In the event reasonable attempts to contact me have been unsuccessful, I hereby give my consent for (1) the administration of any treatment deemed necessary.
In the shorter Oxford dictionary, consent is defined as "the voluntary agreement to or acquiescence in what another person proposes or desires; agreement as to a course of action."
In the medical context and as the law on consent to medical treatment has evolved, it has become a basic accepted principle that "every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body." Clearly physicians may do nothing to or for a patient without valid consent. This principle is applicable not only to surgical operations but also to all forms of medical treatment and to diagnostic procedures that involve intentional interference with the person.
That consent to treatment was lacking or inadequate continues to be a frequent claim against physicians. Obviously it is important therefore that physicians be aware of their legal obligations in obtaining consent from patients. It is hoped this booklet will assist in strengthening this awareness. It is not intended as a legal treatise on the subject of consent but rather as a practical guide for physicians in their day-to-day dealings with patients.
To the general rule that consent must always be obtained before any treatment is administered, there is an important exception. In cases of medical emergency when the patient (or substitute decision maker) is unable to consent, a physician has the duty to do what is immediately necessary without consent. For the physician to declare any clinical situation an emergency for which consent is not required, there must be demonstrable severe suffering or an imminent threat to the life or health of the patient. It cannot be a question of preference or convenience for the health care provider; there must be undoubted necessity to proceed at the time. Further, under medical emergency situations, treatments should be limited to those necessary to prevent prolonged suffering or to deal with imminent threats to life, limb or health.
Even when unable to communicate in medical emergency situations, the known wishes of the patient must be respected. Therefore, before proceeding, the physician will want to be satisfied there has been no indication in the past by way of Advance Directive or otherwise that the patient does not want the proposed treatment. Further, as soon as the patient is able to make decisions and regains the ability to give consent, a proper and "informed" consent must then be obtained from the patient for additional treatment.
In some provinces, legislation permits the designation of substitute decision-makers to provide or refuse consent on behalf of the incapacitated patient. If the substitute decision-maker is immediately available emergency treatment should proceed only with the consent of that individual.
In urgent situations, it may be necessary or appropriate to initiate emergency treatment while steps are taken to obtain the informed consent of the patient or the substitute decision-maker, or to determine the availability of advance directions. However, the instructions as to whether to proceed or not must be obtained as quickly as practicably possible.
When an emergency dictates the need to proceed without valid consent from the patient or the substitute decision-maker, a contemporaneous record (at the time) should be made explaining the circumstances which forced the physician's hand. If the circumstances are such that the urgency might be questioned at a later date, arranging a second medical opinion would be prudent if possible.
The bottom line:
Most legal actions against physicians concerning consent are based on negligence and raise allegations as to the adequacy of the consent discussion with the patient. A claim of assault and battery may, however, be alleged in specific circumstances. A physician may be liable in assault and battery when no consent was given at all or when the treatment went beyond or deviated significantly from that for which the consent was given. Allegations of assault and battery might also be made if consent to treatment was obtained through serious or fraudulent misrepresentation in what was explained to the patient.
Thus, as has happened in various legal actions, it was seen as an assault and battery to carry out an amputation without having received consent to do so; to administer an intravenous anaesthetic agent into the left arm when the patient had specifically forbidden it; to sterilize a patient when consent had been given for a Caesarean section only; to operate on the patient's back when consent had been given only for a procedure on the toe.
In each of these examples, the physicians knew they were proceeding in the medical best interests of the patients and took measures which were clearly medically indicated. However, our courts have repeatedly affirmed that good intentions of the physician cannot be substituted for the will of the patient.
The bottom line:
Consent to treatment may be implied or it may be specifically expressed either orally or in writing. The clinical situation determines the approach required.
Much of a physician's work is done on the basis of consent which is implied either by the words or the behaviour of the patient or by the circumstances under which treatment is given. For example, it is common for a patient to arrange an appointment with a physician, to keep the appointment, to volunteer a history, to answer questions relating to the history and to submit without objection to physical examination. In these circumstances consent for the examination is clearly implied. To avoid misunderstanding, however, it may be prudent to state to the patient an intention to examine the breasts, genitals or rectum.
The foregoing notwithstanding, in many situations the extent to which consent was implied may later become a matter of disagreement. Physicians should be reasonably confident the actions of the patient imply permission for the examinations, investigations and treatments proposed. When there is doubt, it is preferable the consent be expressed, either orally or in writing.
Expressed consent may be in oral or written form. It should be obtained when the treatment is likely to be more than mildly painful, when it carries appreciable risk, or when it will result in ablation of a bodily function.
Although orally expressed consent may be acceptable in many circumstances, frequently there is need for written confirmation. As physicians have often observed, patients can change their minds or may not recall what they authorized; after the procedure or treatment has been carried out, they may attempt to take the position it had not been agreed to or was not acceptable or justified. Consent may be confirmed and validated adequately by means of a suitable contemporaneous notation by the treating physician in the patient's record.
Expressed consent in written form should be obtained for surgical operations and invasive investigative procedures. It is prudent to obtain written consent also whenever analgesic, narcotic or anaesthetic agents will significantly affect the patient's level of consciousness during the treatment.
For consent to serve as a defence to allegations of either negligence or assault and battery, it must meet certain requirements. The consent must have been voluntary, the patient must have had the capacity to consent and the patient must have been properly informed.
Patients must always be free to consent to or refuse treatment, and be free of any suggestion of duress or coercion. Consent obtained under any suggestion of compulsion either by the actions or words of the physician or others may be no consent at all and therefore may be successfully repudiated. In this context physicians must keep clearly in mind there may be circumstances when the initiative to consult a physician was not the patient's, but was rather that of a third party, a friend, an employer, or even a police officer. Under such circumstances the physician may be well aware that the patient is only very reluctantly following the course of action suggested or insisted upon by a third person. Then, physicians should be more than usually careful to assure themselves patients are in full agreement with what has been suggested, that there has been no coercion and that the will of other persons has not been imposed on the patient.
The bottom line:
An individual who is able to understand the nature and anticipated effect of proposed medical treatment and alternatives, and to appreciate the consequences of refusing treatment, is considered to have the necessary capacity to give valid consent. However, there are special circumstances to which particular attention must be given.
The legal age of majority has become progressively irrelevant in determining when a young person may consent to his or her medical treatment. As a result of consideration and recommendations by law reform groups as well as the evolution of the law on consent, the concept of maturity has replaced chronological age. The determinant of capacity in a minor has become the extent to which the young person's physical, mental, and emotional development will allow for a full appreciation of the nature and consequences of the proposed treatment, including the refusal of such treatments.
Legislation in a number of provinces and the territories has codified the law on consent, including the reliance on maturity in assessing a young person's capacity to consent to or refuse medical treatment. Only the Province of Quebec has established a fixed age of 14 years, below which the consent of the parent or guardian or of the court is necessary for the purposes of proposed treatment.
Generally, where the minor patient lacks the necessary capacity, the parents or guardian are authorized to consent to treatment on the minor's behalf. In doing so, the parents or guardian must be guided by what is in the best interests of the minor. This consideration becomes all the more important when the parent or guardian seeks to refuse treatment the physician regards as medically necessary. In these circumstances, there is an obligation on the part of physicians to report the matter to child protection authorities.
Patients must be at least 18 years of age to consent to medical assistance in dying. A minor patient’s parents or guardian cannot consent to assistance in dying on the minor’s behalf.
The bottom line:
It is well accepted that a person who is incapable to make decisions regarding certain matters might still have sufficient mental capacity to give valid consent to medical treatment. Again, it depends on whether the patient is able to appreciate adequately the nature of the proposed treatment, its anticipated effect and the alternatives. Therefore, many individuals who may be mentally infirm or who have been committed to a psychiatric facility continue to be capable of controlling and directing their own medical care, including the right to consent to treatment or to refuse treatment. It is beyond the scope of this general discussion to comment on the various legal requirements pursuant to mental health legislation, but physicians should be generally familiar with the applicable mental health legislation in their jurisdiction, particularly with reference to formal capacity assessments necessary to declare the patient incapable of consent and the appeal process available to the patient.
