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.
"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. "
[Show abstract][Hide abstract] ABSTRACT: Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis.
Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives.
Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise.
The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.
BMC Medical Ethics 11/2005; 6(1):E9. DOI:10.1186/1472-6939-6-9 · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Human biomarker studies in environmental health are essential tools to study the relationship between health and environment. The development of relevant research potential and the setup of bio-monitoring surveys should ultimately lead to a better understanding and prevention of environmentally induced adverse health effects. In this volume we review ethics and data protection in environmental health studies using human biomarkers. The question is raised whether study participants are adequately and equally protected throughout Europe and whether at the same time progress in environmental health related studies is safeguarded. The collection of human samples and data is subject to regulations and rules of different kinds, from deontological codes to data protection laws, from the local to the international level. Within an EU context, the probably most important international references in this respect are the Data Protection Directive (95/46/EC), the Oviedo Convention, more in particular its Additional Protocol concerning biomedical research and Rec(2006)4 on research on biological material of human origin. A critical analysis of research experiences in various EU countries shows that difficulties, ambiguities or even inconsistencies exist in the way ethical and juridical challenges are framed and being dealt with within and across countries. The diverse implementations of EU regulations or international guidelines in domestic law may in particular hinder transnational research and bring about inequalities in the level of protection. Overall, in research on biological material of human origin emphasis is primarily on decisional autonomy and protection of the individual's rights whilst the collective need to protect health as a public asset is relatively less valued. This is particularly striking when personal data or samples collected for a specific research purpose could be of value in a new study. This secondary use often remains very complex or almost impossible, although there are strong and recognized arguments for facilitation of such further use in the context of environmental health research where public interest comes to the forefront and risks are minimal, on the condition that adequate collective protection and control against improper use of samples or data can be installed, and breach of confidentiality or any use of data which would be not in line with the subject's moral stakes can be excluded. An increasing demand exists for adapted communication strategies at all stages of a study, not only at the individual level, but also at the collective level, and including the time of translation of results in preventive actions and policy making. The vital role of communication is obvious. Each communicative act may affect trust in the study at hand and in science in general. Expertise in the field of social sciences is therefore demanded. Even though many improvements regarding the legal and ethical challenges in human studies have already been implemented in the EU in the last years, these issues are not well known among the actors involved and efforts should be devoted to better education and dissemination of information and enhanced transparency targeting researchers but also the general public, the media and the policymakers. Research ethics committees play a pivotal role in assessing to what extent decision making processes fit with both individual and societal interest. 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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