Alan Meisel - Profile on Academia.edu (original) (raw)
Papers by Alan Meisel
Clinical trials (London, England), 2017
Data monitoring committees are responsible for safeguarding the interests of study participants a... more Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees. Prospective data monitoring committee members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. Data monitoring committee members should be protected against legal liability arising from their service. While avoiding brea...
Ethical and Legal Problems in Resuscitation Research
Prehospital and Disaster Medicine, 1985
Medicine has made great advances in the past decade, and is now opening the frontiers of brain re... more Medicine has made great advances in the past decade, and is now opening the frontiers of brain resuscitation. Coinciding with the advances in medicine, society has witnessed great changes. There is an increasing awareness of patients' rights, an increasing desire for self determination, a rejection of the once-accepted paternal role of the physician, and an increasing willingness to challenge physicians in the courts. At the same time, government regulation of biomedical research has been expanding rapidly. The origin of this regulation dates back to the post-World War II Nuremburg trials. In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The evolving concern about human experimentation has led to the current Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA) regulations which became effective July 27,1981. All biomedical research supported by fe...
Dos modelos para la aplicación del consentimiento informado
Bioetica Para Clinicos 1999 Isbn 84 921418 9 1 Pags 151 162, 1999
Journal of the American Academy of Psychiatry and the Law Online, Feb 1, 1986
The law govemlng the obligation of therapists to report their patients' previous criminal acts wa... more 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
Nebraska Law Review, Feb 1, 1977
The term "treatment" will be used broadly to include not only those medical procedures that are i... more 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,
Journal of Health Care Law and Policy, 1999
2. See discussion of physician assisted suicide infra notes 61-74 and accompanying text. 3. See d... more 2. See discussion of physician assisted suicide infra notes 61-74 and accompanying text. 3. See discussion of states which have enacted palliative care statutes infta notes 25-26 and accompanying text.
Journal of the American Academy of Psychiatry and the Law Online, Feb 1, 1980
Lessons from Cruzan
The Journal of Clinical Ethics, Feb 1, 1990
Research on Syphilis in Guatemala in the 1940s: History, Context, and Contemporary Concerns
... Welcome: Dr. Donald S. Burke Panelists: Susan M. Reverby, PhD, Wellesley College, and Sue E. ... more ... Welcome: Dr. Donald S. Burke Panelists: Susan M. Reverby, PhD, Wellesley College, and Sue E. Lederer, PhD, University of Wisconsin Moderator: Alan Meisel, JD, University of Pittsburgh School of Law, Professor of Law and Psychiatry, and Dickie, McCamey & Chilcote ...
インフォームド・コンセント : 臨床の現場での法律と倫理
Legal myths about terminating life support
Archives of Internal Medicine, Aug 1, 1991
There are a number of myths about what the law permits concerning the termination of life support... more There are a number of myths about what the law permits concerning the termination of life support, some of which spring from a fundamental misconception of what law is. A serious misunderstanding of the law can lead to tragic results for physicians, health care institutions, patients, and families. These misunderstandings are (1) anything that is not specifically permitted by law is prohibited; (2) termination of life support is murder or suicide; (3) a patient must be terminally ill for life support to be stopped; (4) it is permissible to terminate extraordinary treatments, but not ordinary ones; (5) it is permissible to withhold treatment, but once started, it must be continued; (6) stopping tube feeding is legally different from stopping other treatments; (7) termination of life support requires going to court; and (8) living wills are not legal.
A Question of Zeal
American Journal of Psychiatry, Oct 7, 2014
Informed consent to medical treatment
Biomedecine Pharmacotherapy, Feb 1, 1983
International Journal of Law and Psychiatry, 1981
The professions of medicine and law often have taken opposing sides on issues concerning patient ... more 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).
Managed care, autonomy, and decisionmaking at the end of life
Houston Law Review University of Houston, Feb 1, 1999
ARTICLE MANAGED CARE, AUTONOMY, AND DECISIONMAKING AT THE END OF LIFE Alan MeiseC Table of Conten... more ARTICLE MANAGED CARE, AUTONOMY, AND DECISIONMAKING AT THE END OF LIFE Alan MeiseC Table of Contents I. Introduction 1394 II. Autonomy and End-of-Life Decisionmaking 1397 A. The Development of the Law of Informed Consent 1399 B. The Right to Refuse ...
