What is a medical experiment? Bernard M. Dickens,
ll
Summary: Innovative therapy
b,
ll
m,
may
coincide with medical experimentation, raising ethical and legal issues, for instance on informed consent and institutional review. Medical treatments may be classified, however, to distinguish novel procedures from experimentation.
appear to
Resume: Qu'est-ce que medicale?
ph d
Therapeutic procedures
and
nontherapeutic
The patienfs perspective The difficulties raised by the con¬ cept of normality give warning that a simple distinction between therapeutic and nontherapeutic procedures will not
l'experimentation easily be drawn. It may be proposed, however, that a patient submits to treatment in a therapeutic setting when
On peut imaginer que les traitements d'avant-garde coincident avec I'experimentation medicale, donnant ainsi naissance a des consequences sur les plans ethique et juridique, par exemple, les experiences faites sur des individus ayant donne leur consentement. On devrait cependant
considerer les traitements medicaux de facon a distinguer nettement les procedes d'avant-garde de
I'experimentation.
National and international codes of ethics on human experimentation have become- the backbone of doctrine on the pursuit of medical investigation and innovation since the Nuremberg trials. Legal decisions on experimentation range from that of Slater v. Baker in 17671 to Halushka v. University of Saskatchewan in 1965.2 Despite these materials, however, doubts remain as to the distinctive nature of medical experimentation on human beings, and physicians and researchers are still confused about which treatment is experi¬ mental and which is not. This article is not intended to provide a definitive answer but to contribute thought on the matter, and in particular to isolate legal approaches to the practice of what can be considered novel in med¬ icine.
Reprint requests to: Dr. Bernard M. Dickens, Faculty of law, University of Toronto, Toronto, Ont. M5S 1AX
he intends either to be placed in or returned to a condition one might de¬ scribe as "normal" for the "healthy" person of his age, or to have a patho¬ logie condition alleviated and thus be able to live as well as he can with the disease. A preliminary stage to ther¬ apeutic treatment is diagnosis, but since this may involve procedures more intrusive than the therapy to which it leads, diagnosis may be regarded as closely analogous to, but distinct from,
therapy. Nontherapeutic treatment serves some interest of the subject's other than preservation of his health. If it is pure experimentation he may appear to serve some interest of the investig-
ator's rather than of his own, but his informed consent to this will be based upon his philanthropic or commercial motivation. In the Halushka case, for instance, the subject applied to the university employment office for a vacation job and was paid $50 for his participation. Similarly, a blood donor may be acting under a philanthropic or a commercial incentive, as may a healthy person who allows medical students to train on him. This latter submission to treatment must be distinguished, however, from that of a patient's in a university or teaching hospital, since his treatment there is usually therapeutic, even if given by students. The power to use a patient in procedures not intended for his therapy depends on the patient's sep¬ arately informed consent, notwith¬
standing that giving such consent may be a precondition to his hospital ad¬ mission for therapy. Mixed motives Approaching medical treatment from the patient's perspective may permit some distinction between ther¬ apeutic and nontherapeutic procedures, but it begs important questions of the mixed motives of particular medical personnel. Reducing the procedures to their elements, therapeutic procedures are intended to yield knowledge for aiding the patient, whereas experimen¬ tal procedures are intended to yield knowledge for
its
own
sake, irrespec¬
tive of the patient who, in this regard, is better described as the subject. In
practice, however, a treating physician may be inspired in giving a patient bona fide therapy by a strong sense of novel inquiry. Therapeutic innovation in seeking to aid a patient may be acknowledged. The fact of novelty alone, however, does not make the procedure experi¬ mental. Equally, any benefit contrived for the subject of nontherapeutic ex¬ perimentation does not make the ex¬ perimental procedure therapeutic. If the advantage is unrelated to the ex¬ periment, such as admission for sep¬ arate therapy to a teaching hospital, the therapy is a different medical transaction from the research. If the advantage arises out of the experiment, the subject may be said to have a commercial motivation, being remunerated for participation not in money but in kind, for instance in better health screening. In a sense, routine treatment of a patient's standard symptoms is a step into the unknown. The patient may react to orthodox medication in un¬ predictable ways, and much medical progress continues to be made by trac¬ ing the pathogenesis of unexpected responses. Nevertheless, the physician's intention to give orthodox treatment
CMA JOURNAL/OCTOBER 4, 1975/VOL. 113 635
and the patient's intention to receive it will render the patient's management nonexperimentally therapeutic. A dif¬ ficulty occurs when the physician, intending therapy, decides to treat the patient in a new way, for instance by applying a new technique for the diag¬ nosed condition or varying the dosage in the usual treatment. // no orthodox treatment exists for the patient's con¬ dition (either because of the condition's novelty or because the orthodox treat¬ ment has become discredited by ad¬ vances in medical knowledge) the phy¬ sician's innovation will be nonexperimental. Indeed, in the absence of any medically accepted treatment, and per¬ haps in the presence of knowledge of attempted treatments that have failed, the doctor must have recourse to novel procedures. //, however, an orthodox treatment
it will be
exists, any departure from
experimental if deliberate,
and negligent if not. Evidence of the orthodox The lawyer approaches the existence or the absence of a standard treatment or treatments for a given condition as a matter of evidence. The search for such evidence is based on information in the recognized textbooks, the opinions of professionally acknowl-
edged leading authorities, current teaching in both medical schools and continuing education courses, and in¬ formation in the common circulating medical journals. The test is objective rather than subjective, accepting an identifiable body of contemporary medical knowledge. Authorities may disagree about the medical nature of a condition, of course, regarding its origin and features, and therefore about its best treatment. For the pur¬ pose of analysis in principle, however, it must be presupposed that some pro¬ fessional consensus exists on how given conditions may properly be managed. Management has some built-in flex¬ ibility. Dosages may be varied within
forced
by the contractual relation of physician and patient, in which the physician's obligation was to attempt to cure only by application of orthodox techniques. The leading case of Slater v. Baker1 in 1767 turned upon this. A noted English surgeon had agreed to treat and straighten the plaintiff's broken leg. The accepted method was to apply compression until the broken bone knitted together, but Baker used a device he had recently developed to extend the leg. When the bone failed to heal properly the plaintiff sued for breach of contract and succeeded; the physician, who by implication had agreed to use proper skill and methods, was held to have acted "ignorantly and unskilfully, contrary to the known rule and usage of surgeons". This case remains good law, but today courts would probably recognize the distinction between negligent treat¬ ment, whether in departure from or¬ thodox management or otherwise, and deliberate use of a new procedure, giving the patient or subject full in¬ formation available and taking all pos¬ sible safeguards against adverse reac¬ tions, including, for instance, conducting prior testing on animals when ap¬ propriate. Nevertheless, when orthodox therapy is available, and the new treat¬ ment
is administered to
prove
more
treatment
see if it will successful, use of the new will be experimental, even
