1. Ethics in Clinical Medicine View from Neurology Overview End-of-life & life-sustaining decisions Research Alan H. Lockwood, MD, FAAN Program Director, Adult Neurology

2. Straightforward Easy to understand (not full of jargon) and fairly short Ethical principles are parallel to those used in research Paperback, relatively inexpensive Not based on ACGME core competencies

3. Overview of Ethical Guidelines 1.Respect for persons 1.Avoid deception and non-disclosure 2.Maintain confidentiality 3.Keep promises (don’t make promises you can’t keep!) 2.Beneficence (act in best interest of patient) 1.Unwise decisions by patients (duty to listen, educate, persuade, compromise): patient’s informed decision prevails 2.Conflicts of interest

4. Overview --- cont 3.Allocate resources justly 4.Use ethical guidelines 1.Interpret in context of specific case 2.Exceptions may be appropriate 3.Different guidelines may conflict 5.Principles, rules 1.Principle = basis for reasoning or a guide for conduct of procedure 2.Rule = defines conduct, binding

5. Overview --- cont 5.Principles, rules, duties (cont) 2.Rules: generalizations that are narrower than principles, binding, prohibit specific behaviors, e.g., obtain informed consent prior to surgery 3.Duties: Lo avoids this term, may connote legal as well as ethical obligation (we will try to get to this with discussion of specific cases, e.g., Quinlan, Cruzan, Schiavo, Tarasoff)

6. Approach to Ethical Dilemmas Gather information What is the clinical situation? Who is the primary decision-maker? What are the views of the healthcare team and stakeholders? Clarify ethical issues What are the pertinent ethical issues and conflicts? Understand best thinking on the issues

7. Approach ---- cont Resolve the dilemmas What pragmatic issues complicate case Hold team meeting Meet with patient or family or both Deal with psychosocial issues directly Ask for help if needed

8. End-of-Life and Life-Sustaining Decisions What is your own personal experience? Have you confronted this dilemma? What are your own values that you would invoke in assisting patients and their families in making these decisions? What conflicts do you foresee that may arise with regard to your personal values and possible requests by patients or their surrogates? How would you deal with these conflicts?

9. Milestones Pure Food and Drug Act (1906) Nuremberg Code (1948) National Research Act of 1974 and Belmont Report –Respect for Persons, Beneficence, Justice Declaration of Helsinki (World Medical Assn) Common Rule (Applies to US funded studies)

10. Case Studies Tuskegee Syphilis Study (1932 – 1972). Jesse Gelsinger Case: gene therapy Hopkins Asthma: death of participant, use of chemical that was not approved drug, no IND Rochester Bronchoscopy case, death of participant from lidocaine

11. Children’s Environmental Exposure Research Study (CHEERS) “The purpose of the study is to learn about levels of pesticides and common household chemicals in homes of young children.” “Collection of accurate micro- environment and macroactivity information for children under the age of 3 years is essential to reduce the default assumptions that are currently being used for quantifying risk.”

12. Ethics in Public Health Research American Journal of Public Health Human Testing of Pesticides: Ethical and Scientific Considerations. 2004;94:1908-1916