Alan Meisel
University of Pittsburgh, Bioethics & Health Law, Faculty Member
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... 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...
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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'... 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...
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Research Interests: Death and Health Law
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... 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,... 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 ...
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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... 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.
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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... 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 ...
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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... 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.
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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 ...
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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... 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.
Research Interests: Information Systems, Jurisprudence, Ethics, Quality of Mental Health Care, Medical Ethics, and 13 moreRisk assessment, Software, Computers, Clinical Medicine, United States, Confidentiality, Legal Liability, Malpractice, Risk Assessment, Medical Records, Quality of health care, Medical and Health Sciences, and Referral and consultation
End-of-life decision making became a matter of public discourse in the mid-1970s with the commencement of litigation in the Karen Ann Quinlan case.1 Although conflicts between physi-cians and patients (or their families) near the end of... more
End-of-life decision making became a matter of public discourse in the mid-1970s with the commencement of litigation in the Karen Ann Quinlan case.1 Although conflicts between physi-cians and patients (or their families) near the end of life about how aggressively to treat must have been ...
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This paper analyzes the association between race and the presence of advance care plan documents (living wills, do not resuscitate (DNR) orders, and do not hospitalize (DNH) orders) in nursing home residents. We conducted secondary... more
This paper analyzes the association between race and the presence of advance care plan documents (living wills, do not resuscitate (DNR) orders, and do not hospitalize (DNH) orders) in nursing home residents. We conducted secondary analysis of publicly available survey data from the 1996 Medical Expenditure Panel Survey-Nursing Home Component, a nationally representative survey of nursing home residents in the United States. There were 3,747 participants in the survey, weighted to represent 1.56 million nursing home residents in the United States. We found that 20% of U.S. nursing home residents in 1996 had documentation of living wills, 48% had DNR orders, and 4% had DNH orders. African Americans are about one-third as likely as Caucasians to have living wills and one-fifth as likely as Caucasians to have DNR orders; Hispanics are about one-third as likely as Caucasians to have DNR orders and just as likely as Caucasians to have living wills. In conclusion, we found that the presence of advance care plans is related to race, even after controlling for health and other demographic factors. These findings call attention to an area where further research is needed to determine whether residents' (and their families') preferences are being elicited and documented.
Research Interests: Risk, Humans, Race relations, Nursing Homes, United States, and 15 moreFemale, Male, Data Collection, The, Ethnic Groups, African Americans, Nursing Home, Aged, Advance Directives, Racial Disparities, Advance Care Planning, Homes for the Aged, Health Services Accessibility, Living wills, and Medical and Health Sciences
ABSTRACT
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William Head, a twenty-seven-year-old leukemia patient from Louisiana, requested that a district court in Iowa intervene in his behalf with the Univer-sity of Iowa Institutional Review Board (IRB). He wanted to have the board make a third... more
William Head, a twenty-seven-year-old leukemia patient from Louisiana, requested that a district court in Iowa intervene in his behalf with the Univer-sity of Iowa Institutional Review Board (IRB). He wanted to have the board make a third effort to contact a potential bone marrow ...
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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... more
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.
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Since its enunciation over 2 decades ago,'the doctrine of informed consent has spawned untold controversy in the courts, among legal scholars, and within the medical profession, and now constitutes one of the primary soIurces of... more
Since its enunciation over 2 decades ago,'the doctrine of informed consent has spawned untold controversy in the courts, among legal scholars, and within the medical profession, and now constitutes one of the primary soIurces of antagonism between doctors and ...
Research Interests: Law, Jurisprudence, Decision Making, Informed Consent, Health, and 14 moreSocial Responsibility, Emergency Medical Services, Humans, Disclosure, Freedom, Paternalism, Social Values, Patient Care, Patient Participation, Mental Competency, Personal autonomy, Reference standards, wisconsin law, and Physician-Patient Relations
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 ...
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1983] INFORMED CONSENT 267 VI. Voluntariness: The Pressures That Come to Bear on Patients 309 A. Structural Pressures 311 B. Situational Pressures 311 C. Voluntariness and "Special" Groups: Studies Involving Psychiatric Patients... more
1983] INFORMED CONSENT 267 VI. Voluntariness: The Pressures That Come to Bear on Patients 309 A. Structural Pressures 311 B. Situational Pressures 311 C. Voluntariness and "Special" Groups: Studies Involving Psychiatric Patients and Research Subjects 312 1. Psychiatric ...
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In the two decades since the Karen Quinlan case first brought the issues that now go under the heading of the "right to die" to the attention of the courts and the public, a well-accepted legal consensus has developed about the... more
In the two decades since the Karen Quinlan case first brought the issues that now go under the heading of the "right to die" to the attention of the courts and the public, a well-accepted legal consensus has developed about the law governing the forgoing of life-sustaining medical treatment. Law and clinical medical practice do not always run in tandem, however, and what law prescribes does not always occur in practice. One aspect of the legal consensus-that artificial nutrition and hydration is a medical treatment and thus may be withheld or withdrawn according to the same procedures and standards as other life-sustaining medical treatments-is probably less well accepted than the remainder. For reasons that I will explain, this is understandable. But what is puzzling is that this element of the consensus seems to be even less well accepted in nursing homes than in acute-care hospitals.
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William Head, a twenty-seven-year-old leukemia patient from Louisiana, requested that a district court in Iowa intervene in his behalf with the Uni-versity of Iowa Institutional Review Board (IRB). He wanted to have the board make a third... more
William Head, a twenty-seven-year-old leukemia patient from Louisiana, requested that a district court in Iowa intervene in his behalf with the Uni-versity of Iowa Institutional Review Board (IRB). He wanted to have the board make a third effort to contact a potential bone marrow ...
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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... 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 handica...
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The authors draw together the disparate scholarly and judicial commentaries on consent to medical treatment to develop a model of the components in the decision-making process regarding consent to or refusal of psychiatric treatment. The... more
The authors draw together the disparate scholarly and judicial commentaries on consent to medical treatment to develop a model of the components in the decision-making process regarding consent to or refusal of psychiatric treatment. The components consist of the precondition of voluntariness, the provision of information, the patient's competency and understanding, and, finally, consent or refusal. They offer two models of valid consent: the objective model, which focuses on the congruence or lack of it between the patient and a "reasonable" person, and the subjective model, which focuses entirely on the patient's actual understanding.
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The authors describe the various tests of competency to consent to treatment used today, which include the following: 1)evidencing a choice, 2)"reasonable" outcome of choice, 3)choice based on "rational" reasons,... more
The authors describe the various tests of competency to consent to treatment used today, which include the following: 1)evidencing a choice, 2)"reasonable" outcome of choice, 3)choice based on "rational" reasons, 4)ability to understand, and 5)actual understanding. They analyze the applicability of these tests to patients' decisions to accept or refuse psychiatric treatment and illustrate the problems of ap-lying these tests by citing clinical case examples. They find that the circumstances in which competency becomes an issue determine which elements of which tests are stressed and which are underplayed.
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1. Hastings Cent Rep. 1978 Oct;8(5):5-6. Must a man be his cousin's keeper? Meisel A, Roth LH. PMID: 363646 [PubMed - indexed for MEDLINE]. MeSH Terms: Adult; Anemia, Aplastic/therapy; Bone Marrow Transplantation*; Human ...
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