Bioethics & Health Law

Observations can be proposed regarding the study by Rydvall and Lynöe [1]. The use of standardised questionnaires in the general population measures the intention of the persons interviewed but not the reality of reasoning in a concrete clinical situation.

Participants: All prosecuting attorneys who are members of the National District Attorneys Association. A total of 2844 surveys were mailed with 2 follow-up mailings at 6-week intervals; 761 surveys were returned for a response rate of 26.8%. The majority of respondents were white men, Protestant, and served in rural areas. Interventions: None. Main Outcome Measures: On the basis of 4 case scenarios, (1) professional behavior as determined by respondents' willingness to prosecute and what criminal charges they would seek; and (2) personal beliefs as determined by whether prosecutors believed the physicians' actions were morally wrong and whether they would want the same action taken if they were in the patient's condition. Results: Most respondents would not seek prosecution in 3 of the 4 cases. In the fourth case, involving physician-assisted suicide, only about one third of the respondents said that they definitely would prosecute. Those who would prosecute would most often seek a charge of criminal homicide. A majority of respondents believed that the physicians' actions were morally correct in each of the 4 cases and would want the same action taken if they were in the patient's position. There was a strong correlation between personal beliefs and professional behaviors. Conclusions: A large majority of responding prosecutors were unwilling to prosecute physicians in cases that clearly fall within currently accepted legal and professional boundaries. In the case of physician-assisted suicide, results reflected a surprisingly large professional unwillingness to prosecute and an even greater personal acceptance of physician-assisted suicide.

This paper explores the development of the informed consent doctrine as it relates to psychiatric practice. The contribution of the issues of civil commitment and the right to refuse treatment to current developments in the informed consent doctrine is also addressed. Special informed consent issues are related to specific categories of psychiatric treatments. Basic in formed consent requirements in psychiatry are seen as still in the formative stages but the constitutional law and common-law foundations for further developments are outlined. The complicated clinical, ethical, and legal issues involved in modern psychiatric treatment are stimulating new interest and concern about the informed consent doctrine throughout medical practice.

In randomized clinical trials, a data monitoring committee (DMC) is often appointed to review interim data to determine whether there is early convincing evidence of intervention benefit, lack of benefit or harm to study participants. Because DMCs bear serious responsibility for participant safety, their members may be legally liable for their actions. Despite more than three decades of experiences with DMCs, the issues of liability and indemnification have yet to receive appropriate attention from either government or industry sponsors. In industry-sponsored trials, DMC members are usually asked to sign an agreement delineating their responsibilities and operating procedures. While these agreements may include language on indemnification, such language sometimes protects only the sponsor rather than the DMC members. In government-sponsored trials, there has been even less structure, since typically there are no signed agreements regarding DMC activities. This paper discusses these ...

Hailed by its proponents as a doctrine that promises more equitable doctorpatient relationships, informed consent has also been decried as posing serious threats to the quality of care in this country. Ultimately, what is at stake in the controversy is nothing less than two equally entrenched but compelling strains in American legal and political history-the protection of individual autonomy versus societal regulation of individual freedom for the greater common good. In the case of psychiatric patients, the issue is further complicated because it is often precisely the patient's very capacity for autonomous action that is in question. Central to the ethical doctrine of informed consent is that patients not only be apprised of and give their written consent to a particular treatment-as required by law-but that they understand what the treatment entails and consent to it.

, 429 F. Supp. 640 (M.D. Pa. 1976) (three-judge court), in which the federal district court declared unconstitutional the key provision of the Pennsylvania civil commitment statute. The next day, the Pennsylvania legislature enacted and the governor signed a new civil commitment bill which had been before the legislature for about a year, and predecessors of which had been debated for several years. 2. See, e.g., Bartley v. Kremens, 402 F. Supp. 1039 (E.D. Pa. 1975) (three-judge court), where the filing of the complaint prompted the Pennsylvania Department of Public Welfare to promulgate regulations to correct the deficiencies alleged to exist in the statutory procedures for the hospitalization of children. See

Over the past quarter century, the doctrine of informed consent has gradually attained preeminence among legal scholars, judges, and ethicists as specifying the legally and ethically acceptable manner by which decisions about health care should be made (Meisel et al. 1977, President's Commission 1982). The doctrine seeks to promote autonomous and rational decisions by patients about their treatment. While seeking to encourage collaborative decisionmaking between patient and caregivers, the law has reiterated and reinforced the right of the competent patient to make decisions about treatment and has placed on the physician the obligation to facilitate such decisions by disclosing to the patient all information that is relevant to the decision that the patient must make, such as the purpose, nature, risks, and benefits of, and alternatives to, the proposed treatment (Meisel 1979). Despite the acceptance that the doctrine has achieved in legal and ethical circles as a prescription for health care decisionmaking, it has received a far different reception among physicians, judging by both the theoretical and the empirical literature. Moreover, the actual conduct of decisionmaking does not seem to be quite what its legal and ethical proponents had envisioned (Katz 1977). Although some of it is methodologically dubious (Meisel and Roth 1981), a body of literature has developed in the last few years which shows that patients are often not told very much about their treatment (Lidz et al. 1984; Gray 1975) and do not understand very much of what they are told even when they do receive information (

