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Protecting study volunteers in research : a manual for investigative sites / Cynthia McGuire Dunn, Gary L. Chadwick

By: Contributor(s): Material type: TextTextPublication details: Boston, MA : CenterWatch, 2004Edition: 3rd edDescription: 383 p. ; 23 cmISBN:
  • 1930624441
Subject(s): NLM classification:
  • W32.5AA1
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
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Includes Examination answer sheet and evaluation form (folded) at end

Includes bibliographical references (p. 181-187) and index

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

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