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Approval by an ethics committee
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After the construction of the protocol, it is important to consider its approval by an ethics committee. Ethics committees are independent and multidisciplinary bodies that issue opinions on study protocols.
A favourable opinion from an ethics committee is designed to: > Ensure the collection of quality data by assessing the relevance and scientific integrity of the protocol; > Verify the ethical aspects of the study including the respect of the rights of the study participants. This approval is required when considering publishing the results of the study. The idea behind ethics committees and the establishment of these bodies are derived from an international framework based inter alia on the Helsinki Declaration16 which states that the “interests of science and society should never take precedence over the wellbeing of the subject” and which is developed by each government within its own legislative framework. The ethical principles protected by the committees are essentially:
> I nformed consent of participants; >T aking into account the strengthening of protection of vulnerable persons (children, people with a mental handicap etc.); >E valuation in terms of risks/benefits to participants; >T he relevance of the study and the scientific quality of its results; >D isclosure of any conflicts of interest. From a practical standpoint, this is an issue of finding out about the existence of an ethics committee in the country where the study is conducted and how it operates. Indeed, even if the principle of the ethics committee is internationally accepted, the ways these are organised and the terminology used differs from country to country. Currently, most governments have established ethics committees. However, in the absence of such a body, it is necessary
1E to resort to the committee present in the country where the organisation it headquarted, in this case, France. For example, concerning the type of studies described in this document, it is necessary, in France, to follow out the following steps: > Prepare a file with the CCTIRS (Advisory Committee on Information Processing for Research in the Field of Health), which gives an opinion on the research methodology, the need for the use of nominative data and the relevance of nominative data in relation to the research objective. > Request the agreement of the CNIL (French Data Protection Authority) whose primary mandate is to protect privacy and individual liberties.
The steps for submitting a study protocol and the deadline for obtaining a favourable opinion represent a long and time-consuming process that must be critically factored in as part of the planning for the study. It is advised at this point to seek the support of an expert who understands the process at the intervention country level.
Type of plan for a survey protocol No matter the type of study, a survey protocol should include the following: 1. Background and justification for the study 2. Definition of the objectives/hypotheses 3. Methodology: – Definition of the study population – Method of sample selection – Analysis plan and analysis software 4. Major topics to be addressed in the questionnaire 5. Ethical Issues 6. Dissemination of results 7. Schedule 8. Budget An example of a KAP survey protocol is appended.
16. T he Helsinki Declaration (1964)[8] is an official document of the World Medical Association that is internationally recognised and which contains the fundamental ethical principles for research in the field of health. [8]. Refer to page 72
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