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COMMENTS – COMMENTAIRES
Minors and Mental Incompetents: Consent to
Experimentation, Gifts of Tissue and Sterilization
Introduction
My concern in this paper is with minors and mental incompe-
tents as subjects of research, as donors of human tissue and as
subjects of sterilization. In each case one must ask who, if anyone,
can properly give consent, and in what circumstances. The question
is both legal and ethical. One must look at the question of consent
to these procedures where the subject is a mentally competent
adult, but first one must examine the subject of consent to medical
treatment.
I. Consent to medical care
Medical care or treatment is the diagnosis, prevention and treat-
ment of illness. The term “health care” may seem synonymous
with medical care but it is intended to be wider. For example, the
World Health Organization says: “[H]ealth is the state of complete
physical, mental and social well-being and not merely the absence
of disease or infirmity.”‘ With this definition of health, the admi-
nistration of contraceptives is probably within health care, whereas
it is outside the term “medical care”.
In general a competent adult may make up his own mind as to
whether to receive medical treatment. Thus the physician should
not treat him without his consent or, of course, in the face of a
prohibition. It was in the context of a prohibition that Mr Justice
Cardozo uttered his oft-quoted statement, that “[e]very human
being of adult years and sound mind has a right to determine what
shall be done with his own body; and a surgeon who performs
an operation without his patient’s consent commits an assault, for
which he is liable in damages”.F
Consent may be by conduct or it may be specific, whether verbal
or written. Hospitals have their own consent forms and sometimes
questions arise as to whether they are too wide or whether the
SPreamble to Constitution, quoted in Curran & Shapiro, Law Medicine and
2 Schloendorff v. Society of the New York Hospital 105 N.E. 92, 93 (N.Y.
Forensic Science, 2d ed.’ (1970), 974.
1914).
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patient actually understood them. This is, of course, a problem
that can come up in any document. A consent prepared by a physi-
cian or institution should be fair and in simple language. There
should be no coercion of the patient to sign it, and every effort
should be made to see that he understands it. Today the main
question is whether the consent must be an “informed consent”.
What is the duty of the physician to disclose the proposed treat-
ment and alternatives and the risk of each procedure (or both) in
order for the consent to be genuine?
Fifty years ago, the Court of Appeal of Ontario held in Kenny
v. Lockwood 3 that the decision as to disclosure of risks is for the
physician on the basis of good medical practice. This was the pre-
vailing rule in the United States until about ten years ago. Critics
of that rule said it was too paternalistic or authoritarian; that there
should be a partnership between doctor and patient, which is only
achieved by complete candor that enables the patient to make an
intelligent decision Since then there have been a number of de-
cisions supporting this thesis. The two leading cases are Canterbury
v. Spence5 and Cobbs v. Grant.0 The ratio of Canterbury is this:
“[t]o enable the patient to chart his course understandably, some
familiarity with the therapeutic alternatives and their hazards
becomes essential”. The physician has a duty of reasonable dis-
closure of the choices with respect to proposed therapy and the
dangers inherently and potentially involved. The patient is- not
bound by the profession’s tradition as to what should be disclosed.
Respect for the patient’s right of self-determination on particular therapy
demands a standard set by law for physicians rather than one which
physicians may or may not impose upon themselves.8
As to the scope of the duty of disclosure, the patient must be given
enough information for an intelligent choice. The standard is ob-
jective: would the reasonable person be likely to attach significance
to the risk or cluster of risks in deciding whether or not to forego
the proposed therapy?
In Cobbs v. Grant the Court asked whether the doctor’s duty
to disclose and his discretion to withhold information are governed
by medical practice or imposed by law? They are imposed by law.
The patient is medically ignorant and is entitled to determine
3 [1932] O.R. 141 (C.A.).
4 See, e.g., Glass, Restructuring Informed Consent (1970) 79 Yale LJ. 1533.
5 464 F. 2d 772 (D.C. Cir. 1972).
6 502 P. 2d 1 (Cal. in banco 1972).
7 Supra, note 5, 781.
8 Ibid., 784.
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COMMENTS – COMMENTAIRES
whether to submit to treatment. His consent must be informed and
he depends on the doctor to inform him. Thus the doctor has “a
duty of reasonable disclosure of the available choices with respect
to the proposed therapy and of the dangers inherently and poten-
tially involved in each …
. [The] evaluation and decision is a non-
medical judgment reserved to the patient alone.”9 But what degree
of disclosure is required? Full disclosure is too broad. The doctor
need not give a lengthy polysyllabic discourse on all possible com-
plications nor need he discuss “the relatively minor risks inherent
in common procedures, when it is common knowledge that such
risks inherent in the procedure are of very low incidence.”’01 For
example, the doctor may be obliged to inquire as to allergies to
avoid adverse reactions. Where the procedure is more complicated,
the jury should be told that “[w]hen a given procedure inherently
involves a known risk of death or serious bodily harm, a medical
doctor has a duty to disclose to his patient the potential of death
or serious harm, and to explain in lay terms the complications
that might possibly occur”.” Then follows this rather vague addi-
tion: “[b]eyond the foregoing minimal disclosure, a doctor must
also reveal to his patient such additional information as a skilled
practitioner of good standing would provide under similar cir-
cumstances”.’2 The scope of the required disclosure is measured
by the patient’s need for whatever information is material to the
decision.
These two cases and some from other states have caused a stir
in the United States, both favourable and unfavourable. A recent
text says that eighteen states in 1975 and 1976 enacted statutes
that either defined or restricted the application of the doctrine of
informed consent in reaction to the crisis in malpractice insurance.
The authors add that “[m]ost of the statutes attempt, in one way or
another, to make it more difficult for a patient to be successful
in a suit against a physician for failure to obtain informed consent”.’ 3
Where do we stand on informed consent in Canada today? The
answer is found in the Supreme Court’s judgments
in Hopp
v. Lepp’4 and Reibl v. Hughes,’5 both decided in 1980. The first of
9 Supra, note 6, 10.
10 Ibid., 11.
11 Ibid.
12 Ibid.
13 Annas, Glantz & Katz, Informed Consent to Human Experimentation:
The Subject’s Dilemma (1977), 38: see also Horan & Halligan, Authority for
Medical Treatment (1980) 22 For the Defence 12, 22.
14 (1980) 112 D.L.R. (3d) 67.
15 (1980) 114 DL.R. (3d) 1.
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these cases was from Alberta. The issue was the adequacy of the
defendant’s answer to the plaintiff’s concern about the seriousness
of an operation for a slipped disc. The trial judge, Brennan J.,
found it adequate 16 but a majority of the Court of Appeal 7 held
otherwise and found the defendant liable. He appealed to the Su-
preme Court, which restored the trial judgment. Chief Justice
Laskin, speaking for the Court, reviewed the cases on informed
consent. After discussing the concept of probable risks (as against
the merely possible) and material risks (as against immaterial),
and of special or unusual risks, the Chief Justice.set out the follow-
ing conclusion:
In summary, the decided cases appear to indicate that, in obtaining the
consent of a patient for the performance upon him of a surgical opera-
tion, a surgeon generally should …, without being questioned, disclose
to him the nature of the proposed operation, its gravity, .any material risks
and any special or unusual risks attendant upon the performance of
the operation. However, having said that, it should be added that the
scope of the duty of disclosure and whether or not it has been breached
are matters which must be decided in relation to the circumstances of
each particular case.’ 8
This passage shows a move toward the proposition that the consent
must be informed.