before it is undertaken. Application of a routine therapy that leads to a breakthrough in knowledge when its results are analysed remains nonexperimental. Equally, an investigator who abandons novel treatment when it threatens to cause harm or to prove fruitless and who then reverts to orthodox therapy has still experimented; he has, indeed, shown the new procedure likely to be of little avail in the circumstances in which he used it. If a procedure is applied as acknowledged orthodox therapy its status is clear, but when it is applied to train the personnel involved in its nonthera¬ peutic application rather than to test the procedure itself, its use may be described as educational rather than experimental. It is usual, of course, for such training to be combined with a therapeutic purpose, the trainee act¬ ing under the direction of an experi¬ enced supervisor who is at hand in case of emergency. Such treatment given in university or teaching hos¬ pitals ranks as normal therapy. In some
instances, however, a procedure may be performed nontherapeutically not so much to train personnel as to test the procedure, for instance by identically repeating an earlier recorded ex¬ periment to analyse its methodology and validate or refute its findings. While this may have an educational aspect it must be ranked as an experi¬ ment. The point at which an initial experiment has evolved into an acknowledged procedure is a matter of professional judgement as established by specialized professional and legal methods. A variant of experimentation by re¬ peating a novel technique is applying a technique orthodox in one setting to untried circumstances; this new use will be tantamount to an experiment, for the difference between applying a novel technique of treating a condition and applying one that is orthodox for
though, upon proving more success¬ ful, it will become the new orthodox treatment. This is recognized at the University of Toronto in that research projects aimed at testing standard ther¬ apeutic treatments with a view to their improvement must be submitted for approval to a human experimentation review committee. Investigators are in¬ formed that university policy on use of human subjects applies to research if: "You will administer a drug, take a blood sample, do a test, or perform any procedure, clinical, therapeutic or otherwise, upon the person of yourself one condition to treat a new condition limits, and different treatments may or someone else, for research rather is semantic rather than substantive. be known to be more or less suitable, than treatment." The problem of mixed motives is Randomized clinical trials depending on different surrounding conditions and likely reactions. Fur¬ approached by seeking to identify not A separate dilemma concerns the ther, some standard treatments may the predominant motive but any signs type of randomized clinical trial in be shown in time to produce adverse of an investigational motive. This prop¬ which one of two or more acknowlside effects, and the evolutionary na¬ erly attempts to protect the patient edged orthodox treatments for a con¬ ture of medical progress results in from even minor experimentation dition is given to a sufferer by random transitional periods when one treatment being concealed within the interstices selection to see whether he makes is superseding another as standard of orthodox therapy, exposing it to the better or worse progress than patients therapy. Nevertheless, the concept of light of peer review and ethical (includ¬ receiving another orthodox treatment. proper management can identify or¬ ing legal) assessment. Cautious and In so far as each treatment given is thodox treatment, and any departure restrained development of an orthodox orthodox therapy, this situation ap¬ from this will be experimentation or procedure the investigator suspects to pears to be nonexperimental. The pa¬ be inadequate will rank as experimental tient's random selection for one such negligence. unless so minor as to come within the treatment is hoped to produce useful Legal development flexible limits of the orthodox. knowledge, but the procedure itself is no less a therapy. Random selection of Historically, the law regarded ex¬ Characterizing procedures perimentation as a species of negli¬ patients for different therapies is no A procedure must be characterized different from randomly distributing gence. This understanding was rein636 CMA JOURNAL/OCTOBER 4, 1975/VOL. 113
physically cosmetic (Globe and Mail, receive emotional satisfaction from his Mar. 15, 1975, page 6). act, which may be a considerable sacrifice when he donates an organ to The profit motive another, even if the other is a close The sale of body parts inter vivos relative. This will not make the act is generally proscribed in Canada un¬ a therapy for him, however, since it der provincial legislation based on the provides him with no remedy but satisfy requirements on confidentiality model Human Tissue Act, except for rather enhances his sense of social or regarding access to records but it is the sale of blood.4 Apart from donating spiritual worth. If, indeed, he suffers not experimental medicine. Ethical blood for payment, however, a person from such a sense of personal worthcriteria for access to records are less may make himself available for the lessness that he feels compelled to demanding than criteria for access to service of medical or dental students, make a heroic sacrifice he may be in the patient's body, and legal tests, for who may carry out inspections and need of psychiatric or psychological instance on informed consent, are more limited orthodox procedures that he help and be unsuitable as a donor. In easily satisfied.3 In a randomized clin¬ does not need. With the exception of many cases in practice, philanthropic ical trial contrasting an orthodox ther¬ fellow students and instructors, and subjects of nontherapeutic treatments apy with a placebo, however, the possibly nurses and hospital auxiliary of an educational and experimental placebo administration appears to be staff, few persons will do so unless nature are already patients undergoing driven by poverty, or perhaps by des- related or perhaps unrelated therapy. medically experimental. to obtain money to buy al¬ They may agree, for instance, to ad¬ peration, Diagnosis cohol or drugs, as the celebrated 1971 ditional blood testing or weighing or The distinctions that exist in therapy study by Titmuss, "The Gift Relation¬ measuring as part of a project making may be drawn regarding diagnosis. ship",5 memorably showed regarding no contribution to their treatment. When there is no standard diagnosis blood donors in the United States. The Their consent to the nontherapy is then for a condition, the use of a new tech¬ suitability of such persons to be sub¬ better sought by someone other than nique in the hope that it will prove jects of experimentation is question- a member of their therapeutic team. diagnostically effective cannot be con¬ able, and it is fortunate that few, if Apart from the legal presumption that sidered experimental. Similarly, when any, educational purposes require a physician exercises undue influence orthodox forms of diagnosis yield no them. Nevertheless, in pure experi¬ in taking the initiative to engage his information on the patient's condition, mentation, for instance into the com¬ patient in transactions intended for the mon cold, novel treatments may require a new form may be applied to see if it physician's advantage, the patient's will prove instructive. New knowledge testing of subjects who may be en¬ freedom of will may in fact have been will emerge as a byproduct of the use couraged to give their time by being subverted. Even in the outpatient situ¬ of the new form, successful or unsuc¬ offered commercial rates. This treat¬ ation he may feel an urge to please cessful, but the physician's sole motive ment, of course, will be experimental, those upon whom he feels dependent for it aims at creating knowledge and for treatment necessary to preserve his is to aid his patient. not at aiding any particular subject. health. Cosmetic treatment Cosmetic treatment in principle is Philanthropy Therapy in clinical practice The philanthropic subject of non¬ nontherapeutic because it concerns a physical condition that at its worst is therapeutic medical procedures can do Diagrammatic analysis All of the above reasoning may be not so serious as to constitute a threat all