Consent for research in hyperacute strokeBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7555.1405 (Published 15 June 2006) Cite this as: BMJ 2006;332:1405
All rapid responses
The argument presented in "Consent for research in hyperacute stroke"
needs some further work. As has been pointed out already by Jeffrey C
McILwain it is factually incorrect in regards to the legal status of proxy
consent. However the overall argument also has some concerning undertones
which this response will try to make clear.
"Giving primacy to individual autonomy leads to a default position
that assumes that incapacitated patients would not wish to participate in
research without personally giving prospective consent. But the ethical
principles of beneficence or social justice justify arguing the contrary
position, namely that citizens have a moral obligation or at least a civic
duty to participate in medical research provided that safeguards against
malpractice are in place."
The first thing that ought to be said in regards to the above claim
is that of course this is the default position. Indeed this is the default
position with competent patients, we presume they do not wish to
participate unless they actively indicate that they want to. This is why
informed consent is considered to be important. It would be odd to treat
the competent as if they did not wish to consent, but the incompetent as
if they always do.
In any case the move from Harris's argument that there is a moral
duty to participate in research to the enforcement of this duty via
presumed consent is too fast. Simply because something is a moral duty
does not mean that it ought to be legally enforced. It seems relatively
straightforward to establish several very powerful moral obligations on
the basis of beneficence or social justice, such as the vast
redistribution of wealth necessary to aid those in third world nations, or
the cessation of the consumption of animals both to prevent animal
suffering but also to enable the resources to be freed to aid the
needy. Presumably the authors of "Consent for research in hyperacute
stroke" would also like these to be legally enforced?
It is a general principle that we should be very cautious of
enforcing moral duties by legal measures. There seems no reason to treat
consent in research, especially consent on behalf of the incompetent, any
Finally Harris’s argument, which the authors seem to rely on, is
limited in scope to certain cases, he is not trying to argue that we
always have a moral obligation to be involved in research, nor that we
ought to always presume that the incompetent will consent. As Harris
himself notes he is not making a argument for this to become general
policy, instead he is arguing that when research is low or no risk, and
there is no way to get competent consent, and the research is likely to
have great benefits then it may be ethical to enroll people in research
despite their incompetent status and the absence of proxy consent. It
is an open question whether the research championed by this editorial
genuinely fits into those limited circumstances.
1. Stobbart, L. Consent for research in hyperacute stroke. BMJ
2. Harris J. Scientific research is a moral duty. J Med Ethics
3. Singer, P. Famine, Affluence and Morality. Philosophy and Public
Affairs 1972;1: 229-243.
4. Rachels, I. Vegetarianism and ‘the other weight problem. In
William Aiken and Hugh LaFollette (eds) World Hunger and Moral Obligation.
Englewood Cliffs, Prentice Hall, 1977: 180-193.
5. See page 245 in particular. Harris J. Scientific research is a
moral duty. J Med Ethics 2005;31: 242-8.
Competing interests: No competing interests
Statutory Instrument 2004 No. 1031 Medicines for Human Use (clinical
trials Regulation 2004) Part 1 Application and Interpretation
"legal representative" means, in relation to a minor or to an adult
unable by virtue of physical or mental incapacity to give informed
consent, and who is, or is being considered as, a subject for a clinical
(a) in relation to adults and minors in England, Wales and Northern
Ireland, and minors in Scotland -
(i) a person, other than a person involved in the conduct of the
trial, who -
(aa) by virtue of their relationship with that adult or that minor,
is suitable to act as their legal representative for the purposes of that
(bb) is available and willing to so act for those purposes, or
(ii) if there is no such person, a person, other than a person
connected with the conduct of the clinical trial, who is -
(aa) the doctor primarily responsible for the medical treatment
provided to that adult, or
(bb) a person nominated by the relevant health care provider
The last two sections marked (aa)(bb) adequately cover the premise of
bypassing autonomous consent or next-of-kin consent, in that the doctor
responsible for the medical treatment or " a person nominated by the
relevant health care provider " which can mean anyone so nominated by a
Trust, even a lay person. However, is their an ethical right that an adult
person (who is not ill and who will not benefit) can give consent on
behalf of another adult? The premise of autonomous consent is that an
individual has the right to declare what can be done to their body. In an
incapacitated person a doctor acts within the "best interests" concept. As
written above all this is bypassed to permit pharmaceutical research on a
patient who lacks capacity to fulfil European Law. Whose interest is best
served by this Statutory Instrument - the patient or patients. Or does it
comply with pressure from pharmaceutical or academic research?
As phrased above A N Other (the relevant health care provider
nominee) can enter an unconscious or incapacitated person into a
pharmaceutical trial in the absence of a next-of-kin.
Competing interests: No competing interests