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Norway: valid (as opposed to informed) consent
MEDICINE AND THE LAW IN EUROPE
Medicine and the law in Europe
Norway: valid (as opposed to informed) consent Aslak Syse The traditional concept of “informed” consent may be too restrictive; “valid” consent may be a more manageable criterion. Norway’s 1999 Patients’ Rights Act comes into force on Jan 1, 2001. This essay asks if this new legislation is compatible with this concept of valid consent—and concludes that it is. In parallel with advances in drug therapy, anaesthesia, and surgery there has been a shift in bioethics from a paternalistic ethic governed by doctors to one based on the patient’s autonomy and integrity. The notion of consent to medical procedures and treatment is a reflection of this, and in many countries this consent is now established in law. The Norwegian Parliament passed a new Patients’ Rights Act in 19991 and one of the chapters in it is on “consent”, this being closely linked to the preceding chapter covering the patient’s right to information. I propose to outline the legal requirements for valid consent (rather than informed consent) and then ask if Norway’s 1999 Act, which comes into force on Jan 1, 2001, meets those requirements.
Background A patient’s absolute right to all necessary information in connection with medical examinations and treatment has been documented over the past 40 years of American legal practice. A 1957 case (Salgo versus Leland Stanford Jr University Board of Trustees) coupled, perhaps for the first time, the terms “informed” and “patient’s consent”. The plaintiff was paralysed after myelography. His doctor had not told him that paralysis was a risk with this investigation. The plaintiff won his case even though the doctor had committed no mistake. Paralysis was a real risk even with a correctly performed procedure. However, the patient had not been properly informed about this risk before the investigation and he was granted damages because the doctor had failed in his duty of disclosure. The court found that if the patient had been properly informed he would have refused myelography. Consent may be deemed invalid if, for example, it has been obtained by deception or coercion; if it does not comply with formal procedures; or if the person lacks the capacity to consent by virtue of mental illness, for instance.
Valid consent From a legal perspective, any consent, if it is to be valid, has to meet three independent preconditions (figure). The three key requirements have to be taken into account simultaneously—a challenge which clinicians face regularly. The weaker a patient’s personal competence, the more stringent must be the procedural considerations. This is to avoid coercion or exploitation, and to ensure that the disclosure of information has taken into account Lancet 2000; 356: 1347–48 Department of Public and International Law, University of Oslo, PO Box 6706, 0130 Oslo, Norway (Prof A Syse MD) (e-mail: [email protected])
THE LANCET • Vol 356 • October 14, 2000
Personal competence?
Valid consent?
Procedural competence? Preconditions for valid consent
Material competence?
the patient’s capacity for understanding and evaluating the situation. Equally, certain radical medical procedures call for stringent requirements to be met on personal and procedural competence. Such preconditions may be specifically formulated, as in Norway’s abortion, sterilisation, and transplantation legislation. These preconditions reflect a general principle of international health law, illustrated by the 1973 US case of Kaimowitz vs Michigan Department of Mental Health. Here the court found that even though a difficult psychiatric patient possessed the competence required to consent to ordinary surgical procedures, and even to “accepted neurosurgical procedures”, his competence would not be sufficient for him to consent to experimental neurosurgical procedures characterised as “dangerous, intrusive, irreversible, and of uncertain benefit to the patient and the society”. While most writers discuss informed consent as a fixed, normative standard, Drane has recommended a “slidingscale” model.2 What he actually presents are three different and fixed standards for personal competence, depending upon the effectiveness and the risks of the procedure under consideration. My approach, however, is based on a continuum. On the whole, I agree with Drane’s recommendations but believe that “valid consent” is a better concept to work with than “informed consent”. For example, when a psychiatric patient with delusions or a patient with mental retardation does not object to safe medical examinations and therapeutic procedures to be done in his or her best interests, valid consent implies respect for that person’s integrity. In this situation “tacit consent” will be sufficient authorisation. The multiple characteristics of the above standard mean that consent may be violated in several ways. Sometimes too little information has been given; at other times the patient may feel under pressure to consent. A
1347
For personal use only. Not to be reproduced without permission of The Lancet.
