The Salim El-Hoss Bioethics and Professionalism Program at the

American University of Beirut, Faculty of Medicine and Dasman Diabetes Institute

In collaboration with the Nuffield Council on Bioethics-UK and in joint sponsorship with Cleveland Clinic

presents its 6th regional conference

Research in Developing Countries

Sunday May 25 – Monday May 26, 2014 The Arab Organizations Headquarters Building, Kuwait

(Headquarters of The Arab Fund for Economic and Social Development)

GENERAL INFORMATION Program Overview

This activity is the 6th Regional Conference held by the Salim El-Hoss Bioethics and Professionalism Program at the American University of Beirut Faculty of Medicine. It aims at bringing together all those concerned (including physicians, researchers, scientists, those concerned with the ethical review of research, policymakers, and research promoters/funders) to explore how ethical research can be promoted in developing countries.

Objectives As a result of attending this course, the participant will be able to:

Examine how research priorities are set – and how high priority research can be encouraged

Recognize the role of pharmaceutical companies

Discuss the ‘exporting’ of research from developed to developing countries

Discuss post-trial access to medicines

Describe how the views of research participants can be better heard

Plan support for the ethical review of research

Establish Institutional Review Board’s responsibilities of researchers (clinicians and scientists)

Formulate ethical reflection into scientific practice

Establish the Arab Network for Research Ethics

Target Audience This annual scientific meeting has been designed for physicians, researchers, scientists, those concerned with the ethical review of research, policymakers, and research promoters/funders.

Accreditation This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of The Cleveland Clinic Foundation Center for Continuing Education and American University of Beirut Medical Center. The Cleveland Clinic Foundation Center for Continuing Education is accredited by the ACCME to provide continuing medical education for physicians. The Cleveland Clinic Foundation Center for Continuing Education designates this live

activity for a maximum of 9.75 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Participants claiming CME credit from this activity may submit the credit hours to the American Osteopathic Association for Category 2 credit.

Evaluation Form and CME Certificate The evaluation and CME certificates are available online. In order to receive AMA PRA Category 1 Credits™, please go to www.ccfcme.org/myCME to complete the course evaluation and to print your CME certificate. Once you enter the site, please enter 021488. The above code is active for 30 days following the symposium. User Instructions: If you are a first-time user of “MyCME,” you will need to create a six-digit password comprised of any combination of letters and/or numbers. This will become your permanent log in for future Cleveland Clinic “MyCME” programs. 1. Log in to www.ccfcme.org/myCME 2. Click on “New User?” located under the login box 3. Complete all the fields in the form and click on “Create Account” 4. Click on “Click Here To Login” 5. Login using the information you just provided in the registration form 6. In the “Regularly Scheduled Series” box, enter the code “021488” 7. Complete all the fields and hit “submit” 8. Your official CME certificate will appear. Please print and keep with your permanent files. Please note: Be sure to print your CME certificate and keep for your files. This is your permanent record; no other certificate will be generated.

Kuwait Institute for Medical Specialization Statement The Research in Developing Countries course also complies with the Kuwait Institute for Medical Specialization Continuing Medical Education guidelines and has been assigned 8 Category 1 CME credits

Faculty Disclosure In accordance with the Standards for Commercial Support issued by the Accreditation Council for Continuing Medical Education (ACCME), The Cleveland Clinic Foundation Center for Continuing Education requires resolution of all faculty conflicts of interest to ensure CME activities are free of commercial bias. The following faculty have indicated they have no relationship which, in the context of their presentation(s), could be perceived as a potential conflict of interest: Naji Abi-Hashem George Abi Saad Waleed Al Faisal Thalia Arawi

Howard Brody Ayman El-Menyar Hamid Hussain Brigitte Khoury Jihad Makhoul Abla Mehio Sibai Hany Sleem Hugh Whittall Katharine Wright

Disclaimer The information in this educational activity is provided for general medical education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient's medical condition. The viewpoints expressed in this CME activity are those of the authors/faculty. They do not represent an endorsement by The Cleveland Clinic Foundation. In no event will The Cleveland Clinic Foundation be liable for any decision made or action taken in reliance upon the information provided through this CME activity.

