The Legal Status of Clinical and Ethics
Policies, Codes, and Guidelines
in Medical Practice and Research
Angela Campbell & Kathleen Cranley Glass’
This article examines the legal status of “soft law”
in the fields of medicine and medical research. Many
areas of clinical practice and research involve complex
and rapidly changing issues for which the law provides
no guidance. Instead, guidance for physicians and re-
searchers comes from what has often been called “soft
law”-non-egislative, non-regulatory sources, such as
ethics policy statements, codes, and guidelines from
professional or quasi-governmental bodies.
This article traces the evolution of these “soft
law” instruments: how they are created, how they are
adopted within the professional community, and how
they become accepted by the courts. It studies the rela-
tionship between soft law instruments and the courts. It
includes an examination of the approaches to judicial
analysis used by the courts in theory and in practice.
The authors then examine the jurisprudence to see how
courts will adopt professional norms as the legal standard
of care in some circumstances and not others. They con-
sider the legal concerns and ethical issues surrounding the
weight attached to professional practices and norms in
law. The authors demonstrate how practices and poli-
cies that guide professional conduct may ultimately
bear weight as norms recognizable and enforceable
within the legal sphere.
Cet article dtudie le statut juridiquc du soft lam, en
m6decine et en recherche m~dicale. Plusieurs domainzs
de pratique clinique et de recherche subissent dzs
changements rapides ct complexes auxquels Io droit
n’est pas toujours en mesure de doanr une r Cponse
ad6quate. Les mdecins et les chercheurs so rdf?rnt
done it cc qu’on appalle communhmnt soft lm, c’cst-
et non
it-dire
riCglementaires tlles que les dclarations de politique
en mati ,re d’thique, les communiqus,, las cad2s ct las
lignes directrices des organismes profcssionnzls ou
para-gouverementaux.
non Ldgislatives
des
sources
avec
la relation qu’ont les tribunau,
Cet article dtudie IPdvolution des ces instruments
de soft lit en analysant lur mode d cr&tion et la
fagon dont
ils sont acceptds par la communautd
professionnelle puis par les tribunaux. Ls autcures
dtudient
les
instruments de soft lia, ct les approchcs d’analyse
judiciaire qu’ils utiliscnC Elles cxaminent dgaleinent la
jurisprudence pour dtudier la fajon dont las tribunatx
adoptent des normes professionnelles afin d’dAluzr
l’tendue du devoir do prudince dans cerainas
situations. Larticle aborda
les questions juridiquas ct
dthiques soulev&s par l’importance =cord~5c par le
droit aux normes et pratiques profession.lles, et
montre comment les pratiques et les politiquas qui
dirigent la conduite professionnelle
uv=nt dzvenir d-s
normes reconnues par Ie droit.
‘Angela Campbell, B.C.L., LL.B. (McGill); LL.M. (Harvard); Law Clerk at the Supreme Court of
Canada. Kathleen Cranley Glass, LL.B., B.C.,., D.CJ; Director, Biomedical Ethics Unit, McGill
University. This work was funded by the Social Sciences and Humanities Research Council of Can-
ada and the Canadian Institutes of Health Research (Medical Research Council).
McGill Law Journal 2001
Revue de droit de McGill 2001
To be cited as: (2001) 46 McGill LJ. 473
Mode de r~fdrence: (2001) 46 R.D. McGill 473
McGLL LAW JOURNAL / REVUE DE DROITDE MCGILL
[Vol. 46
Introduction
I. Policies, Codes, and Guidelines as “Soft Law”
II. Creation of Policies, Codes of Conduct, and Guidelines
Ill. Development as a Professional Norm
IV. Development as a Legal Norm
A. Judicial Analysis of Professional Norms
B. Circumstances in Which Professional Norms May Be Adopted as the
Legal Standard of Care
C. Concerns about the Weight Attached to Professional Practices and
Norms in Law
Conclusion
2001]
A. CAMPBELL& K.C. GLASS – ETmICS CODES: SOFT LAW
475
4
Introduction
The law affects and regulates much of clinical medicine and research in a number
of ways. A significant body of legislation and case law deals with issues such as pri-
vacy, confidentiality, liberty and security of the person, discrimination, competence to
make choices, and disclosure of information for purposes of consent. Yet there are
many situations faced by practitioners, investigators, patients, and research subjects
that go beyond the scope of current law. Much of the guidance in dealing with com-
plex issues comes from sources such as clinical and ethics policy statements, codes,
and guidelines, which are meant to affect positively the conduct of medical practitio-
ners and clinical investigators. Every medical professional is familiar with some of
these, not the least of which is a code of ethics created by a professional organization,
directing the behaviour of doctors, nurses, and other health care professionals. Other
documents come from specialty societies and national and international organizations.
A number of guidelines, codes, and policies trace their roots to governments, and are
drafted by commissions or government-created agencies. They may deal in a general
way with such issues as confidentiality of an individual’s medical record, or they may
refer to specific issues, such as the creation of human embryos for research.
