Consent forms — Documentation of consent
A consent form itself is not consent
Consideration of a consent form to be signed by the patient should not obscure the important fact that the form itself is not the “consent.” The explanation given by the physician, the dialogue between physician and patient about the proposed treatment, is the all important element of the consent process. The form is simply evidentiary, written confirmation that explanations were given and the patient agreed to what was proposed. A signed consent form will be of relatively little value later if the patient can convince a court the explanations were inadequate or, worse, were not given at all.
Apart from providing evidence that a patient consented to proposed treatment, there is another important reason for having consent forms signed. In many Canadian jurisdictions it has become a legal requirement that such a document must be completed before any surgical procedure is undertaken in a hospital.
The bottom line:
The explanation given by the physician, the dialogue between physician and patient about the proposed treatment, is the all important element of the consent process.
The consent form itself is not the "consent." It is simply evidentiary, written confirmation that the explanations were given and that the patient agreed to what was proposed.
In many Canadian jurisdictions it has become a legal requirement that such a document must be completed before any surgical procedure is undertaken in a hospital.
Basic elements
On the basis of experience in advising and defending its members on matters of consent, the Canadian Medical Protective Association believes a satisfactory consent form, adaptable to most situations, should be a relatively simple document, such as the prototype suggested.
Identification and acknowledgement of explanations
The form should name the patient and in general terms the nature of the investigation, treatment or operation. It should name the physician who is to carry out the treatment. There should be included an acknowledgement by the patient that explanations have been given about the nature of the treatment and its anticipated effect, and about any material risks and special or unusual risks. Mention should be made also of the patient's acknowledgement that alternative forms of treatment or investigation have been discussed. The form should allow for acknowledgement by the patient that he or she is satisfied with the explanations and has understood them.
Anaesthesia
Again, as a result of its experience with negligence litigation against physicians, the Canadian Medical Protective Association continues to believe that specific consent, except where required by a statute, is unnecessary for the administration of anaesthesia for surgery. The need for written consent for anaesthesia is seen as limited because ordinarily it should be implicit in the documentation of the pre-anaesthetic examination by the anaesthetist that the patient was properly informed. The pre-anaesthetic visit by the anaesthetist or the anaesthetist's delegate provides an opportunity for discussion about alternative forms of anaesthesia which might be offered, any exclusions imposed by the patient and any particular risks which the examining anaesthetist feels may be appropriate to mention in the particular case.
Although usually the record of the pre-anaesthetic examination will adequately confirm the dialogue which occurred between anaesthetist and patient, if specific consent for anaesthesia is included on a form, care should be taken to avoid provision on the document inviting exclusions to be stated by the patient. Any such exclusions should have been agreed upon at the pre-anaesthetic examination. Failing such discussion and decision, and particularly with a form that offers opportunity for the patient to stipulate exclusions, there is greater risk the patient could impose last minute restrictions on the anaesthetist with the possibility that these might be overlooked.
Added or alternative procedures
The clause in the prototype form authorizing additional or alternative procedures requires some special comment. In their pre-operative explanations to patients, surgeons will always attempt to anticipate in advance what various conditions might be encountered and what alternative procedures might have to be added during the operation. However, not infrequently, circumstances arise which compel the physician to consider an extension of the procedure, something which could not have been anticipated and which was not mentioned to the patient beforehand.
In these situations, the physician may exceed the mandate given by the patient only if failure to take the additional or alternative steps would render ineffective the procedure for which the consent was given or would pose a significant risk to the health or life of the patient. If there arises need to proceed with something wholly different from that to which the patient has given consent and if it be reasonable and not harmful to delay, the patient should be allowed to regain consciousness. Then additional explanations can be given and consent sought for the different procedure. Only when something additional or alternative is immediately necessary and vital to the health and life of the patient, not merely a matter of convenience, should a physician proceed without expressed consent.
Delegation to others
The final paragraph of the prototype consent form is deemed necessary because of two sets of circumstances which are common in practice. The first is the situation where a number of physicians work as a group and where for various reasons work may be delegated to another member of the same group.
