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Ethics versus law: A lawyer's road map to the ethics committee opinion on informed consent
Ethics Versus Law: A Lawyer's Road Map to the Ethics Committee Opinion on Informed Consent Kenneth V. Heland, JD Associate Director, Department of Professional Liability The American College of Obstetricians and Gynecologists Washington, DC
When Socrates and his two great disciples composed a system of rational ethics they were hardly proposing practical legislation for mankind. George Santayana, Reason in Science
s Associate Director of the Department of Professional Liability of the American College of Obstetricians and Gynecologists, I had the opportunity to work with the college's Committee on Ethics in the development of its opinion entitled "Ethical Dimensions of Informed Consent." Although the committee was very solicitous of my legal comments, I cannot help but reflect on the inherent conflict between ethics and law. The quotation from Santayana above crystallizes the conflict. Ethicists are concerned with the ideal, or moral law. Lawyers are concerned with the practical. At many times during the developmental process I felt that the Committee on Ethics was "in the clouds" of an ethical ideal world, whereas I was "in the gutter" of the practical world of law. I almost felt embarrassed to suggest that legal concerns should take precedence over the noble aspirations articulated by the committee, but I made my comments anyhow. I believe that the final opinion reflects a good synthesis of the committee's ethical aspirations and my legal concerns. But the conflict remains. Ethics is not really concerned with what can be done, but with what should be done in a moral sense. According to Webster's Dictionary, ethics is "the discipline dealing with what is good and bad and with moral duty and obligation." On the other hand, Webster's defines law as "a rule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority." Because law is imposed on individuals, it is developed by consensus (eg, legislation), which may vary widely from state to state, and is usually concerned with the minimum conduct that has to be done. To use a medical analogy, the law is like minimal practice standards, whereas ethical aspirations are like optimal standards. I remain concerned that the typical obstetrician-gynecologist in private practice will be unable to attain many of the ethical aspirations articulated in the
A
22
HELAND:COMMENTARY
© 1993 by The Jacobs Institute of Women's Health
1049-3867/93/$6.00
WHI Vol. 3, No. 1 Spring 1993
committee opinion. For those physicians who may be doubtful about their ability to meet these ethical aspirations, I would like to highlight the parts of the opinion that address legal obligations. Physicians should keep in mind that they will be held to the legal requirements of informed consent in their respective states or jurisdictions. The following can be looked upon as a "legal road map" or the "Cliff's Notes version" of "Ethical Dimensions of Informed Consent."
DEGREE OF DISCLOSURE REQUIRED In the section of the opinion entitled "Ethical Applications of Informed Consent," there is an excellent discussion of the degree of disclosure needed for legally valid informed consent in various states and jurisdictions. Physicians who read and comprehend this section, and who understand the degree of disclosure required in their jurisdictions, will be well along the road to fulfilling their legal obligations for informed consent. Nonetheless, a few additional points are in order. Courts have recognized and states have adopted three different degrees of disclosure, which are known as 1) the professional or reasonable physician standard, 2) the materiality or reasonable patient viewpoint standard, and 3) the subjective patient viewpoint standard. The "professional or reasonable physician standard" of disclosure is based on the amount and type of information a "reasonable physician" thinks should be told to a patient about the risks and benefits of a particular procedure. Since 1972, however, many states have adopted the "materiality or reasonable patient viewpoint standard." Under this standard, the legal requirement for information that should be disclosed is based on what a "reasonable person" would want to know about the risks and benefits of a particular procedure. A few courts have even taken the patient viewpoint standard one step further and have created a "subjective patient viewpoint standard." This standard is based on what each individual patient would want to know about a given procedure--not simply what a "reasonable patient" would want to know. Under the "subjective patient viewpoint standard," a physician must disclose differing amounts of information to individual patients based on their personal needs and idiosyncracies---a standard that is almost impossible for individual physicians to understand and apply in practice. Generally, jurisdictions that follow the reasonable physician standard require that less information be provided to patients than in those that adhere to either of the patient viewpoint standards. In the last two decades, many jurisdictions have enacted specific informed consent laws. Some of these laws address the appropriate standard for disclosure. Other laws, such as those in effect in Georgia, Texas, and California, dictate what must be included in an informed consent form. There is little uniformity among these laws as to the procedures to which they apply and what must be told to patients. Some are very broad-based and include a multitude of procedures. Others are quite narrow in scope and apply to only one or two procedures. The bottom line is that physicians must know the degree of disclosure required in their jurisdictions and any specific laws on informed consent that apply in their states. Most state medical societies can be of valuable assistance in providing this information. LIMITS O N I N F O R M E D C O N S E N T The section of the Committee on Ethics opinion entitled "The Limits of Informed Consent" contains an excellent discussion of the situations when W H I Vol. 3, No. I Spring 1993