1. Policies, Codes, and Guidelines as “Soft Law”
Ethics rests primarily on the voluntary actions of individuals, guided by their own
consciences, whereas law is a collectively articulated set of rules backed by the state’s
power to coerce and sanction. In the areas of clinical practice and research, the law
provides only the most general kinds of instruction or prohibition, and is only infre-
quently brought to bear to correct behaviour.’ The role of ethics policies, codes, and
guidelines in legal culture is ambiguous. When they overlap with existing law or are
adopted by legislators in statutes or regulations, it is clear that they represent “legal
standards” or “legal norms” and are binding in judicial decision maling. Standards
that are not enacted in law or regulation, however, do not have a definitive legal status,
even though they may affect the behaviour of health care professionals.
This body of policies, codes, and guidelines has been referred to as “soft law” be-
cause of its uncertain legal status. When the “soft law” at issue deals with profes-
sional, rather than social, standards of conduct, the question of how it should be ap-
plied by a court becomes even more complex. Because the policies, codes, and guide-
lines have not been accepted in law or regulations, it may be argued that they are not
binding on a court. Judges may therefore disregard “soft law” if the standards set by it
are inadequate for ensuring that reasonable care and diligence are exercised in the
‘See AM. Capron, “Research Ethics and the Law” (1983) 128 Prog. Clinical & Biological Res. 13.
MCGILL LAW JOURNAL / REVUE DE DROIT DE MCGILL
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execution of professional responsibilities. The counter-argument is that professional
“soft law” should be shown deference by a court, given that judges do not usually
have sufficient expertise in the field from which the standard emanates and thus are
not fit to substitute their own views for professional opinion.
This article provides an analysis of the legal status of “soft law” in medicine and
medical research. Many areas of clinical practice and research involve complex and
rapidly changing issues for which the law provides no guidance. In this context, guid-
ance for physicians and researchers often comes from non-legislative, non-regulatory
sources, such as ethics policy statements, codes, and guidelines from professional or
quasi-governmental bodies. Clarification of their legal status is thus an important is-
sue. As such, our work is devoted to tracing the evolution of these “soft law” instru-
ments: how they are created, how they are adopted within the professional commu-
nity, and how they become accepted by the courts. This analysis aims to demonstrate
how practices and policies that guide professional conduct may ultimately bear
weight as norms recognizable and enforceable within the legal sphere.
II. Creation of Policies, Codes of Conduct, and Guidelines
The role of policies and guidelines is intimately connected to the history of pro-
fessional self-regulation. For certain professions, most notably law and medicine, self-
regulation dates back to the medieval period, when no central government existed to
dictate codes of conduct for professional groups. Instead, norms concerning accept-
able practice were established by members of the professions themselves.’ In the
medical context, individual physicians functioned as “professionals” and as “entre-
preneurs” before health care systems were financed by the state. Their decisions, both
clinically and economically based, were subject to scrutiny only from the medical
profession, and in the nineteenth century, from peer review and licensing bodies.’
In modem times the state has become the central authority for the regulation of
professional groups. Nevertheless, a key characteristic of professionalism, even by to-
day’s standards, is the power to control professional conduct privately. That is, al-
though the collective authority of the professional group is now granted and delimited
by the state, the autonomy of the individual practitioner within this group is regulated
by the profession itself.’ In this way, it is clear that self-regulation remains an impor-
tant reality for many professional groups, including those in the medical community.
‘See J.K. Lieberman, “Some Reflections on Self-Regulation” in P. Slayton & MJ. Trebilcock, eds.,
The Professions and Public Policy (Toronto: University of Toronto Press, 1978) 89 at 91.
3C. Tuohy & P. O’Reilly, “Professionalism in the Welfare State” (1992) 27 J. Can. Stud. 73.
4Seeibid. at 75, 84.
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A. CAMPBELL & K.C. GLASS -ETHICS CODES:. SOF LAW
477
One of the primary ways that self-regulation is achieved today is through the de-
velopment of practice guidelines that establish normative standards of conduct for
members of a professional community. It is therefore not surprising that most of these
guidelines have traditionally been developed by associations of particular professional
groups. In addition, licensing bodies, accreditation bodies, specialty societies, gov-
ernments, and private sector insurers have also engaged in the formulation of profes-
sional guidelines, although to a lesser extent.5 According to LeBlang, practice guide-
lines in the field of medicine aim to establish the legal standard of care. It is believed
that, by adhering to this standard, health care workers vill be able to defend them-
selves against malpractice claims.6
Medical practice guidelines may, however, serve purposes other than simply pro-
viding legal protection to practitioners in the field. For example, they may also exist to
serve the interests of patients, research subjects, or both. Guidelines and codes inform
patients and subjects of the conduct that the professional must follow in his or her
practice. This empowers those who may otherwise be unaware of their rights regard-
ing treatment or participation in research. According to Brook, access to guidelines
that contain appropriateness ratings of particular treatment procedures would allow
physicians to ensure quality health care for their patients. He maintains that medical
literature must become more specific and directive, and that this can be achieved
through the dissemination of medical practice guidelines.”
Improving the quality of health care may be another incentive for the develop-
ment of guidelines. A 1992 report of the U.S. National Academy of Science’s Insti-
tute of Medicine identified six aspects with which practice guidelines should be con-
cerned! Each of these is related to the goal of providing better health care. These in-
clude cost control, quality assurance, access to health care, patient empowerment, pro-
fessional autonomy, medical liability, and management and rationalization issues.
Once issued, a guideline will be ineffective in fulfilling any of the objectives listed
here until it gains normative status, that is, until it is perceived as establishing how
professional practice must be executed. The following discussion examines how a
guideline becomes normative within the profession, and how it may subsequently be-
come binding in the legal community.