In circumstances where it has been determined that a patient is incapable of consenting to a particular medical treatment, the question as to who is authorized to make the decision will arise. It is now possible in the majority of provinces for a patient to execute an Advance Directive as to future care in the event that the patient becomes incapacitated or is unable to communicate his or her wishes. Advance Directives are sometimes referred to as living wills. Advance Directives may contain explicit instructions relating to consent or refusal of treatment in specified circumstances. In some provinces, Advance Directives may be contained in Powers of Attorney for personal care. An Advance Directive may also be used to appoint or designate an individual who will be authorized to make substitute decisions about consent or refusal of treatment in the event that the patient becomes incapacitated. Again, physicians will want to be generally familiar with any applicable legislation in their particular jurisdiction. Consent to medical assistance in dying cannot be given by way of Advance Directives.
A number of provinces have also enacted legislation for substitute decision-makers which sets out and ranks a list of individuals, usually family members, who are authorized to give or refuse consent to treatment on behalf of an incapable person. The specific legislation in the jurisdiction will generally set out the principles that should guide the substitute decision-maker's treatment decision. Generally speaking, substitute decision-makers must act in compliance with any prior capable wish of the patient, where possible. Consideration of such factors as the individual's current wishes and his or her known beliefs and values may also be required, depending on the jurisdiction. It is clear that the substitute decision-maker should always be guided by the patient's best interests. Substitute consent, including that of a parent for a child, cannot be utilized for proposed treatment which might be regarded as non-therapeutic, such as non-therapeutic sterilization. Physicians will want to be alert to other circumstances that might raise unique issues such as substitute consent in the context of clinical research.
The determination of the patient's best interests, or whether a proposed treatment is "therapeutic" or not can be difficult, and, in circumstances where there are questions or doubts, physicians are encouraged to consult with other physicians and legal counsel. There may be circumstances where an ethical consult would be prudent. Physicians should also be aware that there are legal mechanisms available to address circumstances where concerns exist that a substitute decision-maker may not be acting in the patient's best interests.
In the absence of a valid Advance Directive or duly authorized substitute decision-maker, strictly speaking only the court or someone appointed by the court may properly consent to or refuse medical treatment where the patient lacks the requisite capacity to make the decision. Unfortunately, the legal procedure for the appointment of a guardian of the patient can be lengthy and expensive. As a result, and from a practical standpoint, physicians have often proceeded on the basis of the family's approval where the medical treatment is clearly required, where the patient's condition may deteriorate if not treated promptly, and the treatment is determined to be in the patient's best interests. Should there be any disagreement among family members, or if the proposed treatment carries significant risks, then specific legal advice should probably be sought about that situation.
The bottom line:
For consent to treatment to be considered valid, it must be an "informed" consent. The patient must have been given an adequate explanation about the nature of the proposed investigation or treatment and its anticipated outcome as well as the significant risks involved and alternatives available. The information must be such as will allow the patient to reach an informed decision. In situations where the patient is not mentally capable, the discussion must take place with the substitute decision maker.
The obligation to obtain informed consent must always rest with the physician who is to carry out the treatment or investigative procedure. This obligation may be delegated in appropriate circumstances (to a PGY trainee for example) but before assigning this duty to another, the treating physician should be confident the delegate has the knowledge and experience to provide adequate explanations to the patient.
In special circumstances, an obligation of pre-treatment disclosure may fall to more than one physician involved in the care. For example, a radiologist carrying out an invasive diagnostic procedure would likely be seen as responsible for explaining how the test will be done and the risks attendant upon it. The physician who ordered the test might also be expected to tell the patient, in general terms, about the nature and purpose of the test and alternatives which might be employed.
The bottom line:
Although obtaining a valid consent from patients has always involved explanations about the general nature of the proposed treatment and its anticipated effect, the Supreme Court of Canada, over two decades ago, imposed a more stringent standard of disclosure upon physicians. The adequacy of consent explanations is to be judged by the "reasonable patient" standard, or what a reasonable patient in the particular patient's position would have expected to hear before consenting.
The Supreme Court of Canada has set out in general terms the scope of the physician's duty in informing patients before treatment as follows:
"In summary, decided cases appear to indicate that in obtaining the consent of a patient for the performance upon him of a surgical operation, a surgeon, generally, should answer any specific questions posed by the patient as to the risks involved and should, without being questioned, disclose to him the nature of the proposed operation, its gravity, any material risks and any special or unusual risks attendant upon the performance of the operation. However, having said that, it should be added that the scope of the duty of disclosure and whether or not is has been breached are matters which must be decided in relation to the circumstances of each particular case."
In a subsequent decision, the court extended the obligation of disclosure as follows:
"... a surgeon must also, where the circumstances require it, explain... alternative means of treatment and their risks."
The foregoing does provide physicians with a general basis for deciding the nature and extent of the pre-treatment information which should be given to patients but it can be difficult to apply legal generalizations to specific clinical situations. Therefore, some comment about several of the points raised in these precedent-setting judgments may be helpful.
Throughout these and other legal judgments which have been rendered in more recent years, there is repeated reference to the need to disclose "material" risks to patients. However, there can be some understandable uncertainty as to what in fact does constitute a "material" risk. One court has defined it as follows:
"A risk is thus material when a reasonable person in what the physician knows or should know to be the patient's position would be likely to attach significance to the risk or cluster of risks in determining whether or not to undergo the proposed therapy."
Thus the particular circumstances of the patient are an important determinant of materiality.
It is clear that the materiality of a risk is influenced as well both by the frequency of the possible risk and also by its seriousness should it occur. Generally speaking, the more frequent the risk, the greater the obligation to discuss it beforehand. Further, even uncommon risks of great potential seriousness should be disclosed. In this context the Supreme Court of Canada indicated that even if a risk is "a mere possibility" yet it carries with it serious consequences such as paralysis or death, it should be regarded as material and therefore requires disclosure.
The bottom line:
It has been suggested that not only must the physician provide the necessary details about the nature, consequences and material risks of the proposed treatment in order to obtain informed consent, but also the physician has the duty to ensure the patient has understood the information. This interpretation of the case law goes too far and would place an unfair and unreasonable burden on the physician. In rejecting this obligation, the court, in a recent Scottish case, commented that such an onus upon the physician could only be discharged through "vigorous and inappropriate cross-examination" of the patient.
There is no doubt, however, that the physician does have a duty to take reasonable steps so as to be relatively satisfied that the patient does understand the information being provided, particularly where there may be language difficulties or emotional issues involved. What amounts to "reasonable steps" will very much depend on the individual facts and circumstances of the particular situation.
It seems clear that by engaging in personal dialogue with the patient, the physician will be placed in the best possible position to be reasonably comfortable the patient understands the consent explanation. Personal attendance permits the physician the opportunity to observe the patient's reaction for signs of apparent comprehension or confusion. As well, the ability of the patient to ask questions will often assist the physician to assess the level of patient understanding.
The bottom line:
The issue of consent merits careful consideration by those physicians who may become involved in any research work in which patients or human volunteers are asked to participate.
In terms of the extent to which risks must be disclosed, there is now less distinction between "therapeutic" and "non-therapeutic" research than in earlier years when requirements for informed consent were less stringent. These days, for any treatment or procedure that is innovative or that could be perceived as experimental, anything which may be interpreted as going beyond the need for prophylaxis, diagnosis or therapy, an element of "research" should be assumed. In such circumstances a standard of full disclosure may be applicable when obtaining consent. The concept of therapeutic privilege is inappropriate and no information about a project or clinical trial may be hidden from a patient on the ground that disclosure would result in undue worry or anxiety. As well, researchers must recognize the potential for what might later appear to have been duress or coercion. This is a particularly important consideration if the subject has a physician-patient relationship with a member of the research team.
