AUGUST 200 I ------------ THE SOUTHERN AFRICAN JOURNAL OF HIV MEDICINE

LEGAL AND ETHICAL ISSUES

Steve Andrews, ME ChB, MCFP (SA)
Brooklyn Medical Centre, Cape rerum

Further, the concept of informed consent has slightly
different meanings when viewed legally (a viewpoint

surrounding physician liability in failing to inform, disclose

and assess correctly) and when viewed morally (an ethical

view regarding respect fa" individual autonomy). The
viewpoints are not exclusive: but it is ·important to separate

them if the process of obtaining informed consent is not to

become a legalistic ritual. It is also of importance that this
schema does not assign an overriding importance to

autonomy, and certain autonomy rights may be less
pressing in the face of more weighty moral demands (for

example justice, and the constraints and requirements of

resource allocation). This does not invalidate the concept of

autonomy, or that of informed consent, but emphasises the

interrelatedness of these ideas at a societallevel.

Threshold elements (preconditions)
• Competence (to understand and decide)
• Voluntariness (in deciding)

influences as to what is best for you because of your status

as a self-determining individual'). Autonomy has value in
its own right, but also has instrumental value, as it

promotes individual well-being.

Beauchamp and Childress' define an approach to informed

consent by dividing elements of the concept into those
relating to information and those relating to consent. They

also refer in their definition to the preconditional elements

relating to individual competence and voluntariness in
making decisions.

Informational elements

• Disclosure (of material information)
• Recommendation of (a plan)
• Understanding (of disclosed information and proposed

plan)

Consent elements
• Decision (in favour of or against a plan)
• Authorisation/rejection (of plan)

Some of the specific issues raised by HIV will be analysed in

the light of this model, presenting theoretical and practical

applications to the dilemmas presented. First, however, it is

Historically, the term informed consent is a relatively recent

one. From ancient times until the 1950s, disclosure and

consent-seeking behaviour were largely governed by a

beneficence model. This is well stated in the writings of

Hippocrates: 'Declare the past, diagnose the present,

foretell the future; practise these acts. As to disease, make
a habit of two things - to help, or at least do no harm~'

'Both the low ond morality require thot 0 heolth

professionol obtoin 0 patient's voluntory, informed
consent before providing medical treotment"

A review of the topic with reference to the particular problems posed
by the HIV pandemic

WHAT IS INFORMED CONSENT?

INFORMED CONSENT AND HIV

The above statement would seem to be a fairly
uncontroversial one. Few health care professionals would

argue with the need to obtain informed consent before

intervening in any patient's life. The extent and meaning of
the terms 'informed', and 'consent', however, cause

significant debate. This paper will address a concept and

definition of informed consent, and illustrate that schema
with particular aspects of HIV-related problems in the

application of the principle in day-to-day clinical practice.
It is hoped that the arguments presented will alter the

perception of informed consent as being a signature on a

piece of paper legally indemnifying the professional from

litigation, to one of a dynamic process vital in the
strengthening of the ongoing doctor-patient relationship.

Further, it should be seen as one of the tools for the

breaking down of the terrible secrecy that surrounds this

illness, and which hampers the effective use of available

methodologies for prevention and treatment of HIV and
AIDS.

Driven by the Nuremberg judgements on the Nazi atrocities

of World War II and the emergence of the legal concept of

informed consent in 1957, various external socio-political

forces, and the emergence of a new schema of medical

ethics, shifted the emphasis of disclosure and consent.

Beneficence-based models of ethics ('Because of my

medical knowledge I know what is best for you, and you

will do it') shifted to those centred on patient autonomy ('I

respect your right to decide and to act without controlling



THE SOUTHERN AfRICAN JOURNAL OF IIIV MHICINE ------------

important to decide whether this framework is applicable

to the specific situation we find ourselves in.

This schema has been challenged as being founded on an

individualistic philosophy of personal autonomy, one

which may be at odds with certain cultural value systems,

particularly in the context of communitarian societies. This

argument, known as cultural relativism, implies different

moral values across societies, and must be seriously

considered before entertaining the application of an

individual autonomy-based doctrine of informed consent

in as diverse a cultural environment as South Africa. This is

particularly true when considering issues surrounding HIV,

which have significant personal as well as community

implications. Rachels' challenges the general concept,

arguing that while the application of principles may differ

between societies, the basic moral principles themselves do

not change because of the basic existence requirements of

societies themselves. Lindegger and Richter; argue more

specifically in the South African setting regarding the issue

of autonomy and informed consent in HIV. They present

data from phase I vaccine trial work in KwaZulu-Natal

which suggest that, as regards informed consent,

individual and collective interests are never mutually

exclusive. It is apparent that within collectivist societies an

individual sense of self is not lost, but may in fact be made

more powerful. An autonomy-based practice should be

applied in a culturally sensitive manner, but universal first-

person consent should not be ignored. Community

involvement should be invited only with explicit consent of

the person concerned. It is also important to avoid the

problems of treating cultural norms as absolute, at the risk

of violating other ethical principles. Given the

aforementioned arguments, applying the Beauchamp and

Childress' model in the South African setting would appear

appropriate.

HIV AND INFORMED CDNSENT

THRESHOLD ELEMENTS (PRECONDITIONS)

Beauchamp and Childress' define two conditions that must

be met before entering into an informed consent process

with any patient. These are an assessment of the patient's

competence to decide, and his or her voluntariness, or

degree of separation from others' coercive infiuences.