‘SeeR.N. Battista, “Clinical Practice Guidelines: Between Science and Art” (1993) 148 Can. Med.
Ass’nJ. 385 at 386.
‘See T.R. LeBlang, “Medical Malpractice and Physician Accountability. Trends in the Courts and
Legislative Responses” (1994) 3 Ann. Health L. 105 at 118-20.
‘See RH. Brook, “Practice Guidelines and Practicing Medicine: Are They Compatible?” (1989)
262 J.A.MA. 2037.
‘Institute of Medicine (U.S.), Committee on Clinical Practice Guidelines, Guidelines for Clinical
Practice: Front Development to Use (Washington, D.C.: National Academy Press, 1992) at 1-22, as
cited in Battista, supra note 5.
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Ill. Development as a Professional Norm
Guidelines are created to produce an “authoritative reference point” codifying
conduct recognized as good practice, as well as accepted changes in an evolving area
of a profession.! It is only when professionals in the field agree that a standard is a
“scientific principle” governing the proper performance of their duties that they will
perceive the standard as imperative.'” Thus, the guideline becomes normative when it
endorses accepted and followed professional practice.
This theory is supported by research conducted by Smith and Herbert that aimed
to determine the impact of the recommendations issued by the Canadian Task Force
on Periodic Health Examination upon the current practice of preventive medicine in
British Columbia.” The study revealed that only those recommendations which com-
plied with traditional and recommended practice were followed. Recommendations
prescribing new manoeuvres were not adhered to, as physicians elected to continue to
perform traditional practices known to be accepted in the professional community.
Professional custom and behaviour might seem to be more persuasive than a
written guideline in establishing professional norms. Rather than directing customary
practice, effective guidelines could be a consequence of professional custom and be-
haviour, developed only after a practice or particular change to it has been accepted
and adhered to by the professional community. For instance, Brook advocates the
creation of an institution specifically geared towards the development and testing of
practice guidelines. Although this independent organization would formulate the
guidelines, Brook states that, before being used, the guidelines must be “either
strongly considered by the profession or supported by the literature as resulting in
better health”‘” This analysis implies that physicians and researchers will meet the
professional standard of care if their conduct satisfies accepted professional conduct.
Yet if practice guidelines merely codify customary professional practice, one may
question whether they ever result in changing professional norms.” Where guidelines
deal with a practice new to the profession or a practice accepted by some members of
the profession but rejected by another school, they may effect some change to the
practice. In these circumstances, however, the creation of the guideline must be accom-
‘See J. Chalmers, “Guidelines and Consensus Statements: Their Use and Impact” (1995) 9 J. Hum.
Hypertension 37 at 38.
‘” A. Lajoie, “La normativit6 professionnelle dans le droit: trajets et sp cificit6 formelle” (1995) 16
Droit & Soci~t6 159 at 170-71.
” H.E. Smith & C.P. Herbert, “Preventive Practice among Primary Care Physicians in British Co-
lumbia: Relation to Recommendations of the Canadian Task Force on the Periodic Health Examina-
tion” (1993) 149 Can. Med. Ass’n J. 1795.
‘2Brook, supra note 7 at 3030.
“Lajoie, supra note 10 at 187.
2001]
A. CAMPBELL & K.C. GLASS- ETHICS CODES: SOFrI 4W
4
479
partied by other factors for it to acquire normative status. For instance, guidelines must
be widely disseminated to bring them to the attention of professionals in the field and to
allow for a discourse on whether they should affect current professional practice.”
More important to the status of guidelines, however, are the social and economic
incentives and disincentives that may affect medical practice. Such factors determine
whether professionals accept practice guidelines or codes of conduct and to what de-
gree they will modify their professional conduct according to them.” For example, in
a study conducted by Lomas, physicians were often reluctant to modify their practice
after a guideline had been issued. This was due, in large part, to a perceived threat of
malpractice suits against them for following a practice that had not yet been accepted
within the profession. Other disincentives to implementing a guideline included pa-
tient pressure as well as explicit hospital policies that conflicted with the practice rec-
ommended in the guideline. These socio-economic factors usually act as deterrents to
the acceptance of guidelines that prescribe practices yet to be employed by a profes-
sional community. In such circumstances, they rarely succeed in altering professional
practice and thus do not become normative, even at the professional level.'”
A study completed by Browman et aL identified an eight-step process through
which guidelines are developed and implemented. This research revealed a wide-
spread enthusiasm for guidelines, but only a minimal impact on actual clinical prac-
tices. The authors suggested that this may have resulted from a perception among
physicians that guidelines challenge their autonomy in clinical decision making or
that guidelines fail to consider the specific elements of daily practice.” Other disin-
centives to the implementation of some guidelines may pertain to the practicability of
the prescribed procedures. For instance, where a practice recommended by the guide-
line has not been proven to be of any definite benefit to the patient, physicians may be
reluctant to perform this manoeuvre.”
Therefore, generally speaking, members of a profession will accept a policy,
guideline, or code of conduct as establishing the standard of care only when it en-
dorses conduct that is already widely accepted and practiced. The guideline is then
“J. Lomas, “Words without Action? The Production, Dissemination and Impact of Consensus
Recommendations” (1991) 12 Ann. Rev. Pub. Health 41 at 55ff. See also Smith & Herb-,rt, supra
note 11 at 1799.
