Central Ethics Committee

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

Department of Health (UK). Governance Arrangements for NHS Research Ethics Committee. London Central Office for Research Ethics Committees (COREQ, 2001. 

All CTs (phase IV ones included) need ethical approval by independent central or regional ethics committees, as specified by a Decree of the Minister of Health in 1987, to be issued in an amended form in 1999. Phase I-III trials also need authorization by the competent medicine regulatory authority (the NIP or the Executive Office of the National Chief Medical Officer). The documentation needed for authorization does not differ from that in the EU. In short, it consists of the following (if not specified, it may be in English German may also be accepted) ... 

In most cases, the competent ethics committee for clinical tried approved is a central one. Until the new Decree of the Minister of Hecdth on clinical trials is issued, regional ethics committees are responsible for certain humcin phase III trials. This situation may be changed by the Decree. Updated NIP guidelines or information clarifying the recent situation are always available in English. 

Prior to selection of a clinical study site, the sponsor/CRO must confirm and document, in the prestudy assessment visit report, that the investigator has access to a local ethics committee/ IRB. Local committees cannot be bypassed the only official exception to this requirement is in France, where, by regulation, a central committee may rule for all sites in a multicentre study. However, in the USA, it appears to be common practice for a central IRB to rule for the widely geographically separated areas in the country, and researchers may not inform the local IRB. 

Some research based on observation, collating information from notes and tests already performed for therapeutic purposes, may be permissible without consent because it does not involve direct contact with the child. Researchers must be careful in this matter and consult the Central Office for Research Ethics Committees (COREC) to ascertain this requirement. Non-therapeutic research can be validly consented only when the research can be reasonably said not to go against the child s interests. Even though it is not legally required, research should seek assent from school-age children and should always ensure that the child does not object. 

COREC (Central Office for Research Ethics Committees) (2006). Guidelines for researches patient information sheet and consent form. http //www.corec. org.uk (accessed 13 August 2006). 

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