The second case, Reibl v. Hughes, follows this trend. The de-
fendant operated on the plaintiff for a “plugged” artery near the
brain. A serious stroke resulted. The defendant had not mentioned
the risk of a stroke. Haines J. held that if the defendant had told the
plaintiff of the risk (4% of dying and a further 10% of stroke) the
plaintiff would have refused. Thus Haines J. gave judgment for the
plaintiff.19 The Court of Appeal of Ontario ordered a new trial
because the trial judge’s statement of risk misunderstood the evi-
dence. No one would put the risks to the plaintiff the way Haines
J. proposed. He ignored the risks of not operating. Moreover, the
plaintiff failed to show that he would not have consented had the
defendant disclosed the risk.20
The plaintiff appealed to the Supreme Court. Again Chief Justice
Laskin wrote the judgment for a unanimous Court. He dealt at
length with the causation question: should the Court use an object-
ive or subjective test in deciding whether the plaintiff would have
refused the operation had the defendant disclosed the risk? Earlier
16 (1977) 77 D.L.R. (3d) 321 (Alta S.C., T.D.).
.7 (1979) 98 D.L.R. (3d) 464 (Alta S.C., App. Div.).
‘ 8 Supra, note 14, 81.
19 (1977) 16 O.R. (2d) 306 (H.C.).
20 (1978) 21 O.R. (2d) 14 (C.A.).
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COMMENTS – COMMENTAIRES
cases in the provincial courts had been divided on this issue. The
Chief Justice held the objective test to be preferable and added
“[i]n saying that the test is based on the decision that a reasonable
person in the patient’s position would have made, I should make it
clear that the patient’s particular concerns must also be reasonably
based; otherwise there would be more subjectivity than would be
warranted under an objective test”.21
The Chief Justice reviewed the evidence at length and the find-
ings in the courts below. He concluded that the defendant, in
merely advising the plaintiff that he would do better to have the
operation than not to have it, did not give an adequate disclosure
of the risks. The Chief Justice then asked what the reasonable
person would have done if the risks had been properly disclosed?
He took into consideration that the plaintiff was only a year and a
half from his pension, that there was no apparent “neurological
deficit”, no immediate emergency and yet there was a grave risk
of stroke from the operation, whereas the risk of stroke without
the operation was in the future. Another factor was that the de-
fendant had not made clear to the plaintiff the fact that the opera-
tion would not cure his headaches, whereas the plaintiff thought
it would. In conclusion the Chief Justice said that in his opinion
‘(a reasonable person in the plaintiff’s position would, on a balance
of probabilities, have opted against the surgery rather than under-
going it at the particular time”,Y2 Thus the Supreme Court restored
the trial judgment.
Doubtless these two cases will produce a spate of comment. One
can scarcely object to the proposition that the patient should receive
enough information to make his own decision. It would be unfor-
tunate, however, if the physician’s obligation, as now established,
were to force him into a wooden and mechanical recitation of all
risks as a defence to the possibility of a complaint that he has failed
in his duty of disclosure. I am sure the Chief Justice intended to
confine the obligation of disclosure of risks to those that are
serious. However, even seriousness is relative. Risks that might be
regarded as serioui in a cosmetic operation would not necessarily
be serious in an open-heart operation. Where the proposed pro-
cedure is elective, as it was in Reibl, then there should be an obliga-
tion to describe the alternatives to the operation and the compara-
tive risks. Where, however, an operation is from a medical stand-
point not only desirable but urgent, it seems to me that the doctor
21 Supra, note 15, 17.
22 Ibid., 35.
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should not have to go into details of the risks of the operation and
then go on to describe the possibilities of serious harm or death
that would occur if nothing were done.
I shall now make four short comments on the state of the law
in the light of these two decisions. First, we have had cases holding
that in the absence of informed consent the plaintiff’s action lay
either in battery or negligence or both.2 3 Fortunately, Reibl has not
only put an end to the confusion but has placed the action on its
proper basis. Disclosure is part of the duty of care and its breach
is actionable negligence. Battery “should be confined to cases where
surgery or treatment has been performed or given to which there
has been no consent at all or where, emergency situations aside,
surgery or treatment has been performed or given beyond that to
which there was consent”. 24 Later in his judgment Laskin C.J.C.
said that “unless there has been misrepresentation or fraud to
secure consent to the treatment, a failure to disclose the attendant
risks, however serious, should go to negligence rather than to
battery”. 5 What of the case where the surgeon, through a mis-
understanding, removes thirteen teeth instead of two,-2 or operates
on the spine instead of the foot?27 In these cases the judgments
point to the possibility of an action in either battery or negligence.
It may be that Chief Justice Laskin would classify these cases as
battery, though one can argue that the action is in negligence. There
is no question, of course, where the patient says, of a proposed
anaesthetic, “Don’t touch my left arm.” The touching is clearly a
battery.28 Likewise an unauthorized biopsy for purposes of research
is a battery.29
23 In Halushka v. University of Saskatchewan (1965) 53 D.L.R. (2d) 436,
the Saskatchewan Court of Appeal upheld a jury’s findings of both battery
and negligence with a single award. In Zimmer v. Ringrose (1978) 89 D.L.R.
(3d) 646 (Alta S.C., T.D.), the Court awarded $5,000 for negligence and $1
for battery: the Court of Appeal, in a judgment of 13 February 1981 ([1981) 4
W.W.R. 75), reversed the finding of battery and upheld the judgment in negli-
gence. In Lepp v. Hopp (supra, note 17), the Ontario Court of Appeal gave an
award of $15,000 in both battery and negligence. In Reibl v. Hughes (supra,
note 19),
the trial judge found the defendant liable in both and gave a
single award of $225,000.
24 Supra, note 15, 10.
25 Ibid., 11.
26Parmley v. Yule [1945] S.C.R. 635.
27 Schweizer v. Central Hospital (1974) 6 O.R. (2d) 606 (H.C.).
28 Allan v. New Mount Sinai Hospital (1980) 109 D.L.R. (3d) 634 (Ont. H.C.).
2 9 In Cryderman v. Ringrose (1978) 89 D.L.R. (3d) 32 (Alta S.C., App. Div.)
this question arose but the Court did not have to decide it. The defendant
was liable in negligence for other non-disclosures.
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COMMENTS – COMMENTAIRES
Secondly, both cases confirm that in instances of a nervous or
apprehensive patient the surgeon has some latitude in deciding how
much information of risks to give. Reibl also mentions the possibi-
lity of a patient waiving his right to an explanation of risks.
Thirdly, the Chief Justice makes a strong case for the objective
test in determining causation. Although some judgments and some
writers30 have argued that it is unfair to plaintiffs, I do not
object to it as a general rule. One situation, however, is troubling.
It is that of the patient who asks a direct question: for example, “if
I have the operation for migraine headaches, what are the risks?”
Let us assume that the answer is “none”, when in fact loss of the
sense of smell is a known risk.31 Then let us take an even more
pointed question: “if I have the eye operation will I have double
vision?” Again let us assume a negative answer, although the known
risk is in fact substantial. 2 In these cases the patient has shown to
the doctor his direct concern. It seems to me that, especially in the
second case, a court has a strong indication that whatever the
reasonable person would have decided, the plaintiff would have
decided against the operation.
Fourthly, there is a point that the Supreme Court did not have
to consider. It is this. Let us assume a finding that the patient
would not have consented had the risk been disclosed. In order
to succeed, must he show that the risk that materialized was the
one that should have been disclosed? Canterbury v. Spence says yes:
Halushka v. University of Saskatchewan33 says no. Doubtless one
could write an essay on the application of PalsgraF4 and Wagon
Mound No. P5 to this question. I merely offer the suggestion that
on modern tort principles much is to be said for the position taken
in Canterbury.36
30 See, e.g., Bamberg, Informed Consent after Cobbs – Has the Patient
10 San Diego L. Rev. 913, 924-6; Annas, Glantz &
been Forgotten? (1973)
Katz, supra, note 13, 30-1.