“J. Lomas, “Do Practice Guidelines Guide Practice? The Effect of a Consensus Statement on the
Practice of Physicians” (1989) 321 New England J. Med. 1306 [hereinafter “Do Practice Guidelines
Guide Practice?”]. See also Lajoie, supra note 10.
16″Do Practice Guidelines Guide Practice?”, ibid.
“See G.P Browman et aL, ‘The Practice Guidelines Development Cycle: A Conceptual Tool for
‘8 Smith & Herbert, supra note 11 at 1978.
Practice Guidelines Development and Implementation” (1995) 13 J. Clinical Oncology 502 at 509.
480
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ascribed normative status, as members of the profession recognize it as the standard of
care to which they must adhere in the exercise of their professional responsibilities.
IV. Development as a Legal Norm
A. Judicial Analysis of Professional Norms
Once a guideline is established as a professional norm, does it have normative
status in the legal context? Could a policy adopted by the American or Canadian Col-
lege of Medical Genetics ever have the normative force of law? Do clinical guidelines,
the opinions of expert witnesses called to testify about the accepted standard of care
within the professional community, or both bind the court? If so, professional norms
or codes of conduct, as presented in written guidelines or through expert testimony,
would automatically represent the legal standard of care.
Judicial analysis of professional responsibility, however, involves more than
merely invoking and following current professional opinion about what is acceptable
practice. Rather, courts will scrutinize and challenge these professional standards to
ensure that they are commensurate with the obligations exacted by law. Policies and
guidelines may assist courts in setting the accepted standard by which an individual or
institution will be judged in any particular case. Yet as Pelly et aL describe, courts re-
main the final arbiters of the legal standard of care, and are thus free to base their
judgments on considerations that reach beyond professional norms and guidelines.”‘
In cases where a court finds that policies or guidelines prescribe inadequate standards,
it must formulate more refined norms that meet the legal criteria of reasonableness
and diligence.
This part of our discussion considers Canadian and American case law that re-
veals the impact that professional norms may exert on a court’s assessment of the le-
gal standard of care imposed upon medical professionals. Yet embodied within this
jurisprudence are concerns related to ethical issues that arise within the context of
medical practice and research. In the same way that clinical practice guidelines help
courts discern whether professional conduct was reasonable and consistent with ac-
cepted practices, so may ethics codes guide their assessment of the moral underpin-
nings of professional choices and behaviour. More specifically, they illuminate the
principles that are valued in a community and a society, and thereby help courts de-
cide whether medical decisions and conduct uphold and promote these moral under-
pinnings. Given the importance that ethical guidelines may have for judicial decision
making, the analysis undertaken in this article regarding the development of “soft
‘ 1J.E. Pelly et al., “Clinical Practice Guidelines before the Law: Sword or Shield?” (1998) 169 Med.
J. Aus. 330 at 332.
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A. CAMPBELL & K.C. GLASS- ETHICS CODES: -SOFr LAW
481
law” into legal norms will include instruments premised on ethics, as wel as princi-
ples not premised on ethics.
Canadian law recognizes that the court, as the ultimate decision maker, is not
bound by the profession’s existing norms. Where the court finds that current profes-
sional practice does not meet the legal standard of reasonableness, no defence can be
made by arguing that all professionals in the field follow similar practice. In these cir-
cumstances, the court may dismiss the professional norm and impose a higher stan-
dard on the profession.? The court’s discretion to refuse to be bound by norms estab-
lished by the medical community has also been recognized in American and Austra-
lian jurisprudence.’
Yet how does a court determine whether a professional policy, code, or guideline
prescribes conduct consistent with a reasonable standard of care? There are two ways
in which this task can be accomplished in the context of ethics.2 First, the court may
ask whether the instrument in question reflects international standards and ethical
codes of conduct. If so, this indicates that the guideline, code, or policy prescribes le-
gally and ethically acceptable conduct. A second point of reference for the court is
domestic law. If the policy, code, or guideline deviates from any statement in locally
applicable statutes, regulations, or jurisprudence concerning the requisite skill re-
quired for the relevant professional group, a court may set it aside. Moreover, if the
instrument is markedly inconsistent with international or domestic standards, the court
may find that the practices advocated by it amount to a breach of the requisite stan-
dard of care.’ This implies a risk of liability for those groups overseeing the formula-
tion of policies, professional codes of conduct, and guidelines.’
This discussion suggests that courts are not obliged to follow professional norms
and guidelines, and are free to impose a separate standard of care acceptable in law. In
reality, however, courts are often left without any choice but to accept professional
practice standards. Although domestic and international legislation, regulations, and
jurisprudence provide a body of juridical norms or “official rules” from which courts
may formulate legal conclusions, these norms are often incomplete or imprecise.?
2See Hopp v. Lepp, [1980] 2 S.C.R. 192, 112 D.L.R. (3d) 67. Regarding professional standards
more generally outside the medical context, see eg. Roberge v. Bolduc, [1991] 1 S.C.R. 374, (sub
nonz. Dorion v. Roberge et aL) 78 D.LR. (4th) 666.
” In the U.S. see Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972); in Australia see E v. R.
