Terms and Definitions

Terms and Definitions


THE DEFINITIONS BELOW ARE EXTRACTED FROM RESOLUTION 466/2012 OF THE NATIONAL HEALTH COUNCIL.

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II.4 - research benefits – direct or indirect, immediate or subsequent benefit, earned by the participant and/or their community, as a result of their participation in the research.

II.8 - research proposing institution – organization, public or private, legitimately constituted and qualified, to which the responsible researcher is linked.

II.9 - co-participating research institution – organization, public or private, legitimately constituted and qualified, in which any of the phases or stages of the research is developed.

II.10 - research participant – individual who, in an informed and voluntary manner, or under the clarification and authorization of their legal guardian(s), agrees to be researched. Participation must be free of charge, except for Phase I or bioequivalence clinical trials.

II.11 - sponsor – an individual or legal entity, public or private, that supports the research, through funding, infrastructure, human resources or institutional support.

II.15 - researcher – member of the research team, co-responsible for the integrity and well-being of the research participants.

II.16 - Responsible researcher – person responsible for coordinating the research and co-responsible for the integrity and well-being of the research participants.

II.19 - final report – is the one presented after the end of the survey, totaling its results.

II.20 - partial report – is the one presented during the research, demonstrating relevant facts and partial results of its development.

II.22 - research risk – possibility of damage to the physical, psychic, moral, intellectual, social, cultural or spiritual dimension of the human being, in any research and arising from it.

II.23 - Term of Free and Informed Consent (TCLE) - document in which the free and informed consent of the participant and/or their legal guardian is made explicit, in writing, containing all necessary information, in clear and objective language, of easy to understand, for the most complete clarification of the research in which you intend to participate.

 

Please note: Updates to these and other definitions can be found in the support center, in the upper right corner of the Plataforma Brasil page. If you have any questions, just access the online help or contact the ZIP CODE-Bahiana.