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INFORMED CONSENT

The issue of informed consent is critical in enabling a patient to make a decision regarding the use of any medical intervention. The courts in New York State have consistently recognized and upheld the right of every individual to make his or her own treatment decisions. It is a firmly established principle of the common law of New York that every individual "of adult years and sound mind has a right to determine what shall be done with his body" and control the course of his or her medical treatment. (Schloendorff v. New Fork Hospital, 211 NY 129 (1905)). Pursuant to Rivers v. Katz, 67 N.Y. 2d 48-5 1986) the patient's right to self-determination is deemed paramount to a physician's obligation to provide medical treatment, as is a competent patient's right of refusal for treatment.

There is a significant degree of variability among facilities regarding information provided during the informed consent process, including risks/benefits, the type of ECT device to be used, number and specific placement of electrodes and the need for continuation and maintenance of ECT for extended periods. The ability of a patient to obtain appropriate information regarding ECT and the timeframe in which s/he must evaluate the efficacy of the information, as it relates to the patient, is crucial for the patient to make a reasoned and informed decision.

Steven Brock, a lawyer who once managed the Mental Health Law Project for Nassau/Suffolk Law Services, under a grant funded by the Office of Mental Health, and founder of the Mental Disability Law Clinic at Touro Law School in New York, in written testimony stated:

A commission should be established to manage independent investigation of ECT risks and benefits and improve the current, drastically inadequate procedures for informed consent .... Given the uncertainty as to the safety of ECT, consent procedures should immediately be enhanced. A commission could be charged with developing appropriately conservative requirements for disclosure of the risks of ECT to insure that a reasonable range of information on risks is provided to persons asked to consent to the procedure.

In order to make consent to treatment a real process, it must be made independent of the treating psychiatrists. The current reality is that persons who consent are deemed competent and persons who decline to follow a psychiatrist's recommendation are at severe risk of forced treatment. An independent decision maker, not the treating psychiatrist, should decide competency to consent to ECT in the first instance. And a decision on competency should be made before consent is requested. Those found competent will decide for themselves whether to consent to ECT. Those found not competent will require court approval for ECT whether or not they consent.

Ultimately, the determination of a person's competency to consent to treatment is a legal question quite different from the technical medical and scientific matters in which psychiatrists are trained. Psychologists, on the other hand. receive training that makes them well suited to address both the legal and medical issues involved in determinations of competency. The current system grants the treating physicians extreme power to determine the course of treatment of persons in psychiatric institutions and override their objections to treatment. And in those instances when there is disagreement, the legal process casts the psychiatrist as the adversary of the person he or she is treating, which can profoundly and adversely affect the therapeutic relationship.

Dr. Laura Fochtmann, a psychiatrist and Director of the Electroconvulsive Therapy Service at the State University at Stony Brook, member of the APA's Task Force and co-author of the APA's report and numerous other articles appearing on the neurobiology of ECT, appeared before the Committee on May

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18, 2001 to testify on behalf of the state and national American Psychiatric Association. In relation to informed consent, Dr. Fochtmann stated in her written testimony:

In choosing any medical intervention for a given individual, the potential benefits of treatment must always be weighed against the potential for adverse effects .... Discussing alternative therapeutic options, with their corresponding risks and benefits, is but one aspect of the informed consent process with ECT. In fact, the APA ECT practice recommendations on informed consent are extraordinarily comprehensive and detailed ... modeled after those used at the New York State Psychiatric Institute, include a description of the standard ECT procedure as well as statements that there is no guarantee of the efficacy of ECT ... and that consent is voluntary and can be withdrawn at any time .... The informed consent process does not end with the initiation of the ECT course. Rather, consent is an ongoing process in which the patient receives ongoing feedback on clinical progress and on side effects and has continued opportunities to have questions or concerns addressed.

Also crucial to the informed consent process is the assessment of capacity to provide consent. Individuals with mental illness are considered to have the capacity to consent to ECT unless the evidence to the contrary is compelling .... Under such circumstances, the patient's underlying psychiatric disorder may alter their decision-making capacity, impairing their ability to consent to ECT or other treatments.

In these cases, ECT is sometimes the treatment of choice for individuals who lack capacity to give a fully informed consent .... Nonetheless, a complex balance must be achieved between the rights of an individual to autonomous self-determination and the moral and legal obligations of facilities to provide needed treatment if individuals are dangerous to themselves and others .... Under the ruling in Rivers v. Katz ... the New York Court of Appeals delineated a two step process in order to provide psychiatric treatment for a non-consenting incapable patient. First, the proponent of the treatment must establish by clear and convincing evidence that the patient lacks capacity to make treatment decisions ... the court must then determine that clear and convincing evidence establishes that "the proposed treatment is narrowly tailored to give substantial effect to the patient's liberty interests, taking into consideration all relevant circumstances. including the patient's best interests. the benefits to be gained from the treatment, the adverse side effects associated with the treatment and any less intrusive alternative treatment."