3 1 Koehler v. Cook (1975) 65 D.L.R. (3d) 766 (B.C.S.C.).
32 Calder v. Gilmour [1978] 3 A.C.W.S. 57 (Sask.).
a3 Supra, note 23.
3 4 Palsgraf v. Long Island Ry 162 N.E. 99 (N.Y. 1928).
3 5 Overseas Tankship (U.K.) Ltd v. Morts Dock & Engineering Ltd (The
Wagon Mound No. 1) [1961] A.C. 338 (P.C.).
-uThe uncertainty as to the law on consent to medical treatment has
produced endless commentary in the United States. In Canada there is an
excellent study paper in the Law Reform Commission of Canada’s “Pro-
tection of Life” series, Consent to Medical Care, written by Professor
Margaret Somerville and published in 1979: unfortunately, she was unable
to consider the Supreme Court’s judgments in Lepp or Reibl. Among recent
McGILL LAW JOURNAL
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A. Minors
A mature minor can give his own consent just as an adult can.
There seems to have been a contrary rule in the United States but
never in England or Canada. Indeed, Professor Somerville has
pointed out that Coke said “an infant may bind himself for his …
necessary physic”.37 Johnston v. Wellesley Hospital38 did much to re-
move widespread, though unwarranted, doubts. Even with the re-
duced age of majority there is room for the mature minor who can
give his own consent. The problem is that as the age decreases
uncertainty as to capacity increases. For this reason there should
be legislation.
England has put the age at sixteen.3
1 It is fourteen in Quebec.4″
In British Columbia, it is sixteen, but the physician must first try
to get the parents’ consent.41 The Uniform Medical Consent of
Minors Acte’ also fixes the age at sixteen with the important addi-
tion that where the minor is under that age he may give his consent
if two doctors are of the opinion that the minor understands the
procedure and that the treatment is in his best interests.
In Alberta, the Institute of Law Research and Reform in De-
cember, 1975 made a report4 3 recommending the age of sixteen,
but with a special provision whereby the patient could consent to
treatment in connection with communicable diseases, drug or al-
cohol abuse, prevention of pregnancy, and termination of pregnan-
cy. The Alberta Legislature has not yet passed a statute on the
subject. My prediction is that the government will bring in a bill
before long that is either based on the Institute’s report or on the
Uniform Act. In Saskatchewan the Law Reform Commission has re-
Canadian writings, see also Picard, “The Tempest of Informed Consent”
in Klar, Studies in Canadian Tort Law (1977), ch. 4; Castel, The Nature and
Effects of Consent … in the Medical Field: Criminal and Private Law Aspects
(1978) 16 Alta L. Rev. 293; Sharpe, Informed Consent (1979); Jazvac, Informed
Consent: Risk Disclosure and the Canadian Approach (1978) 36 U. of T. Fac.
L. Rev. 191; Scaletta, Informed Consent and Medical Malpractice: Where Do
We Go from Here? (1980) 10 Man. L.J. 289.
.37Co. Littleton 1722, cited in Somerville, supra, note 36, 73: see also
Dickens, Contractual Aspects of Human Medical Experimentation (1975) 25
U.T.LJ. 406, 414.
-8 [1971] 2 O.R. 103 (H.C.).
39 The Family Law Reform Act, 1969, 1969, c. 46, s. 8.
40 Loi sur la protection de la santg publique, L.R.Q., c. P-35, s. 42.
41 Infants Act, R.S.B.C. 1979, c. 196, s. 16.
42 Uniform Law Conference, 1975 Proc. 30 and 162; Consolidation of
Uniform Acts, 31-1.
43Consent of Minors to Medical Care (1975).
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COMMENTS – COMMENTAIRES
commended a different type of scheme.44 A minor who has capacity
to consent may do so. The court has power to declare whether a
minor has that capacity and power to dispense with parental con-
sent where the law requires it. It is hard to say whether the Legisla-
ture will act on the recommendation.
Where the plaintiff is too young to give his own consent the
common law always recognized the parents’ right to give it. Indeed
at common law the parent has a duty to look after the child’s
medical care. Modern child-welfare
laws provide that parental
neglect or refusal to give medical care is a form of negligence.4 5
Problems arise where the parent refuses on religious grounds to
permit a certain medical procedure, such as the transfusion of
blood. In Alberta there is specific provision that as soon as a child
is apprehended the authority who apprehended him may authorize
medical care without parental consent.4 6
One provision in the English Act is hard to interpret. It says:
“Nothing in this section shall be construed as making ineffective
any consent which would have been effective if this section has not
been enacted.” Does this preserve the mature minor rule for per-
sons under sixteen, or does it permit parental consent for them, or
does it refer to emergencies? The Uniform Act and the Alberta re-
commendations both omit that provision. In my opinion, this is
wise. I see no need to preserve the mature minor rule when the
general age of consent has been brought down to sixteen and where,
in addition, there are provisions permitting consent by the minor
himself in specific cases even where he is under sixteen.
The only province that has enacted the Uniform Act to date is
New Brunswick.4′ In that province, the definition of “medical
treatment” omits “any procedure undertaken for the purpose of
preventing pregnancy.”
A final comment that I should like to make before leaving this
topic has to do with the controversy as to whether minors should
be able to arrange for themselves contraceptive measures and, in
the case of girls, abortion. There has been a tendency to refrain from
meeting this problem directly. The Alberta Report48 is an exception.
This is the most emotion-laden issue in the whole area of medical
44Proposals for a Consent of Minors to Health Care Act (1980).
45 See, e.g., Loi sur la protection de la jeunesse, L.R.Q., c. P-34, and, in
Ontario, The Child Welfare Act, S.O. 1978, c. 85, s. 19 (ix).
48 The Child Welfare Act, R.S.A. 1970, c. 45 (as am.), ss. 16(2) and 17.
4 Medical Consent of Minors Act, S.N.B. 1976, c. M-6.1.
48 Supra, note 43.
McGILL LAW JOURNAL
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consent. In the United States the Supreme Court has held un-
constitutional blanket requirements for parental consent to abor-
tion, 49 and at present there is a case before that Court challenging
a state law requiring mere notice to the parents. 0 The Court has
struck down a state law prohibiting the sale of contraceptives to
minors.51 I do not care to see these questions resolved as consti-
tutional issues. Nor do I contemplate with any satisfaction the fact
that in some cases the minor refuses to take the parents into his
or her confidence, or indeed the sexual permissiveness which makes
the problem acute. However, when the minor wishes to exclude
the parents from participation in the decision, he or she should
have the capacity to decide for himself or herself.
B. Mental incompetents
It is customary to distinguish between the mentally retarded
(Blackstone’s idiot) and the mentally incompetent
or defective
(Blackstone’s lunatic) .52 They will be treated together here. Neither
is necessarily incapable of giving consent, for the retardation may
be mild, and the mental incompetent may have lucid intervals. As
a general rule, however, someone else must authorize medical
treatment for persons in both categories.
In connection with mentally incompetent adults, the Criminal
Code imposes a duty on everyone to provide necessaries for a
mentally ill person under his charge.3 In Alberta, The Mental
Health Act provides that the Board in charge of a facility for such
patients “is under a duty to provide such diagnostic and treatment
services as the patient is in need of and that the staff of the facility
are capable and able to provide”.5 4 The Dependent Adults Act in’
Alberta permits the court to appoint a plenary guardian or a partial
guardian.5 5 In the case of a plenary guardian, section 9 says that the
guardianship order confers on the plenary guardian power “to con-
sent to any health care that is in the best interests of the dependent
adult”. In the case of an order appointing a partial guardian, section
10 enables the court to include the power I have just quoted. Section
4 9 Planned Parenthood of Central Missouri v. Danforth, Attorney General
of Missouri 428 U.S. 52 (1976); Bellotti v. Baird (No. 2) 443 U.S. 622 (1979).
