Ethical issues in clinical research : a practical guide
著者
書誌事項
Ethical issues in clinical research : a practical guide
Wolters Kluwer Health/Lippincott Williams & Wilkins, c2010
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.
目次
SECTION I ETHICAL AND REGULATORY BACKGROUND
Historical Perspective
Ethical Framework for Research
Federal Regulations on Human Participants Research
IRB Review of Human Participants Research
Assessment of Risks and Benefits
Informed Consent
Confidentiality
SECTION II THE RESEARCHER-PARTICIPANT RELATIONSHIP
Identification and Recruitment of Participants
Payment to Research Participants
Responsibility for Incidental Risks
Offering Results of Research Tests to Participants
SECTION III RESPONSIBLE CONDUCT OF RESEARCH
Research Misconduct
Authorship and Its Responsibilities
Patenting and Commercialization of Discoveries
Conflicts of Interest
SECTION IV VULNERABLE PARTICIPANTS
Persons with Impaired Decision-Making Capacity
Research with Children
Research with Adolescents
Emergency and Intensive Care Research
Research with Ethnic and Minority Populations
Research with Prisoners
Clinical Research in Resource-Poor Countries
SECTION V ETHICAL ISSUES IN SPECIFIC TYPES OF RESEARCH
Research with Existing Data and Biological Materials
Observational Studies
Translational Research
Clinical Trials
Genetics, Genomics, and Gene Transfer Research
Stem Cell Research
INDEX
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