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For an increasing number of hospitals and universities the institutional review board (lRB) has become a way of life. Spurred into existence by public outcries about the unethical nature of certain modern scientific experiments, the IRB represents the most visible evidence of institutional commitment to ethical review of clinical research. However, this exponential growth of IRB activities has not occurred without growing pains. Like the Environmental Protection Agency, IRBs have had to develop procedures and standards without a clear consensus as to what would be optimal for science and society. Each IRB has perforce devised its own modus operandi, subject to general principles and guidelines laid down by others but still relatively free to stipulate the details of its functioning. Thus one can applaud the general idea as well as the overall performance of IRBs without asserting that the millenium has arrived. The composition, philosophy, efficiency, responsibilities, and powers of IRBs remain topics suit able for debate. It is still possible (and appropriate) for IRB members to worry both about the propriety of their decisions and the personal costs of their service.
List of contents
Section I: Background and General Principles.- 1. The Evolution of Regulatory Influences on Research with Human Subjects.- 2. Legal Background of the Institutional Review Board.- 3. General Organization of the IRB.- 4. The Costs of IRB Review.- Section II: The Review Process.- 5. General Principles of IRB Review.- 6. IRB Procedures.- 7. Informed Consent.- 8. Research on Investigational New Drugs.- 9. Research Involving Medical Devices.- 10. Continuing Review of Research.- Section III: Special Problem Areas.- 11. Studies Involving Children.- 12. Research on the Therapy of Cancer.- 13. Surgical Research.- 14. Clinical Trials of New Drugs.- 15. Psychiatric Research.- 16. IRBs and the Regulation of Social Science Research.- Annotated Bibliography.- Appendices.- 1. The Nuremberg Code.- 2. The Declaration of Helsinki.- 6. Statement of Investigator, FD Form 1573.- 7. Protection of Human Subjects Assurance/Certification/Declaration, HEW-596.- 8. Application for Approval of a Research Project.- 9. Sample Consent Form.- 10. IRB Reviewer's Checklist.- 11. Request for an Investigational Drug.- 12. Investigational Drug Fact Sheet.- 13. Research Incident Report.- 14. Research Involving Children.- 15. Research Involving Cancer Patients.- 16. Research Involving Psychiatric Patients.- 17. Research Involving an Experimental Invasive Procedure.- 18. Research Involving an Investigational Medical Device.- 19. Research Involving an Investigational New Drug.- 20. Research Involving an Emotional Assessment Interview with Patients.- 21. Research Involving an Emotional Assessment Interview with Relatives of Patients.