50H.L. v. Matheson, from Utah: see 48 U.S.L.W. 2482.
51 Carey, Governor of New York v. Population Services International 431
U.S. 678 (1977).
521 BI. Comm. 303, 304.
53R.S.C. 1970, c. C-34, s. 197(1)(c).
54S.A. 1972, c. 118, s. 24(1).
55 S.A. 1976, c. 63.
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COMMENTS – COMMENTAIRES
1 defines “health care” to include “any procedure undertaken for
the purpose of preventing pregnancy”.
(The other parts of the
definition are obvious.) The question arises whether the guardian
can consent to sexual sterilization of the dependent. I shall deal
with this later under “Sterilization”.
II. Consent to research on humans
Research on humans is doing something to a human being for
the purpose of gaining knowledge. The term “experimentation” can
be given the same definition, but the difficulty is that it is often
used to describe innovative therapy. That is to say the purpose is
both to gain knowledge and to help the patient. Every medical
procedure was innovative at one time. Until thalidomide and the
Kefauver hearings 6 in the United States that led to the amend-
ments to the Food, Drug and Cosmetic Act17 in 1962, it was com-
monplace for drug companies simply to ask physicians to try
out a new drug on their patients. It is now recognized that this is
not the proper way to determine the safety and efficacy of the drug.
There must be systematic research in which the new drug is compar-
ed to an accepted drug or to a placebo (inert substance), or both.
To make the conclusions scientifically sound this is usually done,
at least in the early stages, on a double-blind basis. Neither the
patient nor the person administering the drug knows which sub-
stance the patient receives. This procedure is obviously research,
not therapy.
When ethical codes or statutes speak of experimentation they
may mean experimentation that excludes therapy or they may mean
experimentation that includes an element of therapy. For example,
the Helsinki Declaration 8 gives guidelines for medical research
combined with professional care and other guidelines for non-
therapeutic research. However, some recent ethical codes define
experimentation or research to include experimental therapy as long
as the experimental element is important. Thus the Medical Re-
search Council of Canada has said that the distinction between
therapeutic and non-therapeutic research should be abandoned:
both should come under the heading of research. 9 Later the Nation-
al Commission for the Protection of Human Subjects of Bio-medical
56 See Mintz, The Therapeutic Nightmare (1965).
5721 U.S.C.A. 355. See Talalay, Drugs in Our Society
(1964); Landau,
Regulating New Drugs (1973).
58 World Medical Association, Declaration of Helsinki (1964),
revised at
Tokyo, 1975.
59 Ethics of Human Experimentation (1977), 6-7.
McGILL LAW JOURNAL
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and Behavioral Research in the United States pointed out that the
distinction between research and therapy is blurred because both
often occur together. Its report takes the position that radically
new procedures should be treated as research because formal re-
search today provides the best method of determining whether the
new procedure is safe and effective.0
In Zimmer v. Ringrose the defendant used a silver nitrate treat-
ment to bring about sterility. The plaintiff was not rendered sterile
and subsequently became pregnant and had an abortion. The trial
judge accepted testimony of an expert that the defendant’s pro-
cedure was experimental and should have been handled through a
clinical trial –
that is, treated as research. On appeal the Court of
Appeal did not agree with this finding.6′
Even if there are two accepted procedures but complete dis-
agreement as to which is better, a study to settle the question must
be done on a systematic basis as research. In the case of breast
cancer there may be utter uncertainty as to whether a radical or
simple mastectomy is better in the removal of a tumor of a given
size. Is it proper for those trying to find the answer simply to al-
ternate the surgery without telling each patient that the actual
operation she received was the result of drawing lots? The answer
is no.” Today there are studies to compare partial as against com-
plete mastectomies. The fact that the operation is being performed
on a randomized basis is clearly explained in the consent forms that
have come to my attention.
The basis of all modem statutes and ethical codes is the Nurem-
berg Rules or the Helsinki Declaration (revised at Tokyo in 1975).ca
They require informed consent. Nuremberg says the consent must
be that of the subject, whereas Helsinki permits the substituted
consent of the guardian of an incompetent or the parent of a minor.
An example of an effort to ensure that the consent of the sub-
ject is informed is the United States Food, Drug and Cosmetic Act 4
and the Regulations made thereunder. 5 Where the purpose
is
00 The Belmont Report (1978), 2-4.
6’Supra, note 23. Compare the duty of disclosure as laid down by the
Court of Appeal with that prescribed in Cryderman v. Ringrose, supra,
note 29. The Court of Appeal upheld the judgment in negligence because of
negligent after-care. It also found negligence in the failure to disclose risks
but found an absence of causation.
62 See Fried, Medical Experimentation (1974), esp. ch. 3.
63 Supra, note 58.
6421 U.S.C.A. 355.
65 130.37, Federal Register, June 20, 1967, p. 8753.
1981]
COMMENTS – COMMENTAIRES
solely research, the consent of the subject himself must be obtained.
If there is a therapeutic element the consent of his representative
must be obtained if the subject cannot consent. The definition of
consent is as follows:
“Consent” means that the person involved has legal capacity to give
consent, is so situated as to be able to exercise free power of choice, and
is provided with a fair explanation of pertinent information concerning
the investigational drug, and/or his possible use as a control, as to enable
him to make a decision on his willingness to receive said investigational
drug. This latter element means that before the acceptance of an affir-
mative decision by such person the investigator should carefully consider
and make known to him (taking into consideration such person’s well-
being and his ability to understand) the nature, expected duration, and
purpose of the administration of said investigational drug; the method
and means by which it is to be administered; the hazards involved; the
existence of alternative forms of therapy, if any; and the beneficial effects
upon his health or person that may possibly come from the administration
of the investigational drug.66
Quite apart from the Food, Drug and Cosmetic Act, the American
Department of Health and Human Services (HHS, replacing HEW)
has guidelines governing institutions that receive HHS assistance.
They must give to HHS an undertaking or assurance, as it is called,
to follow these guidelines. They require that a research committee
(called an Institutional Review Board or IRB) must pass on all
protocols (research proposals). The definition of informed consent
is as follows:
(c) “Informed consent” means the knowing consent of an individual or
his legally authorized representative, so situated as to be able to
exercise free power of choice without undue inducement or any
element of force, fraud, deceit, duress, or other form of con-
straint or coercion. The basic elements of information necessary to
such consent include:
(1) A fair explanation of the procedures to be followed, and their
purposes, including identification of any procedures which are ex-
perimental;
(2) A description of any attendant discomforts and risks reasonably to
be expected;
(3) A description of any benefits reasonably to be expected;
(4) A disclosure of any appropriate alternative procedures that might
be advantageous for the subject;
(5) An offer to answer any inquiries concerning the procedures; end
(6) An instruction that the person is free to withdraw his consent and
to discontinue participation in the project or activity at any time
without prejudice to the subject.6 7
66Ibid., at 8754.
6745 C.F.R. 46.107 (1975).
McGILL LAW JOURNAL
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It will be seen that this definition has much in common with
the definition of consent under the Food, Drug and Cosmetic Act.
An additional requirement was recently made whereby the insti-
tution must tell the subject whether it provides compensation in
case of injury.”
For some time in the United States there has been intensive
re-examination of the ethical requirements for research on humans.
In July, 1974 an Act of Congress established the National Commis-
sion for Protection of Human Subjects of Bio-Medical and Behavior-
al Research. The Committee worked for four years and produced
reports on ethical guidelines for research (Belmont Report), psy-
chosurgery, research on institutionalized mentally infirm, research
on the fetus, research involving children, IRB’s, and on ethical
guidelines for delivery of health care by the federal government.
