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On A Question Of Informed Consent

Monday, October 1st, 2001
Dr D K Arya, MB BS, MDpsych, DPM, MRCPsych, DM, FRANZCP, CHMS, DipHSM, MBS, MRACMA. Clinical Director, Mental Health Services, Palmerston North Hospital, New Zealand.

Abstract

To be valid, informed consent has to be voluntary, specific and given by a competent person. Informed consent is to do with respect for the autonomy and dignity of the individual and cannot be waived unless it can be clearly shown that the person is incapable of reasoning rationally or is incapable of autonomic choice. Exceptions to informed consent include an emergency, incompetency, therapeutic privilege and when the patient has waived their right to information or decision-making. How much should be disclosed, what should be disclosed and who can consent is explained.



Introduction

It is suggested that the term "informed consent" was first used only as recently as 1957 in a case from California, Salgo v Leland Stanford Junior University Board of Trustees [ 1 ]. A patient had undergone translumbar aortography and suffered spinal cord injury. As a consequence this patient alleged that insufficient information had been given to him about the procedure before he underwent it. The Court ruled that "a physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment". In elaborating on this principle, the Court then used the term "informed consent" to describe the physician’s duty.

It is important that the consent is "real in the eyes of the law" (Wallace and Johnson 1995). The patient having signed a paper to say that he or she has given informed consent will be meaningless if the following three elements have not been met:

  • The consent is voluntary (not given under threat or duress, or under the effect of stupefying drugs).
  • It is specific (the act carried out must be precisely the act consented to).
  • It has been given by a competent person (ie, an adult of sound mind; a legally competent person, etc).

In the last few years, the informed consent doctrine has evolved rapidly, with particular emphasis being placed on theories of liability and the legal rules governing information exchange as part of valid consent (Ludlam 1978).



Why is it important to have informed consent?

Informed consent is to do with respect for the autonomy and dignity of the individual. In our society a person is viewed as having the right to make their own decisions based on their own values about things that are important to them. The failure to inform or involve the patient in medical decision-making is thus to fail to respect the patient as a person who can reason and choose. Only if it can be clearly shown that the person is incapable of reasoning rationally or is incapable of autonomic choice, informed consent can be waived. The importance of informed consent is highlighted by the fact that even involuntarily committed psychiatric patients have the right to consent to or refuse psychiatric treatment. The Mental Health (Compulsory Assessment and Treatment) Act 1992, s 59(2) states that except during the first month of the currency of a Compulsory Treatment Order, no patient shall be required to accept any treatment unless:

  • The patient, having had the treatment explained to him or her in accordance with section 67 of this Act, consents in writing to the treatment; or
  • The treatment is considered to be in the interests of the patient by a psychiatrist (not being the responsible clinician) appointed for the purposes of this section by the Review Tribunal.



How much should be disclosed

There is some controversy about informed consent at law. This controversy relates to the nature of the disclosure of clinical information by a clinician and whether a professional standard or some other standard of information disclosure should pertain. Traditionally, physician ethics focused more on what physicians perceived to be in the best interest or welfare of their patients. Physicians then tailored disclosure accordingly. In the 1970s, at least in the US, attention turned to the desirability of other standards for disclosure. The professional standard (as above) was rejected and instead a "materiality standard" was proposed. This standard was based on the concept that the duty of physicians to disclose information to their patients is determined not by the standards of the profession but by the needs of patients as decision-makers (Canterbury v Spence [ 2 ]). The Court ruled in Canterbury that the obligation of the practitioner is to disclose what a "reasonable person" would want to know about the treatment before undergoing it.



What should be disclosed?

Consent given has to be very specific, ie, the act carried out must be precisely the act consented to. The usual common law elements of disclosure include:

  1. The nature of the procedure or treatment.
  2. Risks. It is always a good idea to elaborate on the nature of risk, ie, whether risks are material, substantial, probable or significant.
  3. Anticipated benefits, ie, probability of success.
  4. Alternative treatments and their risks and anticipated benefits.

