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Editor: In the design of the CRASH study, Roberts et al seem to be
ignoring one of the basic tenets of clinical research, namely informed
consent by the subject.
Patients suffering from "severe head injury" cannot give informed consent.
In the UK, at least, no other person can give legal consent on their
behalf. The uncertainty principle they mention may indeed allow a doctor
to give treatment to a patient, as the patient may benfit from this
treatment. The patient cannot benefit from being entered into a trial,
however, so the uncertainty principle cannot apply. In short it may be
acceptable to give steroids, but it cannot be acceptable to enter the
patient into a trial. I recognise the problems this presents in ICU and
A&E research, but until the problems of lack of consent have been
fully discussed, this study seems unethical. The advice I was given by the
MDU was not to take part.
Would the BMJ, for instance, consider publishing a trial in which no
patient had given informed consent in advance?
Consent for CRASH study
Editor: In the design of the CRASH study, Roberts et al seem to be
ignoring one of the basic tenets of clinical research, namely informed
consent by the subject.
Patients suffering from "severe head injury" cannot give informed consent.
In the UK, at least, no other person can give legal consent on their
behalf. The uncertainty principle they mention may indeed allow a doctor
to give treatment to a patient, as the patient may benfit from this
treatment. The patient cannot benefit from being entered into a trial,
however, so the uncertainty principle cannot apply. In short it may be
acceptable to give steroids, but it cannot be acceptable to enter the
patient into a trial. I recognise the problems this presents in ICU and
A&E research, but until the problems of lack of consent have been
fully discussed, this study seems unethical. The advice I was given by the
MDU was not to take part.
Would the BMJ, for instance, consider publishing a trial in which no
patient had given informed consent in advance?
Competing interests: No competing interests