 5
    • 33846977561 scopus 로고    scopus 로고
    • Zwölftes Gesetz zur Änderung des Arzneimittelgesetzes Vom 30. Juli 2004
    • Anon. ausgegeben zu Bonn am 5.Aug, 2004
    • Anon. Zwölftes Gesetz zur Änderung des Arzneimittelgesetzes Vom 30. Juli 2004. Bundesgesetz, 2004;1(41), ausgegeben zu Bonn am 5.Aug, 2004.
    • (2004) Bundesgesetz , vol.1 , Issue.41
  • 6
    • 20444433598 scopus 로고    scopus 로고
    • Multicentre trials review process by research ethics committees in Spain: Where do they stand before implementing the new European regulation?
    • Dal-Re R, Ortega R, Morejon E. Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation? J Med Ethics 2005;31:344-50.
    • (2005) J Med Ethics , vol.31 , pp. 344-350
    • Dal-Re, R.1    Ortega, R.2    Morejon, E.3
  • 7
    • 0034728858 scopus 로고    scopus 로고
    • The new system of review by multicentre research ethics committees: Prospective study
    • Tully J, Ninis N, Booy R, et al. The new system of review by multicentre research ethics committees: prospective study. BMJ 2000;320:1179-82.
    • (2000) BMJ , vol.320 , pp. 1179-1182
    • Tully, J.1    Ninis, N.2    Booy, R.3
  • 8
    • 0036792615 scopus 로고    scopus 로고
    • New governance arrangements for research ethics committees: Is facilitating research achieved at the cost of participants' interest
    • [review]
    • Cave E, Holm S. New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest [review]. J Med Ethics 2002;28:318-21.
    • (2002) J Med Ethics , vol.28 , pp. 318-321
    • Cave, E.1    Holm, S.2
  • 9
    • 24944572293 scopus 로고    scopus 로고
    • Reforming research ethics committees. Latest proposals are a missed opportunity for a radical review
    • Ashcroft RE, Newson AJ, Benn PMW. Reforming research ethics committees. Latest proposals are a missed opportunity for a radical review. BMJ 2005;331:587-8.
    • (2005) BMJ , vol.331 , pp. 587-588
    • Ashcroft, R.E.1    Newson, A.J.2    Benn, P.M.W.3
  • 10
    • 4043064261 scopus 로고    scopus 로고
    • Bureaucracy of ethics application
    • Wald DS. Bureaucracy of ethics application. BMJ 2004;329:282-5.
    • (2004) BMJ , vol.329 , pp. 282-285
    • Wald, D.S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.