A fair explanation must always be given about what is proposed, its risks and discomforts, what, if any, benefits might accrue and, if applicable, what appropriate alternative treatments or procedures might be offered. If a blind study is involved, patients must be aware they could stand to derive no benefit at all. Researchers should offer and make themselves available to answer enquiries about what is proposed and should emphasize to patients or subjects they are free to withdraw consent and discontinue participation in the project at any time without prejudice.
It might be argued that minors or adults with mental disability do not have the capacity to consent when research or experimentation figure to any significant extent in clinical management. Physicians should exercise a great deal of caution in dealing with such situations.
The bottom line:
Our courts have reaffirmed repeatedly a patient's right to refuse treatment even when it is clear treatment is necessary to preserve the life or health of the patient. Justice Robins of the Ontario Court of Appeal explained:
"The right to determine what shall, or shall not, be done with one's own body, and to be free from non-consensual medical treatment, is a right deeply rooted in our common law. This right underlines the doctrine of informed consent. With very limited exceptions, every person's body is considered inviolate, and, accordingly, every competent adult has the right to be free from unwanted medical treatment. The fact that serious risks or consequences may result from a refusal of medical treatment does not vitiate the right of medical self-determination. The doctrine of informed consent ensures the freedom of individuals to make choices about their medical care. It is the patient, not the physician, who ultimately must decide if treatment — any treatment — is to be administered."
However, difficulty may arise if it should later be claimed the refusal had been based on inadequate information about the potential consequences of declining what had been recommended. In the same way as valid consent to treatment must be "informed," so it may be argued a refusal must be similarly "informed." Physicians thus may be seen to have the same obligations of disclosure as when obtaining consent, that is, disclosure of the risk to be accepted.
When patients decide against recommended treatment, particularly urgent or medically necessary treatment, discussions about their decision must be conducted with some sensitivity. While recognizing an individual's right to refuse, physicians must at the same time explain the consequences of the refusal without creating a perception of coercion in seeking consent. Refusal of the recommended treatment does not necessarily constitute refusal for all treatments. Reasonable alternatives should be explained and offered to the patient.
As when documenting the consent discussion, notes should be made about a patient's refusal to accept recommended treatment. Such notes will have evidentiary value if there is any controversy later about why treatment was not given.
The bottom line:
Although not strictly an element of the pre-operative consent process, the courts have recently elaborated on the duty or obligation of physicians to properly inform patients in the post-operative or post-discharge period. Thus a physician must conduct a discussion with a patient of the post-treatment risks or complications, even statistically remote ones that are of a serious nature. The purpose is to inform the patient of clinical signs and symptoms that may indicate the need for immediate treatment such that the patient will know to visit the physician or return to the hospital/facility.
The bottom line:
The law on consent will continue to evolve. However, current interpretation of legal judgements dealing with "informed consent" will allow some suggestions which may be of practical assistance to physicians in their attempt to meet the legal standards:
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:
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 below.
Basic elements of a consent form:
Consent to investigation, treatment or operative procedure
(1) I,_________________________________ , hereby consent to undergo the investigation, treatment or operative procedure, _____________________________, ordered by or to be performed by Dr._____________________.
(2) The nature and anticipated effect of what is proposed including the significant risks and alternatives available have been explained to me. I am satisfied with these explanations and I have understood them.
(3) I also consent to such additional or alternative investigations, treatments or operative procedures as in the opinion of Dr.________________________ are immediately necessary.
(4) I further agree that in his or her discretion, Dr._______________________ may make use of the assistance of other surgeons, physicians, and hospital medical staff (including trainees) and may permit them to order or perform all or part of the investigation, treatment, or operative procedure, and I agree that they shall have the same discretion in my investigation and treatment as Dr. _____________________.
day / month / year
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.
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.
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.
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.
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.
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.
In addition to amendments to the Criminal Code, all regulatory authorities (Colleges) have developed guidelines for physicians concerning medical assistance in dying. Physicians should be familiar with the requirements concerning written consent in the Criminal Code and the College guidelines, including the requirements concerning witnesses, the need for the witnesses to be independent, and other information that must be attested to.
Because the essential element of consent is the dialogue and sharing of information between physician and patient, anything which can conveniently facilitate this process is desirable. The pre-treatment consent discussions with the patient are most important and should not be replaced; however, sometimes these discussions can be more informative if they are supplemented by printed or other recommended materials which are given to the patient in advance and can be reviewed at leisure by the patient.
For relatively standardized treatments, investigative or therapeutic procedures, background information about what is being proposed may be provided in the form of, for example, information sheets, printed brochures or electronic resources. This material should outline the nature of the proposed treatment or procedure, its purpose and intended outcome, and should mention significant risks and potential complications which might be of relevance to most patients. Such information resources should invite questions from the patient about the treatment and it should be clear that opportunity will be given for such questioning and for further discussion after the resource has been reviewed.
Information sheets, brochures, and similar materials may not be applicable in many circumstances under which consent is obtained but when they are used should be seen only as an adjunct and not a substitute to consent discussions. Frequently consent explanations must be tailored to the particular circumstances of the individual patient.
Because of the wide variety of circumstances under which consent forms are signed, it is preferable that the information sheet or similar document not be an integral part of the consent form. The signing of a consent form, the acknowledgement that appropriate information has already been given, is often simply an administrative step which does not allow for adequate review of information on which patients must base their decisions for or against treatment. Documents supplementary to consent explanations should be provided well in advance of signing. From time to time when commenting about consent procedures, courts have made it clear, except in urgent and pressing circumstances, patients must be given adequate opportunity to consider the implications of that to which they are consenting.
Consent explanations are sometimes added to in a more elaborate fashion by a videotape recording of the discussion about the proposed treatment or procedure. This adjunct is probably most applicable for cosmetic surgery but may be suitable also in other circumstances.
Regardless of what supplementary methods are employed to provide patients with information prior to consent, it must again be emphasized they can only supplement and not replace dialogue with the patient. For evidentiary purposes, a contemporaneous notation should be made confirming that the supplementary material had been provided and that after reviewing it the patient was given an opportunity to ask questions about it before consenting.
Since legal actions often arise many years after clinical treatment, it is wise to keep older versions of information sheets or other materials in an archive file, with the dates noted of when these were in use,in case they are required during medico-legal difficulties that arise after they are no longer in use.
The bottom line:
It is not unusual that physicians practising in Canada are called upon to provide professional services to patients who are not ordinarily resident in Canada. Many such patients are visitors or tourists who become ill and require urgent or emergent care. Increasingly, however, such patients are individuals, mostly United States residents, who have travelled to Canada specifically to receive elective medical care, perhaps attracted by comparative cost benefits.
Every Canadian physician should appreciate that any foreign patient who brings a legal action because of dissatisfaction with the medical care received in Canada may very well seek to bring that legal action back home where the patient resides. The risk of a foreign action is very important to physicians, as there may very well be limitations on the legal assistance or protection available from, for example, CMPA to member physicians or insurers to other health professionals in connection with such actions.
When a foreign patient brings a legal action against a Canadian physician, one of the principal issues to be determined is whether the foreign court should accept jurisdiction or defer such that the legal action must be brought in Canada. There is a greater likelihood the foreign court will permit the legal action to proceed in the patient's home jurisidiction:
Canadian physicians attending foreign patients in Canada should take steps to encourage that any subsequent medico-legal action be brought in Canada. Before treating a foreign patient (with the exception of emergency cases), all physicians and health care organizations should make reasonable efforts to ensure a Governing Law and Jurisdiction Agreement is completed. These forms are designed to assist in establishing Canadian jurisdiction for any potential legal actions that may result from care or treatment provided by Canadian physicians or health care organizations to non-residents.
The bottom line:
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I,., parent or legal guardian of., born., do hereby consent to any medical care and the administration of anesthesia determined by a physician to be necessary.
By David L. Freedman, MD, JD, FAAEM, Emergency Medicine Physician, Chelsea Community Hospital, Chelsea, MI; Practicing Attorney, Miller, Canfield, Paddock & Stone PLC, Ann Arbor, MI; Jonathan Lawrence, MD, JD, FACEP, Emergency Physician, St. Mary Medical Center Medical-Legal Consultant, Long Beach, CA.
