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Protecting study volunteers in research : a manual for investigative sites / Cynthia McGuire Dunn, Gary Chadwick.
Holman Biotech Commons R853.H8 D86 2002
Available
LIBRA R853.H8 D86 2002
Available from offsite location
- Format:
- Book
- Author/Creator:
- Dunn, Cynthia McGuire.
- Language:
- English
- Subjects (All):
- Human experimentation in medicine.
- Volunteers.
- Medical ethics.
- Human Experimentation--legislation & jurisprudence.
- Bioethical Issues.
- Research--legislation & jurisprudence.
- Ethics, Institutional.
- Human Experimentation--history.
- Professional Role.
- Publishing.
- Research Personnel.
- Social Responsibility.
- Medical Subjects:
- Human Experimentation--legislation & jurisprudence.
- Bioethical Issues.
- Research--legislation & jurisprudence.
- Ethics, Institutional.
- Human Experimentation--history.
- Professional Role.
- Publishing.
- Research Personnel.
- Social Responsibility.
- Physical Description:
- 400 pages ; 23 cm
- Edition:
- Second edition.
- Place of Publication:
- Boston, Mass. : CenterWatch, [2002]
- Contents:
- Instructions for Obtaining Continuing Education Credit 10
- Chapter 1 Historical Perspectives on Human Subject Research 13
- The Nuremberg Doctors Trial of 1946 14
- The Milgram Study 17
- Thalidomide Tragedy 19
- The Study of Untreated Syphilis in the Negro Male 20
- Human Radiation Experiments 23
- The University of Pennsylvania Gene Transfer Experiment 25
- Chapter 2 Ethics and Federal Regulations 28
- Belmont Report 29
- Basic Principles of the Belmont Report 29
- Federal Regulations 36
- Chapter 3 Roles and Responsibilities of Institutions in Human Subject Research 44
- Federal Agencies 48
- Good Clinical Practice 49
- Chapter 4 Roles and Responsibilities of the Investigator and the Study Process 51
- Study Process 56
- Chapter 5 FDA-Regulated Research 62
- Drugs and Biologics/INDs 63
- Sponsor Responsibilities in FDA-Regulated Research 65
- The Study Process for Industry-Sponsored Studies 67
- Sponsor-Investigator-Institution Interaction Issues 71
- Responsibilities of the Investigator-Sponsor 72
- Chapter 6 Behavioral Research Issues 76
- Federal Regulations 77
- Psychological/Social Risks 77
- Deception 78
- Vulnerable Subjects 78
- Privacy and Confidentiality 79
- Study Methods 81
- Quality of Life Issues 81
- Points to Consider 81
- Chapter 7 Publication of Study Results 83
- Withholding Data 89
- Lessons to Be Learned from These Cases 89
- The Data 91
- Chapter 8 Conflicts of Interest in Research 93
- Financial Conflict of Interest 94
- Chapter 9 Informed Consent
- Beyond the Basics 99
- Context 101
- Vulnerable Subjects 103
- Additional Consent Considerations 105
- Chapter 10 Community-Based Qualitative Research 107
- Defining Community-Based Qualitative Research (CBQR) 108
- Maintaining Confidentiality 109
- Study Methods 109
- Disenfranchised Populations 112
- Further Resources 113
- Chapter 11 Ethical Issues in Genetic Research 114
- Federal and State Regulations 115
- Genetic Research and Genetic Testing 117
- Behavioral Genetic Studies 121
- Special Considerations in Protocols and Consent Forms 121
- Gene Transfer Research 125
- Chapter 12 Special Ethical Concerns in Clinical Research 129
- The Use of Placebo 129
- Data Monitoring Committees 134
- Chapter 13 Participant Recruitment and Retention in Clinical Trials 141
- Education of Potential Participants 142
- Why Patients Join Clinical Trials 142
- Recruitment of Special Populations 143
- Recruiting Study Participants 145
- Participant Recruitment/Retention Incentives 147
- Recruitment Strategies by Sponsors 148
- Setting the Proper Tone in Recruiting Subjects 148
- Chapter 14 Research with Secondary Subjects, Tissue Studies and Records Reviews 150
- Secondary Subjects 151
- Research Involving Human Tissues 153
- Research Involving Record Reviews 157
- Appendix B The Belmont Report 165
- Appendix C Code of Federal Regulations 176
- Title 21 Food and Drugs
- Part 50 Protection of Human Subjects 176
- Part 56 Institutional Review Boards 197
- Part 312 Investigational New Drug Application 213
- Part 600 Biological Products: General 277
- Part 812 Investigational Device Exemptions 302
- Title 45 Public Welfare
- Part 46 Protection of Human Subjects 334.
- Notes:
- Includes Examination answer sheet and Evaluation form (folded) at end.
- Includes bibliographical references and index.
- ISBN:
- 1930624360
- OCLC:
- 51164904
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