This book addresses the pressing issues involved with the ethical conduct of research in one developing world region - the Arab Region. Clinical research has soared in the developing world -as pharmaceutical companies continue their search for regions with large, treatment naive populations - including the Arab region, and has profound implications for the health and the economies for the area. The ethical issues involved with the conduct of such research, however, have so far not been adequately addressed. This volume presents the issues regarding research ethics and research governance that have relevance for health authorities, regulators, industry, and academia. As a multi-authored volume it includes both international and local experts on ethical issues in research, representing all stakeholders, thus presenting a balanced view on this timely topic.

Henry Silverman, MD, MA, is Professor of Medicine at the University of Maryland, School of Medicine. He divides his time between caring for patients in the intensive care units, teaching medical ethics to students, residents and faculty, chairing the hospital's ethics committee, directing a training program in research ethics focused in the Middle East, and performing qualitative and quantitative research in research ethics. Dr. Silverman majored in biomedical engineering at Rensselaer Polytechnic Institute, where he received his B.S. and M.S. degrees in 1974. He then studied medicine at The Johns Hopkins University (MD 1974) followed by a residency in internal medicine and a pulmonary and critical fellowship at The Johns Hopkins Hospital (1983). He then became a faculty member at the University of Maryland, School of Medicine. He received his MA Degree in Bioethics from Georgetown University in 1995. His teaching efforts have been recognized by several teaching awards, including the Senior Resident's Award for Teaching (1988),the Senior Medical Student's Award for Humanism in Medicine (2001), and the Master of Public Health Program Teaching and Mentoring Award (2013).

Autorentext

Henry Silverman, MD, MA, is Professor of Medicine at the University of Maryland, School of Medicine. He divides his time between caring for patients in the intensive care units, teaching medical ethics to students, residents and faculty, chairing the hospital's ethics committee, directing a training program in research ethics focused in the Middle East, and performing qualitative and quantitative research in research ethics. Dr. Silverman majored in biomedical engineering at Rensselaer Polytechnic Institute, where he received his B.S. and M.S. degrees in 1974. He then studied medicine at The Johns Hopkins University (MD 1974) followed by a residency in internal medicine and a pulmonary and critical fellowship at The Johns Hopkins Hospital (1983). He then became a faculty member at the University of Maryland, School of Medicine. He received his MA Degree in Bioethics from Georgetown University in 1995. His teaching efforts have been recognized by several teaching awards, including the Senior Resident's Award for Teaching (1988),the Senior Medical Student's Award for Humanism in Medicine (2001), and the Master of Public Health Program Teaching and Mentoring Award (2013).

Inhalt

Introduction to ethical issues in research in the Middle East; Henry Silverman, Thalia Arawi.- A Review of International Guidelines: Controversial Issues; Henry Silverman.- National Guidelines in the Middle East; Ghiath Alahmad.- Bioethicist Islamic Bioethics; Thalia Arawi.- Globalization and Research Ethics Systems in the Middle East Hillary Edwards Current state of research ethics capacity in the Middle East and Current Gaps; Henry Silverman.- The Regulatory Framework and Capacity Case Studies from Jordan, Egypt, Saudi Arabia, Morocco, etc; Vladimir Misik.- Quintiles Issues in research from perspectives of Health Authorities: Experience from Jordan, Dubai, Egypt, Saudi Arabia, Qatar TBD Building Clinical Trial Site Capabilities; Samer El-Kamary and Nadia Zaki.- Recruitment of Participants/Therapeutic Misconception TBD Issues in Informed Consent; Noha Asem and Tamer Hifnawy.- Gender Issues/Cultural Issues; Amal Matar/Thalia Arawi.- Genetic Issues and Biobanks; Ghiath Alahmad.- Research Involving Children; Jihad Makhou.- Refugee Research; Rema Afifi.- Community Participatory Research TBD Health Services Research; Sherine Shawky.- (AUC) Observational Studies TBD International Issues: Avoiding Exploitation Henry Silverman Good Clinical Practice; Tamer Hifnawy.- Responsible Conduct in Research; Thalia Arwai.- Challenges to operations of RECs; Hany Sleem.- Building REC networks; Azza Salah.- Enhancing Patients' Rights Thalia Arawi Assessment of RECs; Henry Silverman.- Perspectives of Investigators towards Research Ethics (summary of current research); Noha Asem.- Teaching Research Ethics; Henk ten Have.