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3 - Clinical Research Ethics

from Part I - Fundamentals

Published online by Cambridge University Press:  13 March 2025

Karen B. Schmaling  and
Robert M. Kaplan
Karen B. Schmaling
Affiliation:
Washington State University
Robert M. Kaplan
Affiliation:
Stanford University
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Summary

Ethical decisions must be made at every phase of a research study. Codes of ethics provide guidance on behaviors that are permissible or nonpermissible for research investigators. In contemporary science, investigators are required to have regular training on the responsible research conduct relevant to studies involving human subjects and animals. Despite this training, ethical lapses occur. This chapter explores some of the basic issues, including ethical mandates on what should be done, what must be done, and what must not be done. We consider the history of serious ethical concerns, such as the Tuskegee experiment. The chapter also reviews historical milestones such as the Belmont report, the Declaration of Helsinki, and the establishment of the Common Rule that is applied for research funded by US federal agencies. Further, the chapter explores challenges relevant to the reporting of conflicts of interests, imperfections in institutional review boards (IRBs), and ethical challenges in studies that use placebos. Among a range of research methods, randomized controlled trials tend to encounter the greatest number of ethical concerns.

Keywords

conflicts of interestequipoiseethicsinstitutional review boards (IRBs)informed consentplaceboresponsible conduct of research
Type
Chapter
Information
Rethinking Clinical Research
Methodology and Ethics
 , pp. 50 - 78
Publisher: Cambridge University Press
Print publication year: 2025

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