From: Impact of funding on biomedical research: a retrospective cohort study
Legal definitions | |
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Huriet-Serusclat Act | French law [16] passed in 1988 and modified in 2004, providing a framework for biomedical research protocols involving human beings. This law set up a national system of research ethics committees. Every protocol involving humans in France must be approved by one of the French research ethics committees. |
Intervention requiring ethics committee approval | according to the French law [16] and to the International Committee for Harmonization- Good Clinical Practices guidelines [17], each intervention made on a human subject requires prior approval of a research ethics committee. This approval is based on the evaluation of protocols, data forms, informed consent and administrative requirements. |
Methodological definitions | |
Study design | Clinical •Descriptive: description of a cohort or a case series with no intervention •Experimental: with an intervention on humans and with a control group •Analytical: a hypothesis is tested on a cohort or in a case-control study Not clinical: protocol for which the subject of research is not a human being (such as protocol on tumour characterisation, protocols on molecules, proteins, etc.). |
Study initiation and completion | Investigators were asked to classify their study as initiated/not initiated and as completed/not completed and the reason for non-completion (on-going/stopped) |
Rating of study results | Investigators were asked to rate the importance of their study results from 1 to 10, 1 being "not important", 10 being "very important". |
Scientific publication | Investigators had to declare if study results were published or not published as a scientific paper |
Oral presentation | Investigators had to declare if study results were presented orally or not (with no details on peer-review, or scope of the meeting: regional, national or international) |
Grey literature | Literature not generally accessible through libraries (internal reports, thesis, abstracts, posters) |