HELAND: COMMENTARY
23
informed consent may be legally limited or omitted. I am concerned, however, that physicians may place too much reliance on these limits. The best legal position for a physician to take is to approach these situations with the attitude that exceptions to full informed consent are almost never justified. Naturally, in a medical emergency a physician may treat a patient without obtaining the patient's consent to the treatment or procedure. But for a situation to qualify legally as a genuine medical emergency it must meet several specific criteria. The patient must be unconscious or incapacitated and suffering a life-threatening or seriously health-threatening condition requiring immediate medical attention. Because the patient is unable to consent in these instances, consent is implied. Implied consent is based on the theory that if the patient were competent, the patient would have consented to the care rendered. Because emergencies may invoke limitations to informed consent, it is particularly important for the physician to document in the patient's record the reason why the care was rendered without that consent. This documentation should include a description of the patient's condition at the time of the emergency, the reason why the emergency existed, and an explanation of why immediate medical attention was necessary. The treatment of minors also raises issues of limitations to informed consent. Informed consent rules applicable to minors raise a number of concerns because the rules vary widely from state to state. Basically, minors are unable to consent to medical treatment, and physicians must obtain consent from the minor's parent or legal guardian when providing all but emergency care. However, every state and the District of Columbia have enacted statutes modifying this special rule to some degree. These statutes usually establish criteria or circumstances under which a minor is permitted to consent to medical care without parental permission. These statutes tend to set a statutory age of consent and/or relate to the ability of minors to consent for specific types of medical care. For example, a statute might permit minors over the age of 16 to consent to contraceptive care. It might also allow a pregnant minor to consent to treatment regardless of age. Most statutes do not deal with all issues relating to medical consent of minors. Physicians may find themselves with little guidance as to how to proceed in some of these situations. As with all patients, a minor should be fully informed before medical treatment is provided. The nature and scope of the legal limitations to informed consent may vary widely from state to state. As with the legally required degree of disclosure and special statutory requirements, prudent physicians should obtain this information from their state medical society. It is in the area of limitations to informed consent that law and ethics are most in harmony. As the Committee on Ethics said, "Some limitations mitigate the obligation of informed consent, and some render it impossible. But any compromise or relaxation of the full ethical obligation of informed consent requires special ethical justification." As a practical lawyer trying to advise physicians of the "best route" to follow, I can only add a resounding "Amen!"
24
HELAND:COMMENTARY
WHI Vol. 3, No. I Spring 1993
When Socrates and his two great disciples composed a system of rational ethics they were hardly proposing practical legislation for mankind. George Santayana, Reason in Science
s Associate Director of the Department of Professional Liability of the American College of Obstetricians and Gynecologists, I had the opportunity to work with the college's Committee on Ethics in the development of its opinion entitled "Ethical Dimensions of Informed Consent." Although the committee was very solicitous of my legal comments, I cannot help but reflect on the inherent conflict between ethics and law. The quotation from Santayana above crystallizes the conflict. Ethicists are concerned with the ideal, or moral law. Lawyers are concerned with the practical. At many times during the developmental process I felt that the Committee on Ethics was "in the clouds" of an ethical ideal world, whereas I was "in the gutter" of the practical world of law. I almost felt embarrassed to suggest that legal concerns should take precedence over the noble aspirations articulated by the committee, but I made my comments anyhow. I believe that the final opinion reflects a good synthesis of the committee's ethical aspirations and my legal concerns. But the conflict remains. Ethics is not really concerned with what can be done, but with what should be done in a moral sense. According to Webster's Dictionary, ethics is "the discipline dealing with what is good and bad and with moral duty and obligation." On the other hand, Webster's defines law as "a rule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority." Because law is imposed on individuals, it is developed by consensus (eg, legislation), which may vary widely from state to state, and is usually concerned with the minimum conduct that has to be done. To use a medical analogy, the law is like minimal practice standards, whereas ethical aspirations are like optimal standards. I remain concerned that the typical obstetrician-gynecologist in private practice will be unable to attain many of the ethical aspirations articulated in the
A
22
HELAND:COMMENTARY
© 1993 by The Jacobs Institute of Women's Health
1049-3867/93/$6.00
WHI Vol. 3, No. 1 Spring 1993
committee opinion. For those physicians who may be doubtful about their ability to meet these ethical aspirations, I would like to highlight the parts of the opinion that address legal obligations. Physicians should keep in mind that they will be held to the legal requirements of informed consent in their respective states or jurisdictions. The following can be looked upon as a "legal road map" or the "Cliff's Notes version" of "Ethical Dimensions of Informed Consent."
