National Bioethics Committee Guidelines and Teachers Handbook for Introducing Bioethics to Medical and Dental Students Developed by: Healthcare Ethics Committee (HCEC) of the National Bioethics Committee (NBC) http://nbcpakistan.org.pk/ Contents 1. Foreword i 2. HCEC Members ii 3. Introduction 1 4. Competencies, Objectives, Teaching and Assessment 4 5. Course Topics 7 6. Course Specifications 8 7. Introduction to Bioethics 17 8. Clinical Ethics 69 9. Medical Error 190 10. Using Patients for Education and Training 216 11. Organ Transplantations Ethics 233 12. Ethics of Physician-Pharmaceutical Industry Interactions 275 13. Human Subject Research Ethics 297 14. Public Health Ethics 304 15. Plagiarism and Scientific Misconduct 314 16. Ethics of Mental Healthcare 334 Foreword April 29, 2017 The primary responsibility of the Health Care Ethics Committee (HCEC) of the National Bioethics Committee (NBC) Pakistan, is to develop and utilize strategies to enhance bioethics capacity in Pakistan. To accomplish this, HCEC organizes and runs bioethics workshops for professionals involved in biomedical research and healthcare delivery systemsand members of Regional and Provincial Bioethics Committees. Recognizing that HCEC should also assist in ways to introduce bioethics to undergraduate medical and dental students and little progress has been made in this equally important area, led to the development of this document. In its first Code of Ethics for healthcare professionals, formulated in 2002, the Pakistan Medical and Dental Council (PMDC) stated that medical and dental colleges, College of Physicians and Surgeons, and universities running postgraduate medical courses “are advised to incorporate medical ethics in their curriculum.” In reality, currently only a handful of medical and dental colleges include any bioethics education as part of their curriculum for students. It is within this background, to address this deficiency, that HCEC worked to develop this comprehensive document, “Guidelines and Teachers Handbook for Introducing Bioethics to Medical and Dental Students.” It is meant to assist universities and colleges in developing their own bioethics curriculum and it also provides useful tools for teachers involved in teaching this discipline. All articles/chapters included in this document are either from the Creative Commons (non-copyright material), or with permission obtained from relevant publishers for full reproduction. Sources are linked for easy accessibility. As and when necessary, HCEC will review and update this document in the future. The process of developing this document extended from February 2013 to August 2014. It included multiple meetings of HCEC, and presentation and discussion of drafts with NBC members for their input. NBC provided its final approval in March 2015. Bringing this document to fruition would not have been possible without the unstinting hard work and long hours spent by HCEC members and other professionals with relevant expertise who were co-opted for this process. A list of these colleagues and their backgrounds, and to whom I remain immensely grateful, appears on the next page. On April 25, 2017, the complete document was presented and discussed in a special meeting in Islamabad called by Mr. Muhammad Ayub Sheikh, Secretary, Ministry of National Health Services, Regulations and Coordination. Besides HCEC members and the Secretary, other relevant participants in the meeting included representatives from PMDC, HEC, and CPSP. The document was appreciated for its relevance and importance, and PMDC was asked to endorse and notify it as a resourse document for all medical and dental collages in Pakistan. The PMDC representive, Dr. Abid Farooqui (Vice President PMDC), promised that this will be done. We appreciate the help of Dr. Waquaruddin Ahmad and Mr. Roshan Kumar from Pakistan Health Research Council (PHRC), Sindh, Pakistan. Our thanks especially to the staff of the Centre of Biomedical Ethics and Culture (CBEC), SIUT - Michelle Fernandes, Aamir Shehzad and Loretta Iqbal - for their time and meticulous help in formulating the document in its final form. Dr. Farhat Moazam MD, PhD Chair, HCEC Professor and Chairperson Center of Biomedical Ethics and Culture, SIUT Karachi, Pakistan i HCEC Members 1. Farhat Moazam MD, FACS, PhD Professor & Chairperson Centre of Biomedical and Culture (CBEC), SIUT Karachi, Pakistan 2. Aasim Ahmad FCPS, MHSc (Bioethics) Professor, Dean & Chief Nephrologist The Kidney Centre Karachi, Pakistan 3. Aamir Jafarey FCPS, FRCS, MBE (Bioethics) Professor Centre of Biomedical and Culture (CBEC), SIUT Karachi, Pakistan 4. Farid Khan PhD Country Manager and Managing Director Pfizer Pakistan and Wyeth Pakistan Karachi, Pakistan 5. Shaukat Ali Jawaid BCom Chief Editor