Ethics Principles Respect for Autonomy Nonmaleficence Beneficence Justice

Ethics Principles • • Respect for Autonomy Nonmaleficence Beneficence Justice

Miscellaneous Ethics Terms • Veracity – honesty, truth-telling • Privacy – a basic right (see HIPAA) • Confidentiality – protecting information you disclose • Fidelity – keeping promises/ agreements, maintaining relationships

Ethics vs. Morals • Ethics – the study of moral beliefs and behavior – branch of philosophy concerned with the nature of morals and moral evaluation (what is right and wrong, virtuous or vicious, and beneficial or harmful (to others)) – We “study” ethics • Morals – What one considers “right” and “wrong” for self – We “have” moral beliefs • Sometimes used interchangeably! http: //www. onlineethics. org/glossary. html

Ethics vs. Morals • Morality - refers to the first-order beliefs and practices about good and evil by means of which we guide our behavior. • Ethics - The explicit, philosophical reflection on moral beliefs and practices. The difference between ethics and morality is similar to the difference between musicology and music. Ethics is a conscious stepping back and reflecting on morality, just as musicology is a conscious reflection on music. http: //ethics. acusd. edu/Glossary. html

Morality • Developed by “social consensus” • We are taught moral norms as we grow up – Don’t lie, steal, or cheat… – Often religion-based • “general” vs. “professional” morality – Be “of good moral character”! • “universal” vs. “community-specific”

Moral Dilemmas • Conflict between moral requirement and self-interest – e. g. Andrew Fastow, ENRON CFO • Confidentiality vs. protection of life – Therapist whose patient makes a threat • Larger Examples: – Bombing of Hiroshima, Invasion of Iraq

Respect for Autonomy • Autonomy = “self-rule” or “selfgovernance” • Freedom from controlling influence • Freedom from inadequate understanding • Lack of autonomy: – Prisoners, mentally incapable, children…

Respect for Autonomy • patient autonomy refers to the capability and right of patients to control the course of their own medical treatment and participate in the treatment decision-making process.

Respect for Autonomy • Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits assault, for which he is liable in damages • [Schloendorff vs. Society of New York Hospital, 105 N. W. 92 (1914)].

Limitations of Autonomy • Competence – Psychologically or legally capable of decision-making – Determined by health professionals and the courts – A relative term that may vary over time

Nonmaleficence • Primum non nocere – Above all [or first] do no harm. • Often considered to be a corollary to the principle of beneficence. • Sometimes interpreted as “do no evil” • Harm is sometimes necessary for greater benefit • The principle of “double-effect” allows harm to achieve greater benefit.

Nonmaleficence • Treatment vs. nontreatment – Withholding (not starting) or withdrawing (stopping) life-sustaining treatment – Extraordinary (or heroic) and ordinary treatment – Artificial feeding and life-sustaining medical technologies – Intended effects vs. foreseen effects

Beneficence • the “first principle” of morality is the dictum “do good and avoid evil” • not a specific moral rule • cannot by itself tell us what concrete actions constitute doing good and avoiding evil

Combined • Nonmaleficence – One ought not to inflict evil or harm • Beneficence – One ought to prevent evil or harm – One ought to remove evil or harm – One ought to do or promote good

Justice • refers to what is owed or due to the individual members of society. • varies according to philosophical and methodological presuppositions from which one approaches the issue.

Specification • The process of making abstract principles specific to a situation • Ethical principles do not by themselves guide specific action • They only make sense when applied to a specific set of circumstances • The possibilities are infinite!

Diversity and Disagreement • People have different moral reasoning • Not always easy to see own “blind spots” • Religious-based differences in medical ethics • There is usually no single solution to a moral problem

Moral Character • Virtues – Socially approved set of traits – Empathy, the “Golden Rule” • Difficult to “learn” as an adult • William Bennett “Book of Virtues” • More apparent in stable and prosperous societies

Biomedical Research • • • Managing potential harm to patients Nuremberg Code Declaration of Helsinki Belmont Report Institutional Review Boards

Nuremberg Code • Directives for Human Experimentation - 1949 • Established after war crimes trials of the Nazis • The voluntary consent of the human subject is absolutely essential • The experiment should be such as to yield fruitful results for the good of society • The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

Nuremberg Code • The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. • No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. • The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