Since these reports came out, Congress has considered a number
of bills, and HHS has made a number of proposals for new regula-
tions. They are still in a state of flux. The latest I have is a set of
proposed regulations by HHS. The requirements for informed con-
sent include the present ones and several more.69
In Canada there is nothing comparable to the HHS guidelines
but some research institutions in fact follow them. Of course we
have reached the stage where these institutions, including universi-
ties, have not only framed their own guidelines but have establish-
ed a research committee or IRB to pass on proposals for research
and to scrutinize the forms of consent to be used. Under Canada’s
Food and Drugs Act 7 0 there are regulations designed to prevent the
sale of new drugs until the manufacturer has filed a submission
with the Minister, but the manufacturer may sell new drugs to
qualified investigators on complying with the requirements in the
regulations. These regulations are far less exacting than those in
the United States under the Food, Drug and Cosmetic Act.71
Apart from the Canadian statute just mentioned, the only legisla-
tion of which I am aware on the subject of research on humans is
68Federal Register, Nov. 3, 1978; see Levine, Advice on Compensation
(1979) 1 I.R.B. 5.
69 46.112 Federal Register, August 14, 1979, p. 47696.
70 R.S.C. 1970, c. F-27.
71 Food & Drugs Regs., Division 8; Consol. Regs. 1978, c. 869 at 6293-6301.
In R. v. Kripps Pharmacy [1980] 6 W.W.R. 579 the accused was charged
with selling a new drug without having filed a submission. A County Court
judge in British Columbia held the regulation invalid not merely as un-
authorized by the Act but as unconstitutional. One might hope the case
goes further.
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COMMENTS – COMMENTAIRES
Article 20 of Quebec’s Civil Code. It permits a person of full age to
consent in writing to submit to an experiment provided the risk
assumed is not disproportionate to the benefit anticipated.72
In the great expansion of research on humans since World War
II, there have been remarkable advances, but at the same time there
have been instances of imposition on subjects, including research
without consent. An English doctor wrote a book alleging improper
research on patients. 3 In the United States research has sometimes
attracted wide criticism; for example, the Tuskegee study on blacks
inflicted with syphilis7 4 and the Willowbrook study in which defect-
ive institutionalized children were given hepatitis with a view to
finding a way to control it in the institution. 5 Dr Beecher, in his
“bombshell” article in 1966, condemned many studies he regarded
as unethicaL76 In the New York cancer-cell case the proceedings
were disciplinary. 7 There has been very little civil litigation. Indeed,
so far as I know, Halushka v. University of Saskatchewan78 is the
only case. The plaintiff volunteered to take part in the study of a
new anaesthetic but was not told that there was risk involved or
that the catheter placed in his arm would go to the heart. He
suffered cardiac arrest. In upholding the jury’s verdict for the
plaintiff, the Court of Appeal said that “[t]he duty imposed on
those engaged in medical research… to those who offer themselves
as subjects for experimentation … is at least as great as, if not
greater than, the duty owed by the ordinary physician or surgeon
to his patient”,79 and “[t]he subject of medical experimentation
is entitled to a full and frank disclosure of all the facts, probabilities
and opinions which a reasonable man might be expected to consider
before giving his consent”. 80
The particular problem in the case of experimentation is that
all the risks cannot be known. Generally, previous tests on animals
have helped to eliminate a substantial amount of risk, but the
researcher cannot know that the risks of which he is aware are
the only ones. Another basic problem that arises both in therapy
72 See Bowker, Experimentation on Humans and Gifts of Tissue: Articles
20-23 of the Civil Code (1973) 19 McGill L.J. 161.
73 Pappworth, Human Guinea Pigs (1967).
74 See Annas, Glantz & Katz, supra, note 13, 59-61.
7 Ibid., 79-81.
76 Beecher, Ethics and Clinical Research (1966) 274 New England 3. Med.
1354.
77 See Katz, Experimentation with Human Beings (1972), Pt 1, ch. 1.
78Supra, note 23.
79 Ibid.
80 Ibid.
McGILL LAW JOURNAL
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and in research, but which is particularly acute in the latter, is this.
Even if the consent form is completely candid and as lucid as
possible, there is no guarantee that the subject who gives consent
really does so with knowledge and free will. There can be subtle
pressures on him both from the outside and because of his position
(e.g., as a prisoner). In addition, by reason of sickness, lack of
intellect, or inability to speak English, he may not truly give an
informed consent. It is for this reason that many people urge that
the institution or its IRB should “monitor” the taking of consents.,’
Should there be legislation in each province .on the subject of
informed consent to research on humans? One should not denigrate
the attempts in the United States food and drug law, and in the
various state laws,82 and in Quebec’s Article 20. I am not sure, how-
ever, that, for the present, legislation is as useful as ethical guide-
lines and IRB’s. In addition, it is helpful to remember Dr Beecher’s
observation:
One must never minimize the importance of striving for truly informed
consent, but the patient’s greater safeguard in experimentation, as
in
therapy, is the skilful, informed, intelligent, honest, responsible, com-
passionate physician.83
A. Research on children
While the “mature minor” rule of the common law or a statute
specifying the age at which an older minor may give his own con-
sent
to medical treatment is sensible, it is arguable that this
should not apply where the procedure is research. None of the
common law provinces has legislated as yet and there is no case
law. In Quebec, Article 20, to which I have referred, says:
A minor, capable of discernment, may [submit to an experiment] with
the consent of the person having the paternal authority and of a judge
of the superior court, provided that no serious risk to his health results
therefrom.
A minor capable of discernment is the mature minor. He may agree
to take part but only if there is no serious risk and with the further
safeguard of parental and judicial consent.
In the common law provinces, what is the situation where the
minor is not mature but is a child? Can the parent or guardian
81 See Gray, Human Subjects in Medical Experimentation (1975), 243-56.
82The most significant state laws are those of New York and California.
See King, Health Policy – Ensuring Informed Consent in Human Experi-
.mentation: A Comparison of the Approaches of Two States (1979) 58 N.
Carolina L. Rev. 137.
83 Research and the Individual (1970), 25.
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COMMENTS – COMMENTAIRES
properly give consent to the child’s participation in research on
the same basis, as though he were volunteering himself? Some
people think that the substituted consent or permission of the
parent or guardian is adequate. I do not agree that the child should
be exposed to risk on this basis. Opinion is, of course, sharply
divided. If advances are to be made in paediatrics then research
must be done on children. I do not think, however, that they should
be exposed to risks for the ultimate benefit of others. The child
should not be exposed to experimentation that carries anything
more than minimal risk. Minimal is, of course, hard to define 4 but
it is more protective of the child than is the usual risk/benefit
formula. There may be rare cases where slightly greater risks are
justified. The testing of Salk vaccine might be an example. I am
not sure that the nationwide tests in the United States caused
merely minimal risk to the children who were first given the vaccine
and yet it turned out to be a boon.
The National Commission, in the United States, has made ten
recommendations respecting research on children. They support
research on children with the approval of an IRB and prescribed
safeguards. The research should not involve more than minimal risk
and the permission of the child and the parent should be given.
Where the risk is more than minimal but the research may benefit
the child himself it may be done if the IRB approves. It may also
be done where the risk is more than minimal if the research may
in future benefit children with the same disease. (This recommenda-
tion was not unanimous.) In other cases where there is a serious
problem in children’s health the research may be done subject to
approval at the national level. There are special protections for
children who are wards of the state or in institutions. 5
The MRC report agrees that research must be done on children
and incompetents. It proposes consent by parent or guardian and,
if that consent is given, a further consent by an ombudsman or
advocate of the child or incompetent. The majority would balance
risk and benefit just as is done where the subject is a competent
adult. Professor Cr6peau refused to expose the minor or incompe-
tent to risk for the benefit of others. The guardian is in a fiduciary
position and has no right to expose his ward to the risks of an
84 The National Commission’s Report on Research Involving Children (1978)
defines minimal risk as “the probability and magnitude of physical or psy-
chological harm .that is normally encountered in the daily lives, or in the
routine medical or psychological examination, of healthy children” (p. xx).