‘ See Medical Research Council of Canada, Report of the 1brkng Group on Liabiliy (Otta w
(1983), 33 SAS.R. 189.
MRC, 1990) at 44.
3 /ba at 44-45.
24Pelly et aL, supra note 19.
2Lajoie, supra note 10 at 162-67.
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Therefore, to interpret or complete the law, judges must borrow from extra-juridical
norms, such as professional standards and guidelines.’
A court’s inclusion of a professional standard or guideline in its analysis may re-
sult in the professional norm’s becoming the legally accepted standard of care. For
example, where experts testify that a guideline or policy establishes customary prac-
tice, courts will be reluctant to set this aside and impose another standard of care.’
Thus, while in theory courts are not bound to follow professional standards and
norms, they are unlikely to disregard them when they are supported and endorsed
within the professional community. Once accepted and applied by a judge, the profes-
sional norm becomes legally normative as well.
B. Circumstances in Which Professional Norms May Be Adopted as
the Legal Standard of Care
The transformation of a “soft law”, professional norm into a legal norm fre-
quently occurs in litigation concerning medical practice or research. Where the law
regarding professional responsibility is unclear or incomplete the court will often refer
to non-legal professional instruments to make legal findings. In these cases, the judge
will usually invoke a policy, code, or guideline with expert testimony to determine
whether it represents customary practice. For example, in Institut Philippe Pinel de
Montrial v. A.G.,’ the Quebec Court of Appeal was faced with the issue of whether a
patient in a psychiatric hospital had the capacity to refuse treatment. The majority de-
cision was based primarily on a test established in the Hospitals Act of Nova Scotia.’
Its decision was also heavily influenced by the test expressed at the 1989 annual con-
gress of L’Association des m6decins psychiatres du Qu6bec. Two norms were at play
in this decision: the first was legal in nature, having been adopted in the statute of an-
other province, and the second had normative status within the profession, having
been recognized and followed by the psychiatric community. The court maintained
that these two tests were complete enough to allow for its assessment of an individ-
ual’s capacity to give or refuse consent to treatment. The court also heard expert tes-
timony from three psychiatrists during proceedings that seemed to affect the major-
ity’s finding that the patient was incapable of refusing treatment.
6P. Jestaz, “Rapport de synth~se (Les Standards)” (1988) 4 R.RJ. 1182.
“SeeD. Jutras, “Clinical Practice Guidelines as Legal Norms” (1993) 148 Can. Med. Ass’n J. 905;
see also T.A. Caulfield, “Health Care Reform: Can Tort Law Meet the Challenge?” (1994) 32 Alta. L.
Rev. 685.
[1994] RJ.Q. 2523, [1994] R.D.F. 641 (C.A.).
R.S.N.S. 1989, c. 208, s. 52(2).
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A. CAMPBELL & KC. GLASS- ETHICS CODES: SOFt-L4W
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4
Similarly, in Dodds v. Schierz’ the Quebec Court of Appeal applied both expert
testimony and practice guidelines to assess the question of professional responsibility.
The trial judge had considered only the opinion of medical experts who testified and
those published in medical literature. The Court of Appeal, however, made additional
reference to a report from the Health Protection Branch (“HPB”) of the Department of
Health and Welfare Canada, ruling that the defendant should have been aware of this
report, which warned against the practice he followed. This judgment indicates that
where a policy establishes the level of skill and care required of a reasonable medical
practitioner, such as the policy espoused in the HPB report, it may be applied as a le-
gal norm. In Dodds the court found that the physician committed a professional fault.
The defendant’s practice was not consistent with that advocated in the code of con-
duct established by the HPB and it was a clinical practice that was not supported by
the experts who testified at trial.
In the United States courts have used a similar approach in assessing the validity
and weight of professional norms in litigation related to medical malpractice. For ex-
ample, in Frakes v. Cardiology Consultants” the Tennessee Court of Appeal held that
parameters set by the American College of Cardiology and the American Heart Asso-
ciation for interpreting exercise treadmill tests administered to patients were admissi-
ble as evidence for assessing the liability of a physician accused of negligence. In
particular, the court held that these guidelines represent the standard of care for the
profession. All three experts who testified at trial reported that these guidelines em-
bodied the consensus standard among cardiologists.
This case demonstrates that practice guidelines, when supported by expert testi-
mony, can wield a large impact on a court’s finding that a health care provider is con-
forming with the standard of care. Even when an accepted guideline prohibits or
merely warns against the defendant’s particular behaviour, a court may use that as the
primary basis for its decision. This principle is illustrated in the ruling in DeJong
(Litigation Guardian of) v. Owen Sound General and Marine Hospital.” In its deci-
sion, the court referred to a hospital planning manual issued by the Institutorial Plan-
ning Branch of the Ministry of Health (Ontario) to determine whether a psychiatric
hospital had acted negligently by placing a suicidal patient in a room with windows
that lacked bars or reinforced safety glass. Hoilett J. ruled that, while the manual did
not set out mandatory principles, it established “relevant considerations” for the
court.33 The hospital’s failure to follow the safety measures recommended in the man-
ual thus appeared to contribute to the court’s finding of negligence in the hospital’s
[1986] R.J.Q. 2623,4 Q.A.C. 20 (C.A.) [hereinafterDods].