that the commercially motivated to health; a condition of such gravity subject can do, and more regarding given graphical expression, as in Table would be classified as in need of cor¬ body-part donation. The fact that he I. Among the dangers of a diagramma¬ rection. The condition may cause the receives a nominal payment for par¬ tic presentation are that it draws divi¬ sufferer psychological harm, however, ticipation in an experiment, to cover sions that are too sharp, and experi¬ and may require therapy on this expenses and in recognition of his dedi- ences are distorted to conform to it, ground; remedial cosmetic treatment cation, does not convert him into a achieving artificiality in the cause of may thus coincide with psychological commercially motivated subject. The a specious neatness. Nevertheless, giv¬ therapy. Usually, however, cosmetic distinction may be decreasingly ob¬ en instances can be rationalized in the treatment concerns conditions that are vious, however, as the honorarium as- format of the diagram, such as the normal, but it enhances the physical sumes commercial proportions in rela¬ historic Slater v. Baker1 judgement appearance, or increases the psycho¬ tion to the task and the risk involved. (therapeutic-physiological-novel-orthological confidence or comfort of the Unlike the commercially motivated dox existing experimental), modern subject, however, the philanthropic kidney donation (nontherapeutic-phipatient, or does both. An uncertain distinction concerns subject may donate tissue for trans¬ lanthropic-orthodox-donation non¬ such treatments as preparing special plantation, such as a kidney. Even the experimental), therapeutic innovation shoes to correct bandy legs, or dental first human kidney transplant was not (therapeutic-( )-novel-no orthodox work upon unsightly teeth, which may experimental, although by definition existing nonexperimental), correc¬ be regarded as orthodox corrective it was novel. The practice of safe kid¬ tion of protruding ears (either nonther¬ therapy or as physically enhancing ney removal was long established, no apeutic cosmetic-enhancing-psycholocosmetic treatment. The distinction is doubt being safer when the donor was gical nonexperimental, or therapeunot purely academic, for government healthy, and the recipient received the tic-psychological-orthodox nonex¬ health schemes may accommodate organ for transplantation when there perimental) and variation of standard therapy but not extend to cosmetic was no orthodox treatment for failure diagnosis (diagnostic-novel-orthodox treatment. In Ontario, for instance, the of both of his. The procedure may existing experimental). minister of health was recently per- have been regarded as experimental, Although the diagram is not defini¬ suaded to change an earlier ruling and however, in that dialysis may have tive, its utility may be measured by decide that the correction of protrud- been considered an established ortho¬ testing its accommodation of further medical treatments. Such testing may ing ears in a 14-year-old girl is psy- dox alternative therapy. Often the philanthropic subject will either permit classification or identify chologically therapeutic and not simply between different physicians known to adhere to different views as to the best orthodox treatment for the condition. Comparison of records of the differently treated patients is hu¬ man research but it does not constitute medical experimentation. It needs to
patients
=
=
.
.
.
=
=
=
=
CMA JOURNAL/OCTOBER 4, 1975/VOL. 113 637
legally relevant issues that must be resolved in particular procedures for their use to be classified as experi¬ mental or nonexperimental. 1. Acupuncture. This procedure is relatively new to Canadian medicine, and if used for conditions having or¬ thodox treatments it will be experi¬ mental. If used for a condition for which no orthodox cure exists, how¬ ever, it would be novel therapy but the
5. Ritual circumcision. This
non¬
therapeutic procedure is cosmetic in the psychological sense of contributing to an individual's sense of well-being through identification with a group to which he belongs (usually through birth) or that he wants to join. 6. Heart transplantation. This physiologically therapeutic procedure may be considered orthodox, subject to its known success rate, and so be not ex¬ not experimental. perimental; alternatively, however, it 2. Vasectomy. This is nontherapeu¬ may still be considered novel, but in tic in that it serves no health need of so far as no other technique exists for the man, and is cosmetic in the sense preserving the patient's life in the con¬ that it releases him from the tension dition heart transplantation intends to the threat of an unwanted pregnancy remedy, it may again appear to be may cause. In removing worry it has nonexperimental. a psychological effect, although this may also lead to improvement in physi¬ Artificial insemination cal performance. A stimulus to thinking about the 3. Genetic screening. This is a diag¬ first principles of medical treatment nostic procedure to see if therapy is arises in considering artificial insemina¬ possible for an inherited condition, or tion, by husband or donor. Pregnancy to see how future procreational ob- may be considered to serve a woman's stacles can be managed. It may now emotional rather than physical needs, be accepted as an orthodox medical and so be psychologically therapeutic, but to think in terms of need may it¬ technique and is not experimental. 4. Placebo treatment of a standard self be emotional. Any detriment to physical/ mental disorder. In treating a physical health through denial of preg¬ disorder psychosomatically, effectively nancy may be psychosomatic and no withholding orthodox therapy will be less requiring of treatment for that experimentation. If a placebo treatment reason. Pregnancy that does not relieve proves no less effective than orthodox an unhealthy condition, however, but treatment, however, the former may provides an elevated sense of fulfilbe classified as within the range of ment, may be considered cosmetic, in the sense of being not necessary for proper management.
continued health but
an
enhancing
formed consent, but those of such un¬ sound mind as to be suitable for it are
Table I.Diagrammatic analysis of medical treatment Medical treatment
Therapeutic
Diagnostic
Physiological
Nontherapeutic
Psychiatric
ical
Cosmetic
Philanthropic
procedure
Psychosurgical
motivation
Enhancing
Physical Orthodox
technique
Orthodox
Novel
therapy
technique
Experiment
No orthodox
technique exists
Psychological
r
Novel
Orthodox
therapy
technique
Novel
technique
i-'-1
-1
Orthodox technique exists
Commercial motivation
-1
Rem< Remedial
Orthodox therapy exists
Experiment
638 CMA JOURNAL/OCTOBER 4, 1975/VOL. 113
No orthodox
therapy exists
Donation
ex¬
perience a woman may want for its psychological advantage in making her feel more a woman and more confident in her sexual role. Further, if it relieves any depression associated with obstacles to conception, it may be part of the link uniting remedial cosmetic treatment with psychological therapy. Psychosurgery Psychosurgical procedures are de¬ signed to apply physical treatment of the brain to a psychiatric condition having a behavioural expression. It may be an orthodox therapeutic treat¬ ment within the limits of existing knowledge, but it cannot be claimed that these limits are accommodating. Most psychosurgery would be novel treatment. Further, forms of orthodox therapy, notably drug therapy, exist for much that psychosurgery would hope to achieve, giving its use beyond the limits of its known effects the status of experimentation. The prospect of such novel psychosurgery being more effective than orthodox therapies makes it no less experimental, of course, at least until the practice of psychosurgery has made further pro¬ gress. A restriction upon progress, how¬ ever, is its experimental status, which may place it in a "Catch-22" situation. It can be performed only with in¬
Educational
Novel
nqui inquiry
Experiment
incapable of giving that consent. How psychosurgery can break out of this definitional stranglehold is not clear, but successful animal experimentation and some modest sheltering behind the prestige of psychiatry may be an advantage. In practice, psychosurgery may be extended by the careful and slow process of working outwards from its existing confined basis as orthodox therapy.