Editor’s Note: This article was originally written by Jonathan D. Lawrence, MD, JD, FACEP and published in January, 1997. Because of the importance of this topic, we have decided to revise and update Dr. Lawrence’s article and revisit this topic. The question of consent continues to be complicated by the attempts of many managed care organizations to give or withhold "authorization for treatment" for minors enrolled in the plans who present to the emergency department (ED). In reality, only the patient or the patient’s appropriate legal representative may authorize medical examination and treatment; managed care organizations may only authorize reimbursement for treatment. With respect to children, this means that a parent or guardian is responsible for giving consent to allow medical personnel to provide medical treatment to a minor. This raises a wide variety of issues that do not arise when the patient is an adult and capable of consenting for himself or herself. For example, what if the person who is legally authorized to consent for the minor is not available when the care needs to be administered? Or worse, what if the parent or guardian makes a poor decision by withholding consent for treatment in a life-threatening situation? Are there situations where society as a whole would benefit by allowing certain minors to give consent for their own treatment? If so, what are those situations? How does the Emergency Medical Treatment and Active Labor Act (EMTALA) affect these questions of consent?
This article answers these questions and more by taking examples, primarily from Michigan and California law, to illustrate the fundamental rule of consent for minors and the various exceptions to the rule. The basic rule, its exceptions, basic procedures, and advice for difficult situations are provided. With this information, the emergency physician will have a basic understanding of consent for minor issues and be more confident when addressing these stressful, consent-related situations.
The editors thank Dr. Lawrence for his excellent contributions to the original text of this article and, in particular for providing the citations to California state law.
Since consent for minors is primarily a subject of state law, while the examples presented in this article generally reflect the majority view, consultation with local counsel is essential prior to implementing policies regarding consent for minors.
Patient consent is a key legal and ethical principle in American medicine. Our society’s view of consent for medical diagnosis and treatment is based on the broad notion of the inviolability of the individual. Courts recognized this principle as applying to medical treatment as early as 1914 when the famous legal scholar, Benjamin J. Cardozo, then a justice of New York’s highest court, wrote that: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body . . . "1 In general terms, this means that, absent consent, every person has the right to be free from intentional offensive contact by another. Failure to obtain consent prior to intentionally touching another person subjects the touching person to potential liability for battery. Since the general acceptance of the doctrine of informed consent was adopted, actions specifically brought for the intentional tort of battery in the medical setting are rare. If a physician has failed to obtain proper informed consent from a patient (a parent or guardian in the case of a minor), the action will generally be for malpractice, and the plaintiff will be required to prove that the physician breached the standard of medical practice in not obtaining the patient’s informed consent, as well as all the other elements of a negligence action.
In order to give informed consent, an individual must be "competent." Competency in this context may be defined as the ability to comprehend and rationally act upon information provided by a health care professional. Adults are presumed to be competent to make medical decisions. While there are many minors who seemingly are fully capable of rationally evaluating medical care decisions, minors are, by law, below the "age of consent." Therefore, the general rule is that minors are not capable of giving consent for medical treatment. As a result, the consent of a minor for medical treatment is ineffective, and the physician must secure the consent of the minor’s parent or other person standing in loco parentis prior to treating the minor. There are, of course, a number of exceptions to this general rule and minors may legally give consent in specific circumstances. For example, minors may become "emancipated" and, thereby, are capable of giving consent; a small number of states have statutes allowing "mature minors" to consent to medical treatment,2 and all states have legislation that allows minors to consent to the treatment of specific medical conditions (e.g., sexually transmitted diseases).
The age at which a minor reaches majority and can, therefore, give consent, varies from state to state. In the vast majority of states, the age at which an individual may give consent for medical treatment is 18. A child is deemed below this age as a matter of law, incompetent to give consent for medical treatment.
The law generally assumes that a competent individual will act on the minor’s behalf. Most of the time, this will be the child’s parent. Sometimes a guardian is assigned by the court to protect the minor’s interests. The individual who may serve as guardian varies from state to state and may include the state itself.
The considerable variety of situations in which children live creates a potential minefield for physicians concerning consent issues. Most of these issues find their answers in state law and, therefore, the answer will vary depending upon the state in which the physician practices.The answer may not always be obvious, and the emergency physician may find him or herself in a difficult situation where immediate consultation with hospital counsel will be necessary. The following discussions primarily refer to Michigan and California law when specific examples are given, and the reader is cautioned that this may not always reflect the law in the reader’s state. A detailed comparison of the law in all states is well beyond the scope of this article. The practicing emergency physician should have a general familiarity with the law in his or her state and should have in place an effective mechanism to contact hospital counsel when legal questions arise, including an emergency situation.
Before proceeding, a brief discussion of the Emergency Medical Treatment and Active Labor Act (EMTALA) relating to consent for minors is in order. Most emergency physicians are at least generally familiar with the provisions of EMTALA. Among other things, EMTALA requires a hospital with an ED to provide an appropriate medical screening examination to any "individual" who comes to the ED for examination or treatment of a medical condition in order to determine whether the individual has an emergency medical condition. Clearly absent from the language of the law is any reference to the age of the individual requesting treatment. Therefore, any minor who presents to the ED requesting treatment for a medical condition requires, at a minimum, an appropriate medical screening examination, whether or not consent has been obtained from a parent or guardian. If no emergency medical condition is found (keeping in mind EMTALA’s broad definition of emergency), then normal consent procedures for minors may proceed. If an emergency condition is found, and the minor’s parent or guardian cannot be located, then the minor should be stabilized consistent with the appropriate standard of care. In such cases, consent will be implied by law, and the emergency physician should proceed with such treatment that a reasonable parent or guardian would consent to under the circumstances. This "emergency exception" to the general rule that parental consent is required is well settled in the law, although courts in the various states differ as to how serious the condition must be to qualify for this "emergency exception." Naturally, attempts to contact the family or guardian, as applicable, should continue as is practicable during the stabilizing treatment. As you read the rules of consent in the following sections, remember that lack of perfect express informed consent because a parent or guardian is not available should never delay necessary emergency treatment of a minor.
Minors accompanied by parents
Minors presenting to the ED accompanied by parents present the least complicated informed consent situation. The general rule is that a minor’s parents have the legal capacity to consent to the treatment of their minor child, and at least one parent’s consent must be obtained. Since a high percentage of children in the United States live with unmarried and divorced parents, considerable variations can and do occur. For children whose parents are divorced, the ability of the parents to give consent for the child may depend on the custody arrangement ordered at the time of the divorce. If one of the parents has sole legal custody, only that parent will have the full legal right to consent for the child. If the divorced parents have joint legal custody (including the right to consent to medical treatment), then either will have the right to consent for the child, unless the court decree requires the consent of both. If a conflict arises between the divorced parents in the latter case, a court order might be required to resolve the dispute. In the case of an emergency where delay might be detrimental to the child, treatment will needs to proceed prior to final resolution of this conflict. Careful documentation, while always a good practice, is particularly advised in such situations.
A minor parent may, in some states, give consent for treatment for his or her child.5 In some states, this leads to the anomalous situation where a minor may give consent for his or her child but not generally for himself or herself.
The rules for guardians are a little more complicated. This is because the role of guardian can vary from case to case, depending on the order from the court. In fact, in some situations, the parents may retain some or all of the ability to consent for medical treatment. For this reason, emergency personnel should ask for the letters of guardianship to determine the scope of the guardian’s authority. If a conflict arises between parents who retain some authority and the guardian, hospital counsel should be consulted. The general rule, however, is that a guardian has the same authority as a parent for nonsurgical treatment of a minor.
Many states also place additional restrictions on the guardian’s ability to authorize a number of other treatments. The only restriction of particular concern to emergency physicians is the additional requirement often placed on the guardian regarding the placement of the child in a mental health facility. Since all of these rules are state specific, consultation with an attorney knowledgeable in local law is necessary.
