[Unnecessary delays in ethical approval of multicentre clinical trials].
Medical ethical committees and institutional review boards serve to protect patients and healthy volunteers participating in research projects. Among clinical researchers there exists a general feeling that, although the importance of protecting research subjects is acknowledged, obtaining approval for a research protocol takes too much time, especially in the case ofmulticentre clinical trials. The Dutch Ministry of Health, Welfare and Sport and the Central Committee on Research involving Human Subjects (CCMO) have tried to streamline and shorten the approval process, but so far these efforts have failed. The failure can be attributed not only to the ethical committees but also to the investigators and hospital management. It is argued that lack of knowledge of the application rules and failure by all parties to observe the appropriate procedures are the major causes of delay. If all involved would adhere strictly to the rules and regulations that are already in place, unnecessary delays would be avoided and research applications would obtain approval within 60 days of submission, even in the case ofmulticentre trials.
Academisch Ziekenhuis Maastricht, afd. Gynaecologie en Verloskunde, Postbus 5800, 6202 AZ Maastricht. tsa@sgyn.azm.nl
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D028744:Ethics Committees, Research / Q000592:standards*; D032984:Ethics, Research; D006801:Humans; D015337:Multicenter Studies as Topic; D009426:Netherlands; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors
Onnodig traag verlopende medisch-ethische toestemming voor multicentrische klinische trials.