31 (29 August 1997), Nashville 01-A-01-9702-CV-0069 (Tenn. CA.), [1997] Tenn. App. LEXIS
597, online: LEXIS (Tennessee, APP) [hereinafter Frakes].
“2 [1996] OJ. No. 809 (Gen. Div.), online: QL (OJRE) [hereinafter DeJongl.
3″Ibid at para. 95.
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decisions regarding the patient’s room and the level of observation under which he
was placed.
Policies and guidelines do not always, however, determine the standard of care
that a court will impose on medical professionals. In DeJong the court also made ref-
erence to the Practice Guideline for Major Depressive Disorder in Adults, a publica-
tion of the American Psychiatric Association, to assess whether the hospital adminis-
tered proper doses of anti-depressant medication to the plaintiff. Although the pre-
scription fell within the parameters set by the guideline, the court ruled that the patient
in this case required higher doses of medication. Its finding was based primarily on
the opinions of experts who testified that, while the practice guidelines were generally
accepted and respected, they were not intended to be construed or to serve as a medi-
cal standard of care.’ This view was adopted in the concurring opinion of Koch J. in
Frakes, who held that, although practice guidelines are relevant for assessing the
proper standard of medical care, they should not necessarily be interpreted as “con-
clusive evidence” of this standard.”
Where applicable, the court may look beyond local and national policies and in-
voke guidelines created by international organizations and committees. For instance,
the Helsinki Declaration,’ which outlines the ethical obligations of physicians and re-
searchers who engage in biomedical research, was applied and followed in Weiss v.
Solomon.” In this decision the court was required to determine whether a physician
had satisfied his duty to disclose the risks of an experimental procedure to a volunteer
subject. The court evaluated the subject’s consent in light of legal provisions in the
Civil Code of Qudbec and the Code de diontologie des mddecins. Yet it also elabo-
rated on the principles set out in domestic legislation by referring to the ethical tenets
established in the Helsinki Declaration. Applying this international instrument, the
court concluded that the physician had failed to disclose adequately the risks involved
in participating as a research subject.
This discussion illustrates how a court may invoke non-legal instruments such as
policies, codes, or guidelines to determine questions of professional liability. Where
no legal norm exists in a statute or regulation or in case law, the guideline, profes-
sional norm, or both will have a significant, perhaps even decisive, impact on a
“Ibid. at paras. 110ff.
” Supra note 31 at para. 45.
“Declaration of Helsinki, Recommendations Guiding Medical Doctors in Biomedical Research In.
volving Human Subjects, adopted by the 18th World Medical Assembly, Helsinki, 1964, rev. Tokyo
(1975), Venice (1983), Hong Kong (1989), reprinted in (1997) 277 J.A.M.A. 925 [hereinafter Hel-
sinki Declaration].
” [1989] RJ.Q. 731,48 C.C.L.T. 280 (Sup. Ct.).
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judge’s conclusion. This essentially results in the professional community, rather than
the legislator or the court, determining the legal standard of care.
Although courts have assessed the weight and validity of policies and practice
guidelines primarily in medical malpractice cases, this analysis may also be under-
taken in other contexts. A recent case argued before the Appellate Division of the Su-
perior Court of New Jersey illuminates the ways in which professional norms may in-
fluence the judicial review of regulations developed and enacted by a legislature.” In
its decision, the court considered challenges to regulations adopted by the New Jersey
Department of Banking and Insurance (“DOBr’) pursuant to the Automobile Insur-
ance Cost Reduction Act.” These regulations purported to maintain the quality of
medical care administered to those injured in automobile accidents, while at the same
time discouraging medically unnecessary treatments and diagnostic tests for certain
back and neck injuries. The regulations set out protocols that developed “care paths”
designed to guide the treatment of such injuries, and thus avoid what was perceived as
unnecessary treatment and overuse of benefits. In reviewing the viability of the proto-
cols in question, the court examined the steps undertaken by the DOBI in devising
them. The evidence revealed that Price Waterhouse Coopers (“PWC”), a health bene-
fits consultant that had been enlisted by the DOBI to develop the “care paths”, had
conducted a literature search of standards set by national organizations. PWC also re-
lied on an extensive bibliography of research that cited nationally accepted health care
management and clinical practice guidelines, as well as guidelines formulated by the
medical community and professional boards to determine commonly accepted profes-
sional standards considered beneficial for the treatment of automobile-related neck
and back injuries. In light of this evidence, the court held that “reliable medical lit-
erature’ and “credible medical evidence” had been considered in establishing stan-
dard treatment protocols for the DOBI. This finding contributed to the court’s ultimate
decision to uphold the legislative validity of the “care paths” developed by the DOBI.
In Europe professional guidelines have also exerted an impact on the drafting of
legislation related to medical issues. Where complex matters are involved, legislators
often turn to independent specialist bodies to prepare the technical information un-
derlying law and policy. Where legislation explicitly incorporates a professional norm
and refers to it as the standard of care, guidelines will carry the force of law. Other-
wise, they will bear no definite legal authority and vil not be considered as legally
binding. Yet even in such cases, professional norms may be legally significant, given
See New Jersey Coalition of Health Care Professionals v. New Jersey Departnient of Banking and
Insurance Division ofInsurance, 732 A.2d 1063,323 NJ. Super. 207 (Sup. Ct. 1999).
