Research in pre-hospital emergency care: is the need for informed consent a barrier?
Dear Sir - John Nicholl recently described problems in obtaining
ethical approval for trials. [1] We have experienced worrying
inconsistencies in the decisions of ethics committees concerning the issue
of informed consent.
Currently in the Welsh Ambulance Service, treatment protocols vary
according to geographical area. Two dosing regimens exist for the
intravenous analgesic nalbuphine and we have therefore developed a
randomised controlled trial to compare their effectiveness in patients who
would usually receive such therapy. Routinely collected data will be
analysed to determine efficacy and the incidence of side effects. The only
difference to routine treatment would be the randomised selection of the
dosing regimen, rather than this being determined by the geographical
location of the patient.
In our applications to Local Research Ethics Committees we identified that
obtaining informed consent from subjects recruited to this study would be
difficult, and may be inadvisable in that the explanation of an RCT cannot
but imply doubt. [2] The presence of pain suggests that truly informed
consent may not be obtainable. [3] Furthermore, explaining the trial and
obtaining consent would delay the administration of an analgesic.
The first LREC that received our submission agreed that obtaining informed
consent would be unethical in the circumstances we described.
Unfortunately they consequently ruled that we could not undertake the
trial as obtaining informed consent should be an essential requirement. We
find this judgement extraordinary: if we do not conduct this study we will
be unable to make a rationale choice about which of these standard
regimens to select. Sometimes it is unethical not to conduct trials. [4]
It was suggested that, instead of an RCT, we conduct independent audits in
the areas where each regimen is utilised. But such a design is flawed and
does not represent best research practice. [5] Patients are likely to have
different characteristics in the two areas, and more subjects would be
required to achieve sufficient power to detect differences in efficacy.
Conducting poorly
designed research is itself unethical, as is recruiting more subjects than
are necessary.
An alternative would be to select a dosing regimen on an anecdotal or
arbitrary basis, but such an approach would be totally inconsistent with
the principles of evidence-based health care.
A second LREC was supportive of our study and of our view that informed
consent was not appropriate, but felt the need to obtain a legal opinion
prior to reaching a decision. A third has granted approval and has agreed
that no form of consent (other than that required for treatment) is
necessary.
This confusion does not bode well for the future of research in emergency
pre-hospital care. One can envisage many such
situations where obtaining informed consent is inappropriate. Discussion
is required to ensure that, as far as possible, good quality and highly
desirable research is not blocked in this important area of health care.
Malcolm Woollard
Executive Officer
Pre-hospital Emergency Research Unit,
Lansdowne Hospital,
Sanatorium Road,
Cardiff
CF1 8UL
Peter Elwood
Honorary Professor
University of Wales College of Medicine,
Llandough Hospital,
Penarth
CF37 2XW
Douglas Chamberlain
Honorary Professor, University of Wales College of Medicine
Pre-hospital Emergency Research Unit,
Lansdowne Hospital,
Sanatorium Road,
Cardiff
CF1 8UL
References
[1] Nicholl, J. The ethics of research ethics committees. BMJ
2000;320:1217.
[2] Tobias, J.S. BMJ's present policy (sometimes approving research
in which patients have not given fully informed consent) is wholly
correct. BMJ 1997;314:1111.
[3] Kestin, I.G. "Technical" consent is inevitable in some
circumstances. BMJ 1998;317:947.
Rapid Response:
Research in pre-hospital emergency care: is the need for informed consent a barrier?
Dear Sir - John Nicholl recently described problems in obtaining
ethical approval for trials. [1] We have experienced worrying
inconsistencies in the decisions of ethics committees concerning the issue
of informed consent.
Currently in the Welsh Ambulance Service, treatment protocols vary
according to geographical area. Two dosing regimens exist for the
intravenous analgesic nalbuphine and we have therefore developed a
randomised controlled trial to compare their effectiveness in patients who
would usually receive such therapy. Routinely collected data will be
analysed to determine efficacy and the incidence of side effects. The only
difference to routine treatment would be the randomised selection of the
dosing regimen, rather than this being determined by the geographical
location of the patient.
In our applications to Local Research Ethics Committees we identified that
obtaining informed consent from subjects recruited to this study would be
difficult, and may be inadvisable in that the explanation of an RCT cannot
but imply doubt. [2] The presence of pain suggests that truly informed
consent may not be obtainable. [3] Furthermore, explaining the trial and
obtaining consent would delay the administration of an analgesic.
The first LREC that received our submission agreed that obtaining informed
consent would be unethical in the circumstances we described.
Unfortunately they consequently ruled that we could not undertake the
trial as obtaining informed consent should be an essential requirement. We
find this judgement extraordinary: if we do not conduct this study we will
be unable to make a rationale choice about which of these standard
regimens to select. Sometimes it is unethical not to conduct trials. [4]
It was suggested that, instead of an RCT, we conduct independent audits in
the areas where each regimen is utilised. But such a design is flawed and
does not represent best research practice. [5] Patients are likely to have
different characteristics in the two areas, and more subjects would be
required to achieve sufficient power to detect differences in efficacy.
Conducting poorly
designed research is itself unethical, as is recruiting more subjects than
are necessary.
An alternative would be to select a dosing regimen on an anecdotal or
arbitrary basis, but such an approach would be totally inconsistent with
the principles of evidence-based health care.
A second LREC was supportive of our study and of our view that informed
consent was not appropriate, but felt the need to obtain a legal opinion
prior to reaching a decision. A third has granted approval and has agreed
that no form of consent (other than that required for treatment) is
necessary.
This confusion does not bode well for the future of research in emergency
pre-hospital care. One can envisage many such
situations where obtaining informed consent is inappropriate. Discussion
is required to ensure that, as far as possible, good quality and highly
desirable research is not blocked in this important area of health care.
Malcolm Woollard
Executive Officer
Pre-hospital Emergency Research Unit,
Lansdowne Hospital,
Sanatorium Road,
Cardiff
CF1 8UL
Peter Elwood
Honorary Professor
University of Wales College of Medicine,
Llandough Hospital,
Penarth
CF37 2XW
Douglas Chamberlain
Honorary Professor, University of Wales College of Medicine
Pre-hospital Emergency Research Unit,
Lansdowne Hospital,
Sanatorium Road,
Cardiff
CF1 8UL
References
[1] Nicholl, J. The ethics of research ethics committees. BMJ
2000;320:1217.
[2] Tobias, J.S. BMJ's present policy (sometimes approving research
in which patients have not given fully informed consent) is wholly
correct. BMJ 1997;314:1111.
[3] Kestin, I.G. "Technical" consent is inevitable in some
circumstances. BMJ 1998;317:947.
[4] Brewin TB. Truth, trust, paternalism. Lancet 1985;ii:490-2.
[5] Sackett, D.L., Haynes, R.B., Guyatt, G.H., Tugwell, P. Clinical
epidemiology. A basic science for clinical medicine. 2nd ed. Boston:
Little, Brown, 1991, p. 192.
Competing interests: No competing interests