A Potpourri of situations
Minor students. State law may provide that a child who becomes ill or injured at school during regular school hours may receive reasonable treatment without the consent of the child’s parent or guardian when the parent or guardian cannot be reached. For example, California law provides that during regular school hours, "unless a parent or guardian has previously filed with the school district a written objection to any medical treatment other than first aid, no liability may be imposed on school officials or health care providers for reasonable treatment of a child when the parent or guardian cannot be reached to give consent."6
Wards or dependents of juvenile court. The court in these cases may give consent for treatment as though the court were the minor’s guardian. In cases where the petition to make the minor a ward or dependent of the court has not yet been finalized, the parents or guardian may still have authority to consent for the child. In these cases, the court may authorize consent if the parents cannot be found or if they refuse to consent to treatment.7
Minors in custody of the police. Emergency physicians commonly find themselves asked by law enforcement officers to examine and treat a minor being held on suspicion of committing a crime. Often, the minor is injured or suspected to be under the influence of an intoxicating substance. In these situations, the police do not, in general, have the authority to consent for the minor’s examination and treatment. Physicians should provide an appropriate medical screening examination as required by EMTALA and, if an emergency condition exists, proceed to stabilize the patient as is required by EMTALA and allowed by the "emergency exception" to the parental consent rule. If no emergency condition is found, the emergency physician must generally wait for consent from the minor’s parent or guardian, absent a court order, before providing further care. This would include requests by the police for blood tests in the absence of an emergent medical condition requiring such a test. If the parent or guardian cannot be located, then the minor may give consent for certain medical treatment. (See section on emancipated minors on pg. 24.)
Minors in custody of foster parents. If the child has been placed in foster care by court order after a final hearing, then the foster parent has the authority to consent to ordinary treatment.8 In California, however, non-emergency surgery would require consent from the legal guardian or the court. If the child is in foster care temporarily pending a hearing, then the foster parent has no authority to consent to any treatment absent a court order. Normally, foster parents are licensed by the state or county and are well aware of the requirements of the law about carrying the necessary papers authorizing consent for the minors in their charge. If any questions arise, hospital counsel should be consulted.
Suspected child abuse victims. All states have child abuse and neglect statutes. Therefore, when child abuse and/or neglect is reasonably suspected and parental consent for examination and treatment is refused, appropriate steps should be initiated to protect the child. This will most often involve the hospital social services department, children’s protective services and, when necessary, hospital counsel and the local police. EDs should have policies in place to deal with these situations.
Parents Unavailable. Children often show up at EDs accompanied by baby-sitters. Other similar situations include children injured while at day or summer camp. Most states allow the hospital to rely on a written consent form, previously executed by the parent, similar to a power of attorney, authorizing an appropriate person to make necessary health care decisions on the minor’s behalf in the parents’ absence. Most legitimate organizations that take care of children have these written consents on file in case of emergencies. Review by hospital counsel of what information must be contained on such forms is advised.
Parents may send their minor children to the hospital with a written note giving consent for treatment. These may be honored unless ED staff question their legitimacy. Of course, if the treatment indicated is at all out of the ordinary, or there is any reason to believe it would be outside the scope of the consent in the note, the parent should be contacted. Always remember that informed consent is a discussion, not a one-way communication, whether it be from the physician to the patient or vice versa. A copy of the note or form should always be kept as part of the permanent medical record.
A common situation arises when casual baby-sitters bring children who have become ill while under their care into the ED. The parents of these children often fail to provide appropriate authorization of treatment for the child and fail to appreciate the potential legal predicament facing their child and the hospital if medical treatment is required and they cannot be reached. Again, the "emergency exception," EMTALA, and common sense take precedence over mere formality. Simultaneous with the provision of appropriate emergency treatment to stabilize the child, steps should be taken to contact the parent or legal guardian.
In response to the recognition that a great many children live in "non-traditional households," California has enacted a statute permitting caregiver authorization.9 This statute allows a non-parent adult relative with whom the minor is living to authorize medical care, if certain requirements are met, by signing a "Caregiver’s Authorization Affidavit." The first requirement is that the minor must be living with the relative. Second, the relative must fit into one of the acceptable categories. The definition of "relative" in this regard is quite broad, ranging from brother and sister to half-brother, half-sister, stepbrother, stepsister, stepparent, aunt, uncle, niece, nephew, first cousin or any relative with the prefix of "grand" or "great." Authorized adults may also include the spouse of any of the above listed individuals, even if the marriage has been terminated by divorce or death. Third, the adult relative accompanying the minor must have obtained the consent of the parents or be unable to contact them. Fourth, the adult relative must sign an affidavit affirming that the first three requirements have been met. Such an affidavit is valid for a period of one year. Once all the requirements have been met, the health care provider may rely on the affidavit to provide services. State law provides immunity from criminal or civil liability for health care providers who rely on such an affidavit. Health care providers are not required to make any further inquiries as to the truth of the statements contained in the affidavit.
All states have enacted statutes that permit minors to give consent for medical treatment in certain situations (e.g., pregnancy, sexually transmitted diseases, substance abuse, etc.). It is important to remember that the circumstances under which a minor may authorize his or her own medical treatment vary widely from state to state.
Self-sufficient minors. A minor 15 years old or older who lives apart from his or her parents and manages his or her own financial affairs may, in some states, give consent for medical treatment without parental or guardian permission.10 The California statute does not draw a distinction between whether the minor is living apart from his or her parents with or without the consent of the parents. Nor does the law address the source of income that is sustaining the minor. A minor in this situation should sign an affidavit affirming that the requirements for self-sufficiency have been met. The hospital may rely on this affidavit, absent any obvious reason to disbelieve it.
Emancipated minors. In Michigan, for example, minors are emancipated and, therefore, may consent to medical treatment in the following situations:
1. When a minor is validly married;
2. When an individual reaches the age of 18 years;
3. During the period when the minor is on active duty with the armed forces of the United States;
4. For the purposes of consenting to routine, nonsurgical medical care or emergency medical treatment to a minor, when the minor is in the custody of a law enforcement agency and the minor’s parent or guardian cannot be promptly located; and
5. For the purposes of consenting to his or her own preventive health care, except vasectomies or any procedure related to reproduction, during the period when the minor is a prisoner under the jurisdiction of the department of corrections or the period when the minor is a probationer residing in a special alternative incarceration unit, if the parent or guardian of the minor cannot promptly be located by the department of corrections.11
Consultation with hospital counsel is advised to review the law regarding emancipation of minors in your state.
Married minors. Minors who are or have been validly married may be authorized to consent to their own health care.12 Note that, in California, the minor need not be currently married to be emancipated. Minors consenting under this provision might be asked to furnish a copy of their marriage certificate, if time and situation permit.
Minors on active duty with the armed forces. Any minor of any age on active duty with any branch of the United States armed forces may generally consent to his or her own health care.13
Pregnant minors. In Michigan, for example, a minor may consent to the provision of prenatal and pregnancy related health care.14 Before providing health care to the minor, however, the minor must be informed that the putative father of the child or the minor’s spouse, parent, or guardian may be notified for medical reasons by the treating physician. In addition, at the initial visit to the health facility or health professional, permission must be requested of the minor to contact the minor’s parents for any additional medical information which may be necessary or helpful to provide proper health care.
Minors with reportable diseases. In California, for example, a minor 12 years of age or older with any disease required to be reported to the local health officer, or a sexually transmitted disease, may give consent for his or her own health care.15
Rape victims older than the age of 12. In California, for example, minor patients older than the age of 12 years may consent to an examination and necessary treatment related to any condition as a result of an alleged rape.16 Parental consent is not required.
Victims of sexual assault younger than the age of 12. Minors younger than 12 years of age who allegedly have been raped or any minor who alleges any of a number of other acts falling under the category of sexual assault may consent for their own care for diagnosis and treatment of conditions that might arise from the assault.17 In contrast to the California statute cited above, documented attempts to reach the parents must be made unless the health care provider reasonably believes the parent was the perpetrator.
