MANUAL FOR RESEARCH ETHICS COMMITTEES

Editorial board -- Acknowledgements -- List of contributors - - Introduction / Sue Eckstein -- Pt. 1. Section I. Fundamental ethical and legal considerations -- Ch. 1. The ethics of clinical research / Calliope (Bobbie) Farsides -- Ch. 2. Research ethics committees and the law / Ian Kennedy and Phil Bates -- Ch. 3. The regulation of medical research: a historical overview / Richard H. Nicholson -- Section II. The research process -- Ch. 4. The regulation of medical research in the UK / Pamela Charnley Nickols -- Ch. 5. Observational and epidemiological research / Nick Dunn - - Ch. 6. Social survey research / Crispin Jenkinson -- Ch. 7. Approaching qualitative research / Alan Cribb -- Ch. 8. Complementary and alternative medicine: challenges for research ethics committees / Julie Stone -- Ch. 9. The ethical review of student research in the context of the governance arrangements for research ethics committees / Richard Ashcroft and Michael Parker - - Ch. 10. The ethics of genetic research / Ruth Chadwick -- Ch. 11. Research or audit? / Anthony Madden -- Ch. 12. Randomised controlled trials / Hazel Inskip and Richard W. Morris -- Ch. 13. Determining the study size / Hazel Inskip and Richard W. Morris - - Ch. 14. Risk assessment for research participants / Kenneth Calman -- Ch. 15. Absorbed radiation in patient and volunteer studies submitted to the ethical committee: a memorandum / Keith Britton and Rosemary Foley -- Ch. 16. A guide to the use of radioactive materials and radiological procedures for research purposes / Niall Moore -- Ch. 17. Indemnity in medical research / Janet Jeffs and Richard Mayon-White -- Ch. 18. The prevention and management of fraud and misconduct: the role of the LREC / Jennifer Blunt and Frank Wells -- Section III. Protecting the interests of research participants -- Section III(A). General principles -- Ch. 19. Understanding clinical trials: a model for providing information to potential participants / Philippa Easterbrook and Joan Houghton -- Ch. 20. The law relating to consent / Andrew Grubb, Rosamund Scott, Penney Lewis and Phil Bates -- Ch. 21. Writing information for potential research participants / Elizabeth Mellor, David K. Raynor and Jonathan Silcock -- Section III(B). Vulnerable participants -- Ch. 23. Research involving vulnerable participants: some ethical issues / Sue Eckstein -- Section IV. International research -- Ch. 24. The ethics of research related to healthcare in developing countries / Nuffield Council on Bioethics -- Pt. II. Section I. Fundamental legal and ethical considerations -- Ch. 25. Ethical principles for medical research involving human subjects / World Medical Association -- Ch. 26. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research / National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research -- Ch. 27. ICH Good Clinical Practice Guideline / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use -- Ch. 28. Governance arrangements for NHS research ethics committees / Department of Health -- Ch. 29. The research governance framework for health and social care / Department of Health -- Ch. 30. EU Clinical Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. / The European Parliament and the Council of the European Union -- Ch. 31 European Convention on human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings / Council of Europe -- Section II. The research process -- Section II(A) General guidelines -- Ch. 32. Good research practice / Medical Research Council -- Ch. 33 Research: the role and responsibilities of doctors / General Medical Council -- Ch. 34. Guidelines for company-sponsored safety assessment of marketed medicines (SAMM) / Association of the British Pharmaceutical Industry -- Ch. 35. Guidelines for medical experiments in non- patient human volunteers / Association of the British Pharmaceutical Industry -- Ch. 36. Facilities for non-patient volunteer studies / Association of the British Pharmaceutical Industry -- Ch. 37. Multi-cenre research in the NHS - the process of ethical review when there is no local researcher / Central Office for Research Ethics Committees -- Ch. 38 Medical devices regulations and research ethics committees / Medical Devices Agency -- Ch. 39. NHS indemnity - arrangements for clinical negligence claims in the NHS / Department of Health -- Ch. 40. Clinical trial compensation guidelines / Association of the British Pharmaceutical Industry -- Ch. 41. Research ethics: guidance for nurses involved in research or any investigative project involving human subjects / Royal College of Nursing -- Ch. 42. Ethical principles for conducting research with human participants / The British Psychological Society -- Ch. 43. Statement of ethical practice / British Sociological Association -- Section II(B). Tissue and genes -- Ch. 44. Human tissue and biological samples for use in research / Medical Research Council -- Ch. 45. Transitional guidelines to facilitate changes in procedures for handling surplus' and archival material from human biological samples / Royal College of Pathologists -- Ch. 46. Code of practice on the use of fetuses and fetal material in research and treatment (extracts from the Polkinghorne Report) / The Stationery Office/Department of Health - - Ch. 47. Guidance on the supply of fetal tissue for research, diagnosis and therapy / Department of Health -- Ch. 48. Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report-section 1) / Gene Therapy Advisory Committee -- Ch. 49. Report on the potential use of gene therapy in utero / Gene Therapy Advisory Committee -- Ch. 50. Human fertilisation and embryology authority - code of practice (extracts) / Human Fertilisation and Embryology Authority -- Section III. Protecting the interests of research participants -- Section III(A). General principles -- Ch. 51. Guidelines for researchers - patient information sheet and consent form / Central Office for Research Ethics Committees -- Ch. 52. ABPI Guidance note - patient information and consents for clinical trials / Association of the British Pharmaceutical Industry -- Ch. 53. The protection and use of patient information (HSG(96)18/LASSL (96)5) / Department of Health -- Ch. 54. The Caldicott Report on the review of patient-identifiable information - executive summary December 1997 / The Caldicott Committee, Department of Health -- Ch. 55. Personal information in medical research / Medical Research Council -- Ch. 56. Use and disclosure of medical data - guidance on the application of the Data Protection Act, 1998, May 2002 / The Information Commissioner -- Section III(B). Vulnerable participants -- Ch. 57. Guidelines for the ethical conduct of medical research involving children / Royal College of Paediatrics and Child Health: Ethics Advisory Committee -- Ch. 58. Clinical investigation of medicinal products in the paediatric population. / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - - Ch. 59. Guidelines for researchers and for ethics committees on psychiatric research involving human participants - executive summary / Royal College of Psychiatrists -- Ch. 60. The ethical conduct of research on the mentally incapacitated / Medical Research Council -- Ch. 61. Volunteering for research into dementia / Alzheimer's Society -- Ch. 62. Knowledge to care: research and development in hospice and specialist palliative care - executive summary / National Council for Hospice and Specialist Palliative Care Services -- Ch. 63. NUS guidelines for student participation in medical experiments and guidance for students considering participation in medical drug trials / National Union of Students - - Ch. 64. Ethical considerations in HIV preventive vaccine research / Joint United Nations Programme on HIV/AIDS (UNAIDS) -- Section IV. International research -- Ch. 65. 2002 international ethical guidelines for biomedical research involving human subjects / Council for International Organisations of Medical Sciences (CIOMS) -- Ch. 66. 1991 international guidelines for ethical review of epidemiological studies / Council for International Organisations of Medical Sciences -- Ch. 67. Operational guidelines for ethics committees that review biomedical research/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Disease (TOR) -- Ch. 68. Registration of an institutional review board (IRB) or independent ethics committee (IEC) / Office for Human Research Protections (OHRP) -- Ch. 69. International guidelines on bioethics (informal listing of selected international codes, declarations, guidelines etc. on medical ethics/bioethics/health care ethics/human rights aspects of health). / European Forum for Good Clinical Practice/Council for International Organisations of Medical Sciences -- Inde