MEDICINE AND THE LAW IN EUROPE
Analytical tool for evaluating whether a consent is valid3 There must be personal competence. The person concerned (patient or representative) must have the formal competence to take the decision in question. Specific provisions about representation are required in the case of a minor or incompetent patient. Further, the person concerned must possess the mental capacity to consent; he or she must understand the situation and the consequences of giving consent. The patient must give consent correctly—ie, there must be procedural competence. The consent given must not be influenced by defects in the contractual assent. The consent must be of the quality that the situation requires—eg, medical research requires informed consent. The consent must comply with specific form-related requirements applicable to the actual case—eg, in Norway sterilisation and transplantation require written consent from patient or donor, respectively. The consent must relate to an issue to which the patient validly may consent. This is the material competence requirement. Penal codes usually define what a person validly may consent to. Under Norwegian law, consent to deliberate grievous bodily harm is not a defence. This will not apply if the harm is in the person’s best interests (eg, major cancer surgery). Nevertheless, euthanasia is unlawful, even when in the patient’s best interests. For persons with reduced mental capacity, for example due to serious mental disorder or mental retardation, additional barriers apply, and these may prevent such a person from giving consent in situations that are questionably in his/her best interests (eg, donating a kidney to a close relative).
qualitative minimum requirement, valid at all times and under all circumstances, is unattainable in my view. The requirement for informed and voluntary consent is not always applicable to non-invasive medical procedures. In most cases, staff should, having provided information to the patient, be able to decide on the necessary procedures without having the patient’s express consent. They must, however, respect a patient’s rejection of any specific examinations or treatments. When the treatment offered is invasive, the doctor will have the responsibility for providing the patient with all necessary information—about the risks and the alternative treatments (and their probable consequences).
Norway’s 1999 legislation The Patients’ Rights Act will take effect on Jan 1, 2001. A general requirement for “informed consent” is not laid down, even though detailed obligations to provide information before medical examinations and treatment are outlined. Also tacit, non-explicit consent is accepted. Normally, written consent is not required. In my opinion, this is a wise choice since it may help to preserve the patient-doctor relationship, one to be continued in future and based on trust and experience. A demand for a written consent can easily conceal the doctor’s disclaimer of responsibility and it bureaucratises the relationship between patient and doctor. Usually, a person acquires health-related autonomy at age 16 years; in other Acts higher age limits are set for donating organs (18) and for sterilisation on request (25), and for both these written consent is required. For those under 16 the parents usually hold the competency to
1348
consent but only in the child’s best interests. If the parental rights are not carried out satisfactorily, the court may decide that the minor shall undergo the necessary examinations and treatment. In an emergency, such as urgent surgery or blood transfusion, a doctor may make decisions based on the principle of necessity. If a 16-year-old is considered incompetent, parental rights prevail until that person reaches the age of 18; after that an additional decisionmaker will most often be appointed who may be a parent but not necessarily. If a patient is temporarily incompetent, for instance as a result of confusion or unconsciousness, health service personnel may make decisions in an emergency. But if there is no emergency, the next of kin will have a certain competence to participate in decisions on behalf of the patient. A representative can only consent to procedures considered to be in the patient’s best interests and only to procedures that the patient does not oppose. (In other Norwegian legislation there are specific provisions on coercion in respect of patients with contagious disease who pose a risk to the public and patients with psychiatric disorders or mental retardation.) Patients above the age of 18 now have the right to turn down treatment suggestions that otherwise might have been forced upon them, according to the principle of necessity. This applies, for example, to the right to refuse blood transfusion, to continue a hunger strike (although not applicable to prisoners and inpatients), and to opt out of a life-sustaining treatment. Euthanasia and assisted suicide continue to be unlawful. The Norwegian Act accords with the requirements for patient treatment in the European Human Rights Convention as well as in other international legal instruments. In my opinion, Norway’s Patients’ Rights Act satisfactorily balances patient autonomy and integrity with the need for efficient examination and treatment when patients have reduced capacity to consent. At the same time, it avoids unnecessary and bureaucratic provisions and regulations. And it avoids unrealistic preconditions such as establishing an obligatory requirement for informed consent before any kind of diagnostic procedure and medical treatment. In short, the Act is a sensible adjustment from the concept of informed consent to one of valid consent—and that is in the best interests of patients and clinicians alike. References 1 2 3
The Norwegian Act of Patients’ Rights. Geneva: WHO (in press). Drane JF. The many faces of competency. Hastings Center Rep 1985; 15 (2): 17–21. Syse A. Coercion in psychiatry: an analytical overview. In: Morrissey JP, Monahan J, eds. Research in community and mental health; vol X. Stanford, CT: JAI Press, 1999: 81–99.
THE LANCET • Vol 356 • October 14, 2000
For personal use only. Not to be reproduced without permission of The Lancet.
