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Table 1 Definitions

From: Impact of funding on biomedical research: a retrospective cohort study

Legal definitions

 

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)