85 Ibid., 1-20.
McGILL LAW JOURNAL
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experiment of no direct benefit to himself. I agree with Professor
Cr~peau.86
B. Research on the mentally infirm
This category of person is analogous to the child. It is quite
possible that in the past drugs have been given and operations
(e.g., pre-frontal lobotomy) have been performed in circumstances
that would not meet the ethical requirements of today. In an Ame-
rican case, Wyatt v. Stickney,87 a class action was brought on behalf
of patients in Alabama’s two mental hospitals to compel them to
improve their facilities and treatment so as to bring them up to
constitutional standards. The Court ordered that this be done and
laid down the minimum standards. These show a humane concern
for the welfare of patients. Two of the standards are relevant here.
The first says that the patient has a right not to be subjected to
experimental research without his informed consent or that of his
guardian and after approval by the institution’s IRB and in com-
pliance with HHS’s rules, which I have set out earlier. The second
says that “patients have a right not to be subjected to treatment
procedures such as lobotomy, electro-convulsive treatment, aversive
reinforcement conditioning or other unusual or hazardous treat-
ment procedures without their express and informed consent after
consultation with counsel or interested party of the patient’s
choice”. In a companion case 88 the Court made a similar order in
connection with institutions for the mentally retarded.
The recommendations of the National Commission in its Report
on Research Involving Those Institutionalized Infirm89 are much
like those for children though there is provision for research being
done over the patient’s objection if a court so authorizes.
In Canada I know of no statute dealing with research on mental
patients. If research is performed and harm befalls them, then the
person doing the research should be legally responsible. Such a case
is unlikely to arise but I know of no common law principle which
permits the guardian or anyone else to expose a mental patient to.
risk that does not come within the concept of health care. When
The Dependent Adults Act was introduced in the Alberta Legislature
in 1975, the Honourable Helen Hunley, the Minister sponsoring the
s6 Supra, note 59, 30-1.
87 (1972) 344 F. Supp. 373 (D.C. Ala 1972).
881bid., 387, af’d sub nom. Wyatt v. Aderholt 503 F. 2d 1305 (5th Cir. 1974).
89 (1978), 1-22.
19813
COMMENTS – COMMENTAIRES
bill, in referring to the guardian’s power to authorize medical
treatment, said this:
Note that the medical treatment must be in the best interests of the
dependent adult as an individual, not the best interests of society. This
is not a provision to give effect to consents to experimental surgery or
involuntary sterilization.9 0
III. Inter vivos transplants
It
is helpful to remember that some human tissue is non-
regenerative. The principal organ of this type in demand for trans-
plants is the kidney. The gift is not fatal to the donor because he has
a remaining kidney. Other tissues are regenerative. The main ones
for transplant purposes are blood, bone marrow and skin, although
skin grafts from one person to another are not usually successful.
Since transplants are modern, there is little authority as
to
one’s right to make a donation. In the case of a competent adult,
the only possible argument against it is that it is a maiming. This
is simply not the case where the tissue is generative. There may be
a stronger argument in the case of a kidney, but even there the
donor is not like the man who cuts off his toes to escape military
service, and it is farfetched to suggest that there is anything un-
lawful in the self-sacrifice of the donor of a kidney. There is of
course the real possibility that the donor consents under pressure
or without knowing the consequences of his sacrifice.
In Canada there is a Uniform Human Tissue Gift Act” which
is in effect in seven provinces and the Northwest Territories. Part
1 provides for inter vivos gifts of tissue. It is limited however to
non-regenerative tissue, which for practical purposes means the
kidney. The donor must be of the age of majority and “able to
make a free and informed decision”. The inference is that his con-
sent must be an informed consent. In my view Part 1 makes no
change whatever in the common law in the case of a competent
adult, though doubtless physicians like to have legislation that
spells out the right to remove a kidney.
Since the Act does not apply to regenerative tissue, the common
law must still apply. In other words, such gifts by competent
adults are permissible. I have no doubt that any court would require
at p. 16.
D0Discussion paper, undated, released 8 July 1975. The passage quoted is
9l See Sugiyama, Inter Vivos Transplantation and the Human Tissue Gift
Act (1976) 34 U. of T. Fac. L. Rev. 124; Clements, The Human Tissue Gift Act
(1979) 3 Legal Med. Q. 39.
McGILL LAW JOURNAL
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informed consent. As to the mature minor, I know of no authority
on the subject. It will be recalled, however, that a mature minor
can agree to run the risks of another person’s negligence. 2 By
analogy one can argue he should be able to consent to run risks
of a gift of tissue in the interest of another’s life or health. When
the age of majority was twenty-one the Canadian Red Cross accept-
ed donations of blood from eighteen-year-old donors. 3 In the
United States, on the other hand, where the view that no minor
can consent even to medical treatment was at one time widely
held, the first marrow and kidney transplants were approved not
only by the parents but by a court.94 One cannot state with confidence
the position as to these transplants under the Canadian common
law. It is possible that the courts would recognize the capacity to
make the donations but would be exacting in the requirement of
informed consent. In Quebec, Article 20 permits a minor “capable
of discernment” to make a gift of tissue on the authority of both
parent and court, and no distinction is made between generative
and non-generative tissue.
The Uniform Human Tissue Gift Act does not deal with regen-
erative tissue, and forbids gifts by minors of non-regenerative tissue.
Should it be amended to permit gifts by mature minors? At one time
the present writer was opposed but is now of the view that with
consent of the parents and approval by a court, a provincial
board and adequate representation of the mature minor, such
legislation can be justified. One can debate whether the provision
should apply to a mature minor (who is like the minor in Quebec
of the age of discernment) or whether it should be fixed at a given
age. The writer prefers the latter, and would keep the age at
sixteen. There is, of course, room for difference of opinion on this
issue.
The excellent report of the Australian Law Reform Commission
on Human Tissue Transplants is instructive. The basic recommen-
dation is that the donor be an adult of sound mind. However, in the
case of minors, there is a recommendation that the transplant may
92 Miller v. Decker [1959] S.C.R. 624; Kubbernus v. Frost (1978) 10 A.R. 445
(S.C., T.D.). In these cases minor passengers were held to be volens in relation
to their driver’s negligence.
93 The writer ascertained this from officials of the Red Cross at Edmonton
in 1963; see Bowker, Legal Liability to Volunteers in Testing New Drugs
(1963) 88 Can. Med. Assn J. 745, 748, n. 33.
94 See Baron, Botsford & Cole, Live Organ and Tissue Transplants from
Minor Donors in Massachusetts (1975) 55 Boston U.L. Rev. 159; Katz, supra,
note 77, 964-72.
1981]
COMMENTS – COMMENTAIRES
be carried out where the tissue is regenerative, and the minor is of
sound mind and agrees to the donation, and a parent consents
and an independent doctor has discussed the proposed removal
with the minor. In the case of non-regenerative tissue, the majority
(four of six) thought it should be lawful when the donor is old
enough to consent and the parents agree and the recipient is a
member of the family, and a special committee of three has approv-
ed. One of the two dissenters was Sir Zelman Cowen, now Governor-
General of Australia. He would simply have prohibited the removal
5 Division 3 of the draft
of non-regenerative tissue from a minor
Ordinance included in the report embodies the majority’s recom-
mendation.