Informed consent is not based on a one-way flow of information; the argument that attendance at a hospital or clinic is necessarily consent to subsequent treatment is invalid and passivity is not necessarily consent. The onus is on the health care worker to actively determine that the client consents.

The question arises as to what patients should be told. In Canada and the US, patients must be informed of all significant risks. The English and New Zealand Courts of Law accept that so long as a patient knew the general nature of the procedure, informed consent is considered valid. A Court will consider what a reasonable doctor should have told the patient under the circumstances - any details that would alarm a sensitive patient and unduly influence that person against treatment need not be given. However, it must be kept in mind that it is not the medical professional but the Court that determines what is reasonable information in any particular case.



Battery or negligence?

If the information about a procedure or treatment is not given, in Canada and the US those carrying out the procedure or prescribing treatment can be liable in battery (touching of another, in anger, without lawful excuse) on the basis that uninformed consent is no consent at all. In New Zealand the courts have considered that lack of full information is a matter of negligence rather than a lack of consent (Sidaway v Bethlem Royal Hospital Governors [ 3 ]) so long as the patient knew the nature of the procedure. Moreover, under the New Zealand Accident Compensation Scheme, there is little opportunity for determining the extent to which a nurse or health professional may be liable in civil proceedings for failure to disclose information to patients. Judge Cartwright (as she then was) stated that patients were entitled to all relevant information concerning treatment and the options for treatment (Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at National Women’s Hospital and Into Other Related Matters).

To establish negligence, since no extra compensation cover is available, patients have to rely on establishing that a doctor or nurse’s duty of care involved the giving of information they lack. The law has established that there is a duty to disclose material or substantial risks but the determination of what these are will depend on the circumstances of individual cases. In Sidaway v Bethlem Royal Hospital Governors [ 3 ], a clear direction was that medical staff have the discretion to decide what disclosure is proper and in the patient’s interest. However, Zelling J in Battersby v Tottman [ 4 ] held that a patient must be allowed to make his or her own decision, despite whether the doctor thinks them well enough or not. The legal opinion appears to be that the more drastic the proposed procedure, the more necessary it is to keep the patient informed about the risks. Although the Court will consider evidence of what is considered proper medical practice, it is ultimately for the Court to determine what the appropriate standard of care is, and the paramount consideration is to be that a person is entitled to make his or her own decision about his or her life.



Who can consent?

Competency to consent is important to determine. Patients may be incompetent to give consent either by reason of their age, mental capacity at the time or their status under other legislation. (eg, Mental Health (Compulsory Assessment and Treatment) Act, 1992 and Protection of Personal and Property Rights Act). A patient may be temporarily unable to give permission for treatment (eg, the patient is unconscious or their sensorium is affected by medication). If the treatment proposed is not in response to an emergency, the medical staff should wait until the patient has regained the capacity to consent.

Consent in relation to children

In New Zealand a person is legally a minor or child until the age of 20 years or earlier if married. Until that time, a minor cannot enter into contract or agree to medical treatment. A parent of the child, a person to whom the parents have given the right to make a decision, a legally appointed guardian or the Court with the jurisdiction to make a decision for the child has the right to consent on behalf of the minor. In addition, the Courts have been willing to give a child the right to consent to treatment if the child is capable of understanding the nature and consequences of the procedure. This does not mean that a parent loses control of his or her child, only that the parent may not be able to sue the health carer in battery for carrying out the treatment. It is important to remember that even if the child is not living with one or both of the parents, the parents’ legal rights and obligations do not cease, therefore, parental consent must be taken.

If the child is capable of understanding the nature and consequences of a procedure or treatment and his or her parents disagree, recent judgements have indicated a tendency for Courts to favour a medical practitioner’s view as to the need of the child for treatment over that of a parent (Gillick v Norfolk and Wisbech Area Health Authority [ 5 ]).

