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Our aim is to correlate the IL-10 serum and BAL levels in critically ill patients with confirmed bronchopneumonia associated with candidiasis or bacterial sepsis and to research whether these levels consent to prove the fungal origin of severe pneumonia associated with severe sepsis.
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Frankly it's a very risky PR strategy at a time when it really has become impossible for Facebook to deny quite how comfortable the company was, up until mid 2015, to hand over reams of personal information on Facebookers to third party users of its developer platform — without requiring these external entities gain individual level consent (friends could 'consent' for all their friends!).
Facebook denies the Cambridge Analytica instance is a data breach — because, well, its systems were so laxly designed as to actively encourage vast amounts of data to be sucked out, via API, without the check and balance of those third parties having to gain individual level consent.
The need for patient-level consent was waived by the Research Ethics Board.
Practice level consent was gained from a lead GP and the practice manager (or equivalent) at each practice.
Cluster-level consent has been obtained through a consultation process involving relevant provincial, county, township, and village authorities.
Community-level consent was widely accepted as either a prerequisite to, a supplement to, or a substitute for individual informed consent in this setting.
We sought cluster-level consent from village leaders and village health, sanitation and nutrition committee members after explaining the study aims, intervention and data collection procedures.
Central to solutions to current ethical concerns entail moving beyond concern with individual level consent and embracing a robust interaction with communities engaged in research.
Practice level consent was obtained to approach individuals, and all staff employed or attached to the practice were invited to participate in the study.
Approval to conduct the study was obtained from the medical ethics committees of the three centers of the Academic Medical Center in The Netherlands, which waived the requirement for individual patient-level consent.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com