Copyright 2014 The Cleveland Clinic Foundation. All Rights Reserved.

Activity Directors: Thalia Arawi, PhD Founding Director, Salim El-Hoss Bioethics & Professionalism Program Clinical Bioethicist Vice Chair, Medical Center Ethics Committee American University of Beirut Faculty of Medicine Beirut, Lebanon George Abi Saad, MD Director Continuing Medical Education Office Associate Professor of Clinical Surgery American University of Beirut Beirut, Lebanon

Faculty

Naji Abi-Hashem, PhD Clinical and Cultural Psychologist Independent Scholar Beirut, Lebanon/ Seattle-Washington, USA Waleed Al Faisal, MD Professor Community Medicine Dubai Health Authority Dubai, UAE Howard Brody, MD, PhD Director, Institute for the Medical Humanities Professor, Family Medicine John P. McGovern Centennial Chair University of Texas, Medical Branch Galveston, Texas, USA Ayman El-Menyar, MD Associate Professor Surgery Weill Cornell Medical College Qatar, Qatar Hamid Hussain, MD Professor Community Medicine Dubai Health Authority Dubai, UAE Brigitte Khoury, PhD Associate Professor, Adult Clinical Psychology Department of Psychiatry American University of Beirut Medical Center Director, Arab Regional Center for Research, Training and Policy Making in mental health Beirut, Lebanon Jihad Makhoul, DrPh Professor, Chair Department of Health Promotion and Community Health WHO Collaborating Center for Health Promotion and the Behavioral Sciences American University of Beirut Beirut, Lebanon

Abla Mehio Sibai, PhD Professor Department of Epidemiology and Population Health Faculty of Health Sciences American University of Beirut Beirut, Lebanon Hany Sleem, MD Chair Institutional Review Board of Medical Research Egyptian Society of Healthcare Development Cairo, Egypt Hugh Whittall Director Nuffield Council on Bioethics London, United Kingdom Katharine Wright Assistant Director Nuffield Council on Bioethics London, United Kingdom

Distinguished Guests Abdulatif Al-Hamad Director General / Chairman The Arab Fund for Economic and Social Development Kuwait

Kazem Behbehani, PhD, FRCPath Director General, Dasman Diabetes Institute Dasman, Kuwait

HE Dr. Salim El-Hoss Former Prime Minister Beirut, Lebanon

Featured International Speakers:

Howard Brody received his MD Degree from the College of Human Medicine, Michigan State University in 1976, and his PhD in Philosophy, also from Michigan State University, in 1977. He completed his residency in family practice at the University of Virginia Medical Center, Charlottesville. Currently he is Director of the Institute for the Medical Humanities and John P. McGovern Centennial Chair in Family Medicine at the University of Texas Medical Branch in Galveston. He is the author of eight books, including The Future of Bioethics (Oxford University Press, 2009) and Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (Rowman and Littlefield, 2007), as well as more than 125 articles on medical ethics, family medicine, and philosophy of medicine. In 1995, he was elected to the Institute of Medicine of the U.S. National Academy of Sciences. He received the Lifetime Achievement Award of the American

Society for Bioethics and Humanities in 2009.

Katharine Wright is Assistant Director of the Nuffield Council on Bioethics, currently leading a project on the ethical issues arising out of the involvement of children in clinical research. Her background is in health policy, law and ethics: before taking up her current post, she spent 9 years at the UK House of Commons, briefing MPs of all political parties on health issues, and then four years in the NHS, monitoring the effect of the Human Rights Act on health law in England. During this time she was also seconded to the English Department of Health to work on patient consent. Her work at the Nuffield Council has included consideration of ethical issues arising in dementia; in the donation of all forms of bodily material for treatment or research; and the sharing of information in the context of people born as a result of the donation of gametes and embryos.