Pulse International Karachi, Pakistan 6. Haroon Ahmed MD, FCPS, FRCPS, DPM Director and Professor of Psychiatry Psycho Social Centre Karachi, Pakistan Co-opted Members: 7. Abdul Ghani PGD (Bioethics) Research and Training Officer Institute of Public Health Quetta, Pakistan 8. Asma Humayun MRCPsych, MMedSci Consultant Psychiatrist Meditrina Healthcare Rawalpindi, Pakistan 9. Saima Pervaiz Iqbal FCPS, MBE (Bioethics) Associate Professor and Section Head Community Health and Family Medicine Shifa College of Medicine Islamabad, Pakistan Acknowledgement: 10. Shahid Shamim FCPS, FRCS, PGD (Bioethics), MHPE Associate Professor Surgery & Head of Medical Education Unit King Abdulaziz University Jeddah, Saudi Arabia ii Introduction The Pakistan Medical and Dental Council (PMDC) formulated its first Code of Ethics in 2002 which stipulated that biomedical ethics should be taught in all medical/dental colleges in the country. This Code was updated in June 2011 and reissued as the “Code of Ethics of Practice for Medical and Dental Practitioners, Regulations 2011”. 1 (PMDC Code of Ethics) The Code advises that medical ethics should be incorporated in the curriculum of all medical and dental colleges, the College of Physicians and Surgeons of Pakistan as well as by Universities running postgraduate medical courses, and calls for “strategies” for the dissemination of information about ethics. Despite this, no formal steps have been taken in this direction, nor is guidance available at a national level for institutions who may wish to undertake teaching of bioethics. Only a handful of colleges and universities in the private and public sector currently include sessions on ethics to varying degrees as part of their undergraduate medical and dental teachings. The concept of professional codes of conduct for healthcare professionals is not a new phenomenon and can be traced back to the era of Hammurabi (3000 BCE). A better known text is the Hippocratic Oath (500 BCE) which still forms the basis for many oaths taken by students upon graduation from medical colleges today. Examples of professional codes are also found in major religious traditions such as Al- Ruhawi’s Adab at Tabib (900 BCE) in Islam and by Moses Maimonides (1200 BCE) in Judaism. These earlier codes, written exclusively by physicians for physicians, focused on the character and duties of professionals and emphasized the principle of beneficence in which the physician decides what lies in the best interest of the patient. These traditional codes, still important today in their emphasis on the virtues required for a good healthcare professional, were formulated during times when medical knowledge was relatively limited and physicians had little to offer in the way of diagnosis and therapy to their patients. The twentieth century saw an explosion in the advancement of medical science, biotechnology, and complex human subject research which changed the face of medical practice and research giving rise to novel ethical dilemmas. Examples included the advent of ventilators allowing irrevocably comatose patients to be kept “alive” for weeks, the capability of transplanting organs from one individual to another, and breakthroughs in genetic and reproductive science. Together with this, the nature of medical practice changed from a relationship between a healthcare giver and his/her patient to a health industry consisting of depersonalized hospitals often run on profit basis and several specialists involved in the care of one patient. Modern medicine led to complex ethical dilemmas that required new solutions, and for which traditional codes alone became inadequate. Contemporary (modern) bioethics emerged in the USA in the 1960s in response to the changing nature of physician-patient interactions, healthcare delivery systems, and the increasing complexity of human subject research. It was driven by several scandalous cases in which patients and research subjects had been exploited by physicians and researchers withholding or providing inadequate information to them. The defining characteristic of bioethics involved a shift from exclusive reliance on medical “facts,” and knowledge and authority of physicians (doctor centered) to recognition that patients have intrinsic rights as equal partners in decisions about therapy and what constitutes their best interest (patient centered). The requirement for providing full information and voluntary consent of subjects also became the key element for ethical research. 1 PMDC Code of Ethics: http://www.pmdc.org.pk/LinkClick.aspx?fileticket=v5WmQYMvhz4%3D&tabid=102&mid=554. 1 Unlike the exclusively physician generated traditional codes of ethics, bioethics is a multidisciplinary field. It incorporates input from non-medical sciences such