Minors seeking mental health treatment. In Michigan, for example, a minor 14 years of age or older may request and receive mental health services, and a mental health professional may provide mental health services on an outpatient basis, excluding pregnancy termination referral services and the use of psychotropic drugs, without the consent or knowledge of the minor’s parent or guardian.18
Minors with substance abuse problems. In Michigan, a minor who is or professes to be a substance abuser may consent to substance abuse-related medical or surgical care, treatment, or services by a hospital, clinic, or health professional. It is not necessary that the parent or guardian be contacted for consent in this situation.19
Child of a minor. Also in Michigan, a minor may consent to the provision of health care to a child of the minor.20 If the natural parents of the child were not married prior to or subsequent to the child’s birth, unless the father has legally adopted the child, only the mother is considered a "parent" of the child.
If none of the exceptions (the list above is illustrative, not exhaustive) applies to a particular minor in the ED and an appropriate medical screening examination fails to reveal an emergency, such that the "emergency exception" to the parental consent rule would apply, the emergency physician and ED would have no authority to treat the minor without first obtaining consent from a parent or guardian. While it is unlikely that a parent could successfully bring a battery action against the physician or hospital (assuming the treatment provided by the physician was not elective), it is not uncommon that the parent might refuse to pay for the services rendered. Particularly in this era of managed care, a minor may not know that his or her non-emergent care is covered only at a particular ED or other location. The emergency physician and hospital may well be denied payment by the managed care organization, leaving the minor’s parents responsible for the bill. Of course, concerns regarding reimbursement should be secondary to ensuring that appropriate care is provided to the minor.
It has been the tradition in emergency medicine, in the case of both adults and children, to obtain specific consent for the performance of certain special procedures. This consent may create particular problems when parents are asked to consent to these procedures on their children. Just what is and what is not covered by the blanket consent given at the admission desk is a subject of some controversy. While it is generally felt that ordinary examinations and procedures that carry a low risk of complications are covered by the blanket consent, procedures that carry higher levels of risk require specific consent. It is important for physicians always to remember that informed consent is an ongoing discussion with the patient (in the case of minors, the parent or guardian), not a signature on a form. The purpose of the form is merely to memorialize the informed consent discussion that took place and to provide evidence that the discussion in fact took place and that specific risks and benefits were discussed.
How risky must the procedure be before special consent is required? Few would argue with the proposition that the performance of surgery under general anesthesia falls under the "risky" category. Most would also agree that radiological procedures using the injection of intravenous contrast also fall under this category. On the other hand, simple venipuncture, for example, does not require special consent (regardless of the fact that, in many children, venipuncture is anything but simple). What about a procedure such as lumbar puncture? The answer is not so clear.
Traditionally, special consent has been obtained for lumbar puncture (LP). Most emergency physicians would agree, however, that this procedure is relatively simple to perform and carries very little significant risk; therefore, should not require a special consent. The tradition of special consent for this procedure probably originates in its undeserved bad reputation among many parents. The not uncommon terrified parental reaction when a physician recommends an LP never fails to amaze emergency physicians. Even a careful explanation of the need for the LP and a description of the procedure often fails to allay parental fears. The most common concern, of course, is paralysis. How many parents know of someone who heard that someone’s cousin was left permanently in a wheelchair as a result of an LP?
Often, the very presentation of a special consent form to be signed increases the level of apprehension of the parents. When obtaining informed consent, it is, of course, essential to discuss with the parents the indications for the procedure, the risks of performing the procedure, the risks of refusing the procedure, and the perceived benefits of performing the procedure. Remember that it is this discussion that constitutes the informed consent, not a signature on a special consent form. In some hospitals it has been the practice for many years to obtain a special consent for LP and, because of the longstanding tradition, it is sometimes difficult to change the policy.
Parental refusal to allow an LP leads to the next question: What does the emergency physician do with the child in whom the physician either suspects meningitis or in whom an LP is part of the standard septic infant workup? In either case, the child should be started on appropriate broad-spectrum antibiotics and admitted. If the suspicion of meningitis is at all significant, treatment should be initiated before the LP results are back in any case. Many a malpractice case has been lost on the issue of delay in treatment until the laboratory analysis of the spinal fluid was in hand. The potentially septic infant, likewise, is often treated empirically. In either case, it is rare that the LP results will alter antibiotic selection, other than discontinuing antibiotics altogether. If the parent refuses the LP, a full description of the discussion regarding the refusal should be documented on the chart as well as on the department’s refusal of treatment form signed by the parent. If the emergency physician believes that the LP is essential, the physician should contact children’s protective services and hospital counsel as necessary.
Parental refusal of treatment
Parental refusal to allow specific or all medical treatment for a minor child presents one of the most frustrating and potentially dangerous aspects of emergency medicine. A competent adult has the right to refuse medical treatment, even when the physician believes that any "reasonable" patient would consent to the treatment. The situation, however, is different when a parent refuses "reasonable" treatment for a minor child. Our society is quite tolerant of the autonomy of parental decision-making in child-rearing, but draws the line at decisions that carry the potential of physical harm to the child. Parental refusal of care may be based on ignorance, distrust, financial, or religious grounds. Intentional abuse or neglect also often results in refusal of care, but in these instances, the parent is usually not present in the ED.
|Risk Management Do’s and Don’ts|
1. Be aware of local state laws and regulations regarding consent for and by minors.
1. Delay a medical screening examination of a minor while awaiting parental or guardian consent._________________________________________________________________________________________
The first and primary weapon to address parental ignorance with respect to parental consent is communication and education of the parents by the physician. The emergency physician should, to the best of his or her ability, try a crash course in educating the parents regarding the disease process potentially afflicting their child. If, in the physician’s judgment, a significant potential for morbidity or mortality is associated with the particular disease process potentially present in the child, and parental consent for appropriate treatment is not forthcoming, the emergency physician must take immediate steps to ensure the safety of the child. In such a case, the physician should enlist all available resources, including the family’s personal physician, social workers, child protective services, hospital counsel. No parent should be allowed to take his or her child from the hospital under such circumstances, even if intervention by the police is required. All states have, by statute, procedures for the authorization of medical care in appropriate cases, despite the objection of the parents or guardian.21 Every ED should have a well-thought-out policy for dealing with such difficult situations.
Case #1. A 7-year-old boy was taken to the ED with complaints of abdominal pain and diarrhea for four days. The emergency physician found on examination that the child had right lower quadrant tenderness with rebound and mild guarding. The child was mildly febrile, but otherwise his vital signs were normal. He was taking fluids by mouth without vomiting. A CBC was performed that showed a white blood cell count of 11,500. Concerned about possible appendicitis, the emergency physician requested a surgical consultation. The surgeon agreed that appendicitis was a distinct possibility and recommended laparotomy, but the parents refused. The parents were allowed to leave with the child against the advice of the physicians. The child returned two days later with obvious peritonitis and a laparotomy revealed a ruptured appendix. The patient eventually recovered after a stormy post-operative course, but continued to complain of chronic diarrhea and abdominal pain.
A malpractice suit was subsequently brought on behalf of the child claiming that the physicians were negligent in allowing the parents to leave with the child in the face of a clinical presentation suggesting appendicitis. The father, in his deposition, stated that he refused surgery because: "I had never heard of appendicitis in a 7-year-old." He had demanded to leave in order to get a second opinion from "a physician friend of the family." The surgeon stated in his deposition that he permitted the child to leave with the parents against medical advice (AMA) because, although the symptoms were consistent with appendicitis, the time course of the disease was atypical, the white blood count was normal (or near normal), and the child did not seem particularly ill. Therefore, while he would have preferred to perform a laparotomy for suspected appendicitis, he felt that the child could have had gastroenteritis and allowing the parents to leave AMA with the child was reasonable. The physicians eventually received a no cause verdict after trial.