The other circumstances are those found in teaching hospitals where PGY trainees and others participate in the care of patients. Delegation of work and responsibility to these post-graduate trainees is essential. They must have assigned to them increasing responsibility for reaching decisions and for carrying out progressively more difficult and complex treatments and procedures once they have shown evidence of ability.
Patients must be informed about the involvement of trainees in their care. At the same time they should be reassured about the quality of that care and the measure of supervision which will be exercised. If patients in teaching hospitals are told that other physicians may be involved in their care, if they are given appropriate reassurances and especially if they have already met the other members of the medical team looking after them, patients will likely accede to the proposals and, most important, can never claim they did not know work might be delegated to someone else.
Some clinical teachers may still have concern that if all of this is done routinely and such acknowledgements are set out on a consent form, some patients might refuse to allow the management to be delegated, insisting that their own attending physician provide it all. This, of course, is the patient's prerogative. If there must be difficulty, better it be resolved beforehand than to be faced later with a patient who thinks the result of treatment is less than ideal and who then claims if it had been known the treatment was to be delegated, consent would have been withheld. Under such circumstances both physician and post-graduate trainee might be relatively defenceless.
Signatures and witnesses
Remembering that consent forms are simply documentary confirmation of consent explanations and the patient's willingness to proceed with what has been proposed, it is preferable to arrange for a patient's signature on the form as contemporaneously as possible with the pre-treatment discussions. Sometimes it is convenient to accomplish this in a physician's office or at the bedside with the physician present. More often, however, the signing may occur as an administrative step during the process of admission to hospital or as part of a hospital ward administrative routine. The patient should be given ample opportunity to consider what he or she is signing and be given adequate opportunity to consider the implications of that to which they are consenting.
Because of the varying circumstances under which consent forms are frequently signed, nurses or other hospital personnel may be asked to witness the signing. It should be remembered that in witnessing a signature the witness simply confirms the identity of the patient who signed the document and that the person's mental state at the time appeared to allow for an understanding of what was signed. The role of the witness has no other legal significance. Most important, the witness to a signature on a consent form should not feel he or she has any obligation whatsoever to provide pre-treatment explanations which, in signing the form, the patient acknowledges having received. A nurse or other person witnessing a patient's signature on a consent form does in no way attest to the adequacy of explanations which have been given by the physician. However, if a patient implies or states that he or she has been inadequately informed about the nature of the proposed treatment, a person witnessing the signature or others present should not press for the signature and the treating physician should be notified.
Some consent forms require the signature of the treating physician who, by signing, acknowledges that consent explanations have been given. Clearly, the purpose of this signature is to direct the physician's attention to his or her legal obligations. Although the purpose of the treating physician's signature may be commendable, having regard to some of the practical considerations in arranging for the completion of consent forms, it may be preferable that this requirement not be contained on the form and imposed. On most occasions the physician will have held the required discussions with the patient previously and may not be readily available at the time when the form is prepared for the patient's signature. Then, if through an administrative failure the physician's signature fails to appear on the form, its absence might be more harmful to the physician's legal interest than if the form did not call for his or her signature in the first place.
Notes in the medical record
A signed consent form has undoubted evidentiary value and is a specific legal requirement in many situations. However, when an informed consent is called into question, a physician's note on the record may be of equal or even greater usefulness for defence purposes. Courts rely heavily on progress notes if it is clear they were made contemporaneously with the events they record.
At the time when consent explanations are given it is a relatively simple matter for the physician to note briefly some of the significant points raised in conversation with the patient. Such notations, particularly if they identify questions or special concerns expressed by the patient, can serve to validate the consent process better than any other documentation.
The note need not be voluminous or time consuming. If it records on the office or hospital chart something relevant to the discussion with the particular patient, it will be much more credible in evidence than the recollections of any of the parties involved in a lawsuit. The contemporaneous progress note about consent can be invaluable and is highly recommended.
Click here to view a sample consent form
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