Guidelines on the practice of ethics committees in medical research
İÇİNDEKİLERCONTENTS NOTE ON THE ORIGIN OF THIS DOCUMENT INTRODUCTION 1. Objectives of Ethics Committees 2. The nature of the decision and the relevance of scientific quality to ethical decisions 3. Mandatory review 4.(a) Definition of a research project (b) Introduction of a novel procedure in categories of patient (c) Novel medical intervention in an individual patient 5. Membership and scope of Ethics Committees 6. Format of applications 7. Mode of working (a) Meetings and postal approval (b) Publications on functioning of Committees (c) Adverse decisions and review (d) Monitoring of approved projects (e) Sanctions (f) Responsibility of clinicians (g) Confidentiality (h) Co - option (i) Quorum (j) Declaration of interest by Committee members 8. Consent (a) Trivial and minimal risk procedures (b) More substantial procedures (c) Witnessed consent (d) Healthy volunteers (e) Subjects whose capacity to give consent is impaired (f) Written consent (8) Documentation of consent (h) Research without consent of the patient (1) Minor procedures (ii) Major procedures (iii) Use of patient records 9. Research involving children 10. Research Involving pregnant and nursing women 11. Research involving mentally ill and defective persons 12. Research involving unconscious or acutely ill persons 13. Research involving other vulnerable social groups 14. Community based research 15. Volunteers : healthy and patient 18. Injuries due to clinical investigation : sponsored by non-industrial organizations sponsored by industry. 17. Medicines (drugs) and osficial requlation 18. Clinical assessment of licensed medicinal products in general practice 19. Miscellaneous topics (a) Placebos (b) Multicentre projects (c) Payments (i) To subjects (ii) To investigators, departments and institution) (d) Research on fetal material (e) Educational activities (f) Publication (g) Cost of Research (h) Fees 20. Select Bibliography  |
