Therapeutic and Non-Therapeutic Medical Procedures -- What are the Distinctions?

By Margaret A. Somerville

Dr. Margaret A. Somerville is Founding Director of The McGill Centre
for Medicine, Ethics and Law, and Gale Professor of Law at McGill
University, Montreal.

Based on a paper presented at The Third Annual Conference 
of The Canadian Institute of Law and Medicine,
"Consent to Health-Care."


Do certain rules or legal requirements relevant to obtaining consent
to a medical intervention differ depending on whether a procedure is
classified as being undertaken with a therapeutic or non-therapeutic
intent? The answer is yes. But the reality is complex because the
therapeutic/non-therapeutic distinction is always combined with other
characterizations of any particular medical intervention and these may
also affect either the legal requirements that apply or the outcome
that results from applying the same legal rule. These other
characterizations include whether the intervention is elective or
non-elective, and whether it constitutes research on non-research:
that is, "practice". The combination of characterizations that one can
evolve include the following [CIRP note: Neonatal circumcision
would fall into the fourth category]:

(1)   therapeutic non-research; (That is, "practice".)
       Within this category, one can distinguish two sub-categories:
       (a)  elective therapy; (b)  non-elective therapy;
(2)   therapeutic research;
(3)   non-therapeutic research; (This category includes research
       on healthy volunteer subjects.) and
(4)   non-therapeutic non-research. (This includes operations on
       donors for live donor organ transplants, aesthetic surgery, and
       non-therapeutic sterilization.)

These classifications will be discussed, first in relation to
competent adults. Then, the modifications needed when the
classification is applied to treatment given to incompetent persons
will be considered.


Elective/Non-Elective

With respect to designating a medical intervention as elective or
non-elective, in one sense, all medical interventions to which
informed consent is obtained are elective. However, the courts seem to
use this term to indicate the degree of therapeutic necessity for
undertaking the particular procedure. It is not easy to determine
exactly how electiveness is being judged, but when it is not a
clear-cut therapeutic decision that the patient should have undergone
any given procedure or when, perhaps, the procedure might benefit the
patient but failure to undergo it will not harm him or her (1), the
procedure will be described as elective. (...)


Research/Non-research

...[I]n the area of "proxy" consent, or as it is better called, 

third-party authorization, as the law presently stands, it is not 
possible for a guardian (or curator) to consent to a non-therapeutic 
research intervention on an incompetent person in his or her care. In 
contrast, guardians (or curators) may consent to some therapeutic 
research interventions on such persons. (...)


Classification system

...it must be brought home to the patient that the intervention is
non-therapeutic, if this is the case. Special care is needed in
ensuring that there is apparent understanding of such information
because patients tend to identify physicians with therapy and find
it hard to believe that a physician would carry out a non-therapeutic
procedure on them, even when they are expressly informed of this
fact. (...)

Finally, there are the non-therapeutic/non-research medical
interventions. These include operations on live donors who give organs
for transplant, non-therapeutic sterilization, and aesthetic or
cosmetic surgery. Some aesthetic surgery may be classified as
therapeutic when there is a definite psychological indication for
undertaking it and, of course, some may even be physically
therapeutic, although in such cases it would probably be labelled
aesthetic surgery. Several Canadian cases have dealt with aesthetic
surgery, but of those that preceded the Supreme Court's decision in
Reibl v. Hughes, some, with all respect, are not clear as to the
required scope of disclosure of information to the patient. In
general, one can say that a very full disclosure is needed when
non-therapeutic medical intervention is involved. More than one court
has indicated expressly that, far from worrying about frightening a
patient by too detailed a disclosure, a physician would have been
well advised to frighten the patient into not requesting or deciding
against a certain procedure (14).

One of the difficulties raised by non-therapeutic/non-research medical
intervention is whether it is legal or illegal. Although the latter
used to be the commonly held view, in all probability there has been a
change of public policy, which allows such intervention to be brought
within the shelter of the law when certain conditions are fulfilled
(15). (...)


Incompetent persons

When one moves outside the competent adult model, then whether a
medical intervention is therapeutic or non-therapeutic becomes most
important....It must always be kept in mind that more care is needed
in giving permission for an intervention on another person than when
we consent to have something done to ourselves. Finally, there is
doubt as to whether third party authorization can be given to a
non-therapeutic/non-research intervention; (...)


Conclusion

...

[W]hether therapy or non-therapy, and research or non-research is
involved may alter the scope of the information that needs to be given
to the patient to obtain his informed consent, and may make one aware
of problems with voluntariness; that is, the presence of coercion.
Such classification will also determine whether a guardian may
authorize an intervention on his or her ward. (...)


Notes:

(1) Miller, B.L., "Autonomy and the Refusal of Life Saving Treatment" (1981), The Hastings Center Report 11(4)22, p. 27.

(14) See, for example, Kelly v. Hazlett (1977), 75 D.L.R. (3d) 536 (Ont. S.C.).

(15) See Somerville, M.A., Medical Interventions and the Criminal Law: Lawful or Excusable Wounding?" (1980), 26 McGill Law Journal (1) 82.