We believe that the strict requirements for judicial approval for court ordered treatment strikes a proper balance between protection of individual autonomy and dignity and the right of all persons to receive appropriate medical care and be free from unnecessary pain and suffering ... With regard to ECT.... relatively few requests are made for court ordered treatment relative to the total number of patients receiving ECT .... APA and NYSPA strongly believe that the APA recommended informed consent process and materials insure the provision of informed consent and that additional regulatory efforts in this area are unnecessary.

NIH CONSENSUS STATEMENT, JUNE, 1985

When a physician has determined that clinical indications justify the administration of ECT, the law requires and medical ethics demand, that the patient's freedom to accept or refuse treatment be fully honored. An ongoing consultative process should take place ... they should discuss the character of the procedure, its possible risks and benefits (including full acknowledgment of post treatment confusion, memory dysfunction. and other attendant uncertainties), and the alternative treatment options (including the option of no treatment at all).

24 It is not easy to achieve this ideal of "Informed consent" in an any aspect of medical practice and there are special difficulties that arise regarding the administration of ECT. In particular, the patients for whom this procedure is medically appropriate may be suffering from a severe psychiatric Illness that, although not impairing their legal competency to consent, may nonetheless cloud judgment in fully weighing all of the available options. Such judgmental distortion does not justify disregarding the patient's choices: rather, it makes it all the more important that the physician strive to identify and clarify the options that the patient alone is entitled to exercise.

The consent given by the patient at the outset of treatment should not be the final exchange on this issue but should be reexamined with the patient repeatedly throughout the course of treatment. These periodic reviews should be initiated by the physician and not depend on patient initiative to "rescind" consent.

There are several reasons for this repeated consenting procedure: because of the rapid therapeutic effect of the procedure itself, the patient, after initial treatments is likely to have enhanced judgmental capacities; the risks of adverse effects increase with repeated treatments, so that the question of continued treatment presents a possibly changed risk/benefit assessment for the patient, and because the short term memory deficits that accompany each administration of ECT, the patient's recollection of the prior consenting transaction might itself be impaired, so that repeated consultations reiterating that patient's treatment options are important to protect the patient's sense of autonomy throughout the treatment process. Moreover, if the patient agrees, the family should be involved in each step of this consultative process (NIH p. 8).

2001 APA TASK FORCE REPORT

The patient should provide informed consent unless s/he lacks capacity or as otherwise specified by law.

There is no clear consensus about what constitutes the capacity to consent.

Capacity to consent should be assumed to be present unless compelling evidence exists to the contrary. The occurrence of psychotic ideation, irrational thought processes or involuntary hospitalization does not, by themselves, constitute such evidence.

There may be concern that the attending physician is biased toward finding that capacity to consent exists when the patient's decision agrees with his or her own.

Informed consent is defined as voluntary when the consenter's ability to reach a decision is free from coercion or duress. In practice, the line between "advocacy" and "coercion" may be difficult to establish

MENTAL HYGIENE LEGAL SERVICES (MHLS)

On May 17, 2001, MHLS provided written comments to the Committee regarding ECT. The MHLS represents patients on facility applications to the courts for orders authorizing the administration of ECT. Under current laws and regulation, the MHLS is not ordinarily notified of cases in which consent for the procedure is obtained from the patient or a surrogate, without court involvement. The MHLS identified a number of concerns with respect to the current practices for obtaining consent for ECT, including:

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OMH regulations do not contain adequate safeguards for ensuring that the patient has been fully informed of the risks and benefits of the procedure and is capable of giving informed consent.

In addition to calling for a written consent document that becomes part of the patient record, including a written disclosure of the risks and benefits, the MHLS maintained that OMH should establish a protocol for assessing a person's capacity to give or withhold informed consent to ECT. The MHLS stated that. "It has been our experience, in both ECT and other treatment cases, that all too often the determination of capacity turns on whether or not the patient agrees with the Doctor."

In the case of non-objecting, incapacitated patients, we question whether OMH has the power to vest relatives with the authority to give surrogate consent to ECT. We also question whether the OMH regulations on surrogate consent for ECT comport with the current statutory framework.

The MHLS stated, "The question of who may give informed consent on behalf of an incapacitated patient is a legislative judgment ... the Legislature has promulgated a statutory mechanism for securing consent from the courts for ECT on behalf of incapacitated persons ... The Court may ... authorize or deny a course of treatment directly, without the appointment of a guardian. The Legislature has authorized non-judicial surrogate consent for other forms of treatment in very limited circumstances, but has not empowered others to give surrogate consent for ECT for incapacitated persons ... In TD. v. OMH, 228 AD 2nd 95, the Appellate Division "specifically reject[ed]" OMH's assertion that MHL Section 3 33 3.03 empowers OMH to promulgate surrogate consent procedures.

OMH regulations are inadequate with respect to the procedure to be followed when surrogate consent for ECT is sought and refused.

