Ethical aspects
In order to recruit a representative population, HEATPPCI
sought to include ‘every patient, every time’.
STEMI is a life-threatening and time-critical event.
Delays in treatment can result in worse outcomes for
patients. As predicted, patients arrived feeling anxious,
unwell and in pain—often feeling the sedative effects of
opiate analgesia. The research team took the view that
any form of meaningful informed consent in this
situation would not be possible. Furthermore, it was felt
unethical to delay treatment and unfair to burden a
patient with a decision concerning clinical research at
this time. The team was successful in gaining full
ethical approval to adopt a strategy of delayed consent.
Patients received no information about the study while
in the throes of their myocardial infarction (MI).
Instead, patients were approached, usually by the
research nurses, at an appropriate time in their recovery.
The fact that they had been randomly allocated to
receive one of two routine treatments was carefully
explained to them. Patients were asked to consent to the
inclusion of their data in the study and to agree to
provide follow-up 28 days later.
Sadly, but not unexpectedly, a number of patients did
not survive their MI. Inclusion of these patients’ data
would be essential to gain maximum understanding