Preserving Public Trust 1st Edition by Institute Of Medicine ISBN 9780309073288 0309073286

Preserving Public Trust 1st Edition by Institute Of Medicine- Ebook PDF Instant Download/Delivery:  9780309073288, 0309073286 
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Product details: 

ISBN 10:  0309073286 

ISBN 13:  9780309073288

Author:  Institute Of Medicine

Table of contents: 

1 Chapters
2 Front Matter
3 ABSTRACT
4 THE COMMITTEE’S TASK
5 MAJOR FINDINGS
6 RECOMMENDATIONS
7 CONCLUDING REMARKS
8 ORGANIZATION OF THE REPORT
9 A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES
10 Advisory Committee on Human Radiation Experiments
11 The National Bioethics Advisory Commission
12 Shutdowns of Clinical Research at Academic and VA Medical Centers
13 A CALL FOR ACCOUNTABILITY
14 DEFINITIONS
15 Subject or Participant?
16 What Is a Human Research Participant Protection Program?
17 The Centrality of Informed Consent
18 The Rise of Clinical Trials and Privately Funded Research
19 Nonbiomedical Research
20 Independent IRBs
21 The Role of the Research Participant
22 Research Monitoring
23 Accreditation Versus Certification
24 MODELS OF ACCREDITATION
25 ELEMENTS OF AN ACCREDITATION PROCESS
26 PRIM&R and the Formation of AAHRPP
27 The VA and NCQA Accreditation Process
28 Self-Evaluation
29 External Evaluation
30 APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT
31 Identifying, Investigating, and Sanctioning Violations
32 Educating Investigators
33 Improving Research Monitoring
34 WILL ACCREDITATION ENHANCE PERFORMANCE?
35 Standards for Accreditation
36 STANDARDS FOR STANDARDS
37 DEVELOPING MEASURES TO ACCOMPANY STANDARDS
38 NEED FOR STANDARDS TO ENCOMPASS MULTIPLE RESEARCH SETTINGS AND METHODS
39 RELATION OF THE STANDARDS TO THE EXISTING REGULATORY REQUIREMENTS
40 STANDARDS FOR QUALITY IMPROVEMENT AND SELF-STUDY
41 NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS
42 NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS
43 REVIEW OF AVAILABLE DRAFT STANDARDS
44 PRIM&R Standards
45 NCQA Standards
46 Extent to Which the Standards Can Be Implemented, Measured, and Enforced
47 What Is Missing
48 INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE
49 RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING
50 Evaluating HRPPP Pilot Accreditation Programs
51 References
52 Appendixes
53 PRESENTATIONS AND PUBLIC COMMENT
54 LITERATURE REVIEW
55 DRAFT STANDARDS FOR ACCREDITATION
56 INTRODUCTION
57 PRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCH
58 GLOSSARY
59 Section 1 – Organizational Responsibilities
60 Section 2 – Institutional Review Boards (IRBs)
61 Section 3 – Investigators and Other Research Personnel
62 PUBLICATIONS CITED IN ACCREDITATION STANDARDS
63 BACKGROUND
64 ORGANIZATION OF THE STANDARDS
65 DEFINITIONS
66 APPENDIX D Committee, Expert Adviser, and Staff Biographies
67 EXPERT ADVISERS
68 LIAISONS
69 STUDY STAFF
70 CONSULTANT
71 Index

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