Protecting study volunteers in research : a manual for investigative sites /

Bibliographic Details
Main Author: Dunn, Cynthia McGuire
Other Authors: Chadwick, Gary
Format: Book
Language:English
Published: Boston, MA : Thomson CenterWatch, [2004]
Edition:Third edition.
Subjects:

MARC

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245 1 0 |a Protecting study volunteers in research :  |b a manual for investigative sites /  |c Cynthia McGuire Dunn, Gary L. Chadwick. 
250 |a Third edition. 
264 1 |a Boston, MA :  |b Thomson CenterWatch,  |c [2004] 
264 4 |c ©2004 
300 |a 383 pages ;  |c 23 cm. 
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500 |a Includes Examination answer sheet and Evaluation form (folded) at end. 
504 |a Includes bibliographical references (pages 181-187) and index. 
505 0 |a Historical perspectives on human subject research -- Ethics and federal regulations -- Roles and responsibilities of institutions in human subject research -- Roles and responsibilities of the investigator and the study process -- FDA-regulated research -- Behavioral research issues -- Publication of study results -- Conflicts of interest in research -- Informed consent - beyond the basics -- Community-based qualitative research -- Ethical issues in genetic research -- Special ethical concerns in clinical research -- Participant recruitment and retention in clinical trials -- Research with secondary subjects, tissue studies and records reviews -- Implementing the HIPAA privacy rule in research 
610 1 0 |a United States.  |b Food and Drug Administration. 
650 2 |a Human Experimentation  |x legislation & jurisprudence. 
650 2 |a Research  |x legislation & jurisprudence. 
650 2 |a Ethics, Institutional. 
650 2 |a Ethics, Research. 
650 2 |a Research Subjects. 
651 2 |a United States. 
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