Human Subjects Research: A Handbook for Institutional Review Boards
Editat de Robert A. Greenwalden Limba Engleză Paperback – 26 mar 2012
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Specificații
ISBN-13: 9781468441598
ISBN-10: 1468441590
Pagini: 320
Ilustrații: XXIV, 291 p.
Dimensiuni: 152 x 229 x 17 mm
Greutate: 0.47 kg
Ediția:Softcover reprint of the original 1st ed. 1982
Editura: Springer Us
Colecția Springer
Locul publicării:New York, NY, United States
ISBN-10: 1468441590
Pagini: 320
Ilustrații: XXIV, 291 p.
Dimensiuni: 152 x 229 x 17 mm
Greutate: 0.47 kg
Ediția:Softcover reprint of the original 1st ed. 1982
Editura: Springer Us
Colecția Springer
Locul publicării:New York, NY, United States
Public țintă
ResearchCuprins
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.