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.
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