Cryobiology The strength of this analysis may be tested by considering possible medical procedures so advanced that no successful or even important development in them has yet occurred. The idea has been proposed, for instance, of applying techniques of cryobiology to deep-freeze the body of a person close to death for preservation until a cure for the cause of the impending death has been developed. A cryobiological process would be physiological therapy of a novel nature, but since no orthodox therapy exists for what it attempts to do - namely, indefinitely to postpone the patient succumbing to disease and to death itself - it would be a nonexperimental therapeutic innovation. The conclusion that to use such a procedure would not be experimental may seem to defy logic. Nevertheless, considering an incident solely within the context of its particular facts, to apply a freezing process that enables a patient to remain alive or virtually in a state of suspended animation when no orthodox treatment can, may be conscientiously presented as analogous to other procedures in which innovative techniques are employed in the face of the ineffectiveness of existing orthodox resources. The problems raised by a technique of suspended animation are greater than can be considered now, however, since they involve both legal and medical questions of whether the patient is alive in the frozen condition. Legal distinctions Since the dividing line between therapeutic innovation and experimentation appears fine at this point, it may in conclusion be stated why it has to be drawn. Different legal incidents are relevant to treatments on different sides of the division. In therapy, including innovative therapy, the physician has the discretion to withhold certain information from his patient when he believes it would prove harmful if given. He must protect his patient from more serious adverse reaction to learning the details of his condition or the full risks of its proposed treatment. Accordingly, the patient may give a lower level of informed consent to treatment.
The right to withhold certain in- References formation is commonly described as 1. Slater v. Baker, 2 Wils LKB] 359; 95 Eng Rep 860, 1767 the physician's therapeutic "privilege", 2. Halushka v. University of Saskatchewan, 53 although the decision not to invoke it DLR 2d 436 (Sask CA), 1966 may constitute malpractice.6'7 In addi3. DICKENS BM: Information for Consent in tion, a patient unable to give prior conhuman experimentation. U of Toronto Law ,1 24: 381, 1974 sent (for instance, because he is unCt al: conscious) may be considered to have 4. MIDDLETON RB, FOSTER M, KEEVER H,material Provincial law for giving transplant given implied consent, affording the moving toward uniformity. Can Med Assoc I 108: 1455, 1973 physician legal authority for the treatment applied for the patient's relief 5. TurMuss RM: The Gift Relationship: from Human Blood to Social Policy. London, Allen and benefit. This is so even when the & Unwin, 1971 orno treatment is innovative because 6. Male v. Hopmans, 2 0 R 457, 465 (Ont CA), thodox therapy exists for the patient's 1967 condition. The innovation may in ex7. Natanson v. Kline, 350 P 2d 1093, 1103 (Sup Ct Kan), 1960 treme cases also be legally subsumed under the heading of treatment necessary to save human life. None of this applies, however, to medical experimentation. Here, the requirement of fully informed consent applies, and in this type of case the courts are increasingly insistent that the subject of the treatment be spared no detail of his relevant condition or AND DIVING MEDICINE. Downsof his exposure to risk. Withholding SUBMARINE view. Ont. Oct. 27 to Nov. 15, 1975. Information: information is liable to condemnation Dr. G.H. Koch, Defence and Civil Institute of Environmental Medicine, 1133 Sheppard Ave. W, and the consequences of operating on P0 Box 2000, Downaview, Ont. the subject without his legal consent. Further, a subject cannot be assumed ORTHOP.DIE. H6pital Saint-Joseph, La Malbale, Le 27 octobre 1975. Renselgnements: Dr to give implied consent to being used P0. Robert Gourdeau, Directeur, education m6dlcale for medical experimentation that is not continue, Facult6 de medecine, Universit. Laval. necessary treatment in that other and Quebec, P0 GiK 7P4 orthodox diagnostic or therapeutic pro- CHIRURGIE. Centre hospitalier de Charlevoix, Le 28 octobre 1975. Rencedures exist for him if he requires Bale Saint-Paul.Dr P0.Robert Gourdeau, Directeur. treatment. It may be added that, in the seignements: education m6dicale contInue, Facult. de m6deuniversity context, experimentation cine, Universit6 Laval, Quebec, P0 GiK 7P4 may require the prior approval of a ABDOMEN AIGU. Centre hospitaller Jonqui.rehuman experimentation review com- Arvida, PG. Le 28 octobre 1975. Renselgnements m6dimittee, whereas no committee (other Dr Robert Gourdeau. Directeur, education continue, Facult. de m6declne, Univerait. than a therapeutic abortion committee) cale Laval, Qu6bec, P0 GiK 7P4 need screen therapy, even of the innovative variety. MUSCULOSKELETAL CONGENITAL DISORDERS. 2-115. Clinical Sciences Building, University This legal framework governing ex- ofRm.Alberta, Edmonton. Oct. 29, 1975. Information: perimentation may not appear to dam- Dr. W. Yakimets, Director. Division of continuRm. 12-103. Clinical age the public and professional interest ing medical education, Sciences Building, University of Alberta, Edmonin medical progress. Innovation is not ton, Alta. T6G 2G3 experimental when orthodox medicine PHYSIOTHERAPY. St. Paul RHEUMATOLOGY provides no adequate treatment for a Hospital, St. Paul,AND Aita. Oct. 29, 1975. Informaa of the pursuit so given condition, tion: Dr. W. Yakimets, Director, division of conRm. 12-103. Clinical new treatment when none exists is not tinuing medical education, Sciences Building, University of Alberta, Edmondemost demanding by the impaired ton, Alta. T6G 2G3 gree of informed consent, and it may Red Deer General Hospital, Red indeed be undertaken with implied THERAPEUTICS. Deer, Alta. Oct. 29, 1975. Information: Dr. W. consent. When, however, a patient can Yakimets, Director, Division of continuing medical education. Rm. 12-103, ClinIcal Sciences be given orthodox therapy, any varia- Building. University of Alberta, Edmonton, Alta. tion or withholding of that therapy is T6G 2G3 informed proper only with his fully P.RINATALIT.. HOtel Dieu dAlma. Alma, P0. Le consent. Thus, an acceptable social bal- 30 octobre 1975. Renselgnements: Dr Robert Gourof ance is struck between the needs deau, Directeur, education m6dicale continue, medical progress by innovation and Facult6 de m6decine, Universit6 Laval, Ou6bec. experimentation, and the patient's right P0 GiK 7P4 P0. not unknowingly to be exposed to risk DIAB.TE. HOpital Saint-Joseph. Beaucevi le,Robert 30 octobre 1975. Renseignements: Dr in diagnosis or treatment in advancing La continue, Gourdeau. Directeur, education m6dlcale medical knowledge. Facult6 de medecine, Universit. Laval, Quebec, P0 GiK 7P4 The author is indebted to his colleague HOtel-Dieu de Rivi6re-du-Loup. Professor E.J. Weinrib, BA, LL B, Ph D H.MATOLOGIE. Riviere-du-Loup, P0. Le 30 octobre 1975. Renselfor comments in the preparation of this gnemants: Dr Robert Gourdeau, Directeur, .dupaper. Professor Weinrib is not account- cation m6dicale continue, Facult6 de m6decine, able, of course, for the views expressed. Universit6 Level, Ou6bec, P0 GIK 7P4 CMA JOURNAL/OCTOBER 4, 1975/VOL. 113 639
P.btgrrnduet'
ll
Summary: Innovative therapy
b,
ll
m,
may
coincide with medical experimentation, raising ethical and legal issues, for instance on informed consent and institutional review. Medical treatments may be classified, however, to distinguish novel procedures from experimentation.
appear to
Resume: Qu'est-ce que medicale?
ph d
Therapeutic procedures
and
nontherapeutic
The patienfs perspective The difficulties raised by the con¬ cept of normality give warning that a simple distinction between therapeutic and nontherapeutic procedures will not
l'experimentation easily be drawn. It may be proposed, however, that a patient submits to treatment in a therapeutic setting when
On peut imaginer que les traitements d'avant-garde coincident avec I'experimentation medicale, donnant ainsi naissance a des consequences sur les plans ethique et juridique, par exemple, les experiences faites sur des individus ayant donne leur consentement. On devrait cependant
considerer les traitements medicaux de facon a distinguer nettement les procedes d'avant-garde de
I'experimentation.
