Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees \u2013 results from a descriptive questionnaire-based study

Malak Moubarak,David Atallah,Sara Abboud,Nadine El Kassis

doi:10.1186/s13063-017-2397-2

Malak Moubarak, David Atallah + Show 2 more

Open Access

https://doi.org/10.1186/s13063-017-2397-2

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Abstract

BackgroundClinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in ‘Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants’ in Lebanon?’MethodsThis was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation.ResultsTen RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards.ConclusionInadequate training of REC members and the lack of anti-bribery policies should be resolved to improve their performance.

Highlights

Clinical trials conducted in Lebanon are increasing
New ethical standards for performing such studies have been released by international organisations such as the ‘Ethics of Research Related to Healthcare in Developing Countries’ by the Nuffield Council on Bioethics in 2002 [4]; the ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ by the Council for International Organisations of Medical Sciences (CIOMS) in 2002 in collaboration with the World Health Organisation (WHO) [5]; and the latest amendment of the Declaration of Helsinki by the World Medical Association (WMA) during its 64th general assembly in 2013 [6]
Research question and study objectives The research question was: ‘Are Research Ethics Committee (REC) adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in ‘Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants’ [14] in Lebanon?’ the study objectives were to describe the qualifications and education of the members of these RECs; to describe policies in place to address the education of REC members, and to describe the adherence of these RECs to World Health Organisation (WHO) ‘Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants’

Summary

Introduction

Clinical trials conducted in Lebanon are increasing. little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. Despite the availability of ethical guidelines, study investigators working in the developing world including the Middle East region, are confronted with issues and doubts concerning the ethical validity of clinical research and the capacity of research ethics [4, 7] In this context and on a global scale, Miller reported in his case analysis of 2002 that the ethical conduct of clinical trials sponsored by the pharmaceutical companies is raising few concerns. Such concerns are focussed on the scientific quality of these trials and the extent to which the trials’ participants are adequately protected. Other factors include ‘preferential funding by industry of projects that are likely to succeed’ [9]

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