Medicine and the law in Europe
Norway: valid (as opposed to informed) consent Aslak Syse The traditional concept of “informed” consent may be too restrictive; “valid” consent may be a more manageable criterion. Norway’s 1999 Patients’ Rights Act comes into force on Jan 1, 2001. This essay asks if this new legislation is compatible with this concept of valid consent—and concludes that it is. In parallel with advances in drug therapy, anaesthesia, and surgery there has been a shift in bioethics from a paternalistic ethic governed by doctors to one based on the patient’s autonomy and integrity. The notion of consent to medical procedures and treatment is a reflection of this, and in many countries this consent is now established in law. The Norwegian Parliament passed a new Patients’ Rights Act in 19991 and one of the chapters in it is on “consent”, this being closely linked to the preceding chapter covering the patient’s right to information. I propose to outline the legal requirements for valid consent (rather than informed consent) and then ask if Norway’s 1999 Act, which comes into force on Jan 1, 2001, meets those requirements.
Background A patient’s absolute right to all necessary information in connection with medical examinations and treatment has been documented over the past 40 years of American legal practice. A 1957 case (Salgo versus Leland Stanford Jr University Board of Trustees) coupled, perhaps for the first time, the terms “informed” and “patient’s consent”. The plaintiff was paralysed after myelography. His doctor had not told him that paralysis was a risk with this investigation. The plaintiff won his case even though the doctor had committed no mistake. Paralysis was a real risk even with a correctly performed procedure. However, the patient had not been properly informed about this risk before the investigation and he was granted damages because the doctor had failed in his duty of disclosure. The court found that if the patient had been properly informed he would have refused myelography. Consent may be deemed invalid if, for example, it has been obtained by deception or coercion; if it does not comply with formal procedures; or if the person lacks the capacity to consent by virtue of mental illness, for instance.
Valid consent From a legal perspective, any consent, if it is to be valid, has to meet three independent preconditions (figure). The three key requirements have to be taken into account simultaneously—a challenge which clinicians face regularly. The weaker a patient’s personal competence, the more stringent must be the procedural considerations. This is to avoid coercion or exploitation, and to ensure that the disclosure of information has taken into account Lancet 2000; 356: 1347–48 Department of Public and International Law, University of Oslo, PO Box 6706, 0130 Oslo, Norway (Prof A Syse MD) (e-mail: [email protected])
THE LANCET • Vol 356 • October 14, 2000
Personal competence?
Valid consent?
Procedural competence? Preconditions for valid consent
Material competence?
the patient’s capacity for understanding and evaluating the situation. Equally, certain radical medical procedures call for stringent requirements to be met on personal and procedural competence. Such preconditions may be specifically formulated, as in Norway’s abortion, sterilisation, and transplantation legislation. These preconditions reflect a general principle of international health law, illustrated by the 1973 US case of Kaimowitz vs Michigan Department of Mental Health. Here the court found that even though a difficult psychiatric patient possessed the competence required to consent to ordinary surgical procedures, and even to “accepted neurosurgical procedures”, his competence would not be sufficient for him to consent to experimental neurosurgical procedures characterised as “dangerous, intrusive, irreversible, and of uncertain benefit to the patient and the society”. While most writers discuss informed consent as a fixed, normative standard, Drane has recommended a “slidingscale” model.2 What he actually presents are three different and fixed standards for personal competence, depending upon the effectiveness and the risks of the procedure under consideration. My approach, however, is based on a continuum. On the whole, I agree with Drane’s recommendations but believe that “valid consent” is a better concept to work with than “informed consent”. For example, when a psychiatric patient with delusions or a patient with mental retardation does not object to safe medical examinations and therapeutic procedures to be done in his or her best interests, valid consent implies respect for that person’s integrity. In this situation “tacit consent” will be sufficient authorisation. The multiple characteristics of the above standard mean that consent may be violated in several ways. Sometimes too little information has been given; at other times the patient may feel under pressure to consent. A
1347
For personal use only. Not to be reproduced without permission of The Lancet.
