Research ethics committee audit: differences between committees.
نویسندگان
چکیده
منابع مشابه
Research ethics committee audit: differences between committees.
The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated he...
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OBJECTIVES To show that a Local Research Ethics Committee (LREC) can carry out an audit of ethical standards in research. To find out if a researcher met certain ethical standards in recruiting subjects for clinical trials and in obtaining their consent. DESIGN Postal questionnaire. SETTING Clinical research by one doctor during one year. SUBJECTS Eleven patients entered in clinical trial...
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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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ژورنال
عنوان ژورنال: Journal of Medical Ethics
سال: 1996
ISSN: 0306-6800
DOI: 10.1136/jme.22.2.78