National and international codes of ethics on human experimentation have become- the backbone of doctrine on the pursuit of medical investigation and innovation since the Nuremberg trials. Legal decisions on experimentation range from that of Slater v. Baker in 17671 to Halushka v. University of Saskatchewan in 1965.2 Despite these materials, however, doubts remain as to the distinctive nature of medical experimentation on human beings, and physicians and researchers are still confused about which treatment is experi¬ mental and which is not. This article is not intended to provide a definitive answer but to contribute thought on the matter, and in particular to isolate legal approaches to the practice of what can be considered novel in med¬ icine.
Reprint requests to: Dr. Bernard M. Dickens, Faculty of law, University of Toronto, Toronto, Ont. M5S 1AX
he intends either to be placed in or returned to a condition one might de¬ scribe as "normal" for the "healthy" person of his age, or to have a patho¬ logie condition alleviated and thus be able to live as well as he can with the disease. A preliminary stage to ther¬ apeutic treatment is diagnosis, but since this may involve procedures more intrusive than the therapy to which it leads, diagnosis may be regarded as closely analogous to, but distinct from,
therapy. Nontherapeutic treatment serves some interest of the subject's other than preservation of his health. If it is pure experimentation he may appear to serve some interest of the investig-
ator's rather than of his own, but his informed consent to this will be based upon his philanthropic or commercial motivation. In the Halushka case, for instance, the subject applied to the university employment office for a vacation job and was paid $50 for his participation. Similarly, a blood donor may be acting under a philanthropic or a commercial incentive, as may a healthy person who allows medical students to train on him. This latter submission to treatment must be distinguished, however, from that of a patient's in a university or teaching hospital, since his treatment there is usually therapeutic, even if given by students. The power to use a patient in procedures not intended for his therapy depends on the patient's sep¬ arately informed consent, notwith¬
standing that giving such consent may be a precondition to his hospital ad¬ mission for therapy. Mixed motives Approaching medical treatment from the patient's perspective may permit some distinction between ther¬ apeutic and nontherapeutic procedures, but it begs important questions of the mixed motives of particular medical personnel. Reducing the procedures to their elements, therapeutic procedures are intended to yield knowledge for aiding the patient, whereas experimen¬ tal procedures are intended to yield knowledge for
its
own
sake, irrespec¬
tive of the patient who, in this regard, is better described as the subject. In
practice, however, a treating physician may be inspired in giving a patient bona fide therapy by a strong sense of novel inquiry. Therapeutic innovation in seeking to aid a patient may be acknowledged. The fact of novelty alone, however, does not make the procedure experi¬ mental. Equally, any benefit contrived for the subject of nontherapeutic ex¬ perimentation does not make the ex¬ perimental procedure therapeutic. If the advantage is unrelated to the ex¬ periment, such as admission for sep¬ arate therapy to a teaching hospital, the therapy is a different medical transaction from the research. If the advantage arises out of the experiment, the subject may be said to have a commercial motivation, being remunerated for participation not in money but in kind, for instance in better health screening. In a sense, routine treatment of a patient's standard symptoms is a step into the unknown. The patient may react to orthodox medication in un¬ predictable ways, and much medical progress continues to be made by trac¬ ing the pathogenesis of unexpected responses. Nevertheless, the physician's intention to give orthodox treatment
CMA JOURNAL/OCTOBER 4, 1975/VOL. 113 635
and the patient's intention to receive it will render the patient's management nonexperimentally therapeutic. A dif¬ ficulty occurs when the physician, intending therapy, decides to treat the patient in a new way, for instance by applying a new technique for the diag¬ nosed condition or varying the dosage in the usual treatment. // no orthodox treatment exists for the patient's con¬ dition (either because of the condition's novelty or because the orthodox treat¬ ment has become discredited by ad¬ vances in medical knowledge) the phy¬ sician's innovation will be nonexperimental. Indeed, in the absence of any medically accepted treatment, and per¬ haps in the presence of knowledge of attempted treatments that have failed, the doctor must have recourse to novel procedures. //, however, an orthodox treatment
it will be
exists, any departure from
experimental if deliberate,
and negligent if not. Evidence of the orthodox The lawyer approaches the existence or the absence of a standard treatment or treatments for a given condition as a matter of evidence. The search for such evidence is based on information in the recognized textbooks, the opinions of professionally acknowl-
edged leading authorities, current teaching in both medical schools and continuing education courses, and in¬ formation in the common circulating medical journals. The test is objective rather than subjective, accepting an identifiable body of contemporary medical knowledge. Authorities may disagree about the medical nature of a condition, of course, regarding its origin and features, and therefore about its best treatment. For the pur¬ pose of analysis in principle, however, it must be presupposed that some pro¬ fessional consensus exists on how given conditions may properly be managed. Management has some built-in flex¬ ibility. Dosages may be varied within
forced
by the contractual relation of physician and patient, in which the physician's obligation was to attempt to cure only by application of orthodox techniques. The leading case of Slater v. Baker1 in 1767 turned upon this. A noted English surgeon had agreed to treat and straighten the plaintiff's broken leg. The accepted method was to apply compression until the broken bone knitted together, but Baker used a device he had recently developed to extend the leg. When the bone failed to heal properly the plaintiff sued for breach of contract and succeeded; the physician, who by implication had agreed to use proper skill and methods, was held to have acted "ignorantly and unskilfully, contrary to the known rule and usage of surgeons". This case remains good law, but today courts would probably recognize the distinction between negligent treat¬ ment, whether in departure from or¬ thodox management or otherwise, and deliberate use of a new procedure, giving the patient or subject full in¬ formation available and taking all pos¬ sible safeguards against adverse reac¬ tions, including, for instance, conducting prior testing on animals when ap¬ propriate. Nevertheless, when orthodox therapy is available, and the new treat¬ ment
is administered to
prove
more
treatment
see if it will successful, use of the new will be experimental, even
before it is undertaken. Application of a routine therapy that leads to a breakthrough in knowledge when its results are analysed remains nonexperimental. Equally, an investigator who abandons novel treatment when it threatens to cause harm or to prove fruitless and who then reverts to orthodox therapy has still experimented; he has, indeed, shown the new procedure likely to be of little avail in the circumstances in which he used it. If a procedure is applied as acknowledged orthodox therapy its status is clear, but when it is applied to train the personnel involved in its nonthera¬ peutic application rather than to test the procedure itself, its use may be described as educational rather than experimental. It is usual, of course, for such training to be combined with a therapeutic purpose, the trainee act¬ ing under the direction of an experi¬ enced supervisor who is at hand in case of emergency. Such treatment given in university or teaching hos¬ pitals ranks as normal therapy. In some