MEDICINE AND THE LAW IN EUROPE
Analytical tool for evaluating whether a consent is valid3 There must be personal competence. The person concerned (patient or representative) must have the formal competence to take the decision in question. Specific provisions about representation are required in the case of a minor or incompetent patient. Further, the person concerned must possess the mental capacity to consent; he or she must understand the situation and the consequences of giving consent. The patient must give consent correctly—ie, there must be procedural competence. The consent given must not be influenced by defects in the contractual assent. The consent must be of the quality that the situation requires—eg, medical research requires informed consent. The consent must comply with specific form-related requirements applicable to the actual case—eg, in Norway sterilisation and transplantation require written consent from patient or donor, respectively. The consent must relate to an issue to which the patient validly may consent. This is the material competence requirement. Penal codes usually define what a person validly may consent to. Under Norwegian law, consent to deliberate grievous bodily harm is not a defence. This will not apply if the harm is in the person’s best interests (eg, major cancer surgery). Nevertheless, euthanasia is unlawful, even when in the patient’s best interests. For persons with reduced mental capacity, for example due to serious mental disorder or mental retardation, additional barriers apply, and these may prevent such a person from giving consent in situations that are questionably in his/her best interests (eg, donating a kidney to a close relative).
qualitative minimum requirement, valid at all times and under all circumstances, is unattainable in my view. The requirement for informed and voluntary consent is not always applicable to non-invasive medical procedures. In most cases, staff should, having provided information to the patient, be able to decide on the necessary procedures without having the patient’s express consent. They must, however, respect a patient’s rejection of any specific examinations or treatments. When the treatment offered is invasive, the doctor will have the responsibility for providing the patient with all necessary information—about the risks and the alternative treatments (and their probable consequences).
Norway’s 1999 legislation The Patients’ Rights Act will take effect on Jan 1, 2001. A general requirement for “informed consent” is not laid down, even though detailed obligations to provide information before medical examinations and treatment are outlined. Also tacit, non-explicit consent is accepted. Normally, written consent is not required. In my opinion, this is a wise choice since it may help to preserve the patient-doctor relationship, one to be continued in future and based on trust and experience. A demand for a written consent can easily conceal the doctor’s disclaimer of responsibility and it bureaucratises the relationship between patient and doctor. Usually, a person acquires health-related autonomy at age 16 years; in other Acts higher age limits are set for donating organs (18) and for sterilisation on request (25), and for both these written consent is required. For those under 16 the parents usually hold the competency to
1348
consent but only in the child’s best interests. If the parental rights are not carried out satisfactorily, the court may decide that the minor shall undergo the necessary examinations and treatment. In an emergency, such as urgent surgery or blood transfusion, a doctor may make decisions based on the principle of necessity. If a 16-year-old is considered incompetent, parental rights prevail until that person reaches the age of 18; after that an additional decisionmaker will most often be appointed who may be a parent but not necessarily. If a patient is temporarily incompetent, for instance as a result of confusion or unconsciousness, health service personnel may make decisions in an emergency. But if there is no emergency, the next of kin will have a certain competence to participate in decisions on behalf of the patient. A representative can only consent to procedures considered to be in the patient’s best interests and only to procedures that the patient does not oppose. (In other Norwegian legislation there are specific provisions on coercion in respect of patients with contagious disease who pose a risk to the public and patients with psychiatric disorders or mental retardation.) Patients above the age of 18 now have the right to turn down treatment suggestions that otherwise might have been forced upon them, according to the principle of necessity. This applies, for example, to the right to refuse blood transfusion, to continue a hunger strike (although not applicable to prisoners and inpatients), and to opt out of a life-sustaining treatment. Euthanasia and assisted suicide continue to be unlawful. The Norwegian Act accords with the requirements for patient treatment in the European Human Rights Convention as well as in other international legal instruments. In my opinion, Norway’s Patients’ Rights Act satisfactorily balances patient autonomy and integrity with the need for efficient examination and treatment when patients have reduced capacity to consent. At the same time, it avoids unnecessary and bureaucratic provisions and regulations. And it avoids unrealistic preconditions such as establishing an obligatory requirement for informed consent before any kind of diagnostic procedure and medical treatment. In short, the Act is a sensible adjustment from the concept of informed consent to one of valid consent—and that is in the best interests of patients and clinicians alike. References 1 2 3
The Norwegian Act of Patients’ Rights. Geneva: WHO (in press). Drane JF. The many faces of competency. Hastings Center Rep 1985; 15 (2): 17–21. Syse A. Coercion in psychiatry: an analytical overview. In: Morrissey JP, Monahan J, eds. Research in community and mental health; vol X. Stanford, CT: JAI Press, 1999: 81–99.
THE LANCET • Vol 356 • October 14, 2000
For personal use only. Not to be reproduced without permission of The Lancet.