The Guardianship Act 1968 provides that the consent of the child of or over 16 years of age to any medical, surgical or dental procedure (including a blood transfusion), or donation of blood, shall have affect as if the child were of full age. Section 25A provides that a female of any age may consent, or refuse her consent, to an abortion as if she were of full age. However, this provision is not enough to rule out the right of the parents at law. Therefore, where the consent of a child is presumed or obtained, treatment should be discussed with the child’s parents/guardian.

If a child is considered to be in need of treatment and a guardian will stand in the way of a child receiving it, one can make application to the High Court under s 9 of the Guardianship Act to have the Court made the guardian of the child for the specific purpose of consenting to necessary treatment being given. The Court can create wardship, which has been used to overcome parental refusal to consent. The wardship jurisdiction of the High Court exists quite separately as part of the Court’s inherent jurisdiction, the "parens patriae" jurisdiction (lit "parent of the state"; derived the English common law which empowered the monarch to act as guardian and protector of people under legal disability - eg, children and the mentally incompetent.)

There is also a possibility where parents want a child to receive treatment but the child objects. If the treatment is given, the health care provider will be open to an action in battery by the child. On the other hand, to fail to give treatment would leave him/her open to an action in negligence by the parents (if they can prove that not giving treatment has caused direct harm to the child). The Court of Appeal (England) in a case Re W [ 6 ] reiterated parental rights to consent to treatment of minors, even where they became "Gillick-competent" or any "understanding minor". The Court expressed consent as being a type of "flak-jacket", giving protection to the health carer from a suit in battery. So long as the health carer has a "flak-jacket" from either the parent or the child, he or she can act against the wishes of the other (subject, of course to good medical judgement).

If the child is under the care of a third party, the third party is acting in loco parentis (in the place of the parents) and they therefore have delegated authority to consent. It is suggested that this authority would only apply to consent to treatment, which is necessary for "the continued good health of the minor and which is impractical to delay until a parent or guardian could be contacted".

In New Zealand, if parents are not available and the child is not in the care of someone else or no such person can be reasonably found or is capable of consenting, consent may be given by a District Court Judge or the Chief Executive of Child, Youth and Family Service.



Consent in relation to intellectually disabled

Children and adults who have an intellectual disability may or may not be capable of giving consent. It is important to establish whether the person with the intellectual disability is capable of understanding the particular medical procedure proposed. If they are not capable of giving consent, their rights are protected by the Protection of Personal and Property Rights Act 1988. This Act is based on the idea that an incapacitated person should be encouraged to make decisions about themselves to the greatest extent possible. For people who are not capable, the law requires that only a person legally empowered to consent on their behalf may do so. The Court can appoint a welfare guardian under this Act, which gives the guardian the right to permit or disallow treatment on behalf of the patient.

The appointment of welfare guardianship be distinguished from the Power of Attorney. The Act provides for the granting of enduring Power of Attorney to a person chosen by another person to handle his or her affairs once he or she becomes incapacitated. This is not a Court appointment and the power can only be signed by the donor of the power and witnessed by two people. In practice, an enduring Power of Attorney is granted when a person realises that he or she has become incapacitated. A welfare guardian appointment is made on behalf of anyone who is unable to appoint someone to look after their affairs. Having said that, both welfare guardians and persons with enduring Power of Attorney can consent to treatment on the person they represent. It must be remembered that even the welfare guardian and person with enduring Power of Attorney cannot consent for another person to electroconvulsive therapy, medical experimentation or any treatment which would destroy brain tissue.

In a situation where no welfare guardian has been appointed, no one has enduring Power of Attorney and a patient is unable to consent to treatment, an application can be made by any person who has a real interest in the client’s welfare to the High Court to exercise its power of parens patriae. The Guardianship Act 1968 has similar provisions dealing with the care of the children and the Mental Health (Compulsory Assessment and Treatment) Act 1992 has provisions allowing a Court to make orders for the welfare of mentally disordered persons.



