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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:
United States. > Food and Drug Administration.
Human Experimentation > legislation & jurisprudence.
Research > legislation & jurisprudence.
Ethics, Institutional.
Ethics, Research.
Research Subjects.
United States.
Table of Contents:
  • 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