DEGREE OF DISCLOSURE REQUIRED In the section of the opinion entitled "Ethical Applications of Informed Consent," there is an excellent discussion of the degree of disclosure needed for legally valid informed consent in various states and jurisdictions. Physicians who read and comprehend this section, and who understand the degree of disclosure required in their jurisdictions, will be well along the road to fulfilling their legal obligations for informed consent. Nonetheless, a few additional points are in order. Courts have recognized and states have adopted three different degrees of disclosure, which are known as 1) the professional or reasonable physician standard, 2) the materiality or reasonable patient viewpoint standard, and 3) the subjective patient viewpoint standard. The "professional or reasonable physician standard" of disclosure is based on the amount and type of information a "reasonable physician" thinks should be told to a patient about the risks and benefits of a particular procedure. Since 1972, however, many states have adopted the "materiality or reasonable patient viewpoint standard." Under this standard, the legal requirement for information that should be disclosed is based on what a "reasonable person" would want to know about the risks and benefits of a particular procedure. A few courts have even taken the patient viewpoint standard one step further and have created a "subjective patient viewpoint standard." This standard is based on what each individual patient would want to know about a given procedure--not simply what a "reasonable patient" would want to know. Under the "subjective patient viewpoint standard," a physician must disclose differing amounts of information to individual patients based on their personal needs and idiosyncracies---a standard that is almost impossible for individual physicians to understand and apply in practice. Generally, jurisdictions that follow the reasonable physician standard require that less information be provided to patients than in those that adhere to either of the patient viewpoint standards. In the last two decades, many jurisdictions have enacted specific informed consent laws. Some of these laws address the appropriate standard for disclosure. Other laws, such as those in effect in Georgia, Texas, and California, dictate what must be included in an informed consent form. There is little uniformity among these laws as to the procedures to which they apply and what must be told to patients. Some are very broad-based and include a multitude of procedures. Others are quite narrow in scope and apply to only one or two procedures. The bottom line is that physicians must know the degree of disclosure required in their jurisdictions and any specific laws on informed consent that apply in their states. Most state medical societies can be of valuable assistance in providing this information. LIMITS O N I N F O R M E D C O N S E N T The section of the Committee on Ethics opinion entitled "The Limits of Informed Consent" contains an excellent discussion of the situations when W H I Vol. 3, No. I Spring 1993
HELAND: COMMENTARY
23
informed consent may be legally limited or omitted. I am concerned, however, that physicians may place too much reliance on these limits. The best legal position for a physician to take is to approach these situations with the attitude that exceptions to full informed consent are almost never justified. Naturally, in a medical emergency a physician may treat a patient without obtaining the patient's consent to the treatment or procedure. But for a situation to qualify legally as a genuine medical emergency it must meet several specific criteria. The patient must be unconscious or incapacitated and suffering a life-threatening or seriously health-threatening condition requiring immediate medical attention. Because the patient is unable to consent in these instances, consent is implied. Implied consent is based on the theory that if the patient were competent, the patient would have consented to the care rendered. Because emergencies may invoke limitations to informed consent, it is particularly important for the physician to document in the patient's record the reason why the care was rendered without that consent. This documentation should include a description of the patient's condition at the time of the emergency, the reason why the emergency existed, and an explanation of why immediate medical attention was necessary. The treatment of minors also raises issues of limitations to informed consent. Informed consent rules applicable to minors raise a number of concerns because the rules vary widely from state to state. Basically, minors are unable to consent to medical treatment, and physicians must obtain consent from the minor's parent or legal guardian when providing all but emergency care. However, every state and the District of Columbia have enacted statutes modifying this special rule to some degree. These statutes usually establish criteria or circumstances under which a minor is permitted to consent to medical care without parental permission. These statutes tend to set a statutory age of consent and/or relate to the ability of minors to consent for specific types of medical care. For example, a statute might permit minors over the age of 16 to consent to contraceptive care. It might also allow a pregnant minor to consent to treatment regardless of age. Most statutes do not deal with all issues relating to medical consent of minors. Physicians may find themselves with little guidance as to how to proceed in some of these situations. As with all patients, a minor should be fully informed before medical treatment is provided. The nature and scope of the legal limitations to informed consent may vary widely from state to state. As with the legally required degree of disclosure and special statutory requirements, prudent physicians should obtain this information from their state medical society. It is in the area of limitations to informed consent that law and ethics are most in harmony. As the Committee on Ethics said, "Some limitations mitigate the obligation of informed consent, and some render it impossible. But any compromise or relaxation of the full ethical obligation of informed consent requires special ethical justification." As a practical lawyer trying to advise physicians of the "best route" to follow, I can only add a resounding "Amen!"
24
HELAND:COMMENTARY
WHI Vol. 3, No. I Spring 1993