Abstract
Waiver of Consent for Low-Risk Studies
Highlights
The first concerns the observational nature of research [2,3]
Authors define the study as ‘time sensitive’ and explain that the study cannot be performed if prior consent is not waived
No legislation contains provisions permitting waiver of prior consent due to the urgency to start research. Solving this issue is possible in Canada by using Tri-Council Policy statement (TCPS)-2, article 37.7 (c), when “...it is impossible or impracticable to carry out the research ...”
Summary
The first concerns the observational nature of research [2,3]. Observational studies are usually designed using ‘noninterventional’ methods, meaning that the research adds no extra intervention to the usual care of the patients/participants. An emergency situation is another common reason for permitting the waiver of consent [4,5]. Authors define the study as ‘time sensitive’ and explain that the study cannot be performed if prior consent is not waived.
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