Role of research ethics committee in follow-up and publication of results

Clinical Pharmacology Unit, Hospital Clínic, Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
The Lancet (Impact Factor: 45.22). 04/2003; 361(9362):1015-6. DOI: 10.1016/S0140-6736(03)12799-7
Source: PubMed


Follow-up of clinical trials is a commitment rarely fulfilled by research ethics committees (RECs). We assessed the output of clinical trials submitted in 1997 to our REC, and talked to principal investigators, sponsors, contract research organisations, or a combination of these. During 1997, our REC reviewed 166 clinical trials, and approved 158. The recruitment rate was lower than expected in 45% (64/143) of all initiated clinical trials; 64% (92/143) were finished in accordance with protocol. 3 years after, the results of only 21% (26/123) of finished clinical trials were published in peer-reviewed journals, rising to 31% (38/123) if in-press articles were included. RECs should devote more effort and resources to assess public dissemination of results of clinical trials.

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    • "The four articles previously published collected information on only one or two ethics committees[1-4]. These studies did not describe the general situation at a country level and they provided information only when the investigator was not lost for follow-up. "
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Respect for human dignity and equality of moral status of all individuals, social justice, solidarity and democratic participation may thereby be appealing reflections of European values and useful complements to the four conventional bioethical principles (autonomy, beneficence, non-maleficence, and justice) that are widely applied for evaluating policies, programs or activities that may entail risk to human health. To achieve more consistency in the research conditions nationally and internationally an ethics committee at the level of the ‘European research area' could be envisaged, mainly focusing on transnational research. Moreover, the analysis and evaluation of different cases in different situations would build-up an extensive knowledge and experience that may serve as an inspiring starting point for a well informed societal debate. This way, gradually, more consistency in the handling of study proposals and increased transparency in decision making might be reached, lifting the daily practices and the protection of both individual and community interest to a higher level of meeting up with ethical concerns in transnational research. Researchers have the duty to support the translation of research results in preventive actions at individual and at collective level whenever relevant. Participatory processes will facilitate the inclusion of arguments from the societal perspective and increase trust and mutual understanding between all parties involved, add to the legitimacy of the final outcome and the public support for the policy decision-making process, and implement democracy. This report has been prepared as part of ECNIS Workpackage 12: Socio-ethical impact of biomarker use.
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    Full-text · Article · May 2003 · The Lancet
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