Table 2

Evaluation of criteria for research without prior consent and their applicability to the Vermont Oxford Network Heat Loss Prevention (HeLP) Trial

Criteria	Applicability to HeLP Trial
A serious threat to the prospective participant requires immediate intervention	Premature delivery—women present emergently Hypothermia is an independent risk factor for mortality in premature infants.9–12 14–17 Hypothermia remains exceedingly prevalent.9
No standard efficacious care exists or research offers a real possibility of direct benefit	Three RCTs and five historical controlled trials (HCTs) show differences for admission temperatures between wrapped and unwrapped infants.18–20 23 24 Clinical equipoise remains.25 26
Risk of harm is not greater than that involved in standard efficacious care	No evidence of harm based on clinical trials and routine use in some NICUs.27
The prospective participant is unconscious or lacks the capacity to understand the research	Not applicable (infant is not yet born).
Third party consent cannot be secured	Insufficient time if emergent delivery. Consent is not unfettered from duress (and therefore not truly ‘consensual’).
No relevant prior directive by the participant is known to exist	Not applicable (infant not yet born).