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A 21 year-old woman • A 21-year-old woman attends a party, drinks alcohol and takes Valium. After returning home she becomes unconscious. She is taken to a hospital where she stops breathing, is resuscitated, and is placed on a ventilator. After several months the family is told she is in a persistent vegetative state and is unlikely to recover. The family requests she be removed from the ventilator but the hospital and doctor object. The ethics committee is consulted. • What should you do? Why • What more would you like to know?
IN RE QUINLAN 70 N.J. 10 (1976) 355 A.2d 647 IN THE MATTER OF KAREN QUINLAN, AN ALLEGED INCOMPETENT. The Supreme Court of New Jersey. Argued January 26, 1976. Decided March 31, 1976.
Human Rights and EthicsCentral State Hospital Richard L. Elliott, MD, PhD, FAPA Professor and Director, Medical Ethics Mercer University School of Medicine Adjunct Professor Mercer University School of Law
Goals • Purposes of ethics training • What do you hope to get out of this? • Competencies of ethics committees • Foundations of medical ethics • Principles • Legal • How to make decisions about ethical issues?
Why learn medical ethics? • Consultations on specific clinical ethics cases • Consultations on specific policies • Consultations on personnel (HR) issues • Consultations to other organizations • Consultations on training needs in ethics and professionalism • Consultations on research • Personal and professional growth
What do ethics committee members need to know and to be able to do? • Core Competencies for Clinical Ethics Committees • http://www.ukcen.net/uploads/docs/education_resources/core_competencies1.pdf
Core Competencies – Ethical Assessment Skills • Ability to recognize and discuss moral conflicts within the clinical situation • Ability to understand the moral perspective of all parties • Ability to explain the ethical dimension of a case to those involved and to others • Ability to formulate and justify morally acceptable solutions • Ability to review established practices that have generated moral concerns or conflicts, to determine whether change is necessary.
Core Competencies – Operational Skills • These are required in the process of resolving conflict, reducing uncertainty, and building consensus, and include: • Ability to facilitate meetings, record cases etc. • Skills in facilitation, of both case consultation discussions and CEC meetings. • Mediation skills required to negotiate conflict resolution in situations of emotional distress.
Core Competencies – Interpersonal Skills • Active listening. • Communication skills. • Advocacy skills to enable articulation of the views of those who find it difficult to express themselves.
Core Competencies - Knowledge • Introduction to ethical theory and moral reasoning • Awareness of the position of the CEC/Forum in the hospital framework and links to clinical governance • Relevant knowledge of clinical terms and disease processes. • Beliefs and perspectives of patients and staff population and community staff. • Relevant professional codes of ethics, e.g. GMC and Nursing Council. • Relevant health care law. • Local and national government policy, e.g. resource allocation.
Core Competencies – Personal Characteristics • Tolerance, patience and compassionEnables disparate views to be held in difficult situations • Honesty, fair mindedness, self-knowledge and reflectionEnables recognition of personal limitations and development of relationships based on of trust and respect • Courage • Enables voices of weak and vulnerable to be heard and dissenting views to be put to those in authority. It involves the skill of advocacy • Prudence, humility • Enables individuals not to go beyond their level of competency and/or to acknowledge conflicts between personal moral views and role in consultation. • Integrity • Enables pursuit of ethically relevant options when it might be convenient to do otherwise. Moral integrity should underpin all ethics consultations
How are we going to help you become competent in medical ethics?
Course Overview • I. Background • II. Ethical principles and analysis • III. Ethics and law • IV. Informed consent and competence • V. Applications to CSH • Schedule is flexible!
Session 1 - Background Why is medical ethics important? • A brief history of ethics and ethics committees • What do we mean by “ethics” and how is this distinguished from “morality” and “legality?” • What do we mean by “medical ethics?” • Who are the key figures and what are the key ideas in the evolution of medical ethics? • a. Hippocrates, Percival, AMA • Nuremberg • Tuskegee Study of Syphilis • The Belmont Report - ethics and human rights
Session 2 – Ethical principles and analysis What is medical ethics and what are its principles? Principles of medical ethics • Autonomy • Beneficence • Non-maleficence • Social justice • How to recognize and respond to an ethical issue • How to analyze an ethical issue
Session 3 – Law and ethics What is “The Law” and how does it relate to the Ethics Committee? • Different types of “law” • Statutory law • Examples • Reporting requirements • O.C.G.A. • Federal vs. state and potential conflicts • Case law • Appellate courts and jurisdiction • Examples • Olmstead • Parham • EMTALA • Others?
Session 4 – Specific Issues Informed consent Elements of informed consent Capacity vs. Competence What can we do when a patient is thought to lack capacity? What is implied consent? Therapeutic privilege? DNR orders O.C.G.A., DBHDD policy Other ethical issues important to CSH • 1. Research? • 2. Confidentiality?
Session 5 – Applications to Ethics Committee Mock ethics case consultations Evaluation of Ethics Committee functions Structure Membershipand meetings Composition – Patient/community involvement? Process Knowledge and skills of members Adequacy of ethics consultation process Data on numbers, types of consultations, and trends Comments on group process within the committee Outcomes Timeliness- Do you have a requirement? Do you meet it? How often does treatment team follow recommendations? Satisfaction of committee members, customers? And now . . .
