|
• We strongly encourage active epidemiological, translational,
and clinical research during the pandemic.
• It is strongly recommended that all Canadian adult
and pediatric ICU’s participate in a national epidemiological
study.
• Institutional review boards (IRBs) must appreciate
the urgency and importance of gaining knowledge that can
be rapidly translated into improving practice during a pandemic.
IRBs should consider protocols submitted under pandemic
conditions for expedited review. In addition IRB’s
must consider alternatives to full board reviews. For example,
expedited review or full board review by the REB of the
Principal Investigator’s institution with expedited
review at other participating centres
Consent
The urgency placed during a pandemic for rapid acquisition
of information and ability to determine optimal care for
patients requires participation of large numbers of patients
in a short time frame. We feel that this urgency meets the
spirit and requirements as outlined in the tri-council policy
for waived consent.
Alternative consent models that could be invoked included
deferred consent (deferred to patient / deferred to surrogate
decision maker) or 2 physician consent. Hybrid consent models
could be proposed, for example waived or deferred consent
in the absence of an SDM or a request from the SDM as to
whether the patient would ‘object to participating’
in the presence of an SDM. Consent models could be tailored
to the level of risk incurred by participation (low, moderate,
high).
|