instances, however, a procedure may be performed nontherapeutically not so much to train personnel as to test the procedure, for instance by identically repeating an earlier recorded ex¬ periment to analyse its methodology and validate or refute its findings. While this may have an educational aspect it must be ranked as an experi¬ ment. The point at which an initial experiment has evolved into an acknowledged procedure is a matter of professional judgement as established by specialized professional and legal methods. A variant of experimentation by re¬ peating a novel technique is applying a technique orthodox in one setting to untried circumstances; this new use will be tantamount to an experiment, for the difference between applying a novel technique of treating a condition and applying one that is orthodox for
though, upon proving more success¬ ful, it will become the new orthodox treatment. This is recognized at the University of Toronto in that research projects aimed at testing standard ther¬ apeutic treatments with a view to their improvement must be submitted for approval to a human experimentation review committee. Investigators are in¬ formed that university policy on use of human subjects applies to research if: "You will administer a drug, take a blood sample, do a test, or perform any procedure, clinical, therapeutic or otherwise, upon the person of yourself one condition to treat a new condition limits, and different treatments may or someone else, for research rather is semantic rather than substantive. be known to be more or less suitable, than treatment." The problem of mixed motives is Randomized clinical trials depending on different surrounding conditions and likely reactions. Fur¬ approached by seeking to identify not A separate dilemma concerns the ther, some standard treatments may the predominant motive but any signs type of randomized clinical trial in be shown in time to produce adverse of an investigational motive. This prop¬ which one of two or more acknowlside effects, and the evolutionary na¬ erly attempts to protect the patient edged orthodox treatments for a con¬ ture of medical progress results in from even minor experimentation dition is given to a sufferer by random transitional periods when one treatment being concealed within the interstices selection to see whether he makes is superseding another as standard of orthodox therapy, exposing it to the better or worse progress than patients therapy. Nevertheless, the concept of light of peer review and ethical (includ¬ receiving another orthodox treatment. proper management can identify or¬ ing legal) assessment. Cautious and In so far as each treatment given is thodox treatment, and any departure restrained development of an orthodox orthodox therapy, this situation ap¬ from this will be experimentation or procedure the investigator suspects to pears to be nonexperimental. The pa¬ be inadequate will rank as experimental tient's random selection for one such negligence. unless so minor as to come within the treatment is hoped to produce useful Legal development flexible limits of the orthodox. knowledge, but the procedure itself is no less a therapy. Random selection of Historically, the law regarded ex¬ Characterizing procedures perimentation as a species of negli¬ patients for different therapies is no A procedure must be characterized different from randomly distributing gence. This understanding was rein636 CMA JOURNAL/OCTOBER 4, 1975/VOL. 113
physically cosmetic (Globe and Mail, receive emotional satisfaction from his Mar. 15, 1975, page 6). act, which may be a considerable sacrifice when he donates an organ to The profit motive another, even if the other is a close The sale of body parts inter vivos relative. This will not make the act is generally proscribed in Canada un¬ a therapy for him, however, since it der provincial legislation based on the provides him with no remedy but satisfy requirements on confidentiality model Human Tissue Act, except for rather enhances his sense of social or regarding access to records but it is the sale of blood.4 Apart from donating spiritual worth. If, indeed, he suffers not experimental medicine. Ethical blood for payment, however, a person from such a sense of personal worthcriteria for access to records are less may make himself available for the lessness that he feels compelled to demanding than criteria for access to service of medical or dental students, make a heroic sacrifice he may be in the patient's body, and legal tests, for who may carry out inspections and need of psychiatric or psychological instance on informed consent, are more limited orthodox procedures that he help and be unsuitable as a donor. In easily satisfied.3 In a randomized clin¬ does not need. With the exception of many cases in practice, philanthropic ical trial contrasting an orthodox ther¬ fellow students and instructors, and subjects of nontherapeutic treatments apy with a placebo, however, the possibly nurses and hospital auxiliary of an educational and experimental placebo administration appears to be staff, few persons will do so unless nature are already patients undergoing driven by poverty, or perhaps by des- related or perhaps unrelated therapy. medically experimental. to obtain money to buy al¬ They may agree, for instance, to ad¬ peration, Diagnosis cohol or drugs, as the celebrated 1971 ditional blood testing or weighing or The distinctions that exist in therapy study by Titmuss, "The Gift Relation¬ measuring as part of a project making may be drawn regarding diagnosis. ship",5 memorably showed regarding no contribution to their treatment. When there is no standard diagnosis blood donors in the United States. The Their consent to the nontherapy is then for a condition, the use of a new tech¬ suitability of such persons to be sub¬ better sought by someone other than nique in the hope that it will prove jects of experimentation is question- a member of their therapeutic team. diagnostically effective cannot be con¬ able, and it is fortunate that few, if Apart from the legal presumption that sidered experimental. Similarly, when any, educational purposes require a physician exercises undue influence orthodox forms of diagnosis yield no them. Nevertheless, in pure experi¬ in taking the initiative to engage his information on the patient's condition, mentation, for instance into the com¬ patient in transactions intended for the mon cold, novel treatments may require a new form may be applied to see if it physician's advantage, the patient's will prove instructive. New knowledge testing of subjects who may be en¬ freedom of will may in fact have been will emerge as a byproduct of the use couraged to give their time by being subverted. Even in the outpatient situ¬ of the new form, successful or unsuc¬ offered commercial rates. This treat¬ ation he may feel an urge to please cessful, but the physician's sole motive ment, of course, will be experimental, those upon whom he feels dependent for it aims at creating knowledge and for treatment necessary to preserve his is to aid his patient. not at aiding any particular subject. health. Cosmetic treatment Cosmetic treatment in principle is Philanthropy Therapy in clinical practice The philanthropic subject of non¬ nontherapeutic because it concerns a physical condition that at its worst is therapeutic medical procedures can do Diagrammatic analysis All of the above reasoning may be not so serious as to constitute a threat all that the commercially motivated to health; a condition of such gravity subject can do, and more regarding given graphical expression, as in Table would be classified as in need of cor¬ body-part donation. The fact that he I. Among the dangers of a diagramma¬ rection. The condition may cause the receives a nominal payment for par¬ tic presentation are that it draws divi¬ sufferer psychological harm, however, ticipation in an experiment, to cover sions that are too sharp, and experi¬ and may require therapy on this expenses and in recognition of his dedi- ences are distorted to conform to it, ground; remedial cosmetic treatment cation, does not convert him into a achieving artificiality in the cause of may thus coincide with psychological commercially motivated subject. The a specious neatness. Nevertheless, giv¬ therapy. Usually, however, cosmetic distinction may be decreasingly ob¬ en instances can be rationalized in the treatment concerns conditions that are vious, however, as the honorarium as- format of the diagram, such as the normal, but it enhances the physical sumes commercial proportions in rela¬ historic Slater v. Baker1 judgement appearance, or increases the psycho¬ tion to the task and the risk involved. (therapeutic-physiological-novel-orthological confidence or comfort of the Unlike the commercially motivated dox existing experimental), modern subject, however, the philanthropic kidney donation (nontherapeutic-phipatient, or does both. An uncertain distinction concerns subject may donate tissue for trans¬ lanthropic-orthodox-donation non¬ such treatments as preparing special plantation, such as a kidney. Even the experimental), therapeutic innovation shoes to correct bandy legs, or dental first human kidney transplant was not (therapeutic-( )-novel-no orthodox work upon unsightly teeth, which may experimental, although by definition existing nonexperimental), correc¬ be regarded as orthodox corrective it was novel. The practice of safe kid¬ tion of protruding ears (either nonther¬ therapy or as physically enhancing ney removal was long established, no apeutic cosmetic-enhancing-psycholocosmetic treatment. The distinction is doubt being safer when the donor was gical nonexperimental, or therapeunot purely academic, for government healthy, and the recipient received the tic-psychological-orthodox nonex¬ health schemes may accommodate organ for transplantation when there perimental) and variation of standard therapy but not extend to cosmetic was no orthodox treatment for failure diagnosis (diagnostic-novel-orthodox treatment. In Ontario, for instance, the of both of his. The procedure may existing experimental). minister of health was recently per- have been regarded as experimental, Although the diagram is not defini¬ suaded to change an earlier ruling and however, in that dialysis may have tive, its utility may be measured by decide that the correction of protrud- been considered an established ortho¬ testing its accommodation of further medical treatments. Such testing may ing ears in a 14-year-old girl is psy- dox alternative therapy. Often the philanthropic subject will either permit classification or identify chologically therapeutic and not simply between different physicians known to adhere to different views as to the best orthodox treatment for the condition. Comparison of records of the differently treated patients is hu¬ man research but it does not constitute medical experimentation. It needs to
patients
=
=
.
.
.
=
=
=
=
CMA JOURNAL/OCTOBER 4, 1975/VOL. 113 637
legally relevant issues that must be resolved in particular procedures for their use to be classified as experi¬ mental or nonexperimental. 1. Acupuncture. This procedure is relatively new to Canadian medicine, and if used for conditions having or¬ thodox treatments it will be experi¬ mental. If used for a condition for which no orthodox cure exists, how¬ ever, it would be novel therapy but the
5. Ritual circumcision. This
non¬
therapeutic procedure is cosmetic in the psychological sense of contributing to an individual's sense of well-being through identification with a group to which he belongs (usually through birth) or that he wants to join. 6. Heart transplantation. This physiologically therapeutic procedure may be considered orthodox, subject to its known success rate, and so be not ex¬ not experimental. perimental; alternatively, however, it 2. Vasectomy. This is nontherapeu¬ may still be considered novel, but in tic in that it serves no health need of so far as no other technique exists for the man, and is cosmetic in the sense preserving the patient's life in the con¬ that it releases him from the tension dition heart transplantation intends to the threat of an unwanted pregnancy remedy, it may again appear to be may cause. In removing worry it has nonexperimental. a psychological effect, although this may also lead to improvement in physi¬ Artificial insemination cal performance. A stimulus to thinking about the 3. Genetic screening. This is a diag¬ first principles of medical treatment nostic procedure to see if therapy is arises in considering artificial insemina¬ possible for an inherited condition, or tion, by husband or donor. Pregnancy to see how future procreational ob- may be considered to serve a woman's stacles can be managed. It may now emotional rather than physical needs, be accepted as an orthodox medical and so be psychologically therapeutic, but to think in terms of need may it¬ technique and is not experimental. 4. Placebo treatment of a standard self be emotional. Any detriment to physical/ mental disorder. In treating a physical health through denial of preg¬ disorder psychosomatically, effectively nancy may be psychosomatic and no withholding orthodox therapy will be less requiring of treatment for that experimentation. If a placebo treatment reason. Pregnancy that does not relieve proves no less effective than orthodox an unhealthy condition, however, but treatment, however, the former may provides an elevated sense of fulfilbe classified as within the range of ment, may be considered cosmetic, in the sense of being not necessary for proper management.
continued health but
an
enhancing
formed consent, but those of such un¬ sound mind as to be suitable for it are
Table I.Diagrammatic analysis of medical treatment Medical treatment
Therapeutic
Diagnostic
Physiological
Nontherapeutic
Psychiatric
ical
Cosmetic
Philanthropic
procedure
Psychosurgical
motivation
Enhancing
Physical Orthodox
technique
Orthodox
Novel
therapy
technique
Experiment
No orthodox
technique exists
Psychological
r
Novel
Orthodox
therapy
technique
Novel
technique
i-'-1
-1
Orthodox technique exists
Commercial motivation
-1
Rem< Remedial
Orthodox therapy exists
Experiment
638 CMA JOURNAL/OCTOBER 4, 1975/VOL. 113
No orthodox
therapy exists
Donation
ex¬
perience a woman may want for its psychological advantage in making her feel more a woman and more confident in her sexual role. Further, if it relieves any depression associated with obstacles to conception, it may be part of the link uniting remedial cosmetic treatment with psychological therapy. Psychosurgery Psychosurgical procedures are de¬ signed to apply physical treatment of the brain to a psychiatric condition having a behavioural expression. It may be an orthodox therapeutic treat¬ ment within the limits of existing knowledge, but it cannot be claimed that these limits are accommodating. Most psychosurgery would be novel treatment. Further, forms of orthodox therapy, notably drug therapy, exist for much that psychosurgery would hope to achieve, giving its use beyond the limits of its known effects the status of experimentation. The prospect of such novel psychosurgery being more effective than orthodox therapies makes it no less experimental, of course, at least until the practice of psychosurgery has made further pro¬ gress. A restriction upon progress, how¬ ever, is its experimental status, which may place it in a "Catch-22" situation. It can be performed only with in¬
Educational
Novel
nqui inquiry
Experiment
incapable of giving that consent. How psychosurgery can break out of this definitional stranglehold is not clear, but successful animal experimentation and some modest sheltering behind the prestige of psychiatry may be an advantage. In practice, psychosurgery may be extended by the careful and slow process of working outwards from its existing confined basis as orthodox therapy.
