Casebook on Ethical Issues in International Health Research Editors: Richard Cash Daniel Wikler Abha Saxena Alexander Capron Casebook on Ethical Issues in International Health Research Editors: Richard Cash Daniel Wikler Abha Saxena Alexander Capron Associate editor: Reva Gutnick Editorial guidance provided by Astrid Stuckelberger and Philippe Chastonay, University of Geneva WHO Library Cataloguing-in-Publication Data Casebook on ethical issues in international health research / edited by Richard Cash … [et al]. 1.Ethics, Research. 2.Research - standards. 3.Health services research. 4.Research design. 5.Case reports. I.Cash, Richard. II.Wikler, Daniel. III.Saxena, Abha. IV.Capron, Alexander M. V.World Health Organization. ISBN 978 92 4 154772 7 (NLM classification: W 20.5) © World Health Organization 2009 All rights reserved. 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Using this casebook This casebook has been developed as a teaching tool for instructors and workshop leaders rather than as a textbook for students or workshop participants. There is no need for participants to have copies of the casebook: facilitators can provide participants with individual case studies and chapter introductions relevant to the research ethics topic being addressed. Individual case studies and chapter introductions relevant to the research ethics topic being addressed can be photocopied from the print version or downloaded from the WHO web site without additional permission from WHO, unless the planned use is in conjunc- tion with commercial purposes. Please ensure that the WHO source is appropriately acknowledged. If you plan to publish, adapt or translate the materials, please contact WHO directly at the following email: [email protected] ❚ © Copyright World Health Organization 2009 CASEBOOK ON ETHICAL ISSUES IN INTERNATIONAL HEALTH RESEARCH Table of contents Acknowledgements ............................................................................................................. 8 Foreword ................................................................................................................................ 9 The editors ............................................................................................................................10 Introduction .........................................................................................................................11 Teaching Guide ....................................................................................................................15 The Case Studies ..................................................................................................................35 Chapter I Defining “Research” .............................................................................................................37 Introduction : When must an ethics committee’s approval be sought? Case 1. SARS and airplane passengers ...................................................................................................................... 42 Case 2. Evaluating sexual health and family planning programmes .............................................................. 43 Case 3. A treatment for central nervous system conditions .............................................................................. 44 Case 4. Documenting the health conditions of an indigenous community................................................ 45 Chapter II Issues in Study Design ........................................................................................................47 Introduction : Designing scientifically (and ethically) sound studies Case 5. Referral of severely ill children to hospital ................................................................................................ 55 Case 6. Negotiating safe sex practices ....................................................................................................................... 56 Case 7. Investigating treatment recommendations ............................................................................................. 57 Case 8. Testing a new HBV vaccine ............................................................................................................................. 58 Case 9. Tuberculosis prevention in HIV-positive people ..................................................................................... 59 Case 10. Developing a vaccine for malaria............................................................................................................... 60 Case 11. Should race be listed as a risk factor? ....................................................................................................... 62 Case 12. Short-course AZT to prevent mother-to-child transmission of HIV .............................................. 63 Case 13. Testing an ayurvedic medicine for malaria ............................................................................................. 65 Case 14. Evaluating the use of traditional medicines for diarrhoea ............................................................... 67 Case 15. Twin registry genetics .................................................................................................................................... 68 Table of contents ❚ CASEBOOK ON ETHICAL ISSUES IN INTERNATIONAL HEALTH RESEARCH Case 16. Observing newborn care practices ........................................................................................................... 69 Case 17. Compassionate intervention during an observational study .......................................................... 70 See also: Case 3. A treatment for central nervous system conditions Case 21. Pregnancy in health research Case 27. Micronutrient supplementation for pregnant women Case 42. Determining who constitutes the community Case 43. Evaluation research on a disability rehabilitation programme Chapter III Harm and Benefit.................................................................................................................71 Introduction : Are research benefits and harms fairly distributed? Case 18. Rotavirus vaccine ............................................................................................................................................. 76 Case 19. Pneumonia vaccine trial ................................................................................................................................ 78 Case 20. Early termination of a trial ............................................................................................................................ 79 Case 21. Pregnancy in health research ...................................................................................................................... 80 Case 22. Acting in the face of conflicting evidence .............................................................................................. 81 See also: Case 7. Investigating treatment recommendations Case 10. Developing a vaccine for malaria Case 11. Should race be listed as a risk factor? Case 13. Testing an ayurvedic medicine for malaria Case 28. Breastfeeding and mother-to-child HIV transmission Case 38. Mental health problems of survivors of mass violence Chapter IV Voluntary Informed Consent .............................................................................................83 Introduction : Is consent to research voluntary, knowing, and competent? Case 23. Testing high doses of vitamin A on children .......................................................................................... 92 Case 24. Breast cancer in South Asia .......................................................................................................................... 93 Case 25. Testing a microbicide ....................................................................................................................................