31 NJ. Stat. 39:6A-1.1 (2000).
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that they represent the “state-of-the-art”, and thus may provide guidance for those
charged with devising law and policy related to intricate medical and ethical issues.’
This analysis reveals the significant impact that professional norms and practices
may wield on judicial decision making. Yet even before a court considers the rele-
vance of professional standards for determining the legal standard of care, it must de-
cide whether expert opinion is admissible evidence for the determination of a profes-
sional norm. In Daubert v. Merrell Dow Pharmaceuticals” the U.S. Supreme Court
established a list of questions, commonly referred to as the “Daubert factors”, that can
be used to test the admissibility of the opinion of an expert scientific witness. Included
among these “Daubert factors” is “[w]idespread acceptance” of the opinion within a
relevant scientific community.2
The Daubert factors were subsequently applied in Moore v. Ashland Chemicals.”
In this decision the majority held that, in assessing the admissibility of expert testi-
mony, a trial judge must first determine whether the witness is qualified as an “ex-
pert”. To do so, the court must consider whether the opinion he or she proffers is
“grounded in the methodology of his discipline, i.e., the body of principles, methods,
rules and postulates of his field of expertise; and whether his opinion is relevant to the
case”
This suggests that, in addition to the requirements set by fundamental evidentiary
rules, the admissibility of expert testimony will be contingent on whether it is consis-
tent with the body of professional “soft law” that currently serves to guide those prac-
tising in a given area of expertise. Courts will rely on professional norms not only to
decide whether the conduct in question meets the legal standard of care, but also to
decide whether it will hear and consider testimony of other professionals regarding
that conduct. In light of Daubert and Ashland, it seems that if the expert opinion prof-
fered does not reflect current accepted practices in a given profession, the court will
not consider that testimony as relevant or reliable, and thus it will not be admitted.
C. Concerns about the Weight Attached to Professional Practices
and Norms in Law
The significant degree to which courts rely on professional norms to discern what
constitutes juridically acceptable professional conduct has been the subject of aca-
‘0 See e.g. PJ. Schwartz et aL, “The Legal Implications of Medical Guidelines-A Task Force of the
European Society of Cardiology” (1999) 20 Euro. Heart J. 1152.
509 U.S. 579, 113 S. Ct. 2786 (1993) [hereinafter Daubert cited to U.S.].
,2Ibid at 594.
41 126 E3d 679 (5th Cir. 1997) [hereinafter Ashland].
“Ibid at 691.
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A. CAMPBELL & KC. GLASS- ETHICS CODES: -SOFT LAW”
487
demic criticism in the legal community. According to Arnold and Sprumont, profes-
sional norms should never be presumed by a court to represent the legal standard of
care. Allowing the guidelines or any professional norm to be the sole source for es-
tablishing the standard of care may result in the self-regulation of professional bodies.
This would insulate professionals from legal scrutiny of their practice, and would di-
minish their accountability to the recipients of their services. They therefore advo-
cate that legislative action be taken to establish the legal standard of care for the medi-
cal profession. This legislation may encompass current medical custom or may im-
pose a more rigorous standard. In either case, it would eliminate the danger of allow-
ing the practice and the profession to be completely self-governing. Similarly, Jutras
maintains the view that, while practice guidelines and professional norms may influ-
ence a court’s decision, they should not be regarded as legal norms. It is only once the
“key legal players”, that is, legislators and judges, have accepted that a professional
norm has met the legal standard of care that it should be binding in judicial decision
makingf
In addition to legal concerns, ethical issues of self-regulation in the medical pro-
fession have also been considered. Because medical professionals do not have an ex-
pertise in ethics, standards set by this community may not be consistent with ideas in-
herent in ordinary social morality and ethics.’For this reason, there must be a constant
dialogue between the medical profession and ethicists about acceptable professional
conduct. As such, to be ethical from a community or social standpoint, guidelines
must reflect not only professional standards, but also the norms of the society in
which professionals function. Thus, just as guidelines cannot be accepted as estab-
lishing the legal standard of care, so they cannot be held to represent the ethical norms
of conduct for professionals in the medical community.
Although concerns regarding professional self-regulation may be well founded in
theory, an approach that advocates fixing all professional norms into the letter of the
law has certain practical difficulties, particularly within the fiamework of newly de-
veloping areas of medicine and research. The ethical issues that surface in such con-
texts are not static; they arise as new knowledge is gained and new technologies are
developed. A legislative approach does not have regard to the evolving nature of
practice in these fields, and would be workable for only some, but not all, of the ethi-
cal issues that may arise.
.R Arnold & D. Sprumont, “The ‘Nuremberg Code’: Rules of Public International Law” in U.
Tr6hler & S. Reiter-Theil, eds., Ethdcs Codes in Medicine: Foundations and Acdievements of Codifi-
cation Since 1947 (Brookfield, Vt.: Ashgate, 1998) 84.
45Jutras, supra note 27.
4′ A. Lynch, ‘Medical Professionalism: Toward a Contemporary Canadian Model” (1992) 27 J.
Can. Stud. 107.
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Conclusion
While policies, codes, and guidelines concerning ethical professional conduct
may exhort certain behaviour, they do not enforce it. What society demands for en-
forcement purposes falls short of what it may promote as ethical conduct. The law’s
collectively articulated provisions, backed by the power of sanction, are representative
of society’s interests. Nevertheless, statutory provisions are cumbersome as instru-
ments, and frequently not flexible or nuanced enough to provide the detailed guidance
required in complex and rapidly developing fields of medicine and research. In some
cases, the standard of care required by the law is less rigorous than the norms estab-
lished in a guideline, policy, or code.