Competence is essentially a legal term, referring to a court

determination. It is widely used, however, as it is less

cumbersome than 'decisional capacity:' In practical terms,

it refers to the assessment of whether a patient will be able

to enter a consent process competently. In the setting of

HIV, this relates to situations such as where patients are

delirious or partially or totally demented as a result of HIV

disease. This may include patients presenting in a

conscious or semi-conscious state with any combination of

opportunistic infections, substance abuse and/or trauma.

Obtaining consent for interventions and procedures under

these circumstances, and in particular assessing

competence to provide informed consent to testing and

procedures, is compromised. Morally and legally, this would

constitute an exception to the requirement for first-person

consent, as would the setting where emergency care was

immediately necessary to prevent serious harm. This

problem is further complicated by the doctrine of

substituted judgement, where another person makes an

emergency decision on behalf of the index patient,

supposedly in the best interests of the temporarily

incompetent person. In the setting of HIV illness, the

association with sexual and maternal transmission, as well

as the stigma society assigns to the illness, may have

serious ramifications for such surrogates, calling into

question their ability to make objective decisions in such

situations. These issues must be considered by clinicians

when entering into diagnostic and therapeutic

relationships with patients, and may necessitate delays in

instituting interventions until the patient is considered

sufficiently autonomous to provide consent personally. In

the USA, the Federal Patient Self Determination Act

(effective December 1991) recognises that institutions are

responsible for enabling patients to plan for the eventuality

that they may later lack decision-making capacity'

The problem of voluntariness is also important as a

precondition to consent procedures, and sets a

requirement that the patient enter the health care

relationship without undue coercion. This is obviously an

impossible to meet criterion if set absolutely No person is

entirely free from coercive infiuences. But the requirement

of voluntariness calls for substantial autonomy and

substantial freedom from overt and subtle coercive forces.

This can be difficult to assess, but it must be remembered

that a consent given in a non-voluntary fashion is neither

morally nor legally binding. Here overt issues ['my

employer sent me for the HIV test') and more subtle ones

('I'm not yet comfortable with HAART, but my friends all say

I should, so I suppose I should start therapy') should be

recognised by the alert clinician.

INFORMATIONAL ELEMENTS

These elements of the informed consent procedure can

cause significant problems both in understanding and in

application. The decision regarding how much to disclose

(should all possible side-effects of a drug be disclosed, for

example?) and how to deal with the tension between

beneficence and autonomy inherent in the process of

recommendation is at the heart of the patient-professional,
dialogue. This tension is not easily resolved, but of help is

the reminder that informed consent is not static, but rather

an ongoing process. Disclosure should involve sufficient

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AUGUST 2001------------

information so that the patient can make an informed
decision, and should form part of an ongoing process. In
discussing antiretroviral therapy, for example, known major

side-effects should be initially disclosed, as well as
requirements for dosing, cost implications, etc. The

discovery of new long-term side-effect profiles (for
example mitochondrial toxicities associated with the

nucleoside reverse transcriptase inhibitors,' and the
lipodystrophy syndrome primarily associated with the

protease inhibitors') can be incorporated into the ongoing
dialogue between doctor and patient In a similar way,

recommendation of plans is an ongoing process involving
both parties in the decisions undertaken. Both disclosure

and plan-making should be undertaken from a central

platform of respect for the patient's right to self-
governance, and the questions 'what do you want to
know?' and 'what do you want to do?' are of great value in

this assessment.

It is also important that the patient has an adequate
understanding of the information disclosed, and the plan

proposed. Faden and Beauchamp' formulate their

definition of understanding as follows: 'A person has a full
and complete understanding of an action if there is a fully

adequate apprehension of all the relevant propositions or
statements (those that contribute in any way to obtaining

an appreciation of the situation) that correctly describe (1)

the nature of the action, and (2) the foreseeable

consequences and possible outcomes that might follow as

a result of performing and not performing the action:

A detailed exposition of the concept of understanding is

not within the scope of this paper. However, language and
cultural barriers to understanding are among the most

common problems encountered in the process of informed

consent in the local setting. Clinicians should attempt to

deal with complex issues as simply as possible, and in the

patients' mother tongue if he or she is not fluent in the

physician's own language. Further, the complexities and

rapid changes in the field, coupled with the multitude of

social myths surrounding HIV and AIDS need to be

considered and incorporated into the thinking surrounding

disclosure and planning. Patients should be given adequate

time to consider options, and to ask questions regarding

diagnostics and therapy.

CONSENT ELEMENTS

Actual consent or refusal of consent follows the preceding

threshold and informational elements. Initially, this

involves the decision of the substantially autonomous
patient for or against the plan proposed, and the

subsequent authorisation for the intervention to proceed,
or the rejection of such intervention. A very difficult aspect

of informed consent can be the acceptance by the clinician
of the patient's decision not to follow what is, in the mind

of the doctor, the best and most appropriate course of
action (for example, a refusal to commence antiretroviral
therapy). It has been argued that in such cases doctors

should make judgements as to what is best for their
patients, and convince them of the correctness of such

judgements. -, Others, however, have seen this as mere

paternalism," and argue, as does the author, that the
emphasis on autonomy and patient choice must form the

centre of any doctor-patient relationship, and further,
must include the option of choice in opposition to the

doctor's chosen plan. This does not imply passive
agreement on the part of the clinician, but rather an active

respect for the autonomous action of the patient.

In conclusion, informed consent can be seen as a very

active part of the doctor-patient relationship. Far from

being a mere legal notion, static and situational, it carries
great moral significance, and impacts greatly upon the

day-to-day management of disease. In the management of

the HIV-infected patient, this broader moral concept of
informed consent provides a powerful tool for the

empowerment of the individual, the strengthening of the

doctor-patient relationship, and for the successful
management and prevention of HIV.

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THE SOUTHfRN AFRICAN JOURNAL Of HIV MfOlCINf