Page 105 - ACCCN's Critical Care Nursing

82 S C O P E O F C R I T I C A L C A R E

clinical care reveals a pronounced tension between three In many countries, if patients believe that clinicians have
competing factors: (1) Paternalistic conservatism about abused their right to make informed choices about their
disclosure of information to patients has been eroded by care, they can pursue a remedy in the civil courts for
moral arguments now largely accepted by the medical having been deliberately touched without their consent
profession; (2) While many patients may wish to be given (battery) or for having received insufficient information
information about available treatment options, many about risks (negligence). To avoid the accusation of
also appear to be cognitively and emotionally ill equipped battery, clinicians need to make clear what they are pro-
to understand and retain it; and (3) Even when patients posing to do and why ‘in broad terms’. With respect to
do understand information about potential treatment negligence, the amount of information about risks
options, they do not necessarily wish to make such required is that deemed by the court to be ‘reasonable’ in
choices themselves, preferring to leave final decisions in light of the choices that patients confront. 25
the hands of their clinicians. 23
If a person is assessed as not being competent, consent
Consent is considered valid when the following criteria must be sought from someone who has lawful authority
are fulfilled; consent must: to consent on his or her behalf. If the courts have
appointed a person to be a guardian for an incompetent
● be informed (the patient must understand the broad individual, then the guardian can provide consent
nature and effects of the proposed intervention and on behalf of that individual. However, even for formally-
the material risks it entails) appointed guardians, certain procedures are not
● be voluntarily given allowed and the consent of a guardianship authority is
● encompass the act to be performed required. If there is no guardianship order then, strictly
● be given by a person legally competent to do so.
speaking, consents for healthcare treatment may be given
For incompetent individuals, the situation is less clear only by the guardianship authority. Some states have leg-
and varies between jurisdictions. islated to allow this authority to be delegated to a ‘person
responsible’ or ‘statutory health authority’ without
To be competent, an individual must:
prior formal appointment. This person would usually be
● be able to comprehend and retain information a spouse, close relative or unpaid carer of the incompe-
● believe it (i.e. they must not be impervious to reason, tent individual. As with formally appointed guardians,
divorced from reality or incapable of judgement after the powers of a ‘person responsible’ are limited by
reflection) statute. 19
● be able to weigh that information up (i.e. consider the
effects of having or not having the treatment) Consent to research involving humans
● make a decision based on that ability.
Consent in human research is guided by a variety of dif-
Many jurisdictions around the world have legislation to ferent documents. In Australia this predominantly
cover the case of an adult who is incompetent to give includes the National Health and Medical Research
consent. The legislation varies as to what situations are Council (NHMRC) and the National Statement on Ethical
8
covered, but some common themes are apparent. Conduct in Human Research (2007); while in New
Zealand it is by the Health Research Council of New
In an emergency, healthcare treatment may be provided Zealand (HRCNZ), Guidelines on Ethics in Health
without the consent of any person, although ‘emergency’ Research and the HRCNZ Operational Standard for Ethics
has not routinely been formally defined. It should also Committee (OS). 26,27 In the UK guidance is provided
be noted that nurses must seek consent for all procedures by the General Medical Council. In the US there are
24
that involve ‘doing something’ to a patient (e.g. admini- required elements of written Institutional Review Board
stering an injection), and should be wary of relying on (IRB) procedures under Department of Health and
‘implied’ consent. Seeking consent in this type of every- Human Services (HHS) regulations for the protection of
day situation is less formal than obtaining consent for a human subjects and relevant Office for Human Research
surgical intervention, although it still represents ethically Protections (OHRP) Department of Health and Human
(and legally) prudent practice. Consent should never be Services ‘guidance’ regarding each required element.
implied, despite the fact that the patient is in a critical
17
care area. Obtaining consent generally involves explain- Although the specific detail varies between organisations
ing the procedure and seeking affirmation from the and jurisdictions, in general ‘consent to medical research
patient (or guardian/family), ensuring that there is under- documentation’ should include the following: 19
standing and agreement to the treatment. This principle ● A statement that the study involves research
is clearly articulated by the General Medical Council in ● An explanation of the purposes of the research
the UK with the following statement: ● The expected duration of the subject’s participation
● A description of the procedures to be followed
Successful relationships between doctors and patients depend on ● Identification of any procedures which are
trust. To establish that trust you must respect patients’ autonomy experimental
– their right to decide whether or not to undergo any medical ● A description of any reasonably foreseeable risks or
intervention … [They] must be given sufficient information, in discomforts to the subject
a way that they can understand, in order to enable them to ● A description of any benefits to the subject or to others
make informed decisions about their care. 24 which may reasonably be expected from the research