Commentary. Although the physicians eventually prevailed in this litigation, they were subjected to the emotional and financial trauma of a lawsuit and might have saved themselves the trouble had they taken more time to educate the parents regarding the risk of appendicitis in their child. Spending a little extra time talking to and educating parents often can prevent a subsequent lawsuit. The dilemma faced by the surgeon and the emergency physician in this case is typical of the sort of judgment calls required when parents refuse recommended treatment. This was not a case where it would have been appropriate to involve children’s protective services or the courts; however, other interventions might have been appropriate (e.g., social services). In this case, the physicians made a judgment call. They made their recommendations to the family, documented the father’s refusal and the discussion of the possible consequences of his refusal, yet left the door open for them to return. While the physicians eventually prevailed in this case, it is never good to allow yourself to be placed at the mercy of a jury.
Distrust can evolve from many sources, some from within the ED, others from without. Some common external sources of distrust include a personal distrust of health care providers in general and physicians in particular, racial or cultural animus, fear (grounded or not) of being exposed to law enforcement or immigration authorities, and pre-existing parental psychiatric disorders. The encounter with emergency personnel may also engender distrust. This may arise from a lack of effective communication skills on the part of either the parents, the emergency department personnel, or both. Distrust often arises when parents observe what they interpret as incompetence, such as watching multiple unsuccessful attempts at starting an IV. Excess waiting time and perceived rudeness often also give rise to these same feelings. Distrust coupled with ignorance is a particularly difficult combination.
Common reasons for refusal of a particular procedure (e.g., LP) can include familial lore that some distant relative was paralyzed from the procedure or that another hospital killed a relative. Irrational fears and an inability to make sensible decisions result from these family myths. In attempting to get consent for a procedure such as an LP, most physicians have faced the situation where the parents refuse because they don’t want their child to suffer any more pain, despite repeated attempts to caution the parents of the consequences of untreated meningitis.
Some parents also distrust their own decisions. This may occur, for example, in certain groups of immigrant women who are often fearful of making any important decisions without the advice and agreement of their husbands, who may not be available at the time consent is needed and traditionally may not allow their wives to make any important decisions.
The first step in dealing with these situations is patience. Emergency physicians should always try to defuse any tensions that may already have arisen between the staff and the parents. Social workers and other ancillary personnel may prove extremely useful in this regard. Seek out relatives and friends of the parents who may be more amenable to reason and may help either defuse the situation and/or help convince the parents of a reasonable course of treatment. If all else fails, and delay for purposes of obtaining consent may harm the child, contact children’s protective services and, when necessary, hospital counsel.
Case #2. A 14-month-old girl was brought to the ED by her parents because of a two-day history of fever, cough, and lethargy. She was seen promptly by the nursing staff and emergency physician. The physician determined that the child appeared dehydrated and septic and so required a septic work-up. A CBC, blood cultures, chemistry profile, urinalysis, and chest x-ray were ordered, and an LP was anticipated. The nurses had some trouble drawing the child’s blood and starting an IV because of difficulty finding a vein. They were successful after several attempts, but the parents became increasingly distraught at observing their child crying and the nurses’ inability to start the IV. By the time the physician approached the parents to explain the LP, the parents were in the process of dressing the child. They requested that the IV be discontinued and stated that they wanted to leave "to go to another hospital." The physician could not convince them to stay. The policy of that ED regarding AMAs was that no follow-up instructions or referrals were to be given. The parents left after signing the AMA form. The baby unfortunately died of meningococcal meningitis 12 hours later, having not been brought to another hospital. The subsequent malpractice lawsuit brought against the physicians was settled for $200,000 prior to trial.
Commentary. This case is a perfect example of what may result when distrust develops and is not effectively addressed. The parents, already upset about having a sick child, became distrustful at what they perceived as ineptitude on the part of the nursing staff. In this case, the emergency physician, hospital, and nursing staff made several errors. First, the situation with the nurses and the multiple attempts at venipuncture apparently was allowed to get out of control. When the parents started to become distraught, several actions should have been taken. The parents could have been escorted from the room by a social worker or another nurse and the procedures more fully explained. The nurses also could have called the physician to attempt intravenous access when the nurses failed. When the parents expressed their intention to leave, it was the physician’s responsibility, in the face of a child who was most likely toxic in appearance, to either convince the parents to allow treatment of the child to continue or, if this failed, to enlist whatever resources necessary to protect the child. If the emergency physician truly believed the child was seriously ill and required immediate treatment and was unable to enlist the parents’ cooperation, he or she had an obligation to inform the parents that appropriate legal measures would be taken under the child protection laws of the state. Finally, the department’s AMA policy, which provided that no follow-up instructions or referral would be given when patients left AMA, was simply wrong. When a patient is allowed to leave AMA, there should always be an open-ended invitation to return to the ED and attempts to otherwise arrange care.
Occasionally, parents may refuse hospitalization or treatment of their child because they cannot afford it. Although this seems to fly in the face of reason when the health of a child is at stake, it must be taken at face value. Every hospital should have policies in place that can assist needy parents (e.g., payments over time, a charity fund, etc.). The hospital, of course, has an obligation under EMTALA to provide stabilizing care regardless of the patient’s (or parent’s) ability to pay. Again, never allow a toxic appearing child to be taken by a parent from the ED prior to appropriate treatment.
Refusal based on religious beliefs
Parental consent issues may assume constitutional proportions where religious beliefs are concerned. The First Amendment prohibition on laws respecting an establishment of religion or prohibitingthe free practice thereof has come face-to-face throughout our country’s history with religious practices that may be at odds with the medical opinions of treating physicians. Prominent among these practices are reliance upon faith healing and the refusal of blood product transfusions. The general rule is that competent adult patients have the right to refuse any treatment on any grounds, including religious ones. The courts, however, have made it quite clear that the same principle does not apply to parents’ decisions regarding the medical treatment of their minor children.22 While allowing adults great latitude with regard to their religious beliefs, the courts will generally not permit a minor’s health to suffer as a result of denial of care because of parental religious beliefs. Note, however, that the risk to the minor of forgoing the recommended medical treatment must be substantial and not simply speculative.
A child treated by faith healing is often not seen in the ED until the child is moribund, since such parents may shun traditional medicine. Children in such a condition must be aggressively treated despite the wishes of the parents. Historically, both these children and children whose parents refuse blood product transfusions in life-threatening situations are made temporary wards of the court for the purpose of providing medical treatment. In both of these situations, it is imperative that hospital counsel be consulted so that an emergency motion and hearing before the court may occur expeditiously.
Case #3. A 16-year-old was involved in an automobile accident and was seriously injured, sustaining fractures of both legs and multiple lacerations. He informed the staff in the ED that he was a Jehovah’s Witness and that it was against his religious beliefs to receive blood products. The orthopedic surgeon determined that surgery was necessary to reduce and fixate the right leg. The boy’s father consented to surgery with the proviso, however, that no blood products could be administered.
Blood loss during surgery and as a result of other injuries led the boy’s surgeon to believe that blood administration would be required to save his life, but the father continued to refuse to allow a transfusion. Pursuant to hospital policy, the hospital risk manager consulted on an emergent basis with hospital counsel who petitioned and received from the court the emergency appointment of a guardian ad litem to opine as to whether a blood transfusion would be in the best interests of the boy. An emergency hearing was held and an order allowing the transfusion was issued. Blood was administered and the minor eventually fully recovered from his injuries.
The minor and his mother subsequently sued the hospital, the risk manager, the physicians, and the guardian ad litem in federal court for violations of the minor’s and parent’s constitutional rights. The federal district court dismissed the suit on a motion for summary judgment, and the plaintiffs appealed. The court of appeals dismissed the appeal as frivolous and awarded the hospital double costs and attorney fees.
Commentary. Although the suit was unsuccessful, it illustrates several important concepts. First, the Jehovah’s Witnesses’ doctrine against receiving blood product transfusions is among the most strongly held of religious beliefs. Despite insurmountable odds, this boy’s family felt so strongly about the violation of their beliefs that they went to the time, expense, and grief of filing a lawsuit. This underscores the need to follow proper protocol and procedure when contemplating overruling the adamant desires of a minor’s parents. In this case, hospital risk management involved legal counsel early on to assure that proper procedure was followed. Second, this case demonstrates that the courts may not allow parents’ religious or other strongly held beliefs to adversely affect the health of their children. The fact that this case was dismissed on motion for summary judgment means that the parents were unable to present sufficient evidence against the hospital and physicians for a jury to find in their favor.