In the Capital Territory, a Transplantation and Anatomy Ordi-
nance embodying the draft Ordinance has been passed with only
minor changes. Queensland and the Northern Territory each passed
an Act on the lines of the draft Ordinance, but omitting Division 3.16
In the United States under the common law it is now generally
agreed that the parents cannot give a valid consent to the donation
of a kidney by their minor child. The consent of the court is re-
quired. In the first case, from Boston in 1957, donor and recipient
were nineteen-year-old identical twins. The judge found that the
healthy twin understood the proposed operation and had con-
sented. Then he accepted psychiatric evidence that the brother’s
death would have a grave emotional impact on the healthy twin.
He held that the operation was necessary for the healthy twin’s
continued health and well-being and that the operation would
confer benefit on him as well as upon the recipient. In the case of
fourteen-year-old twins the same reasoning was appliedV 7 Professor
Curran’s observation was that the “benefit” was more the preven-
tion of possible detriment.98
In the Connecticut case of Hart v. Brown 9 the children were
identical twins just under eight years of age. In authorizing the
transplant, the Court relied more on the right of the parents to
make a substituted judgment than on the theory of psychological
95The Law Reform Commission of Australia, Report No. 7
(1977), 50-1
(para. 112).
96 Letters from Mr Justice M. D. Kirby, Chairman of the Australian Law
Reform Commission, to the writer, dated respectively 25 March 1980 and 30
June 1980.
97Katz, supra, note 77, 971 sets out the judgment.
98 Curran, A Problem of Consent: Kidney Transplantation in Minors (1959)
34 N.Y.U. L. Rev. 891; see also Sharpe, The Minor Transplant Donor (1975)
7 Ottawa L. Rev. 84, 96-9.
99 289 A. 2d 386 (Super. Ct 1972).
McGILL LAW JOURNAL
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benefit. However the Court accepted the opinion that the donor
would enjoy a better future life if her ailing sister were kept alive
and found “some benefit” for the donor.
In the last case, Little v. Little100 from Texas, Anne was a
fourteen-year-old girl with Down’s syndrome. Her younger brother
was threatened with death from kidney failure. On the mother’s
application the Court authorized the transplant. It did so not on
the basis of the “substituted judgment” doctrine, 10 but in view
of the psychological benefits that Anne would receive in the pre-
servation of her brother’s life and satisfaction in making the dona-
tion.
We have been speaking of the minor as a transplant donor. The
position of the mentally incompetent adult is analogous. In the
United States the leading case is Strunk v. Strunk.0 2 Jerry was
twenty-seven years old with the mental age of six. His brother
Tommy required a kidney in order to survive. The only donor in
the family who was suitable from a medical standpoint was Jerry.
The evidence was that he was greatly attached to Tommy and that
Tommy’s visits were important to Jerry as therapy, so that there
was justification for authorizing the transplant. A majority accepted
this evidence. One should not overlook the forceful dissent. In two
subsequent cases, Re Richardson103 and Re Pescinsky’0 4 the Court
refused the order. In the first case, from Louisiana, the Court found
that the transplant would not be in the best interest of the proposed
donor. In the second case, from Wisconsin, the Court held that it
had no jurisdiction to make the order.
As a matter of policy, should there be legislation authorizing
the guardian or the court to give permission to the donation of
tissue by a person who is incompetent either because of age or
mental incapacity? Often the argument is advanced that this is a
matter for the parent or guardian and that the courts and legislature
should not intervene. 05 This assumes that the parent or guardian
100 576 S.W. 2d 493 (Civ. App. 1979).
101 For a strong argument in favour of the substituted-judgment doctrine,
see Robertson, Organ Donations by Incompetents and the Substituted Judg-
ment Doctrine (1976) 76 Colum. L. Rev. 48.
102 445 S.W. 2d 145 (Ky 1969).
103 284 So. 2d 185 (Ct App. La 1973), 284 So. 2d 338 (La 1973).
104 226 N.W. 2d 180 (Wis. 1975).
105See, e.g., Goldstein, Medical Care for the Child at Risk; on State
Supervention of Parental Autonomy (1977) 86 Yale L.
645. At 66870 the
author criticizes Hart v. Brown, not for the result, but because the Court
was not endowed with the capacity to determine what risks to take for
someone else’s child.
19813
COMMENTS – COMMENTAIRES
will always act in the best interests of the child. This assumption
may often be true but certainly not universally. That is why we
have child-welfare statutes. The strongest case for authorization of
the transplant by a court or other tribunal is in the case of identical
twins. From the parents’ standpoint one can understand their wish
to have the donation made. However, the doctrine of the substituted
judgment is questionable and the argument that the donation is
in the best interests of the child is hard to accept. The Ontario Bill
mentioned earlier l
(s. 17(3)) permits the representative of a child
or mental incompetent to consent to a donation of tissue, both
regenerative and non-regenerative, but the approval of a Health
Procedures Protection Committee is required. I cannot find in the
Bill any criteria to guide the Committee. 7 The idea of a Committee
to check abuses is commendable, but particularly in the case of a
proposed kidney transplant, one might think that if it is to be per-
mitted at all when the donor has not capacity to give his own
consent, it should be restricted to a donation between brother and
sister. Indeed I am not persuaded it should be done even in that
case.
IV. Sexual sterilization
Where the person is an adult of sound mind, there is nothing
in the Criminal Code or elsewhere to prevent him or her from
undergoing this procedure.’
The dictum of Lord Denning in
Bravery v. Bravery 9 seems to have misled some people. He said
that it is illegal even when the person agrees to it. This is simply
wrong. However, the operation is, for practical purposes, irre-
versible, and certainly the physician is obliged to explain this to
the patient.
The problem arises in connection with minors and mental in-
competents, and particularly with the retarded, whether minor or
100 The Child Welfare Act, S.O. 1978, c. 85.
107 The nearest relative of one not mentally competent to consent to a
health care service may authorize that service (s. 8(2)); and he must act in
good faith having regard to the best interests of the proposed recipient (s.
12); and health care service means a service provided by a person under The
Health Disciplines Act. The question remains: is the removal of a kidney a
health care service for the donor?
108See Kouri, The Legality of Purely Contraceptive Sterilization (1976) 7
R.D.U.S. 1; Dickens, Eugenic Recognition in Canadian Law (1975) 13 Osgoode
Hall L.. 547, 556-62; Wilson, Voluntary Sterilization: Legal and Ethical Aspects
(1979) 3 Legal Med. Q. 13; Kouri, Non-therapeutic Sterilization (1979) 57 Can.
Bar Rev. 89, 92-4.
109 [1954] 3 All E.R. 59, 67-8 (C.A.).
McGILL LAW JOURNAL
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adult. The early statutes in the United States authorizing steriliza-
tion, sometimes without consent, were principally concerned with
eugenics. In Alberta The Sexual Sterilization Act was along these
lines. Enacted in 1928,110 it was repealed in 1972.1″ As the Act
stood just before repeal, a statutory board could authorize steriliza-
tion of patients with psychosis, mental retardation, syphilis, epilepsy
and Huntington’s chorea. The grounds for sterilization were the risk
of transmission of disease to offspring and the risk of mental injury
to progeny or to the patient. Consent of the patient was required,
except in the case of psychosis, where substituted consent of the
parent or guardian was permitted, and in the case of mental defect-
ives, where no consent was needed.
The Act attracted criticism on both genetic and procedural
grounds. Two geneticists made strident attacks on the Act.” 2 The
motion to repeal” 3 shows that the Government relied on them
heavily. In moving repeal, Mr King had three grounds – medical,
legal and moral. As to the first, the Act was genetically unsound
and the Eugenics Board had not the expertise nor the information
to make sound decisions. Secondly, the Act was ambiguous and had
other flaws (here Mr King relied on Professor McWhirter’s opinion
that those involved in the procedure were guilty of a crime under
the Criminal Code). Thirdly, the Act violated the fundamental human
right to procreate by permitting the government to order the
sterilization of certain people without consent. “It is our view that
this is a reprehensible and intolerable philosophy and program for
this province and this government”, said Mr King. He did not seem
troubled about substituted consent, for he said sterilization could
still be carried out with parental consent.