The term "treatment" will be used broadly to include not only those medical procedures that are intended to ameliorate illness and injury, but also diagnostic procedures designed to determine the nature of the disorder and the appropriate course of treatment. 2. The terms "medical" and "medicine" are used herein to include treatment that might more properly be characterized as surgical, dental, or podiatrical. The same general principles of liability apply, however, regardless of the characterization of the treatment. W. PROSSER, HANDBOOK OF THE LAW OF ToRTs § 32, at 161-62 (4th ed. 1971) [hereinafter cited as PROSSER]; see, e.g., Simpson v. Davis,-Kan.-, 549 P.2d 950 (1976). 3. Other civil causes of action, in addition to negligence, may be brought against physicians for misfeasance or nonfeasance. Abandonment, assault and battery, breach of contract, deceit, and miscellaneous other charges form the basis for action against physicians. See generally 1 D. LouIsELL & H. WILLIAMS, MEDICAL MALPRACTICE I 8.08-.13 (1973) [hereinafter cited as LOUISELL & WILLIAMS]; Smith, Antecedent Grounds of Liability in the Practice of Surgery, 14 ROCKY MT. L. REv. 233 (1942). The great bulk of cases against physicians, however, involve allegations of negligent medical treatment, or what is usually referred to as "malpractice." 4. The problem of defining "bad results" is exceedingly complex. The term may be defined from the patient's perspective, from the physician's, or from the perspective of the larger medical profession (i.e., the so-called "experts" in a particular area of medicine). It may be viewed in terms of a deviation from an expected outcome if the best T. O'CONNELL, ENDING INSULT TO INJURY 72 (1975). See also HEW,

Since 1976, when the New Jersey Supreme Court decided the Karen Ann Quinlan case (In re Quinlan, 355 A.2d 647 (NJ), 1976 cert. denied, 429 US 922, 1976), it has been apparent that the concept of quality of life is fundamental to end-of-life decisionmaking. Yet there has been a great deal of reluctance by courts--which have been the primary engine of lawmaking in end-of-life matters--to use this concept overtly.

The professions of medicine and law often have taken opposing sides on issues concerning patient care. Differences over the right to treatment, experimentation on institutionalized patients, and de-institutionalization of mental patients are but a few examples where the two professions have fallen into debate over the ethical and practical responsibilities owed to patients. The vocal and public nature of those debates may foster a popular conception of inherent conflict between the two disciplines. From this point of view, the present controversy over informed consent to treatment may be regarded as one battle in an ongoing war between two powerful professional disciplines. Conflict between psychiatry and law over informed consent for mental patients is well documented in the literature. Lawyers have championed the doctrine of informed consent as an instrument for reform of the doctor-patient relationship (Note, 1970), as a check on the indiscriminate use of therapeutic procedures (Plotkin, 1977), and as a new theory of medical liability (Meisel, 1977). Physicians have attacked the doctrine as a myth, unsuitable to the realities of clinical practice (Leeb & Bowers, 1976; Laforet, 1976) and a legal ploy to entrap the unwary physician in litigation (Delee, 1976; Burnham, 1966). Almost all major medical specialities have found reason to take exception to the doctrine. However, medicine and law are not uniformly divided on the issue. Some lawyers have been critical of informed consent (Seidelson, 1976; Chayet, 1976). A few physicians have supported it as a means to protect the patient and involve him or her in medical decisionmaking (Crile, 1976, 1972; Hatcher, 1976).

The term "treatment" will be used broadly to include not only those medical procedures that are intended to ameliorate illness and injury, but also diagnostic procedures designed to determine the nature of the disorder and the appropriate course of treatment. 2. The terms "medical" and "medicine" are used herein to include treatment that might more properly be characterized as surgical, dental, or podiatrical. The same general principles of liability apply, however, regardless of the characterization of the treatment. W. PROSSER, HANDBOOK OF THE LAW OF ToRTs § 32, at 161-62 (4th ed. 1971) [hereinafter cited as PROSSER]; see, e.g., Simpson v. Davis,-Kan.-, 549 P.2d 950 (1976). 3. Other civil causes of action, in addition to negligence, may be brought against physicians for misfeasance or nonfeasance. Abandonment, assault and battery, breach of contract, deceit, and miscellaneous other charges form the basis for action against physicians. See generally 1 D. LouIsELL & H. WILLIAMS, MEDICAL MALPRACTICE I 8.08-.13 (1973) [hereinafter cited as LOUISELL & WILLIAMS]; Smith, Antecedent Grounds of Liability in the Practice of Surgery, 14 ROCKY MT. L. REv. 233 (1942). The great bulk of cases against physicians, however, involve allegations of negligent medical treatment, or what is usually referred to as "malpractice." 4. The problem of defining "bad results" is exceedingly complex. The term may be defined from the patient's perspective, from the physician's, or from the perspective of the larger medical profession (i.e., the so-called "experts" in a particular area of medicine). It may be viewed in terms of a deviation from an expected outcome if the best T. O'CONNELL, ENDING INSULT TO INJURY 72 (1975). See also HEW,

The law govemlng the obligation of therapists to report their patients' previous criminal acts was reviewed. Most often, discussions of this subject fall under the general category of "misprision of a felony," that is, the presumed general obligation of all citizens to report felonies that come to their Ittentlon. Review of federal law revealed that the courts have consistently interpreted the federal misprision statute as requiring active concealment of a crime, not a mere failure to report, in order to convict for the offen ... State law Is more diverse. Only one state has a general misprision statute labeled as such, and .. veral states have recently repealed such statutes. The strong trend In states without statutes Is to reject misprision as a common law crime, becuase of Its Incompatibility with modem notions of justice. Most states, however, have limited reporting statutes, such as for child abuse or gunshot wounds, that Impose similar obligations. Therapists' reporting of past crimes may be affected by clinical and ethical concems, as well as by obligations to protect future victims. In almost all jurisdictions, however, the fear of prosecution for failure to report a past crime should not be a factor in deciding on a course of action. than three years, or both. s