Table 2

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

CriteriaApplicability 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).