Since repeal, sterilization of minors has been performed under
Alberta’s health insurance plan. In the period 1976-1978 inclusive,
a total of seventy-eight hysterectomies were performed, eleven
other sterilizations on girls and eight on boys. The reasons given
are retardation and birth defects. As best I can gather, the hysterec-
tomies were related to inability of the females to attend to personal
hygiene.
In Ontario, which has never had a Sterilization Act, there were
fifty of
in 1976 three hundred and eight sterilizations of minors –
110 S.A. 1928, c. 37.
M S.A. 1972, c. 87. The only other province ever to have a Sexual Steriliza-
tion Act was British Columbia: enacted by S.B.C. 1933, c. 59 it was repealed
by S.B.C. 1973, c. 79.
“12 McWhirter & Weijer, The Alberta Sterilization Act, a Genetic Critique
ll 3Alberta Hansard (31 May 1972), 58-33
(1969) 19 U.T.L.J. 424.
to 58-41.
19811
COMMENTS – COMMENTAIRES
boys and the rest of girls, of which one hundred and nine were
hysterectomies .114
As to adult mental defectives in Alberta, I do not know the
position. When The Dependent Adults Act was introduced, the res-
ponsible Minister stated it was not the intention to cover steriliza-
tion. The definition of health care includes contraception but, quite
apart from the Minister’s disclaimer, it would be odd to find that a
legislature which repealed The Sexual Sterilization Act out of
solicitude for the fundamental right to procreate had by a side-
wind conferred on the guardian of a dependent adult the power
to authorize sterilization in the name of contraception.
Turning now to the common law, can a parent give valid consent
to the sterilization of a minor child? Here one must note the common
distinction between therapeutic and non-therapeutic sterilization.
If an organ is diseased and the operation is a by-product of the
removal of the organ, it is obviously therapeutic. Sterilization for
genetic purposes, that is to prevent the birth of a defective child,
is not considered therapeutic, though one could argue that the birth
of such a child might affect the mother’s health. Sterilization for
simple contraceptive purposes is also non-therapeutic whatever be
the motive.
There may be cases where it is hard to classify the sterilization.
Frequently a hysterectomy is performed on retarded girls because
of inability to attend to personal hygiene. The Ontario Association
for the Mental Retarded classifies this as non-therapeutic,”15 whereas
at least some physicians tend to regard it as therapeutic.: 6
In many cases the parents seek sterilization of a minor daughter
because she is more or less retarded and they fear pregnancy. In
England Heilbron J. in Re D117 held this to be non-therapeutic and
made the child a ward to prevent the sterilization. The trend of
decisions in the United States is the same in the case of the minor
and also of the defective adult.”8
114 Cited in Law Reform Commission of Canada, Sterilization (1979), 155,
from Zarfas, Sterilization of the Mentally Retarded (a speech given to the
Ontario Psychiatric Association, 5 October 1978).
115 Ibid., 96-7.
116 This is my understanding from conversations with gynaecologists and
pediatricians, and is at least implied by the Ontario Medical Association
guideline (c) for the sterilization of mentally retarded persons, set out in
the Working Paper, ibid., 102-3.
117 [1976] Fain. 185, [1976] 1 All E.R. 326.
118 See Holder, Legal Issues in Pediatrics and Adolescent Medicine (1977),
274-80.
McGILL LAW JOURNAL
[Vol. 26
In the latter category there is in Canada an important case
now in the courts. It is Re Eve from Prince Edward Island. The
mother applied to be made a committee of her daughter and for
authorization to consent to a tubal ligation. Mr Justice McQuaid
concluded that he had no authority to exercise the role of parens
patriae, much as he sympathized with the mother’s worry over the
danger of pregnancy.” 9 In appeal, this judgment was reversed by a
divided Court.120 Mr Justice Campbell held that the court by reason
of its parens patriae jurisdiction could authorize non-therapeutic
sterilization of a mentally retarded person. He then held that the
sterilization would be in Eve’s best interest and that her committee
should be able to exercise a “substituted right” to choose steriliza-
tion. The operation would not cause Eve substantial injury. Finally,
Campbell J. held that the decision as to the type of operation, tubal
ligation or hysterectomy, should be left to the committee.
Mr Justice Large agreed with the order proposed by Campbell
J. After a lengthy review of the evidence, he distinguished the En-
glish case of Re D on the facts. His conclusion was that the pro-
cedure is a medical one. Just as the court could authorize a blood
transfusion for a child in the face of parental objection, so it can
order the sterilization. It is for her protection.
Mr Justice MacDonald dissented. He held that the proposed
operation was not for Eve’s benefit, welfare or protection, but rather
a deprivation of a basic human right. He said the Court had jurisdic-
tion in exceptional cases to authorize non-therapeutic sterilization
but that this was not one of them. He listed fourteen factors that
should be considered. After quoting at length from a working
paper published by the Law Reform Commission of Canada’-” he
concluded that on the facts before the Court the operation was
not for Eve’s benefit. He expressed a fear that the precedent set in
authorizing her sterilization would mean authorization of steriliza-
tions for mere convenience, and that the Court’s power might be
abused.
One point to note about this case is that the mother did not
attempt to have the sterilization performed without judicial autho-
rization, which, as mentioned above, has in recent years been com-
monplace in the case of defective minors in Ontario and Alberta.
In Re Eve the courts are at least trying to articulate the principle
119Reported sub nom. Re E. (1979) 10 R.F.L. (2d) 317 (P.E.I.S.C.).
120 (1980, 1981) 115 D.L.R. (3d) 283 (P.E.I.S.C. in banco), now in appeal
before the Supreme Court of Canada.
121 Supra, note 114.
1981]
COMMENTS – COMMENTAIRES
on which the authorization should be granted. In my opinion this
should be provided by legislation. The Law Reform Commission’s
working paper has a number of useful suggestions. The trend
today is to provide for sterilization of minor defectives on the basis
of the best interest of the patient, or, in the language of the New
Zealand statute,’2 for the good of the patient. This may include
reasons that would not be within the phrase “therapeutic steriliza-
tion”. The difficult problem is to decide whether to leave the statute
there or whether to spell out criteria. The latter is preferable but
there is always the danger of making them too wide. Any Steriliza-
tion Act, in addition to specifying the grounds for the sterilization,
should provide a careful set of safeguards to ensure that the patient’s
interest will be protected by the court or other tribunal that is
making the decision.
Conclusion
In all of the procedures – medical care, experimentation, trans-
plants and sterilization –
there is need for special solicitude for
those who cannot consent for themselves. Their “best interests”
are of some help. The National Commission had three basic ethical
principles for research on humans –
respect for persons, benefi-
cence and justice.’2 Professor Charles Fried says that in medical
care and research the patient has a right to lucidity, autonomy,
fidelity and humanity. 24 Dr Paul Ramsey speaks frequently of the
“canon of loyalty” which a parent owes to his child, the doctor to
his patient, and the investigator to his subject 25 Although the
application of these various principles is not always self-evident –
indeed one of them may compete with others –
their general ac-
ceptance will help to ensure against the overreaching of those who
cannot consent for themselves.
W. F. Bowker*
’22Contraception,
Sterilization and Abortion Act, 1977, (set out in Steri-
lization, supra, note 114, 149; and the relevant section is s. 10).
123 See The Belmont Report, supra, note 60, 4-10.
124Fried, Medical Experimentation, supra, note 62, 101-4.
2 5 See Patient as Person (1970), passim.
‘
* Of the Institute of Law Research and Reform, Edmonton, Alberta.
