Multicentre research ethics committees: have they helped?
نویسندگان
چکیده
منابع مشابه
Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?
OBJECTIVES To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004. DESIGN AND SETTING Prospective study of applications of MCT submitted to RECs. MAIN MEASUREMENTS Protocol related features and evaluat...
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In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths...
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UNLABELLED The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials. DISCUSSION The Finnish law makes an arbitrary distinction between medical research and other health research, and the European Union's directive for good clinical trials further differentiates drug ...
متن کاملResponses of local research ethics committees to a study with approval from a multicentre research ethics committee.
itself. The multicentre research ethics committee system was set up to deal with such procedural difficulties. Improvements in the system have occurred. However, local research ethics committees have been reluctant to abandon their autonomy sufficiently to allow efficient functioning of this system, and this has been identified as a potential reason for continuing concerns about the new system....
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Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 ("the Regulations"). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qual...
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ژورنال
عنوان ژورنال: Journal of the Royal Society of Medicine
سال: 1999
ISSN: 0141-0768,1758-1095
DOI: 10.1177/014107689909201002