ISBN-10:
1930624646
ISBN-13:
2901930624640
Pub. Date:
06/28/2012
Publisher:
CenterWatch
Protecting Study Volunteers in Research 4th Edition: A Manual for Investigative Sites / Edition 4

Protecting Study Volunteers in Research 4th Edition: A Manual for Investigative Sites / Edition 4

by Cynthia Dunn

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Product Details

ISBN-13: 2901930624640
Publisher: CenterWatch
Publication date: 06/28/2012
Edition description: New Edition
Pages: 554
Product dimensions: 6.00(w) x 1.25(h) x 9.00(d)

Table of Contents

Instructions for Obtaining Continuing Education Credit10
Chapter 1Historical Perspectives on Human Subject Research13
Introduction13
The Nuremberg Doctors Trial of 194614
The Milgram Study17
Thalidomide Tragedy19
The Study of Untreated Syphilis in the Negro Male20
Human Radiation Experiments23
The University of Pennsylvania Gene Transfer Experiment25
Conclusion26
Chapter 2Ethics and Federal Regulations28
Introduction28
Belmont Report29
Basic Principles of the Belmont Report29
Federal Regulations36
Chapter 3Roles and Responsibilities of Institutions in Human Subject Research44
Introduction44
Federal Agencies48
Good Clinical Practice49
Chapter 4Roles and Responsibilities of the Investigator and the Study Process51
Introduction51
Study Process56
Chapter 5FDA-Regulated Research62
Introduction62
Drugs and Biologics/INDs63
Sponsor Responsibilities in FDA-Regulated Research65
The Study Process for Industry-Sponsored Studies67
Sponsor-Investigator-Institution Interaction Issues71
Responsibilities of the Investigator-Sponsor72
Chapter 6Behavioral Research Issues76
Introduction76
Federal Regulations77
Psychological/Social Risks77
Deception78
Vulnerable Subjects78
Privacy and Confidentiality79
Study Methods81
Quality of Life Issues81
Points to Consider81
Chapter 7Publication of Study Results83
Introduction83
Withholding Data89
Lessons to Be Learned from These Cases89
The Data91
Chapter 8Conflicts of Interest in Research93
Introduction93
Financial Conflict of Interest94
Chapter 9Informed Consent--Beyond the Basics99
Introduction99
Context101
Vulnerable Subjects103
Additional Consent Considerations105
Conclusion106
Chapter 10Community-Based Qualitative Research107
Introduction107
Defining Community-Based Qualitative Research (CBQR)108
Maintaining Confidentiality109
Study Methods109
Disenfranchised Populations112
Further Resources113
Chapter 11Ethical Issues in Genetic Research114
Introduction114
Federal and State Regulations115
Some Points to Consider115
Genetic Research and Genetic Testing117
Behavioral Genetic Studies121
Special Considerations in Protocols and Consent Forms121
Gene Transfer Research125
Chapter 12Special Ethical Concerns in Clinical Research129
The Use of Placebo129
Data Monitoring Committees134
Chapter 13Participant Recruitment and Retention in Clinical Trials141
Introduction141
Education of Potential Participants142
Why Patients Join Clinical Trials142
Recruitment of Special Populations143
Recruiting Study Participants145
Participant Recruitment/Retention Incentives147
Recruitment Strategies by Sponsors148
Setting the Proper Tone in Recruiting Subjects148
Conclusion149
Chapter 14Research with Secondary Subjects, Tissue Studies and Records Reviews150
Introduction150
Secondary Subjects151
Research Involving Human Tissues153
Research Involving Record Reviews157
Chapter 15Implementing the HIPAA Privacy Rule in Research159
Introduction159
Covered Entities in Research162
Classes of Data Under the Privacy Rule164
General Requirements for Uses and Disclosures of PHI168
Uses and Disclosures of PHI for Research170
Authorizations to Use or Disclose PHI for Research172
Waivers of Authorization174
Reviews Preparatory to Research175
PHI From Deceased Persons175
Use or Disclosure of Limited Data Sets176
Disclosures to Business Associates176
Subject Screening177
Subject Recruitment177
Research Databases and Repositories179
Conclusion180
Appendix AReferences, Resources and Suggested Readings181
Appendix BThe Belmont Report188
Appendix CCode of Federal Regulations199
Title 21--Food and Drugs
Part 50--Protection of Human Subjects200
Part 56--Institutional Review Boards216
Part 312--Investigational New Drug Application229
Part 600--Biological Products: General279
Part 812--Investigational Device Exemptions299
Title 45--Public Welfare
Part 46--Protection of Human Subjects326
Appendix DGlossary354
Appendix EAbbreviations360
Index362
Examination366
About CenterWatch377

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