8.1 General

"The core notion that decisions regarding medical care are to be made in a collaborative manner between patient and physician" has, over the last few decades, evolved into a formal legal doctrine of informed consent (Appelbaum et al. 1987, p. 12). Such doctrine serves to focus on a number of important questions regarding the nature of consent to treatment. What is informed consent? Who should provide consent, and under what circumstances? How, and by whom, should capacity for consent be determined? What information should be provided to the consentor and by whom? And how should consent be managed with incompetent or involuntary patients? General reviews of informed consent issues as they relate to ECT can be found in Parry (1986), Roth (1986), Taub (1987), and Winslade (1988), while capacity for consent and the use of ECT in incompetent and/or involuntary patients is specifically addressed in Roth et al. (1977), Salzman (1977), Culver et al. (1980), Roy-Byrne and Gerner (1981), Gutheil and Bursztajn (1986), Mahler et al. (1986), Applebaum et al. (1987), Wettstein and Roth (1988), Levine et al (1991), Reiter-Theil (1992), Martin and Bean (1992), Martin and Clancy (1994), Bean et al (1994), and Boronow et al (1997).

The psychiatric profession, both in the United States and elsewhere, has made a number of attempts to offer practical guidelines for the implementation of consent in the clinical setting. In this regard, the conceptual requirements for informed consent posed by the 1978 APA Task Force on ECT are still applicable; 1) a patient who is capable of understanding and acting reasonably upon such information, 2) the provision of adequate information, and 3) the opportunity to consent in the absence of coercion (American Psychiatric Association 1978). Specific recommendations concerning consent for ECT often reflect a trade-off between the preservation of the autonomy of the patient and the assurance of the patient's right to receive treatment (Ottosson 1992).

A crucial hallmark of informed consent is the quality of interactions between the consentor and the physician, particularly since consent for ECT is an ongoing process. In general, the more the physician keeps the consentor abreast of what is transpiring and involves the consentor in everyday decision making, and the more he/she is sensitive to the consentor's concerns and feelings regarding, these decisions, the fewer problems there will be with the consent process.

8.2 The Requirement for Consent.

Since informed consent for ECT is mandated, both ethically and by regulation, it is incumbent upon facilities using ECT to implement and monitor compliance with reasonable and appropriate policies and procedures. Although the practitioner legally obliged to follow state and local regulatory requirements concerning consent for ECT, judicial and political efforts should be made to correct overregulation (Winslade et al. 1984; Taub 1987). In this regard, ECT should not be considered different from other medical or surgical procedures with comparable risks and benefits. Regulations should not unduly obstruct the patient's right to treatment, since unnecessary suffering, increased physical morbidity, and even fatalities may result if procedures to provide ECT to incompetent or involuntary patients (see below) are needlessly prolonged (Mills and Avery 1978; Roy-Byrne and Gerner 1981; Tenenbaum 1983; Walter-Ryan 1985; Miller et al. 1986; Johnson 1993).

8.3 When and by Whom Should Consent Be Obtained?

As with consent for medical and surgical procedures, the patient should provide informed consent unless lacking capacity or otherwise specified by law. The involvement of significant others in this process should be encouraged (Consensus Conference 1985) but not required (Tenenbaum 1983).

ECT is unusual, but not unique, among medical procedures in that it involves a series of repetitive treatments over an appreciable time period (typically 2 to 4 weeks for an acute ECT course). Because it is the series of treatments, rather than any single treatment, that confers both the benefits and adverse effects of ECT, consent should apply to the treatment series as a whole (unless otherwise required by state law).

Since an ECT course generally extends over multiple weeks, the informed consent process should continue across this period. Patient recall of consent for medical and surgical procedures is commonly faulty (Roth et al. 1982; Miesel and Roth 1983; Herz et al 1992; Hutson and Blaha 1991; Swan and Borshoff 1994). For patients receiving ECT, this recall difficulty may be exacerbated by both the underlying illness and the treatment itself (Sternberz and Jarvik 1976; Squire 1986). For these reasons, the consentor should be provided ongoing feedback regarding clinical progress and side effects and any questions should be addressed. Particularly if the consentor expresses reluctance about receiving ECT, h/she should be reminded of his/her right to accept or refuse further treatment.

Continuation/maintenance ECT (see Chapter 13) differs from a course of ECT in that (1) its purpose is the prevention of relapse or recurrence, (2) the patient's clinical condition is improved compared to that preceding the index ECT course, and (3) it is characterized by both a greater inter-treatment interval and a less well-defined endpoint. Because the purpose of continuation/maintenance treatment differs from an acute course of ECT, a new informed consent process should be initiated, including the signing of a separate consent form. As a series of continuation ECT typically lasts at least 6 months, and because continuation/ maintenance ECT is provided to individuals who are clinically improved and already knowledgeable about the treatment, a 6-month interval is adequate before readministration of the formal consent document (unless state law requires otherwise).

Ideally, the consent process involves discussions with the consentor about general aspects of ECT and information unique to the patient, as well as the signing of the informed consent document. The information essential to consent to ECT should be provided by a knowledgeable physician. Ideally, this person should also have a therapeutic alliance with the patient. In practice this requirement can be accomplished by the attending physician, treating psychiatrist, or other knowledgeable physician acting individually or in concert. It may also be helpful for other, professional staff to provide further information to the consentor. Consent for anesthesia may either be included in the ECT consent process or separately obtained by an anesthetist.