Evaluation of competency to give informed consent

Roth et al (1977) summarised a number of different standards for evaluating competency. There should be evidence that the individual:
1. Evidences a choice
2. Chooses reasonably
3. Chooses rationally
4. Has the ability to understand information which lead to consent; or
5. Actually understands.

It is proposed that a graded approach for assessing subjects competency be adopted so that the rights of patients are balanced with the need to gain new knowledge. Depending upon the patient’s mental state and level of understanding, information about a treatment or procedure should be imparted. Disorder of cognition, volition or affect can each compromise a patient’s competency but may not make the patient fully incompetent in terms of giving informed consent.

When dealing with patients who may not be competent, an increased burden is placed on the health care provider to demonstrate and document the patient’s understanding, as well as his or her attempt to educate the patient, to prove that the patient consent was valid. Therefore, when determining whether patients are competent or not, it is important to focus on a patient’s understanding through systematic questioning or testing to ensure maximum patient participation.



What are exceptions to informed consent?

Meisel (1979) has suggested four exceptions:
1. Emergency
2. Incompetency
3. Therapeutic privilege and
4. Waiver.

In an emergency, there is a long-standing common law tradition that consent need not be obtained. However, adults of sound mind who require emergency treatment, and are conscious, can refuse consent to emergency procedure. Similarly, a person who has imposed a valid restriction on the treatment (that could potentially be given) cannot be given that treatment if emergency physicians know about this restriction. In Malette v Shulman [ 7 ], the Ontario Court of Appeal, stated that the person carrying a card which imposed a valid restriction on a treatment could not be given that treatment even if it was required to save her life. It was the responsibility of the patient if harmful consequences arise from her decision.

There can be a conflict between staff and the patient over provision of emergency life saving treatment. One option is for staff to take the matter to the High Court. As mentioned before, the High Court has inherent jurisdiction, parens patriae, to make any ruling affecting the well being of any citizen who is in need. Decisions can be made urgently, with consequent legal protection of medical personnel in carrying out the Court’s ruling. The parens patriae jurisdiction for children is addressed in the High Court under s 9(1) of the Guardianship Act 1968. The Courts in the US and the UK have overruled decisions of patients not to accept treatment if it was in the interest of the patient (and/or even an unborn child (eg, Raleigh Fitkin-Paul Morgan Memorial Hospitalv Anderson [ 8 ]; Re S (Adult: Refusal of Medical Treatment [ 9 ]), although in New Zealand the Courts do not recognise that the foetus has an illegal rights. In John F. Kennedy Memorial Hospital v Heston [ 10 ], the Court actually held that hospital staff, being dedicated to saving life, would be prevented from carrying out their functions according to their professional standards if they stood aside and did not give a transfusion to an objecting patient.

The act of suicide poses particular difficulty. The overwhelming practice in New Zealand has been to provide emergency treatment to preserve lives of people who want to commit suicide. One reason used for doing so is a generalised belief that most attempted suicides are really cries for help rather than genuine attempts to end life.

The Courts readily accept the medical opinion that although a person’s behaviour is suicidal, the intention to die cannot be said with certainty to be present. The law, where in doubt, opts for life rather than no life, and treatment rather than no treatment.

Even though consent need not be obtained from an "incompetent person", however, this does not mean that incompetent patients cannot be engaged in a dialogue, that they should not be told what is going to happen or that they should be excluded entirely from the decision-making process. The patient’s competency may change (eg, as a result of treatment).

An exception to informed consent is therapeutic privilege. Many courts have permitted physicians to withhold information from patients, even information that may be relevant to obtaining informed consent, if, in a physician’s judgement, providing the information would clearly harm the patient, especially so as to render him or her as an inadequate decision-maker (Meisel 1979). Therapeutic privilege is not a licence to withhold information on the basis that, were the patient to learn the information, he would not consent. Instead, it is a way of reconciling physicians’ traditional allegiance to promoting the welfare of patients with the requirement of informed consent law.