According to the MHLS, "Even if OMH has the authority to empower third persons to give surrogate consent for ECT, Part 27 of the OMH regulations violates due process principles, as it fails to require notice to the patient that he or she is believed to be incapacitated and that surrogate consent for ECT will be sought ... In addition, we are aware of cases where consent for ECT has been refused by a surrogate and the facility has ignored the surrogate's refusal of consent and shopped the OMH surrogate list for someone else who would agree. This approach is not permissible under OMRDD regulations, which establish a hierarchy of surrogates and require a court application where the first available surrogate objects."

The Legislature should consider amending Section 35 of the Judiciary Law to make it clear that independent psychiatrists and psychologists may be appointed by the courts in ECT and other cases in which judicial authorization is sought for treatment.

According to MHLS, currently Section 35 of the Judiciary Law expressly provides for the appointment of an independent psychiatrist or psychologist to assist the courts only in commitment and habeas corpus proceedings arising out of State operated facilities.

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INFORMATION ABOUT ECT, OFFICE OF MENTAL HEALTH

In regard to OMH's proposed consent procedure, the July, 2001 OMH document states:

In New York State, persons treated by ECT must be given an explanation of the proposed procedure and course of treatment, including a discussion of the expected benefits, reasonable foreseeable risks, and any reasonable alternative to the proposed treatment. New York's law and regulations state that no patient may be treated with ECT over his or her objection as long as s/he retains the capacity to make a reasoned decision concerning treatment.

SURVEY OF THE PROVISION OF ELECTRO-CONVULSIVE THERAPY (ECT) AT NEW YORK STATE PSYCHIATRIC CENTERS BY THE COMMISSION ON QUALITY OF CARE, AUGUST 7,2001

At the request of Mental Health Committee Chairperson Luster, the CQC agreed to conduct a survey of the provision of ECT at state psychiatric centers. ECT is currently administered in Manhattan Psychiatric Center, Creedmoor Psychiatric Center, Pilgrim Psychiatric Center, the Psychiatric Institute (PI) and Rockland Psychiatric Center. The results of this survey, received by the Committee on October 2, 2001 found that "protocols varied in detail regarding the procedure itself, as well as in issues such as physician privileging and determining capacity to consent." (October 2, 2001 letter.)

Regarding informed consent. the CQC report states:

Obtaining a patient's informed consent for ECT... is the subject matter of 14 NYCRR Section 27.9. Section 27.9 ... has been superceded, though only in part. Section 27.9 ... provides that if the patient does not have the requisite capacity to consent to ECT treatment but does object, the objection may be overridden administratively by the hospital. However, this provision of Section 27.9 has been superceded as a result of the Court of Appeals' 1986 decision in Rivers v. Katz. OMH promulgated Section 527.8 to supercede this provision in order to clarify that an incapacitated patient may be treated over objection only by a court order.

Only Pilgrim's operational policy defines capacity to consent .... For a patient who has sufficient mental capacity to give informed consent to ECT, according to policy at PI, Pilgrim and Creedmoor, only the patient can give consent, and if the patient refuses to consent, ECT will not be administered and the hospital will not go to court. If ECT treatment is deemed necessary for a competent patient who refuses ECT, Rockland and Manhattan policy allows them to go to court to obtain an order for treatment over objection.

Policies generally define the length of time a consent is valid. At PI, the informed consent is good for up to 25 treatments of a single course of ECT ... At Pilgrim, consent is good for 25 treatments or three months, whichever comes first ... Creedmoor requires new consent every three months. Rockland requires that consent be updated every six months. Manhattan has no written requirement for renewing informed consent, but does require that MHLS be notified before anyone, consenting or not, receives ECT. Policies at PI, Pilgrim, Creedmoor indicate that legally designated surrogates or a court of competent jurisdiction can give consent to ECT if the patient lacks capacity ... but does not object. Creedmoor mandates that two psychiatrists, neither associated with the ECT unit, must certify that a patient lacks capacity ... and they must further certify that the patient does not object. At Manhattan and Rockland, court orders are required before ECT can be given to anyone who is determined to lack capacity to give consent (pgs.6-7).

The impact of bias on the determination of capacity to consent necessitates extensive review as part of the informed consent process. While the APA Task Force Report identified the possibility of bias by

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the attending physician regarding capacity when the patient agrees with the attending physician's decision, it did not comment on the possibility of bias when the patient does not agree with the attending physician's decision to use ECT. Another instance of possible bias may occur when the patient does not have capacity and does not object to ECT. Great care needs to be taken to ensure that the patient's diagnosis is the correct one. ECT has been shown to be effective with certain diagnoses and not with others. Misdiagnosis, either as the result of bias or human error, can lead to faulty judgments regarding capacity to consent and validity of information provided during the informed consent process. The involvement of mental health professionals, such as clinical psychologists, who have no Involvement in ECT, will help to ensure that patients are diagnosed correctly and that bias in capacity determinations is minimized.

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