Cryobiology The strength of this analysis may be tested by considering possible medical procedures so advanced that no successful or even important development in them has yet occurred. The idea has been proposed, for instance, of applying techniques of cryobiology to deep-freeze the body of a person close to death for preservation until a cure for the cause of the impending death has been developed. A cryobiological process would be physiological therapy of a novel nature, but since no orthodox therapy exists for what it attempts to do - namely, indefinitely to postpone the patient succumbing to disease and to death itself - it would be a nonexperimental therapeutic innovation. The conclusion that to use such a procedure would not be experimental may seem to defy logic. Nevertheless, considering an incident solely within the context of its particular facts, to apply a freezing process that enables a patient to remain alive or virtually in a state of suspended animation when no orthodox treatment can, may be conscientiously presented as analogous to other procedures in which innovative techniques are employed in the face of the ineffectiveness of existing orthodox resources. The problems raised by a technique of suspended animation are greater than can be considered now, however, since they involve both legal and medical questions of whether the patient is alive in the frozen condition. Legal distinctions Since the dividing line between therapeutic innovation and experimentation appears fine at this point, it may in conclusion be stated why it has to be drawn. Different legal incidents are relevant to treatments on different sides of the division. In therapy, including innovative therapy, the physician has the discretion to withhold certain information from his patient when he believes it would prove harmful if given. He must protect his patient from more serious adverse reaction to learning the details of his condition or the full risks of its proposed treatment. Accordingly, the patient may give a lower level of informed consent to treatment.
The right to withhold certain in- References formation is commonly described as 1. Slater v. Baker, 2 Wils LKB] 359; 95 Eng Rep 860, 1767 the physician's therapeutic "privilege", 2. Halushka v. University of Saskatchewan, 53 although the decision not to invoke it DLR 2d 436 (Sask CA), 1966 may constitute malpractice.6'7 In addi3. DICKENS BM: Information for Consent in tion, a patient unable to give prior conhuman experimentation. U of Toronto Law ,1 24: 381, 1974 sent (for instance, because he is unCt al: conscious) may be considered to have 4. MIDDLETON RB, FOSTER M, KEEVER H,material Provincial law for giving transplant given implied consent, affording the moving toward uniformity. Can Med Assoc I 108: 1455, 1973 physician legal authority for the treatment applied for the patient's relief 5. TurMuss RM: The Gift Relationship: from Human Blood to Social Policy. London, Allen and benefit. This is so even when the & Unwin, 1971 orno treatment is innovative because 6. Male v. Hopmans, 2 0 R 457, 465 (Ont CA), thodox therapy exists for the patient's 1967 condition. The innovation may in ex7. Natanson v. Kline, 350 P 2d 1093, 1103 (Sup Ct Kan), 1960 treme cases also be legally subsumed under the heading of treatment necessary to save human life. None of this applies, however, to medical experimentation. Here, the requirement of fully informed consent applies, and in this type of case the courts are increasingly insistent that the subject of the treatment be spared no detail of his relevant condition or AND DIVING MEDICINE. Downsof his exposure to risk. Withholding SUBMARINE view. Ont. Oct. 27 to Nov. 15, 1975. Information: information is liable to condemnation Dr. G.H. Koch, Defence and Civil Institute of Environmental Medicine, 1133 Sheppard Ave. W, and the consequences of operating on P0 Box 2000, Downaview, Ont. the subject without his legal consent. Further, a subject cannot be assumed ORTHOP.DIE. H6pital Saint-Joseph, La Malbale, Le 27 octobre 1975. Renselgnements: Dr to give implied consent to being used P0. Robert Gourdeau, Directeur, education m6dlcale for medical experimentation that is not continue, Facult6 de medecine, Universit. Laval. necessary treatment in that other and Quebec, P0 GiK 7P4 orthodox diagnostic or therapeutic pro- CHIRURGIE. Centre hospitalier de Charlevoix, Le 28 octobre 1975. Rencedures exist for him if he requires Bale Saint-Paul.Dr P0.Robert Gourdeau, Directeur. treatment. It may be added that, in the seignements: education m6dicale contInue, Facult. de m6deuniversity context, experimentation cine, Universit6 Laval, Quebec, P0 GiK 7P4 may require the prior approval of a ABDOMEN AIGU. Centre hospitaller Jonqui.rehuman experimentation review com- Arvida, PG. Le 28 octobre 1975. Renselgnements m6dimittee, whereas no committee (other Dr Robert Gourdeau. Directeur, education continue, Facult. de m6declne, Univerait. than a therapeutic abortion committee) cale Laval, Qu6bec, P0 GiK 7P4 need screen therapy, even of the innovative variety. MUSCULOSKELETAL CONGENITAL DISORDERS. 2-115. Clinical Sciences Building, University This legal framework governing ex- ofRm.Alberta, Edmonton. Oct. 29, 1975. Information: perimentation may not appear to dam- Dr. W. Yakimets, Director. Division of continuRm. 12-103. Clinical age the public and professional interest ing medical education, Sciences Building, University of Alberta, Edmonin medical progress. Innovation is not ton, Alta. T6G 2G3 experimental when orthodox medicine PHYSIOTHERAPY. St. Paul RHEUMATOLOGY provides no adequate treatment for a Hospital, St. Paul,AND Aita. Oct. 29, 1975. Informaa of the pursuit so given condition, tion: Dr. W. Yakimets, Director, division of conRm. 12-103. Clinical new treatment when none exists is not tinuing medical education, Sciences Building, University of Alberta, Edmondemost demanding by the impaired ton, Alta. T6G 2G3 gree of informed consent, and it may Red Deer General Hospital, Red indeed be undertaken with implied THERAPEUTICS. Deer, Alta. Oct. 29, 1975. Information: Dr. W. consent. When, however, a patient can Yakimets, Director, Division of continuing medical education. Rm. 12-103, ClinIcal Sciences be given orthodox therapy, any varia- Building. University of Alberta, Edmonton, Alta. tion or withholding of that therapy is T6G 2G3 informed proper only with his fully P.RINATALIT.. HOtel Dieu dAlma. Alma, P0. Le consent. Thus, an acceptable social bal- 30 octobre 1975. Renselgnements: Dr Robert Gourof ance is struck between the needs deau, Directeur, education m6dicale continue, medical progress by innovation and Facult6 de m6decine, Universit6 Laval, Ou6bec. experimentation, and the patient's right P0 GiK 7P4 P0. not unknowingly to be exposed to risk DIAB.TE. HOpital Saint-Joseph. Beaucevi le,Robert 30 octobre 1975. Renseignements: Dr in diagnosis or treatment in advancing La continue, Gourdeau. Directeur, education m6dlcale medical knowledge. Facult6 de medecine, Universit. Laval, Quebec, P0 GiK 7P4 The author is indebted to his colleague HOtel-Dieu de Rivi6re-du-Loup. Professor E.J. Weinrib, BA, LL B, Ph D H.MATOLOGIE. Riviere-du-Loup, P0. Le 30 octobre 1975. Renselfor comments in the preparation of this gnemants: Dr Robert Gourdeau, Directeur, .dupaper. Professor Weinrib is not account- cation m6dicale continue, Facult6 de m6decine, able, of course, for the views expressed. Universit6 Level, Ou6bec, P0 GIK 7P4 CMA JOURNAL/OCTOBER 4, 1975/VOL. 113 639
P.btgrrnduet'