Hugh Whittall studied Philosophy and Politics in the early 1980s, and has since worked in policy roles, mostly in areas where developments in health and science can give rise to social and ethical concerns. He became Director of the Nuffield Council on Bioethics in February 2007, since which time the Council has published reports on issues including public health, dementia, human bodies in treatment and research, and emerging biotechnologies. Before joining the Nuffield Council, Hugh was at the Department of Health, where he was involved with the preparation and passage of the Human Tissue Act 2004, and the setting up of the Human Tissue Authority. He was also involved in end-of-life issues and transplantation policy, having initiated the Organ Donation Task Force which reported to Ministers with recommendations on how to improve organ donation rates.

Prior to that Hugh spent three years at the European Commission in Brussels, where he was involved in the funding and promotion of bioethics research, and was for seven years Deputy Chief Executive of the Human Fertilisation and Embryology Authority, responsible for licensing, policy and communications.

PROGRAM:

Sunday May 25, 2014 08:30am – 09:00am Registration

09:00am – 09:10am Opening Words

HE Dr. Abdulatif Al-Hamad 09:10am – 09:15am Word of HE Dr. Salim El-Hoss 09:15am – 09:20am Opening Words

Dr. Kazem Behbehani

CME Sessions 09:20am – 9:30am Welcome and Introduction

Dr. Thalia Arawi

09:30am – 10:25am Research in Developing Countries: What are the Ethical Issues? Mr. Hugh Whittall

10:25am – 10:30am Questions & Answers 10:30am – 10:55am Are Western Approaches to Research, Diagnosis, and

Treatment Universal? A cross Cultural Perspective Dr. Naji Abi Hashem

10:55am – 11:00am Questions & Answers 11:00am – 11:30am Coffee Break 11:30am – 11:55am Misconducts…Facts, Figures and Approach to Minimization

Dr. Hamid Hussain 11:55pm – 12:00 pm Questions & Answers 12:00pm – 12:25pm Challenges to the Application of Research Ethics: Researchers'

Views from Lebanon and Qatar Dr. Jihad Makhoul

12:25pm – 12:30pm Questions & Answers

12:30pm – 12:55pm Mental Health Research in the Arab Region: Challenges and Opportunities Dr. Brigitte Khoury

12:55pm – 13:00pm Questions & Answers

13:00pm – 13:30pm Panel Discussion: Dr. Thalia Arawi, Mr. Hugh Whittall and Ms. Katharine Wright

13:30pm – 14:30pm Lunch

Arab Organizations Headquarter tour after lunch

The Arab Organizations Headquarters Building was completed in 1994. It blends modern architectural techniques with traditional artisan crafts and is considered one of the most acclaimed buildings in the Middle East, drawing thousands of visitors from across the globe.

Monday May 26, 2014

09:00am – 09:55am Research in Developing Countries: The Nuffield Report then and now Ms. Katharine Wright

09:55am – 10:00am Questions and Answers 10:00am – 10:55am After Trial, Poor Patients Continued Access to the Drug: A

Success Story Dr. Hany Sleem

10:55am – 11:00am Questions and Answers 11:00am – 11:30am Coffee Break 11:30am – 11:55am Ethics in Aging Research in Arab Countries: A Scoping Review

of Two Decades Dr. Abla Mehio Sibai

11:55am – 12:00pm Questions and Answers 12:00pm – 12:25pm Arab World Contribution to Biomedical Research

Dr. Waleed Al Faisal 12:25pm – 12:30pm Questions and Answers 12:30pm – 12:55pm Establishing a Clinical Research Unit and its Impact on the

New Trauma System in Qatar Dr. Ayman El-Menyar 12:55pm – 13:00pm Questions and Answers 13:00pm – 14:30pm Lunch 14:30pm – 16:00pm Arab Research Ethics Network

Dr. Thalia Arawi

Organizer

For more information about this course, please contact: Continuing Medical Education Office Salim El Hoss Bioethics & American University of Beirut Professionalism Program P.O. Box 11-236 Riad El Solh American University of Beirut Beirut 1107 2020 P.O. Box 11-236 Riad El Sol Lebanon Beirut 1107 2020 Tel: +961-1-350 000 ext 4717/8 Lebanon Fax: +961-1-744 467 Tel: +961-1-350 000 ext 4896 Email: cme@aub.edu.lb Email: ta16@aub.edu.lb Web: http://cme.aub.edu.lb Web: http://shbpp.aub.edu.lb