Abstract
BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.
Highlights
Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.capacity for ethics review is not universal
This study aimed to examine current practices and views of Ethical Review Committees (ERC) and Ethics Committees (EC) members on the issue of informed consent in the local context and in comparison to international requirement
Participants Twenty-nine participated in the study, exceeding the sample size of 20 decided as sufficient during the consensus meetings. They were drawn from approximately 60 members of five ERCs and one EC that functioned in Sri Lanka at the time of the study
Summary
Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.capacity for ethics review is not universal. Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. There were ERCs in 5 out of 7 medical schools in Sri Lanka at the time of conducting this research [1]. There were three ERCs and two ECs in professional associations and research institutions. Medical faculties at Colombo and Peradeniya universities were the first institutions to establish formal ERCs in late 1970's [1]. Review and approval by an ERC is mandatory for research [4]. Reputable academic institutions in the developed world insist ethical approval from both sponsoring and host countries for collaborative research [5,6]. Ethics review capacity is not universally the same. Even if it is, demanding universal standards have met with opposing arguments especially in the standard of care issue [5]
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