Informed consent
The basic principle regarding informed consent is that people have the right to control what is done to their person; therefore optometrists should not do anything to a patient without the patient's consent. There is an ethical as well as a legal imperative to obtain the patient's informed consent, although studies indicate that truly informed consent is an impossible goal.(1)
It is essential that there is a sound optometrist-patient relationship that allows good communication between these parties.
To be able to make informed decisions about their health care, patients must receive sufficient information to make an informed intelligent choice.(2) Classe(3) lists three basic categories under which liability for failure to obtain informed consent can be incurred:
- failure to disclose the risks of proposed treatments or procedures;
- failure to disclose alternatives to therapy;
- failure to disclose abnormalities;
The optometrist must include all the information that they expect the patient would consider relevant in making a decision. The patient is thus entitled to:
- have all procedures and clinical diagnoses explained;
- a complete explanation of the recommended treatment and alternative methods of treatment;
- a description of the expected outcomes of the recommended treatment and alternative methods of treatment;
- disclosure of the anticipated costs and time involved in any treatment;
- a description of the benefits and adverse consequences of any diagnostic or treatment procedure;
- advice on what can be expected if nothing is done.
As well as not withholding necessary information, optometrists must not make misrepresentations by mis-stating known facts.(3)
Note: There is a possible exemption from giving a patient full information in circumstances where to do so may be harmful to the patient. As well, it is not strictly correct that a patient's informed consent has to be obtained before any medical treatment is carried out. Any invasive procedure performed without consent constitutes a trespass to the person for which damages may be claimed, unless the failure to obtain consent is justified by necessity (eg. in an emergency).(4)
As many patients will not understand the technical terms used in optometry they should be able to ask as many relevant questions as are necessary to understand the examination and treatment and should be given sufficient time to make an informed decision. Information should be provided in a form and manner appropriate to the patient's circumstances, personality, expectations, fears, beliefs, values and cultural background; advice should be given with no coercion.(5) When deciding what information should be given the practitioner should consider the personality and temperament of the patient and the patient's attitude; the patient's level of understanding; the nature of the treatment and the magnitude and likelihood of possible harm (information about serious harm should be given even if the possibility of such harm is slight; information about slight harm should be given if the risk of this occurring is great).(4)
Where necessary an interpreter should be used to assist the patient to understand the information given by the optometrist.
Failure by a practitioner to disclose the risks associated with a proposed treatment and possible alternative treatments may expose the practitioner to liability for damages in negligence if something goes wrong. For an action against a practitioner to proceed it must be established that(4):
the practitioner's failure to disclose the information was unreasonable;
this failure caused harm to the patient.
Patients have the right to withhold consent and to refuse treatment, advice or the performance of any procedure. The patient has the right to withdraw their consent at any stage; thus they can terminate an examination or treatment at any stage and can comply or not comply with any advice or treatment given.
Where the patient is a minor or is under the care of a guardian, the consent of the parent or guardian must be obtained for procedures and treatment. There could be situations when parental consent is required and parents have differing views regarding a course of treatment. Such issues could be difficult to resolve when parents are separated/divorced. The optometrist would need to establish which party is responsible for decisions regarding the management of the patient and may need to seek legal advice.
The gaining of informed consent does not mean that optometrists must get patients to sign a consent form for every procedure?patients give implied consent to many procedures by employing the optometrist to perform an eye examination. Optometrists should gain informed consent for any 'invasive' procedures ie procedures such as contact tonometry or those that pose some risk to the patient. In some cases it may be advisable for the optometrist to have a patient sign that their consent was given for a particular procedure; this would be mandatory in the case of any procedures of a research nature. In other cases it may be advisable for the optometrist to request the patient to sign that their consent was withheld eg. refusal to have tonometry performed, refusal to have pupils dilated.
Where an optometrist has expressly sought and received informed consent, it should be noted on the record card, indicating the particular aspect of treatment for which consent was sought and that the patient indicated their consent.
Informed consent must cover prescription of spectacles, contact lenses and other visual aids or training material prescribed by the optometrist. The patient should receive accurate advice in advance of likely costs of recommended treatment and receive an itemised account detailing fair and reasonable fees and charges.
Optometrists should take the time to gain informed consent so that patients are better educated and less likely to be displeased with the course of treatment because of unrealistic expectations.(6)
Where there has been a failure to warn, the practitioner is not liable to the patient unless it can be shown that, if advised, the patient would have refused treatment.(7)
Information can be provided using preprinted material, videotapes, or by an office assistant but these forms of information should not be used in place of verbal warnings by the optometrist himself as there may be no feedback relating to the patient's comprehension of the warning.(7)
The consent given by the patient must be freely given. Patients should not be placed under any undue pressure to consent. This doesn't mean optometrists cannot 'advise forcefully', but research subjects, in particular, should not be offered inducements to consent to procedures.
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