Informed consent and incompetent medical patients
The Journal of Family Practice, Mar 1, 1985
The mentally incapacitated patient is frequently encountered in the general medical hospital. Inc... more The mentally incapacitated patient is frequently encountered in the general medical hospital. Incapacity is the clinical state in which a patient is unable to participate in a meaningful way in medical decisions. Mentally incapacitated patients relinquish the authority, that is the competent patient's right, to choose among professionally acceptable alternative treatments. Such patients, therefore, require a surrogate decision-maker. There are certain clinical situations in which questions of incapacity are especially important to consider. In a study for the President's Commission for the Study of Ethical Problems in Medical Biomedical and Behavioral Research, the most common problem in recognizing incapacity was found with previously capable patients who became transiently incapacitated during the course of hospitalization. Questions of incapacity or the authority of surrogate decision-makers also arose with comatose, mentally retarded, mentally ill, and physically handicapped patients. While standards to determine capacity remain unclear, a practical approach is to demonstrate that a patient is able to describe the physician's view of the situation and to understand the physician's opinion as to the best intervention. When a patient is deemed to be incapacitated, the physician should turn to family members, whenever possible, to make decisions.
From Tragedy to Catastrophe: Lawyers and the Bureaucratization of Informed Consent
Informed consent to medical treatment: an analysis of recent legislation
University of Pittsburgh Law Review University of Pittsburgh School of Law, Feb 1, 1980
1. Univ Pittsbg Law Rev. 1980 Spring;41(3):407-564. Informed consent to medical treatment: an ana... more 1. Univ Pittsbg Law Rev. 1980 Spring;41(3):407-564. Informed consent to medical treatment: an analysis of recent legislation. Meisel A, Kabnick LD. PMID: 11665252 [PubMed - indexed for MEDLINE]. MeSH Terms: Consent ...
Suppose the Schindlers Had Won the Schiavo Case
Ethical and legal issues related to the use of computer programs in clinical medicine
Annals of Internal Medicine, Apr 1, 1985
As computer programs are used with increasing frequency in the clinical setting, ethicists, lawye... more As computer programs are used with increasing frequency in the clinical setting, ethicists, lawyers, computer scientists, clinicians, and patients must confront a group of problems: In what situations is it appropriate to use a medical computer program? Who should use these programs and how should they be used? What is the legal status of a computer program that provides medical advice? Can a proper balance be achieved between confidentiality of patient information and shared access to records by health care personnel? How can regulatory agencies, physicians, and patients determine if a program is safe for human use? Will programs be able to communicate with users well enough to prevent clinically harmful misunderstandings? Because few if any definitive answers are yet available, these questions remain the subject of much discussion.
Clinical trials (London, England), 2017
Data monitoring committees are responsible for safeguarding the interests of study participants a... more Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees. Prospective data monitoring committee members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. Data monitoring committee members should be protected against legal liability arising from their service. While avoiding brea...
Ethical and Legal Problems in Resuscitation Research
Prehospital and Disaster Medicine, 1985
Medicine has made great advances in the past decade, and is now opening the frontiers of brain re... more Medicine has made great advances in the past decade, and is now opening the frontiers of brain resuscitation. Coinciding with the advances in medicine, society has witnessed great changes. There is an increasing awareness of patients' rights, an increasing desire for self determination, a rejection of the once-accepted paternal role of the physician, and an increasing willingness to challenge physicians in the courts. At the same time, government regulation of biomedical research has been expanding rapidly. The origin of this regulation dates back to the post-World War II Nuremburg trials. In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The evolving concern about human experimentation has led to the current Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA) regulations which became effective July 27,1981. All biomedical research supported by fe...
Dos modelos para la aplicación del consentimiento informado
Bioetica Para Clinicos 1999 Isbn 84 921418 9 1 Pags 151 162, 1999
Journal of the American Academy of Psychiatry and the Law Online, Feb 1, 1986
The law govemlng the obligation of therapists to report their patients' previous criminal acts wa... more 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
Nebraska Law Review, Feb 1, 1977
The term "treatment" will be used broadly to include not only those medical procedures that are i... more 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,
Journal of Health Care Law and Policy, 1999
2. See discussion of physician assisted suicide infra notes 61-74 and accompanying text. 3. See d... more 2. See discussion of physician assisted suicide infra notes 61-74 and accompanying text. 3. See discussion of states which have enacted palliative care statutes infta notes 25-26 and accompanying text.
Journal of the American Academy of Psychiatry and the Law Online, Feb 1, 1980
Lessons from Cruzan
The Journal of Clinical Ethics, Feb 1, 1990
Research on Syphilis in Guatemala in the 1940s: History, Context, and Contemporary Concerns
... Welcome: Dr. Donald S. Burke Panelists: Susan M. Reverby, PhD, Wellesley College, and Sue E. ... more ... Welcome: Dr. Donald S. Burke Panelists: Susan M. Reverby, PhD, Wellesley College, and Sue E. Lederer, PhD, University of Wisconsin Moderator: Alan Meisel, JD, University of Pittsburgh School of Law, Professor of Law and Psychiatry, and Dickie, McCamey & Chilcote ...