Nuremberg Code • Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death • The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

Nuremberg Code • During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. • During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Nuremberg Code • Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181 -182. . Washington, D. C. : U. S. Government Printing Office, 1949. • Link to full document

Declaration of Helsinki WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects • Adopted in 1964 • Last updated in 2000 • Link to full document

Belmont Report • In 1975, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the first national commission on bioethics, outlined three basic ethical principles to be used in research involving human subjects • Link to Full Report

Belmont Report • • (1) Respect for persons; (2) Beneficence; and (3) Justice. Application of these general principles to the conduct of research leads to requirements of informed consent, burden/benefit assessment, and the equitable selection of research subjects. • The Belmont Report became the basis for Institutional Review Boards (IRBs).

Institutional Review Boards • An interdisciplinary institutional committee responsible for reviewing proposed and ongoing research projects to ensure that they are ethically sound adhere to federal regulations regarding research experiments involving human subjects

Institutional Review Boards • Seven criteria that need to be satisfied in order for an IRB to approve a research proposal: • 1) risks to subjects must be minimized; • 2) risks to subjects must be reasonable in relation to anticipated benefits; • 3) selection of subjects must be equitable; – See checklist for research proposals

Institutional Review Boards • 4) enough information must be disclosed in order for participants to be able to give informed consent; • 5) informed consent must be documented; • 6) the research proposal must include provisions for monitoring safety of the participants; • 7) privacy and confidentiality of participant information must be maintained appropriately.

Informed Consent • Elements of Informed Consent: – – – Competence Disclosure Understanding Voluntariness Consent

Medical Ethics Controversies • • Medically administered nutrition and hydration Artificial ventilation Abortion/stem cell research Assisted suicide/euthanasia Rule of double effect Rationing of healthcare Emergency contraception … and many, many more!

Tampering, Adulterating, and Misbranding Drugs Robert R. Courtney, 49, of Kansas City, Missouri, and his corporation, Courtney Pharmacy Inc. , pleaded guilty on February 26 to 20 felony criminal charges related to the incorrect preparation and dispensing of cancer drugs. Courtney and his corporation have admitted to the following crimes: On eight occasions between May 17 and June 19, 2001, he committed "consumer product tampering" by preparing i. v. solutions that did not contain the amount of paclitaxel or gemcitabine ordered by the treating physician. This tampering resulted in serious bodily injury and involved a substantial risk of death to the affected patients. On six occasions—three times each on August 7 and 13, 2001—he committed "adulteration of a drug" by preparing i. v. solutions that did not contain the amount of paclitaxel or gemcitabine ordered by the treating physician. He did this knowing that the drug solutions’ strength and potency were less than that represented on the labels.

Tampering, Adulterating, and Misbranding Drugs On six occasions—three times each on August 7 and 13, 2001—he committed "misbranding of a drug" by labeling containers of paclitaxel or gemcitabine to misrepresent the actual strength and potency of the drug in the corresponding i. v. solution. Through his plea agreement, Courtney has admitted that he also diluted and tampered with paclitaxel and gemcitabine solutions administered to 26 additional patients, for a total of 34 persons. He also admitted that he diluted and tampered with cisplatin and carboplatin on an unspecified number of occasions. In addition, he admitted that he conspired to traffic in stolen drugs and that, by tampering and diluting drugs but not informing the treating physician, he caused that physician to file false Medicare claims. An ongoing investigation into the Courtney case has resulted in at least four other people confessing to dealing in stolen prescription drug products.

Tampering, Adulterating, and Misbranding Drugs Two of those cases involved retired pharmaceutical salesmen who admitted to buying stolen drugs from a man who worked in the pharmacy storeroom of the University of Colorado Hospital in Denver. The former hospital worker confessed in April to stealing drugs from the facility and selling them. The investigation also netted a Kansas City pharmacist who, through a plea agreement, surrendered his pharmacy license to state authorities in Kansas and Missouri. Gary S. Ravis, 58, pleaded guilty to knowingly buying stolen drugs from one of the salesmen. Ravis was sentenced in April to five years of probation, 2500 hours of community service, and a $250, 000 fine. He must spend the first six months of his probation under electronic monitoring in his home. Source: Office of the United States Attorney for the Western District of Missouri.