This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, and suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees.
1. The origin of the ethical review of medical research; 2. Medical Research Ethics Committees: protecting patients, researchers and institutions; 3. The researcher and his/her facilities; 4. The importance of informed consent; 5. Evaluating risks and benefits; 6. What kinds of procedure is it acceptable to expose research participants to, and how often?; 7. Confidentiality; 8. Clinical trials; 9. Research with healthy volunteers; 10. Are placebos ethical?; 11. Arrangements for compensation; 12. Research with children, persons with intellectual disability and other vulnerable groups; 13. Research on surplus blood and other tissue; 14. Questionnaire and interview studies; 15. Epidemiological studies; 16. Genetic research: special ethical considerations; 17. Gene therapy; 18. Research on fetuses; 19. Animal to human transplantation; 20. Post approval monitoring of research by ethics committees.