This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this site. Copyright 2009, The Johns Hopkins University, Nancy Kass, Holly Taylor, Anant Bhan, and Joe Ali. All rights reserved. Use of these materials permitted only in accordance with license rights granted. Materials provided “AS IS”; no representations or warranties provided. User assumes all responsibility for use, and all liability related thereto, and must independently review all materials for accuracy and efficacy. May contain materials owned by others. User is responsible for obtaining permissions for use from third parties as needed. Welcome and Introduction to the Course Nancy Kass, Holly Taylor, Anant Bhan, and Joe Ali Introduction Faculty Course objectives Course logistics - Review syllabus - Review assignments 3 Faculty Nancy Kass, ScD - Phoebe R. Berman Professor of Bioethics and Public Health, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health - Deputy Director for Public Health, Johns Hopkins Berman Institute of Bioethics Fields of interest - U.S. and international research ethics, public health ethics, HIV/AIDS policy, informed consent, preparedness/ethics 4 Faculty Holly Taylor, PhD, MPH - Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health - Core Faculty, Johns Hopkins Berman Institute of Bioethics Field of interest - Local implementation of federal regulations regarding the conduct of human subject research 5 Faculty Anant Bhan, MBBS, MHSc - Independent Researcher, Bioethics and Public Health, Pune, India - Bioethicist, Ethical, Social and Cultural Program for Grand Challenges in Global Health Initiative Fields of interest - Bioethics, especially research ethics, public health ethics, and ethics of biotechnology - Public/global health 6 Faculty Support Joe Ali, JD - Senior Administrative Coordinator, Johns Hopkins Berman Institute of Bioethics Fields of interest - Health law, international research ethics, moral philosophy, philosophy of medicine 7 Students Please go to the course Electronic Bulletin Board and introduce yourself to us and your fellow students 8 Course Objectives Recognize the relevant ethical principles related to the conduct of human subject research Understand and apply ethics framework to moral problems encountered in research with human subjects Explore commonly encountered research ethics challenges and consider options for resolving them Recognize and use applicable U.S. and Indian rules and regulations related to human subject research, including ethics committee requirements 9 Course Overview History of research ethics - U.S. - South Asia Introduction to ethical principles Framework for ethical analysis - Introduction - Application 10 Course Overview Ethics committees Informed consent Study design Risk/benefit assessment 11 Course Overview Honesty/integrity in science - Falsification - Authorship - Conflicts of interest Privacy and confidentiality Justice - Subject selection - Resource allocation 12 Course Logistics Review schedule - Knowledge assessment - Lectures 13 Course Logistics Review schedule - Knowledge assessment - Lectures - Case discussions Active participation 14 Course Logistics Review schedule - Knowledge assessment - Lectures - Case discussions Active participation - Assignments Homework Knowledge assessments 15 Course Logistics Review schedule - Knowledge assessment - Lectures - Case discussions Active participation - Assignments Homework Knowledge assessments Readings - Available online 16 Questions? Technology Course administration 17 Questions? Technology Course administration Course content 18 Thank You Thank you for your participation in this course