インフォームド・コンセント : 臨床の現場での法律と倫理
Legal myths about terminating life support
Archives of Internal Medicine, Aug 1, 1991
There are a number of myths about what the law permits concerning the termination of life support... more There are a number of myths about what the law permits concerning the termination of life support, some of which spring from a fundamental misconception of what law is. A serious misunderstanding of the law can lead to tragic results for physicians, health care institutions, patients, and families. These misunderstandings are (1) anything that is not specifically permitted by law is prohibited; (2) termination of life support is murder or suicide; (3) a patient must be terminally ill for life support to be stopped; (4) it is permissible to terminate extraordinary treatments, but not ordinary ones; (5) it is permissible to withhold treatment, but once started, it must be continued; (6) stopping tube feeding is legally different from stopping other treatments; (7) termination of life support requires going to court; and (8) living wills are not legal.
A Question of Zeal
American Journal of Psychiatry, Oct 7, 2014
Informed consent to medical treatment
Biomedecine Pharmacotherapy, Feb 1, 1983
International Journal of Law and Psychiatry, 1981
The professions of medicine and law often have taken opposing sides on issues concerning patient ... more 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).
Managed care, autonomy, and decisionmaking at the end of life
Houston Law Review University of Houston, Feb 1, 1999
ARTICLE MANAGED CARE, AUTONOMY, AND DECISIONMAKING AT THE END OF LIFE Alan MeiseC Table of Conten... more ARTICLE MANAGED CARE, AUTONOMY, AND DECISIONMAKING AT THE END OF LIFE Alan MeiseC Table of Contents I. Introduction 1394 II. Autonomy and End-of-Life Decisionmaking 1397 A. The Development of the Law of Informed Consent 1399 B. The Right to Refuse ...
Informed consent and incompetent medical patients
The Journal of Family Practice, Mar 1, 1985
The mentally incapacitated patient is frequently encountered in the general medical hospital. Inc... more The mentally incapacitated patient is frequently encountered in the general medical hospital. Incapacity is the clinical state in which a patient is unable to participate in a meaningful way in medical decisions. Mentally incapacitated patients relinquish the authority, that is the competent patient's right, to choose among professionally acceptable alternative treatments. Such patients, therefore, require a surrogate decision-maker. There are certain clinical situations in which questions of incapacity are especially important to consider. In a study for the President's Commission for the Study of Ethical Problems in Medical Biomedical and Behavioral Research, the most common problem in recognizing incapacity was found with previously capable patients who became transiently incapacitated during the course of hospitalization. Questions of incapacity or the authority of surrogate decision-makers also arose with comatose, mentally retarded, mentally ill, and physically handicapped patients. While standards to determine capacity remain unclear, a practical approach is to demonstrate that a patient is able to describe the physician's view of the situation and to understand the physician's opinion as to the best intervention. When a patient is deemed to be incapacitated, the physician should turn to family members, whenever possible, to make decisions.
From Tragedy to Catastrophe: Lawyers and the Bureaucratization of Informed Consent
Informed consent to medical treatment: an analysis of recent legislation
University of Pittsburgh Law Review University of Pittsburgh School of Law, Feb 1, 1980
1. Univ Pittsbg Law Rev. 1980 Spring;41(3):407-564. Informed consent to medical treatment: an ana... more 1. Univ Pittsbg Law Rev. 1980 Spring;41(3):407-564. Informed consent to medical treatment: an analysis of recent legislation. Meisel A, Kabnick LD. PMID: 11665252 [PubMed - indexed for MEDLINE]. MeSH Terms: Consent ...
Suppose the Schindlers Had Won the Schiavo Case
Ethical and legal issues related to the use of computer programs in clinical medicine
Annals of Internal Medicine, Apr 1, 1985
As computer programs are used with increasing frequency in the clinical setting, ethicists, lawye... more As computer programs are used with increasing frequency in the clinical setting, ethicists, lawyers, computer scientists, clinicians, and patients must confront a group of problems: In what situations is it appropriate to use a medical computer program? Who should use these programs and how should they be used? What is the legal status of a computer program that provides medical advice? Can a proper balance be achieved between confidentiality of patient information and shared access to records by health care personnel? How can regulatory agencies, physicians, and patients determine if a program is safe for human use? Will programs be able to communicate with users well enough to prevent clinically harmful misunderstandings? Because few if any definitive answers are yet available, these questions remain the subject of much discussion.