The “soft law” of professional communities has been important in assisting courts
with questions of professional responsibility. In the absence of a legal norm on a par-
ticular issue, “soft law” may be the determinative factor in the outcome of a case.
Legislators may also adopt, or courts may follow, clinical and ethics policies, codes,
or guidelines if they meet the requirements of the legal standard of care. The cases
discussed above demonstrate that a court’s acceptance of these instruments as the le-
gal standard of care involves hearing expert testimony which corroborates the practice
recommended by them. At this last stage of the evolution of policies, codes, or guide-
lines, they become transformed into legal norms, and for the common law, become
binding for future judicial decisions.
This evolution of “soft law” into legal norms may take place within various areas
of medicine and research, and is particularly likely to occur in fields characterized by
rapid and ongoing developments. In this context it is often impossible for the law to
match the pace of change, leaving many aspects of professional conduct unregulated
by legislation or jurisprudence. Continued technological advancements in genetic sci-
ence provide one example of this, and reveal the importance of “soft law” for guiding
clinical practice and research. Physicians and investigators working in genetics are
confronted with novel and complex ethical issues, many of which have yet to be ad-
dressed by the courts or legislatures. As a result, many policies, codes, and guidelines
have been developed for the ethical conduct of clinical genetics and genetic research.
The formulation of “soft law” for guiding genetic medicine and research has been
levels, as well as by profes-
undertaken by bodies at the international ‘ and national
” See e.g. UNESCO, Universal Declaration on the Human Genome and Human Rights (Paris:
UNESCO, 1997), reprinted in Records of the General Conference, UNESCO, 29th Sess., 29 C/Res.
19 (1997) at 41, online: UNESCO
accessed: 11 November 2000); Convention for the Protection of Human Rights and Dignity of the
Human Being with Regard to the Application of Biology and Medicine: Convention on Hutan Rights
and Biomedicine, Eur. T.S. 164, online: Council of Europe
2001]
A. CAMPBELL & K.C. GLASS- ETHICS CODES: SOFT L4w
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4
sional agencies committed to promoting ethical conduct in clinical genetics and ge-
netic research.” These codes, policies, and guidelines provide an ethical framework
for the professional endeavours undertaken within this domain. Yet given the rela-
tively short time since its creation, this body of “soft law” has yet to be the subject of
extensive judicial or legislative attention and interpretation. Nevertheless, in fields as
new and as quickly burgeoning as genetics, the presence of codes, policies, and
guidelines is essential for setting the initial parameters of acceptable clinical and re-
search practices. Moreover, these instruments provide a benchmark for legal institu-
tions seeking to define protocols of professional conduct mandated by law. As the
discussion here reveals, however, whether such professional standards will also bear
normative force at law depends upon either the will of legislators or the judgment of
the courts.
Sciences (CIOMS), ‘International Guidelines for Biomedical Research Involving Human Subjects” in
Z. Bankowski & R.J. Levine, eds., Ethics and Research on Htunan Subjects: International Guide-
lines: Proceedings of the XXVIth CIOMS Conference, Geneva, Switzerland, 5-7 Februat, 1992
(CIOMS: Geneva, 1992) Annex 1.
” In Canada see e.g. Medical Research Council of Canada, National Sciences and Engineering
Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policv
Statement Ethical Conductfor Research Involving Humnans (Ottawu: MRC, 1998).
In the U.K. see eg. Advisory Committee on Genetic Testing, Code of Practice and Guidance on
Hwnan Genetic Testing Services Supplied Direct to the Public (London: Health Departments of the
United Kingdom, 1997), online: Department of Health (U.K.)
Genetic Testing for Late Onset Disorders (London: Health Departments of the United Kingdom,
1997), online: Department of Health (U.K.)
cessed: 11 November2000).
In the U.S. see e.g. National Advisory Council for Human Genome Research, “Statement on Use
of DNA Testing for Presymptomatic Identification of Cancer Risk” (1994) 271 J.A.MA 785; E.
Marshall, “Policy on DNA Research Troubles Tissue Bankers” Science 271″5248 (26 January 1996)
440.
See e.g. American Society of Human Genetics Ad Hoe Committee on DNA Technology, DNA
Banking and DNA Analysis: Points to Consider (1987), online: Federation of American Societies for
Experimental Biology
(date accessed: 11
November 2000); American Society of Human Genetics, “Statement on Informed Consent for Ge-
netic Research” (1996) 59 Am. J. Hum. Genetics 471; American Society of Human Genetics,
“Statement of the American Society of Human Genetics on Genetic Testing for Breast and Ovarian
Cancer Predisposition” (1994) 55 Am. J. Hum. Genetics; American Society of Human Genetics,
Professional Disclosure of Failial Genetic Information (1998), online: Federation of American So-
cieties for Experimental Biology
cessed: 11 November 2000); American College of Medical Genetics Storage of Genetics Materials
Committee, Statenent on Storage and Use of Genetic Materials (1995), online: Federation of Ameri-
can Societies for Experimental Biology
cessed: 11 November 2000).