If one thing must be remembered regarding consent for minors in the ED, it is to "Do the Right Thing." The general rule is that, prior to treatment of a minor, consent from the minor’s parent or guardian is required. There are, however, numerous exceptions to this rule, most importantly, the "emergency exception." When parents or legal guardians are not available, the law requires appropriate medical screening and stabilization of emergencies with or without consent. When parents are available but refuse life-saving treatment, the law provides mechanisms to temporarily take the child into the custody of the court. The true test of the emergency physician’s interpersonal skills lies in handling the difficult cases that do not amount to life-threatening emergencies, but when delay in treatment would be detrimental to the child. In these cases, the physician’s job is to convince hesitant caregivers of what is best for the child without becoming defensive or hostile if the physician’s recommendations are challenged. Only by demonstrating patience and calm will the emergency physician engender the trust necessary to accomplish what is best for the child.
1. Schloendorff v Society of New York Hospital, 211 N.Y. 125 (1914).
2. Because of the subjective nature of this concept, most states have not adopted "mature minor" statutes. West Virginia is one state that has adopted this doctrine. See, Belcher v Charleston Area Med. Ctr., 422 S.E.2d 827 (W.Va. 1992).
3. EMTALA, 42 U.S.C. § 1395dd, has been discussed in previous issues of ED Legal Letter. This discussion is merely a brief discussion of the application of EMTALA to the specific issue of consent for minors. Regular readers of ED Legal Letter should be familiar with the provisions of EMTALA.
4. 42 U.S.C. § 1395dd.
5. M.C.L.A. § 333.9132.
6. Hospital Law Manual § 4-1 (Health Law and Compliance Center, Aspen Publishers, Inc. ed., 1974-1999) (hereinafter, "Hospital Law Manual"). See, Cal. Educ. Code §§ 49407 and 76407.
7. See, e.g., California Welfare and Institutions Code, §§ 362 and 727.
8. California Health and Safety Code, §1530.6.
9. California Family Code, §§ 6550 and 6552.
10. See, e.g., California Family Code, § 6922.
11. M.C.L.A. § 722.4.
12. See, e.g., California Family Code, § 7002 and M.C.L.A. § 722.4.
14. M.C.L.A. § 333.9132.
15. California Family Code, § 6926.
16. California Family Code, § 6927.
17. California Family Code, § 6928.
18. M.C.L.A. § 330.1707.
19. M.C.L.A. § 333.5121.
20. M.C.L.A. § 333.9132.
21. Hospital Law Manual, § 4-3.
22. See, e.g., In re McCauley, 564 N.E.2d 411 (Mass. 1991) (Court ordered transfusion of an 8-year-old leukemia patient whose parents were Jehovah’s Witnesses.).
Atrium Health Union is a 175-bed hospital in Monroe, NC, providing comprehensive emergency services and specialty medical care. The campus offers a variety of medical services, including a day surgery center, cancer treatment center, long-term care facility, behavioral health center, specialty care clinics, a community wellness and outreach program, a women and children’s center, interventional heart program and physician practices. Over the past 15-plus years our hospital has been serving the Monroe area, and we have worked to add new services and more specialized physicians and programs to meet the growing healthcare needs of our community.
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John and Jane Doe grant permission to Eric Johnson to act on our behalf to I authorize Doe Arms nursing home to administer emergency medical care to my.
At 3:00am an ambulance pulls into the emergency department carrying a young man suffering life threatening stab wounds. The man is drifting in and out of consciousness and unable to answer the paramedics’ questions coherently. He is accompanied by a friend who says that they were out celebrating the friend’s 18th birthday (the friend thinks that the patient is due to turn 18 next month), when the patient was attacked and his wallet was taken. The patient’s friend goes on to say that the patient is very religious, “a Jehovah’s Witness I think – his parents are really strict”, but does not know any further details. As the young man’s wallet has been taken, there is no way for the emergency department staff to verify any of this information.
Upon initial assessment, it becomes evident that if the patient does not receive an urgent blood transfusion, he is likely to die. What issues do the emergency physicians face from a legal perspective, and how does the law assist them to do their job?
The Legal Position
The legal framework governing consent in emergency situations in Queensland is complex, and often attracts criticism. There is an obvious conflict between administering life saving medical treatment (such as a blood transfusion) and a patient’s absolute right to refuse treatment.
The key consideration for the emergency physicians is the patient’s capacity to refuse treatment. Under the common law a competent adult is entitled to refuse medical treatment. Under Queensland legislation, capacity is defined as a person who is capable of:
In the above scenario, the patient’s capacity is clearly impaired and the patient is unable to give coherent instructions to treating physicians. In circumstances where the adult lacks capacity, emergency treatment (including a blood transfusion) can generally be performed without consent.
Pursuant to section 63 of the Guardianship and Administration Act 2000, ‘health care’ may be given to an adult without consent, in circumstances where:
‘Health care’ includes treatment to diagnose, maintain or treat a physical or mental condition. A blood transfusion would fall within this definition. Provided all 4 points above are satisfied, a blood transfusion may be administered to an adult, without consent.
A blood transfusion should not be given in circumstances where the physician is aware that the adult objects to it in an advance health directive. But what about a ‘no blood card’? Should this be followed?
A ‘no blood card’ in itself does not meet the strict legal requirements to constitute an advance health directive  - however it may indicate that such a directive is in place. The issue under the legislation is whether the knowledge of a ‘no blood card’ constitutes knowledge of an advance health directive. Unfortunately there is no clear answer to this, and much will depend upon the circumstances.
In the above scenario the patient’s wallet has been stolen, and there is no way to verify whether he carried a ‘no blood card’. However, before a blood transfusion can be administered, consent may be required from his parents or guardian, as there some suggestion that the patient is a minor (that is, under the age of 18).
In the event that the patient’s parents were contacted, and they refused to give consent to the blood transfusion, what should the emergency physicians do? In Queensland, there is no criminal liability on the part of a physician who administers a blood transfusion to a child, without consent, provided that:
Further, if a transfusion is administered in accordance with these requirements, the legislation deems the transfusion to have been administered with consent (although this does not impact any liability for other issues regarding the transfusion, for example if it was executed negligently).
The same considerations apply in circumstances where a minor’s parents cannot be contacted.
What should treating physicians do, and how can hospitals help their doctors?
In order to navigate the complexities of refusal of treatment, it is suggested that hospitals have clear policies in place addressing each of the above issues. This should include policies addressing assessment of capacity, consent, minors, refusal of treatment and a specific refusal of blood policy.
In determining whether an adult patient has the requisite capacity to refuse treatment, there should be a thorough documentation of the assessment of capacity. This should go beyond the standard GCS, and address whether the patient fully understands the implications of a decision to refuse treatment. Medical practitioners – particularly those dealing with patients in an emergency setting – should be supported by the hospital having in place a clear policy regarding who is responsible for making this assessment on a given shift (eg. the consultant/senior registrar), whether another practitioner or nurse should witness the assessment and who should be notified of the outcome.
If a patient is found to have capacity, or if a minor’s parents or guardian are contacted, and objections are raised to potentially life saving treatment, the hospital policy might include steps such as:
In the situation of a parent/guardian refusing a blood transfusion for a minor, if the treating doctor decides to administer the transfusion without consent the requirements of the Transplantation and Anatomy Act 1979 must be followed and documented. In particular, the treating doctor must ensure that either a second medical practitioner examines the child and agrees that the transfusion is necessary, or a medical superintendent of a base hospital provides consent before the transfusion is administered. As this issue may arise for emergency physicians in a time critical situation outside normal business hours, relevant contact details should be readily accessible.
Purpose: To enable parents to authorize emergency treatment for children I DO NOT give my consent for emergency medical or dental treatment of my child.