Protecting Study Volunteers in Research: A Manual for Investigative Sites

by Dunn, Cynthia McGuire, M.D.; Chadwick, Gary L.

• ISBN13: 9780967302911
• ISBN10: 0967302919
• Format: Paperback
• Copyright: 2000-01-01
• Publisher: Centerwatch Inc

Table of Contents

Instructions For Obtaining Continuing Education Credit	i
Historical Perspectives on Human Subject Research	1	(14)
Introduction	1	(1)
The Nuremberg Doctors Trial of 1946	2	(3)
The `Milgram Study'	5	(2)
Thalidomide Tragedy	7	(1)
The Study of Untreated Syphilis In The Negro Male	8	(3)
Human Radiation Experiments	11	(2)
Conclusion	13	(2)
Ethics and Federal Regulations	15	(18)
Introduction	15	(1)
Belmont Report	16	(1)
Basic Principles of Belmont Report	16	(9)
Federal Regulations	25	(8)
The Roles and Responsibilities of Institutions in Human Subject Research	33	(8)
Introduction	33	(1)
Research Institution	33	(4)
Federal Agencies	37	(1)
Good Clinical Practice (GCP)	38	(3)
The Roles and Responsibilities of the Investigator and The Study Process	41	(16)
Introduction	41	(1)
Investigator's Role and Responsibilities	42	(3)
Research Team Roles and Responsibilities	45	(1)
Study Process	46	(11)
FDA-Regulated Research Issues	57	(16)
Introduction	57	(1)
Drugs and Biologics/INDs	58	(1)
Medical Devices/IDEs	59	(1)
Sponsor Responsibilities in FDA-Regulated Research	60	(2)
The Study Process for Industry-Sponsored Studies	62	(5)
Sponsor Investigator Institution Interaction Issues	67	(1)
Responsibilities of The Investigator-Sponsor	67	(6)
Behavioral Research Issues	73	(6)
Introduction	73	(1)
Federal Regulations	73	(1)
Psychological/Social Risks	74	(1)
Deception	75	(1)
Vulnerable Subjects	76	(1)
Privacy and Confidentiality	76	(1)
Study Methods	77	(1)
Quality of Life Issues	77	(1)
Points to Consider	78	(1)
Publication of Study Results	79	(148)
Introduction	79	(6)
Withholding Data	85	(1)
Lessons to be Learned From These Cases	86	(1)
The Data	87	(1)
Summary	88	(3)
Appendix
Appendix A: References, Resources and Suggested Readings	91	(4)
Appendix B: The Belmont Report	95	(14)
Appendix C: Code of federal Regulations	109	(110)
Appendix D: Glossary	219	(6)
Appendix E: Abbreviations	225	(2)
Index	227	(2)
Examination Questions	229