What do we mean that something is ethical? • Legal • What are the sources of “law”? • Can something be legal but not moral? • Current legal controversies: gun ownership, Affordable Care Act, abortion • Moral • Where do we get moral beliefs? • Can something be ethical but not moral? • Current moral controversies: same sex marriage, abortion • Ethical • What are ethical codes? • Current ethical controversies: physician assisted suicide, euthanasia, futility of care, how to allocate scarce resources • Where do ethical codes come from?
Why is history important? • Understanding how we got here helps us understand the foundations • Advances in medicine require advances in ethics • More diversity in staff and patients requires more diverse ethical views • Appreciating the evolution of medical ethics helps us to anticipate the need for new, creative thinking in how we consider situations. Perhaps the way we looked at issues in the past is no longer adequate.
I swear by Apollo, the healer, Asclepius, Hygieia, and Panacea, and I take to witness all the gods, all the goddesses, to keep according to my ability and my judgment, the following Oath and agreement: To consider dear to me, as my parents, him who taught me this art; to live in common with him and, if necessary, to share my goods with him; To look upon his children as my own brothers, to teach them this art; and that by my teaching, I will impart a knowledge of this art to my own sons, and to my teacher's sons, and to disciples bound by an indenture and oath according to the medical laws, and no others. I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone. I will give no deadly medicine to any one if asked, nor suggest any such counsel; and similarly I will not give a woman a pessary to cause an abortion. But I will preserve the purity of my life and my arts. I will not cut for stone, even for patients in whom the disease is manifest; I will leave this operation to be performed by practitioners, specialists in this art. In every house where I come I will enter only for the good of my patients, keeping myself far from all intentional ill-doing and all seduction and especially from the pleasures of love with women or men, free or slaves. All that may come to my knowledge in the exercise of my profession or in daily commerce with men, which ought not to be spread abroad, I will keep secret and will never reveal. If I keep this oath faithfully, may I enjoy my life and practice my art, respected by all humanity and in all times; but if I swerve from it or violate it, may the reverse be my life.
DBHDD Ethical Standards • http://sos.georgia.gov/elections/georgia%20code%20of%20ethics.htm
Background to TSUS • Jenner vaccinated boy, exposed him to smallpox • 1840s J. Marion Sims - surgical experiments on enslaved women and infants without anesthesia • 1874 MD opened skull of woman with tumor and stimulated cortex with electricity until she died • 1896 LPs done on children at Children’s Hospital in Boston without parental consent to see if LP harmful • 1900 US Army infected prisoners with bubonic plague • Many other examples of deliberate infections with syphilis, tuberculosis, cholera, . . . • Informed consent not well developed until 1960s
Yellow fever Walter Reed, MD 1851-1902 Jesse Lazear, MD PhD 1866-1900
“To know syphilis is to know medicine”Sir William Osler 1849-1919
Early Treatments for Syphilis Julius Wagner-Jauregg, MD 1857-1940 Paul Ehrlich, MD 1854-1915
Syphilis - 1930 • Widespread • Leading cause of admission to mental hospitals • Treatment dangerous, unclear if favorable risk/benefit ratio in later stages • Mercury, arsenicals, bismuth, malaria • Previous study of course of syphilis in whites • Study needed to compare outcomes in treated vs. untreated syphilis
Tuskegee Study of Untreated Syphilis • 1932-1972 US PHS • 600 subjects • 399 with syphilis, 201 controls • To determine course of untreated syphilis in African American men • Julius Rosenwald Fund
Penicillin and Syphilis • Penicillin available 1943 • Treatment of venereal diseases mandatory in Alabama • Henderson Act of 1943 required treatment of venereal diseases • Subjects received notices from draft boards ordering treatment
Nuremberg Code (1947) • Voluntary consent of competent individual • Benefits society, not obtainable by other means • Sufficient scientific basis to justify experiment • Avoids unnecessary suffering and injury • Avoid disabling injury or death unless MDs are subjects • Degree of risk proportional to societal benefit • Facilities and preparations to protect subjects • Conducted by qualified investigators • Subject can terminate participation • Investigator should terminate if unsafe to participant
World Medical Association Declaration of Helsinki • 1964, most recently clarified 2004 • Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care. • Questions use of placebos
Tuskegee Study 1968 Peter Buxtun voices concerns 1969 CDC, AMA, NMA reaffirm support for TSUS 1972 Buxtun approaches AP, expose published 1973 HEW Report critical of Study
Ethical Problems with TSUS • Failure to inform subjects of nature of study and their illness • Deception regarding LP “treatment” • Failure to inform subjects of penicillin • Failure to offer penicillin • Failure to inform partners of risks • Was failure to offer Rx at outset unethical?
Retrospective Ethical Assessments • Some things are always right • Categorical imperative • Deceiving patients for Study purposes • Some things are right or wrong only in a culturally relative sense • Informed consent • AMA 1847 unethical telling patients bad news
Was Tuskegee An Isolated Incident? • 1946-48 Guatemala syphilis study • 1956-70 Hepatitis and Willowbrook State School • 1961 Milgram Yale study • 1963 Cancer and Jewish Hospital for Chronic Diseases • 1960-72 Cincinnati radiation exposure experiments • 1971 Zimbardo Stanford prisoner experiments • 1993-95 Johns Hopkins lead study • 2011 Las Vegas MD indicted for infusing stem cells
