Protecting Study Volunteers in Research: A Manual for Investigative Sites

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

• ISBN13: 9781930624443
• ISBN10: 1930624441
• Edition: 3rd
• Format: Paperback
• Copyright: 2004-06-01
• Publisher: Centerwatch Inc

Summary

In addition to addressing current and emerging issues that are critical to our system of human subject protection oversight, Protecting Study Volunteers in Research has been expanded to include a chapter on how to implement the HIPPAA Privacy Rule in research. Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2003, page 47342) and was designed to help organizations provide the highest standards of safe and ethical treatment of study volunteers. This manual will be routinely referenced for ethical considerations and insights, and for a comprehensive review of regulations and guidelines not conveniently found elsewhere. Protecting Study Volunteers in Research has become required reading in many academic institutions, IRBs and investigative sites and is a suggested training resource by regulatory agencies and research sponsors. Biopharmaceutical and CRO companies ha

Author Biography

Cynthia McGuire Dunn, M.D., is President of CMD Advisor in Rochester, N.Y., which specializes in clinical monitoring and drug development Gary L. Chadwick, Pharm.D., M.P.H., CIP, is Associate Provost and Director, Office for Human Subject Protection for the University of Rochester, and Associate Professor, Division of Medical Humanities at the University of Rochester School of Medicine and Dentistry

Table of Contents

Instructions for Obtaining Continuing Education Credit	10	(3)
Historical Perspectives on Human Subject Research	13	(15)
Introduction	13	(1)
The Nuremberg Doctors Trial of 1946	14	(3)
The Milgram Study	17	(2)
Thalidomide Tragedy	19	(1)
The Study of Untreated Syphilis in the Negro Male	20	(3)
Human Radiation Experiments	23	(2)
The University of Pennsylvania Gene Transfer Experiment	25	(1)
Conclusion	26	(2)
Ethics and Federal Regulations	28	(16)
Introduction	28	(1)
Belmont Report	29	(1)
Basic Principles of the Belmont Report	29	(7)
Federal Regulations	36	(8)
Roles and Responsibilities of Institutions in Human Subject Research	44	(7)
Introduction	44	(4)
Federal Agencies	48	(1)
Good Clinical Practice	49	(2)
Roles and Responsibilities of the Investigator and the Study Process	51	(11)
Introduction	51	(5)
Study Process	56	(6)
FDA-Regulated Research	62	(14)
Introduction	62	(1)
Drugs and Biologics/INDs	63	(2)
Sponsor Responsibilities in FDA-Regulated Research	65	(2)
The Study Process for Industry-Sponsored Studies	67	(4)
Sponsor--Investigator--Institution Interaction Issues	71	(1)
Responsibilities of the Investigator-Sponsor	72	(4)
Behavioral Research Issues	76	(7)
Introduction	76	(1)
Federal Regulations	77	(1)
Psychological/Social Risks	77	(1)
Deception	78	(1)
Vulnerable Subjects	78	(1)
Privacy and Confidentiality	79	(2)
Study Methods	81	(1)
Quality of Life Issues	81	(1)
Points to Consider	81	(2)
Publication of Study Results	83	(10)
Introduction	83	(6)
Withholding Data	89	(1)
Lessons to Be Learned from These Cases	89	(2)
The Data	91	(2)
Conflicts of Interest in Research	93	(6)
Introduction	93	(1)
Financial Conflict of Interest	94	(5)
Informed Consent---Beyond the Basics	99	(8)
Introduction	99	(2)
Context	101	(2)
Vulnerable Subjects	103	(2)
Additional Consent Considerations	105	(1)
Conclusion	106	(1)
Community-Based Qualitative Research	107	(7)
Introduction	107	(1)
Defining Community-Based Qualitative Research (CBQR)	108	(1)
Maintaining Confidentiality	109	(1)
Study Methods	109	(3)
Disenfranchised Populations	112	(1)
Further Resources	113	(1)
Ethical Issues in Genetic Research	114	(15)
Introduction	114	(1)
Federal and State Regulations	115	(1)
Some Points to Consider	115	(2)
Genetic Research and Genetic Testing	117	(4)
Behavioral Genetic Studies	121	(1)
Special Considerations in Protocols and Consent Forms	121	(4)
Gene Transfer Research	125	(4)
Special Ethical Concerns in Clinical Research	129	(12)
The Use of Placebo	129	(5)
Data Monitoring Committees	134	(7)
Participant Recruitment and Retention in Clinical Trials	141	(9)
Introduction	141	(1)
Education of Potential Participants	142	(1)
Why Patients Join Clinical Trials	142	(1)
Recruitment of Special Populations	143	(2)
Recruiting Study Participants	145	(2)
Participant Recruitment/Retention Incentives	147	(1)
Recruitment Strategies by Sponsors	148	(1)
Setting the Proper Tone in Recruiting Subjects	148	(1)
Conclusion	149	(1)
Research with Secondary Subjects, Tissue Studies and Records Reviews	150	(9)
Introduction	150	(1)
Secondary Subjects	151	(2)
Research Involving Human Tissues	153	(4)
Research Involving Record Reviews	157	(2)
Implementing the HIPAA Privacy Rule in Research	159	(22)
Introduction	159	(3)
Covered Entities in Research	162	(2)
Classes of Data Under the Privacy Rule	164	(4)
General Requirements for Uses and Disclosures of PHI	168	(2)
Uses and Disclosures of PHI for Research	170	(2)
Authorizations to Use or Disclose PHI for Research	172	(2)
Waivers of Authorization	174	(1)
Reviews Preparatory to Research	175	(1)
PHI From Deceased Persons	175	(1)
Use or Disclosure of Limited Data Sets	176	(1)
Disclosures to Business Associates	176	(1)
Subject Screening	177	(1)
Subject Recruitment	177	(2)
Research Databases and Repositories	179	(1)
Conclusion	180	(1)
Appendix A: References, Resources and Suggested Readings	181	(7)
Appendix B: The Belmont Report	188	(11)
Appendix C: Code of Federal Regulations	199	(155)
Title 21---Food and Drugs
Part 50---Protection of Human Subjects	200	(16)
Part 56---Institutional Review Boards	216	(13)
Part 312---Investigational New Drug Application	229	(50)
Part 600---Biological Products: General	279	(20)
Part 812---Investigational Device Exemptions	299	(27)
Title 45---Public Welfare
Part 46---Protection of Human Subjects	326	(28)
Appendix D: Glossary	354	(6)
Appendix E: Abbreviations	360	(2)
Index	362	(4)
Examination	366	(11)
About CenterWatch	377