The final exception to informed consent is waiver. Physicians need not give information to patients who do not want it, who ask not to receive it or who request that the information disclosure is abbreviated. Patients may waive information or their rights to decide. Other patients waive decision-making but not information disclosure. Informed consent is an ethical imperative and patients must be allowed to play the role they want to play in decision-making. Therefore, patient waiver of information or decision should be honoured. It is important to document such a waiver when informed consent would otherwise be the norm.



How to obtain consent

Informed consent is not deemed to have been given by virtue of a patient signing a form. It is not an event but should be seen as a process that takes place over time.

Therefore, a signed consent form cannot be used as sole evidence of informed consent having been obtained. It has been suggested that information should initially be presented to patients in a discussion-like format while allowing patients to ask questions. Benefits, risks and alternative treatments should be explained. It is helpful if the physician does not make a recommendation until the patient has had an opportunity to indicate his or her preference and values that underlie it. The physician should then explain the recommendations and the patient is asked to choose (Katz 1984). In this way both physician and patient understand the rationale for each other’s choice, a process of communication for consent that is too often lacking (Lidz, Meisel, Zerubavel et al 1984). Documentation of the patient’s consent or refusal then should be accomplished, not necessarily through a form (unless it is clearly required by law, eg, s 59(2) of the Mental Health Act 1992), but by an explanatory note on the patient’s case notes about what has been said and what the patient understood.

Although written consent offers some protection to both users and providers, it constitutes no more than a "prompt" to both service providers and users. It should not be considered a full documentation of the process of confirmed choice. Rather than having a "consent form" documentation, recording the process involved in making informed choices is more important.

In general terms, documentation should consist of notes outlining what information was given to the consumer and what questions were raised by him or her. It is important to record information on the proposed treatment of procedure, possible side effects and risks, the degree of risks and probability of its occurrence, possible alternative therapies, their probable outcomes and risks, expected success rate and who gave what information. It is also important to include a statement that the client may withdraw their consent at anytime without jeopardising their care. A statement by the client that they understood the explanation, or other verifications that the client understood the explanation, should also be included.

The signature on a consent form does not necessarily settle any question that might later arise about the information on which the consent was based.



References

Guardianship Act 1968. Wellington: New Zealand Government.
Katz J. Why doctors don’t disclose uncertainty. Hastings Center Report 1984; 14:35-44.
Lidz CW, Meisel A, Zerubavel E, et al. Informed consent. A study of decision making in psychiatry. New York: Guilford; 1984.
Ludlam JE. Informed consent. Chicago: American Hospital Association; 1978.
Meisel A. The "exceptions" to the informed consent doctrine: Striking a balance between competing values in medical decisionmaking. 1979 2 Wis L Rev 413-488.
Mental Health (Compulsory Assessment and Treatment) Act 1992. Wellington: New Zealand Government.
Protection of Personal and Property Rights Act 1988. Wellington: New Zealand Government.
Roth LH, Meisel A, Lidz CW. Tests of competency to consent to treatment. Am J Psych 1977; 134:279-284.
Wallace M, Johnson S. Health Care and the Law. 1st ed.Wellington: Brookers; 1995. p 64.

1. Salgo v Leland Stanford Junior University Board of Trustees 317P 2d 170 (Cal Ct App 1957)
2. Canterbury v Spence 464 F 2d 772, 782 (DC Cir 1972)
3. Sidaway v Bethlem Royal Hospital Governors [1985] 1 All ER 643
4. Battersby v Tottman (1985) 37 SASR 524
5. Gillick v West Norfolk and Wisbech Health Authority [1986] AC 112; [1985] 3 All ER 402.
6. W (a minor: medical treatment), Re [1992] 4 All ER 627
7. Malett v Shulman [1991] 2 Med LR 162.
8. Raleigh Fitkin-Paul Morgan Memorial Hospital v Anderson 201 A 2d 537 (NJ 1964)
9. S (adult: refusal of medical treatment), Re [1992] 2 All ER 671
10. John F Kennedy Memorial Hospital v Heston 279 A 2d 670 (1971)



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